chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Headache (Slight); Low grade temaperature; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache (Slight)) and PYREXIA (Low grade temaperature) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfa), Lupus nephritis (Lupkynis (Vaclosporin) Since 12/1/21 for lupus nephritis) and Sjogren's. Concomitant products included VOCLOSPORIN (LUPKYNIS) from 12-Jan-2021 to an unknown date for Lupus nephritis, MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache (Slight)) and PYREXIA (Low grade temaperature). At the time of the report, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache (Slight)) and PYREXIA (Low grade temaperature) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient received both dose (1st and 2nd dose) in the morning (am) No treatment details were provided.   This case was linked to MOD-2022-538122, MOD-2022-569113, MOD-2022-569115 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Headache (Slight); Sore arm; Low-grade temp; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache (Slight)), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low-grade temp) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfa), Lupus nephritis (Lupkynis (voclosporin) since 12-Jan-2021) and Sjogren's. Concomitant products included VOCLOSPORIN (LUPKYNIS) from 12-Jan-2021 to an unknown date for Lupus nephritis, MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HEADACHE (Headache (Slight)), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low-grade temp). At the time of the report, HEADACHE (Headache (Slight)), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low-grade temp) outcome was unknown. Not Provided          The patient received both dose (1st and 2nd dose) in the morning (am).  The patient reported that she did not had adverse effect with the first  3 moderna shots, low grade temperature, headache (slight) and sore arm but nothing out of the ordinary.   No treatment information was provided.   This case was linked to MOD-2022-538122, MOD-2022-569112, MOD-2022-569115 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Minor pain discomfort directly across the chest below breast/Discomfort after the last 3 doses; Minor pain discomfort directly across the chest below breast/Band of minor pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Minor pain discomfort directly across the chest below breast/Discomfort after the last 3 doses) and CHEST PAIN (Minor pain discomfort directly across the chest below breast/Band of minor pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Adhesive tape allergy, Benign prostatic hyperplasia and Blood pressure high. Concomitant products included TAMSULOSIN for Benign prostatic hyperplasia, VALSARTAN for Blood pressure high, VITAMINS NOS (DAILY VITAMINS), L-CITRULLINE, L-ARGININE [ARGININE], CUCURBITA PEPO SEED, SERENOA REPENS FRUIT, SITOSTEROL, ZINC OXIDE (PROSTATE PLUS), CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), PYCNOGENOL, CORDYCEPS SINENSIS (CORDYCEPS) and VITAMIN B3 for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced CHEST DISCOMFORT (Minor pain discomfort directly across the chest below breast/Discomfort after the last 3 doses) and CHEST PAIN (Minor pain discomfort directly across the chest below breast/Band of minor pain). At the time of the report, CHEST DISCOMFORT (Minor pain discomfort directly across the chest below breast/Discomfort after the last 3 doses) and CHEST PAIN (Minor pain discomfort directly across the chest below breast/Band of minor pain) had not resolved.            It was reported that patient got symptoms about 2 days after the shot. Patient felt minor pain, discomfort 2 inches high straight across his chest and was more prominent on the right side. Pain was away from the side of heart, continued on a straight line across the chest and went directly under the heart side. Patient felt discomfort once in a while throughout the day but mostly felt it when he was cooking dinner. Patient told it took a day for an episode to start after vaccination and he could not remember how long they lasted for but patient was still experiencing. Patient had not gone to the doctor for labs or tests about myocarditis/pericarditis.  No treatment medication was reported.   This case was linked to MOD-2022-569121, MOD-2022-569123 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2022: Patient details, Reporter details, vaccine details, medical History and concomitant medications.
Age: 59.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Nasopharyngitis, Rash macular, Skin disorder, Skin exfoliation, Vaccination site reaction
Clinical narrative: Finger tips always break out with spots; Vaccination site reaction; Several colds; Broke out peeling and red dots all over body after getting the second COVID vaccination; Broke out peeling and red dots all over body after getting the second COVID vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Finger tips always break out with spots), VACCINATION SITE REACTION (Vaccination site reaction), NASOPHARYNGITIS (Several colds), RASH MACULAR (Broke out peeling and red dots all over body after getting the second COVID vaccination) and SKIN EXFOLIATION (Broke out peeling and red dots all over body after getting the second COVID vaccination) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced SKIN DISORDER (Finger tips always break out with spots), VACCINATION SITE REACTION (Vaccination site reaction), NASOPHARYNGITIS (Several colds), RASH MACULAR (Broke out peeling and red dots all over body after getting the second COVID vaccination) and SKIN EXFOLIATION (Broke out peeling and red dots all over body after getting the second COVID vaccination). At the time of the report, SKIN DISORDER (Finger tips always break out with spots), VACCINATION SITE REACTION (Vaccination site reaction), NASOPHARYNGITIS (Several colds), RASH MACULAR (Broke out peeling and red dots all over body after getting the second COVID vaccination) and SKIN EXFOLIATION (Broke out peeling and red dots all over body after getting the second COVID vaccination) outcome was unknown. Not Provided          It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medication information was provided. The finger tips always break out with spots, broke out peeling and red dots all over body after getting the second COVID vaccination and several colds with Humira.  No treatment medication information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 1 Booster dose administered past expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Booster dose administered past expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 Booster dose administered past expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 Booster dose administered past expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. The vaccination coordinator reported that one of their veterans received first and second dose at facility (in contact information) but received a booster dose at their primary care doctor. The HCP (Health care professional) called to find out the viability of the booster dose that was administered past manufacturer expiration date. It was unknown by HCP when the vial was initially stored in the refrigerator and could contact facility where booster was administered. It was unknown to the HCP if the vial had undergone any temperature excursions. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2022: Follow-up includes non-significant information where reporter email address was updated.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal
Clinical narrative: Almost had a heart attack from COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Almost had a heart attack from COVID-19 Vaccine) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    There was no reported medical history.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, the patient experienced FEELING ABNORMAL (Almost had a heart attack from COVID-19 Vaccine). At the time of the report, FEELING ABNORMAL (Almost had a heart attack from COVID-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medication was not reported.  Therapy date and duration of Moderna COVID-19 vaccine was unknown. The daily dose of Humira was given as citrate free (4-2) (1 in 1 once). Therapy duration and date of Humira was unknown. It was reported that the health care professional gave patient's pen to other patient's of the HCP with Humira (40 mg/0.4ml) (40 milligram, solution for injection in pre-filled pen.)- Drug prescribing error.  The causality for the event of Almost had a heart attack from COVID-19 Vaccine with Humira was not reported. It was unknown if the patient was enrolled in COVID-19 vaccine trial.  Treatment information was not provided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion
Clinical narrative: After taking Paxlovid, had a rebound effect of some symptoms of congestion; After taking Paxlovid, had a achey body; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (After taking Paxlovid, had a rebound effect of some symptoms of congestion) and MYALGIA (After taking Paxlovid, had a achey body) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (dose number: 1, lot number: EP6955, location: left arm, administration time: 08:30 AM) on 07-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (dose number: 2, lot number: EW0162, location: left arm and administration time: 08:30 AM) on 28-Apr-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and Pfizer / BioNTech. Concurrent medical conditions included Allergy NOS.   On 16-Nov-2021 at 4:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 12-May-2022 at 12:45 AM, the patient experienced NASAL CONGESTION (After taking Paxlovid, had a rebound effect of some symptoms of congestion) and MYALGIA (After taking Paxlovid, had a achey body). At the time of the report, NASAL CONGESTION (After taking Paxlovid, had a rebound effect of some symptoms of congestion) and MYALGIA (After taking Paxlovid, had a achey body) was resolving.            No concomitant medication was reported.  Patient never took any medication within 2 weeks of starting COVID-19 treatment.  Device date was reported as 15-May-2022.  No treatment medication was reported.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Mild Fever after first primary shot for 1 day; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild Fever after first primary shot for 1 day) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (Mild Fever after first primary shot for 1 day). On 05-Mar-2021, PYREXIA (Mild Fever after first primary shot for 1 day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-569419, MOD-2022-569417, MOD-2021-225686 (Patient Link).   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Immunisation reaction, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: Mild Fever after first primary shot for 1 day; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild Fever after first primary shot for 1 day) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (Mild Fever after first primary shot for 1 day). On 05-Mar-2021, PYREXIA (Mild Fever after first primary shot for 1 day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-569419, MOD-2022-569417, MOD-2021-225686 (Patient Link).   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation reaction, Lymphadenopathy, Mouth ulceration, Pain
Clinical narrative: mouth has about 6 ulcers in it; immune reaction; lymph node about the side of a baseball under her left arm; chills; aches/pain; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH ULCERATION (mouth has about 6 ulcers in it), IMMUNISATION REACTION (immune reaction), PAIN (aches/pain), LYMPHADENOPATHY (lymph node about the side of a baseball under her left arm) and CHILLS (chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 039D21A, 030M20A and 012L20A) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL HYDROCHLORIDE (INDERAL), SERTRALINE HYDROCHLORIDE (ZOLOFT), MELATONIN and TRAZODONE for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced PAIN (aches/pain) and CHILLS (chills). On 16-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MOUTH ULCERATION (mouth has about 6 ulcers in it), IMMUNISATION REACTION (immune reaction) and LYMPHADENOPATHY (lymph node about the side of a baseball under her left arm). At the time of the report, MOUTH ULCERATION (mouth has about 6 ulcers in it), IMMUNISATION REACTION (immune reaction), PAIN (aches/pain), LYMPHADENOPATHY (lymph node about the side of a baseball under her left arm) and CHILLS (chills) outcome was unknown.            No Medical History information was reported. Patient reported not tested positive for COVID-19 at any point. The lymph node under her left arm  looked like someone took a red magic marker and drew a sun on her arm. Treatment included heating pad under the arm and patient had not taken anything so far, the patient reported that she might take Tylenol.
Sex: M
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: received the vaccine using an aspiration technique; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (received the vaccine using an aspiration technique) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (received the vaccine using an aspiration technique). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (received the vaccine using an aspiration technique) outcome was unknown.            No Concomitant medications were provided by the reporter.  No Treatment medications were provided by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: General physical health deterioration, Lymphadenopathy, Osteoarthritis, Pain in extremity
Clinical narrative: osteoarthritis; health concerns; hands hurt; swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (osteoarthritis), GENERAL PHYSICAL HEALTH DETERIORATION (health concerns), LYMPHADENOPATHY (swollen lymph node) and PAIN IN EXTREMITY (hands hurt) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (moderate to severe).   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. In December 2021, the patient experienced LYMPHADENOPATHY (swollen lymph node). On an unknown date, the patient experienced OSTEOARTHRITIS (osteoarthritis), GENERAL PHYSICAL HEALTH DETERIORATION (health concerns) and PAIN IN EXTREMITY (hands hurt). At the time of the report, OSTEOARTHRITIS (osteoarthritis) and LYMPHADENOPATHY (swollen lymph node) had not resolved and GENERAL PHYSICAL HEALTH DETERIORATION (health concerns) and PAIN IN EXTREMITY (hands hurt) outcome was unknown.            Concomitant medication of the patient was not reported.  Formulation of Humira (Adalimumab) was specified as Solution for injection in pre-filled pen.  No treatment information was provided by the reporter.  It was unknown if the patient was enrolled in a COVID-19 Vaccine trial.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of swollen lymph node with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of osteoarthritis, health concerns and hands hurt with Humira (Adalimumab) was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Sunburn
Clinical narrative: Sunburn; Condition aggravated//flare in eyes/Sinus/Ears; This spontaneous case was reported by a consumer and describes the occurrence of SUNBURN (Sunburn) and CONDITION AGGRAVATED (Condition aggravated//flare in eyes/Sinus/Ears) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In February 2022, the patient experienced CONDITION AGGRAVATED (Condition aggravated//flare in eyes/Sinus/Ears). On an unknown date, the patient experienced SUNBURN (Sunburn). At the time of the report, SUNBURN (Sunburn) and CONDITION AGGRAVATED (Condition aggravated//flare in eyes/Sinus/Ears) was resolving.            No Concomitant medications were provided by the reporter. No Treatment medications were provided by the reporter.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, FLUX, UNK
Symptoms: Influenza, Injection site pain, Pain
Clinical narrative: Injection site pain/Stinging/burning with injections; Flu symptoms; Generalized aching/Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms), PAIN (Generalized aching/Body Aches) and INJECTION SITE PAIN (Injection site pain/Stinging/burning with injections) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination, INFLUENZA VACCINE for an unknown indication and ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In 2021, the patient experienced INFLUENZA (Flu symptoms) and PAIN (Generalized aching/Body Aches). On an unknown date, the patient experienced INJECTION SITE PAIN (Injection site pain/Stinging/burning with injections). At the time of the report, INFLUENZA (Flu symptoms), PAIN (Generalized aching/Body Aches) and INJECTION SITE PAIN (Injection site pain/Stinging/burning with injections) outcome was unknown.            Concomitant medications details were not reported by the reporter.  Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Rebound effect
Clinical narrative: Rebound of symptoms.; This spontaneous case was reported by a consumer and describes the occurrence of REBOUND EFFECT (Rebound of symptoms.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    Concurrent medical conditions included Drug allergy (Allergy).   On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced REBOUND EFFECT (Rebound of symptoms.). At the time of the report, REBOUND EFFECT (Rebound of symptoms.) was resolving.            No concomitant medication was provided.  Reported event was rebound of symptoms, device date - 12 MAY 2022.  No treatment received.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Antinuclear antibody, Antiphospholipid antibodies positive, Arthralgia, Back pain, Pain
Clinical narrative: Rheumatoid arthritis came back; Positive for lupus; Hip/ankle/knee ache; Back ache; Right foot and couple of toes ache; COVID injection cause her arm to swell up; Aches and Pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4380909-00 (AbbVie).  A 67-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160679), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis came back"; ANTIPHOSPHOLIPID ANTIBODIES POSITIVE (non-serious), outcome "unknown", described as "Positive for lupus"; ARTHRALGIA (non-serious), outcome "recovering", described as "Hip/ankle/knee ache"; BACK PAIN (non-serious), outcome "recovering", described as "Back ache"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "Right foot and couple of toes ache"; VACCINATION SITE SWELLING (non-serious), outcome "not recovered", described as "COVID injection cause her arm to swell up"; PAIN (non-serious), outcome "recovering", described as "Aches and Pain". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: Positive, notes: Positive for lupus. The action taken for adalimumab was unknown.  The reporter assessed causality between events "rheumatoid arthritis came back", "positive for lupus", "hip/ankle/knee ache", "back ache", "right foot and couple of toes ache", "covid injection cause her arm to swell up" and "aches and pain" and BNT162b2 as possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, a contributory role of the suspect product BNT162b2 to the reported events cannot be excluded. Vaccination date and event onset dates  were not provided. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Rheumatoid arthritis, Vaccination site swelling
Clinical narrative: Rheumatoid arthritis came back; Positive for lupus; Hip/ankle/knee ache; Back ache; Right foot and couple of toes ache; COVID injection cause her arm to swell up; Aches and Pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4380909-00 (AbbVie).  A 67-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160679), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis came back"; ANTIPHOSPHOLIPID ANTIBODIES POSITIVE (non-serious), outcome "unknown", described as "Positive for lupus"; ARTHRALGIA (non-serious), outcome "recovering", described as "Hip/ankle/knee ache"; BACK PAIN (non-serious), outcome "recovering", described as "Back ache"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "Right foot and couple of toes ache"; VACCINATION SITE SWELLING (non-serious), outcome "not recovered", described as "COVID injection cause her arm to swell up"; PAIN (non-serious), outcome "recovering", described as "Aches and Pain". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: Positive, notes: Positive for lupus. The action taken for adalimumab was unknown.  The reporter assessed causality between events "rheumatoid arthritis came back", "positive for lupus", "hip/ankle/knee ache", "back ache", "right foot and couple of toes ache", "covid injection cause her arm to swell up" and "aches and pain" and BNT162b2 as possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, a contributory role of the suspect product BNT162b2 to the reported events cannot be excluded. Vaccination date and event onset dates  were not provided. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Incorrect dose administered, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Inappropriate dose of Vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 at 18:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 40 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hyperlipidemia (stopped statins for paxlovid tx)" (unspecified if ongoing), notes: notes: stopped statins for paxlovid tx. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "Inappropriate dose of Vaccine administered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: D0: Sx, negative rapid test; (2022) Positive, notes: D1: Sx, positive Cue test, strong positive LFT; (2022) Strong positive, notes: D2: Sx worsened, fever/chills/cough, strong positive LFT; (2022) Weak positive, notes: D3: Sx maintained, fever/chills/cough, weak positive LFT; (2022) Negative, notes: D4: Sx improving significantly, negative LFT; (2022) D5: Sx resolved, negative Cue,, notes: D5: Sx resolved, negative Cue, negative LFT, final day of Paxlovid; (2022) Positive, notes: D11: LFT Positive (today). Therapeutic measures were taken as a result of covid-19. Clinical course included: The patient received treatment for COVID-19 from 01May2022 to 05May2022. No known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Supraventricular tachycardia, Viral infection
Clinical narrative: that they gave me, SVT my heart rate went 230 beats a minute and normally it's 77; Now I got a new virus yesterday since I got it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose 1), for COVID-19 immunization, reaction(s): "never had any problem"; Moderna (Dose 2), for Covid-19 Immunization, reaction(s): "never had any problem"; Moderna (Dose 3), for COVID-19 immunization, reaction(s): "never had any problem". The following information was reported: SUPRAVENTRICULAR TACHYCARDIA (medically significant), outcome "unknown", described as "that they gave me, SVT my heart rate went 230 beats a minute and normally it's 77"; VIRAL INFECTION (non-serious), outcome "unknown", described as "Now I got a new virus yesterday since I got it". The patient underwent the following laboratory tests and procedures: Heart rate: 230 beats a minute; 77, notes: normally. Clinical course: I had 3 Moderna shots and never had any problem, the Booster shot that they gave me, SVT my heart rate went 230 beats a minute; Now I got a new virus yesterday since I got it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested Ag positive 12May no symptoms; tested Ag positive 12May no symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EL3247), on 12Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 33 years and on 23Mar2021 as dose 2, single (Lot number: EL3247) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12May2022, outcome "unknown" and all described as "tested Ag positive 12May no symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive. It was unknown if therapeutic measures were taken as a result of covid-19. Clinical course: It was unknown if patient had any other vaccine in four weeks. She was on vacation after wedding in (event occurred country name withheld) and tested Ag positive 12May no symptoms  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Pfizer COVID-19 Vaccine killed his mother and lawsuits are coming.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (002191).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "Pfizer COVID-19 Vaccine killed his mother and lawsuits are coming.". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Additional information: The caller mentioned that the Pfizer COVID-19 Vaccine killed his mother and lawsuits are coming.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pfizer COVID-19 Vaccine killed his mother and lawsuits are coming.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER8732), on 16Apr2021 as dose 2, single (Lot number: ER8731), in left arm and on 07Feb2022 as dose 3 (booster), single (Lot number: FK9896) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 01Jan2019, stop date: 12May2022; CARVEDILOL, start date: 01Feb2021, stop date: 12May2022; AMLODIPINE, start date: 01Oct2021, stop date: 12May2022; NEXIUM [ESOMEPRAZOLE MAGNESIUM], start date: 01Jan2019, stop date: 12May2022; ACYCLOVIR [ACICLOVIR], start date: 01Jan2019, stop date: 12May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (10May2022) Positive, notes: Rebound of covid symptoms 5 days after last treatment of plaxovid. Therapeutic measures were taken as a result of covid-19.  Additional information: The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient did previously receive a COVID-19 Vaccine. No treatment ae reported. No known allergies.  Follow-Up (18May2022): Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Paxlovid: Treatment of COVID-19; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Batch/Lot number: unknown), on 15Feb2021 as dose 2, single (Batch/Lot number: unknown), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: ROSUVASTATIN; METOPROLOL; EZETIMIBE; LEVOTHYROXINE. The following information was reported: VACCINATION FAILURE (medically significant), 13 days 7 hrs after the suspect product(s) administration, outcome "not recovered", COVID-19 (medically significant), outcome "not recovered" and all described as "Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid was given for the treatment of Covid-19 treatment. Device timestamp was reported 12May2022.  Additional Information: treatment start date was 27Apr2022 and treatment stop date was 01May2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE, start date: Jan2019, stop date: 01May2022; SYNTHROID, start date: Jan2019. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (07May2022) Negative, notes: Tested Negative Day 7. Stayed Negative Day 7, 8 and 9; (10May2022) Positive, notes: Positive again Day 10. Rebound. Therapeutic measures were taken as a result of covid-19. Clinical course: Paxlovid was given for covid 19 treatment on 01May2022 and stopped on 06May2022. Other medication was also given in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EM266), in left arm, on 04Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 20Aug2021 as dose 3 (booster), single (Lot number: FC3182) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiacs" (unspecified if ongoing), notes: Other medical history: Celiacs; "RA" (unspecified if ongoing), notes: Other medical history: RA; "Barretts" (unspecified if ongoing), notes: Other medical history: Barretts; "known allergies: Gluten" (unspecified if ongoing). Concomitant medication(s) included: DEXILANT, start date: 10Oct2016; LO LOESTRIN FE, start date: 22May2019. Past drug history included: Morphine, reaction(s): "known allergies: morphine"; Mucinex, reaction(s): "known allergies: mucinex". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.Clinical Course: The second day of Paxlovid patient started itching all over and got a rash on patient's  leg and back. Patient Went to bed and woke up with a crippling headache. The taste of this medicine is absolutely horrendous. Every dose was like licking a rusted lead pipe
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 12May2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) negative; (12May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Clinical Course: Patient had rebound mild symptoms of 12May2022 and tested positive again on 2 at home tests. I had already tested negative on 09May2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events COVID-19 , DRUG INEFFECTIVE and the administration of the vaccine cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Paxlovid: Treatment of COVID-19; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) on 06Apr2021 at 14:00 as dose 2, single (Lot number: ER8729), in left arm and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details: patient received treatment with Paxlovid, from 26Apr2022 to 01May2022. Adverse event: Return of COVID symptoms after completion of 5-day course of Paxlovid. Symptoms returned 9 days after initial onset and lasted another 5 days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.