chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Aplastic anaemia, Blood test
Clinical narrative: Aplastic anemia; This spontaneous case was reported by a consumer and describes the occurrence of APLASTIC ANAEMIA (Aplastic anemia) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 024M20A) for COVID-19 vaccination.     Patient had no medical history of allergies and not had COVID plus test or diagnosis. No acute and chronic illnesses at the time of vaccination was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jan-2021, the patient experienced APLASTIC ANAEMIA (Aplastic anemia) (seriousness criteria hospitalization and medically significant). At the time of the report, APLASTIC ANAEMIA (Aplastic anemia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: low blood cells (Low) low blood cells.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were provided.  Patient visited his primary doctor and he did a blood test, where they found out he had low blood cells, he was admitted at the hospital that day, but because his case was complex, they had to refer him to another hospital. He was currently admitted in the hospital receiving treatment and blood transfusions forhis aplastic anemia.  He was in the hospital receiving treatment for his aplastic anemia. Medication and blood transfusion for the aplastic anemia was reported.  Company Comment: This spontaneous case concerns a 69-year-old male patient, with no medical history reported, who experienced the unexpected serious event of Aplastic anemia. The event occurred approximately 2 days after receiving the first dose of mRNA-1273 Vaccine and resulted in hospitalization. The patient is currently admitted in the hospital receiving treatment and blood transfusions for his aplastic anemia. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old male patient, with no medical history reported, who experienced the unexpected serious event of Aplastic anemia. The event occurred approximately 2 days after receiving the first dose of mRNA-1273 Vaccine and resulted in hospitalization. The patient is currently admitted in the hospital receiving treatment and blood transfusions for his aplastic anemia. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: The HCP stated that 3 doses were administered from the opened vial/ Temperature excursion; Temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The HCP stated that 3 doses were administered from the opened vial/ Temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2022 at 8:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 07-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The HCP stated that 3 doses were administered from the opened vial/ Temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The HCP stated that 3 doses were administered from the opened vial/ Temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter reported that 3 doses were administered among which 2 doses were booster and 1 dose was a full dose. Excursion temperature maximum 33.4 degrees Fahrenheit and minimum 19.5 degrees Fahrenheit. Excursion occurred on 07-Feb-2022 with the duration of 612 minutes. Vails were stored at room temperature and were moved from freezer to refrigerator on 04-Feb-2022. Vails looked normal on visual inspection. patient doesn't experienced any side effect 8:00 am Monday (07-FEB-2021) Digital readout on data logger reading -22.5F for freezer and 19.9F for refrigerator. vaccine bottles from refrigerator had no signs of freeze, i.e. no ice or crystallized solids in the vaccine bottle the refrigerator temperature controller dial adjusted to 5 from initial number 7. no water bottles in refrigerator and frozen coolant packs in freezer at this time or any other times. 9:11 am (07-FEB-2021) refrigerator data logger reading is 27.7F freezer data logger reading is -10.3F.  the temperature controller dial is on number 5 9:55 am (07-FEB-2021) refrigerator data logger reading is 32.5F and freezer data logger reading is -0.9F. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2022: Patient demographics updated, product details updated, new Event added.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID19 after receiving 2 primary doses of the Moderna Covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID19 after receiving 2 primary doses of the Moderna Covid vaccine) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Inflammatory bowel disease (Taking Linzess to treat this illness.) since 2018 and Drug allergy (Allergy to Lactose). Concomitant products included LINACLOTIDE (LINZESS) for Inflammatory bowel disease.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for COVID19 after receiving 2 primary doses of the Moderna Covid vaccine). At the time of the report, COVID-19 (Tested positive for COVID19 after receiving 2 primary doses of the Moderna Covid vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2021, SARS-CoV-2 test positive: positive (Positive) Positive.         It had been stated that Other vaccines given within 1 month prior to Moderna COVID-19 vaccine  reported as Unknown. It had been reported that after second dose of the Moderna Covid 19 vaccine Paitent did not experienced any symptoms. No Treatment medication reported.  Company comment: This spontaneous case concerns a 21-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI event of COVID-19. The patient received 2 doses of mRNA 1273 COVID-19 vaccine with 34 days interval. The patient tested positive for SARS-COV-2 test 6 months and 15 days after the second dose of mRNA 1273 vaccine. No further details were provided regarding patient symptoms, course of disease and treatment. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2022-486076, MOD-2022-486108 (Patient Link).; Sender's Comments: This spontaneous case concerns a 21-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI event of COVID-19. The patient received 2 doses of mRNA 1273 COVID-19 vaccine with 34 days interval. The patient tested positive for SARS-COV-2 test 6 months and 15 days after the second dose of mRNA 1273 vaccine. No further details were provided regarding patient symptoms, course of disease and treatment. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over the body after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all over the body after first vaccine) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced RASH (Rash all over the body after first vaccine). At the time of the report, RASH (Rash all over the body after first vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Reporter reported that her husband had skin reactions after vaccinations. Patient had not anaphylaxis or other symptoms. The rash went away by itself.   This case was linked to MOD-2022-487144 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Yawning
Clinical narrative: Excessive yawning; lingering fatigue; This spontaneous case was reported by a consumer and describes the occurrence of YAWNING (Excessive yawning) and FATIGUE (lingering fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third 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 and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced YAWNING (Excessive yawning) and FATIGUE (lingering fatigue). At the time of the report, YAWNING (Excessive yawning) and FATIGUE (lingering fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal.         No concomitant medication was given.  No treatment medication was given Reportedly, patient did not get covid and blood work was done last week.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Nerve injury
Clinical narrative: Gilliam Barre and lost 50% of the nerves in legs; Gilliam Barre and lost 50% of the nerves in legs; Initial information was received on 12-Feb-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who experienced gilliam barre and lost 50% of the nerves in legs (guillain-barre syndrome) while receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (formulation, strength, batch number and expiry date: unknown) via unknown route in an unknown administration site for immunization.  In 2015, the patient developed guillain-barre syndrome as event and 50% nerve damage in legs as a symptom of guillain-barre syndrome (unknown latency) following the administration of Influenza vaccine.   Seriousness criteria: guillain-barre syndrome as event and 50% nerve damage in legs as a symptom of Guillain-barre syndrome were assessed as medically significant.  Action Taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Gilliam Barre and lost 50% of the nerves in legs).  At time of reporting, the outcome was Unknown for the event gilliam barre and lost 50% of the nerves in legs.; Sender's Comments: Sanofi Company Comment dated 18-Feb-2022: This case involves a patient of unknown demographics who had guillain-barre syndrome, after he/she was treated with Influenza vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past medical history, medical treatment(s), vaccination(s) and family history precludes comprehensive case assessment.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inflammation, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: At first it was a hard, swollen, and red lump that was hot to the touch at the injection site, that showed up the day after shot. Then over the course of 6 days, it got progressively worse. The hard red lump remained in the center of the upper arm, but redness, swelling, itchiness and inflammation spread out from the center lump. The reaction continues to spread farther away from the center, across my upper arm. I am feeling exhausted from my body constantly attacking the area.  It continues now, going on day 7 with no end in sight.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: At first it was a hard, swollen, and red lump that was hot to the touch at the injection site, that showed up the day after shot. Then over the course of 6 days, it got progressively worse. The hard red lump remained in the center of the upper arm, but redness, swelling, itchiness and inflammation spread out from the center lump. The reaction continues to spread farther away from the center, across my upper arm. I am feeling exhausted from my body constantly attacking the area.  It continues now, going on day 7 with no end in sight.
Age: 35.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE reported; he received his second dose of GARDASIL 9 over 1 year after his initial first dose; This spontaneous report was received from a 37-year-old male patient, referring to himself. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 26-AUG-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis. On 07-FEB-2022 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis over 1 year after his initial first dose (inappropriate schedule of product administration). No additional adverse event reported.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: temperature excursion; This spontaneous report was received from a medical student, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 16-NOV-2021, the patient was vaccinated with improper stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot# T034880, but upon internal validation established as non-valid, dose, route and strength were not provided) for prophylaxis. The vaccine administered experienced temperature excursions of 50.29 Degree Fahrenheit for 2 hours (product storage error). There was no previous temperature excursion.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Incorrect product storage; This spontaneous report was received from the patient's parent referring to a 5-year-old (also reported as 4 (unit not reported)) male patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.   On 13-APR-2021, the patient was vaccinated with incorrect storage varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot# and expiration date were not provided) for prophylaxis at the private doctor's office (incorrect product storage). The temperature excursion occurred as a result of reading from a Data Logger. No adverse event was reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional adverse events reported; A dose of PROQUAD was administered instead of MMR II, that was concomitantly given with a dose of VARIVAX to a 1 year old child by mistake today; A dose of PROQUAD was administered instead of MMR II, that was concomitantly given with a dose of VARIVAX to a 1 year old child by mistake today; This spontaneous report was received from a registered nurse referring to a 1-year-old patient. The patient's current condition, pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 15-FEB-2022, nurse stated a dose of vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U029179 and expiration date upon internal validation was 08-MAR-2023), 0.5ml was administered instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II), that was concomitantly given with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # U024765 and expiration date upon internal validation was 10-AUG-2023), , 0.5 ml to a 1 year old child by mistake on same day for prophylaxis (wrong product administered and Accidental overdose). No other information given. No additional adverse events reported.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Arm soreness; fever; muscle aches; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 25th January 2022, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced pain in arm, fever and muscle pain. On an unknown date, the outcome of the pain in arm, fever and muscle pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fever and muscle pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced very difficult side effects like arm soreness, fever and muscle aches for 2 days and then felt OK. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shots and I'm still getting it three times/Suspected vaccination failure; Getting it three times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the shots and still got shingles three times. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I had my 2 shots last year and I now have shingles/ Suspected vaccination failure; I have it now, painful; I have it now- painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received 2 shots of shingles vaccine last year and at the time of reporting had shingles. The shingles were painful. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Age: 63.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Injection site pain, Joint swelling, Peripheral swelling
Clinical narrative: soreness in the injection site; extreme swelling of his hands; swelling has spread to the elbows and his shoulders; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TOZINAMERAN (COVID 19 VACCINE BOOSTER PFIZER) for prophylaxis.   On 2nd December 2021, the patient received Shingrix and COVID 19 VACCINE BOOSTER PFIZER. In December 2021, less than a month after receiving Shingrix, the patient experienced injection site pain, hand swelling and swollen joints. On an unknown date, the outcome of the injection site pain, hand swelling and swollen joints were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, hand swelling and swollen joints to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife who was reporting on behalf of her husband.  The patient received both Shingrix and Covid-19 vaccine booster shot (Pfizer) in the left arm on 2nd December 2021. She reported that after receiving Shingrix, patient experienced extreme swelling of his hands and soreness in the injection site.  Swelling started in December and started in the wrist.  In the last few weeks from reporting, swelling had spread to the elbows and his shoulders.  Swelling had not resolved. Soreness in the injection site (left arm) also started in December and had not yet resolved till the time of reporting. The reporter did not consent to follow up. This case has been linked to the case US2022028936 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022028936:same reporter
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Drug interaction, Insomnia, Nausea, Tremor
Clinical narrative: consumer inquired if there are any interactions between the 2 products/Possible vaccine and drug interaction; Experienced insomnia; Nausea; Shaking; This case was reported by a consumer via call center representative and described the occurrence of possible vaccine-drug interaction in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included escitalopram (Lexapro) for anxiety disorder.   Concurrent medical conditions included anxiety disorder.   On 7th February 2022, the patient received the 1st dose of Shingrix. On 14th February 2022, the patient started Lexapro at an unknown dose and frequency. In February 2022, between 1 and 2 weeks after receiving Shingrix, the patient experienced drug interaction, insomnia, nausea and tremor. The action taken with Lexapro was unknown. On an unknown date, the outcome of the drug interaction, insomnia, nausea and tremor were unknown.   It was unknown if the reporter considered the drug interaction, insomnia, nausea and tremor to be related to Shingrix.  Additional details were reported as follows: The patient received the 1st dose of Shingrix vaccine and then started Lexpro on 14th February 2022.  The reporter inquired if there were any interactions between the 2 products and stated that the side effects started after taking Lexpro.  The patient experienced insomnia, nausea and shaking.  The patient was referred to healthcare professional.  It was unknown if the reporter considered the insomnia, nausea and tremor to be related to Laxapro. The reporter consented to follow up to contact health care professional and consumer for follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Night sweats
Clinical narrative: NIGHT SWEATS; VERY WEAK; This spontaneous report received from company representative via social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced night sweats, and very weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very weak and night sweats was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected, Vitamin B12
Clinical narrative: he started to have high levels of Vitamin B12, enough for him to stop receiving Vitamin B12 injections since 3-4 months ago; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (he started to have high levels of Vitamin B12, enough for him to stop receiving Vitamin B12 injections since 3-4 months ago) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Vitamin B12 deficiency.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (he started to have high levels of Vitamin B12, enough for him to stop receiving Vitamin B12 injections since 3-4 months ago). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (he started to have high levels of Vitamin B12, enough for him to stop receiving Vitamin B12 injections since 3-4 months ago) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vitamin B12: high (High) high levels of Vitamin B12.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.   It was reported that patient was not able to absorb Vitamin B12 through food therefore received Vitamin B12 injections for 10 years. Patient started to have high levels of Vitamin B12, enough for him to stop receiving Vitamin B12 injections for 3-4 months ago.  No treatment medication information was given.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: terribly sick; Initial information received on 10-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced terribly sick while receiving vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, dose , frequency, strength and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination. Batch number and expiration date were requested.  On an unknown date the patient developed a non-serious event "terribly sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (terribly sick).  At time of reporting, the outcome was Unknown for the event terribly sick.
Age: 5.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: flublok vaccine was administered to 5 year old children with no reported adverse event; Initial information received on 09-Feb-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 5 years old patient of unknown gender who had administered Influenza Quadrivalent Recombinant Vaccine [Flublok Qiv] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Quadrivalent Recombinant Vaccine(form, route, frequency, strength, administration site, batch number, expiry date not reported) for immunization. Information on batch number was requested.  On same day following the administration of Influenza Quadrivalent Recombinant Vaccine it was reported that "flublok vaccine was administered to 5 year old children with no reported adverse event" (product use issue).  Action taken was not applicable.  Outcome was Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Allergy test positive, Arthropod bite, Feeling abnormal, Headache, Hunger
Clinical narrative: nervousness; hunger; feeling bad; insect bite; headaches; Initial information received on 10-Feb-2022 regarding an unsolicited valid  non-serious case received from a consumer   This case involves a 63 years old male patient who experienced nervousness, hunger, feeling bad, insect bite and headaches while receiving vaccine influenza USP trival A-B subvirion no preservative vaccine [Fluzone].  The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient's past medical history included minor itch At the time of the event, the patient had ongoing Allergy to formaldehyde  Concomitant medications included Vitamin B12 Nos [Vitamin B12 Nos].  On 28-Oct-2021, the patient received a dose of suspect influenza USP trival A-B subvirion no preservative vaccine (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination. Information on batch number was requested.  It was reported that after the administration of vaccine the patient had developed nervousness and hunger that lasted till Jan-2022 and he started to feel better but then took a B12 shot and he started back feeling bad (feeling abnormal). Also, mentioned that he took Vitamin B 12 injections before starting the flu shot which was given by his employer, does not remember which site had it in or the exact name and Vitamin B 12 gives him a minor itch. States he is seeing a neurologist and has been having headaches (headache) (onset and latency: unknown) and will have some minor surgery for a hernia but doesn't know when since he hasn't scheduled it as yet, has an insect bite he is going to start antibiotics for in the next couple of days. Further the patient had asked that how long does the flu shot stay in your body and Would antibiotics help this situation, as patient had heard that it has formaldehyde in it and patient was allergic to formaldehyde but his doctor usually signs off so, patient do not have to take it but this year he didn't get a chance to have him sign me off.  Also, he had a patch test recently for allergies and is allergic to formaldehyde.   Relevant laboratory test results included: Skin test - On an unknown date:  patch test [allergic to formaldehyde]  Action taken: was not applicable.  It was not reported if the patient received a corrective treatment for the events (nervousness, hunger, feeling abnormal, arthropod bite and headaches)   Outcome: recovered/resolved on an unknown date in Jan-2022 for hunger and nervousness and unknown for rest all events
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Nervousness
Clinical narrative: nervousness; hunger; feeling bad; insect bite; headaches; Initial information received on 10-Feb-2022 regarding an unsolicited valid  non-serious case received from a consumer   This case involves a 63 years old male patient who experienced nervousness, hunger, feeling bad, insect bite and headaches while receiving vaccine influenza USP trival A-B subvirion no preservative vaccine [Fluzone].  The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient's past medical history included minor itch At the time of the event, the patient had ongoing Allergy to formaldehyde  Concomitant medications included Vitamin B12 Nos [Vitamin B12 Nos].  On 28-Oct-2021, the patient received a dose of suspect influenza USP trival A-B subvirion no preservative vaccine (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination. Information on batch number was requested.  It was reported that after the administration of vaccine the patient had developed nervousness and hunger that lasted till Jan-2022 and he started to feel better but then took a B12 shot and he started back feeling bad (feeling abnormal). Also, mentioned that he took Vitamin B 12 injections before starting the flu shot which was given by his employer, does not remember which site had it in or the exact name and Vitamin B 12 gives him a minor itch. States he is seeing a neurologist and has been having headaches (headache) (onset and latency: unknown) and will have some minor surgery for a hernia but doesn't know when since he hasn't scheduled it as yet, has an insect bite he is going to start antibiotics for in the next couple of days. Further the patient had asked that how long does the flu shot stay in your body and Would antibiotics help this situation, as patient had heard that it has formaldehyde in it and patient was allergic to formaldehyde but his doctor usually signs off so, patient do not have to take it but this year he didn't get a chance to have him sign me off.  Also, he had a patch test recently for allergies and is allergic to formaldehyde.   Relevant laboratory test results included: Skin test - On an unknown date:  patch test [allergic to formaldehyde]  Action taken: was not applicable.  It was not reported if the patient received a corrective treatment for the events (nervousness, hunger, feeling abnormal, arthropod bite and headaches)   Outcome: recovered/resolved on an unknown date in Jan-2022 for hunger and nervousness and unknown for rest all events
Age: 3.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK was administered to 37 month old female patient (Drug use in unapproved age group) with no reported adverse event; Initial information was received on 14-Feb-2022 regarding an unsolicited valid non-serious case received from a health care professional via call center.  This case is linked to case 2022SA054691(CLUSTER).  This case involves a 37 months old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (drug use in unapproved age group) with no reported adverse event.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Feb-2022, the patient received 0.5 ml of suspect influenza quadrivalent recombinant vaccine suspension for injection for 1 day via Intramuscular route in right quadriceps, lot-QFAA2152 (with an unknown expiry date) for immunization.   On 14-Feb-2022,the patient developed a non-serious event "FLUBLOK was administered to 37 month old female patient (Drug use in unapproved age group) with no reported adverse event (latency same day) following the administration of influenza quadrivalent recombinant vaccine.    Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event flublok was administered to 37 month old female patient (drug use in unapproved age group) with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heavy menstrual bleeding, Menstruation irregular, Muscle spasms, Premenstrual syndrome
Clinical narrative: Irregular period? about ten days after the vaccine (which was my second dose) my period came early (I am usually on a 28 day cycle that has only ever been disrupted by pregnancy or nursing). It was accompanied by very heavy cramps, fatigue and general PMS symptoms. The period was very heavy and lasted two full weeks. My typical period is four days with only a day and a half of heavy period.  When I got my third shot in  November 2021, I had a skipped period in December, followed by two irregular periods in January. I will submit a different form for this one.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching
Clinical narrative: Systemic: Occassional muscle spasms/twitching-Mild, Additional Details: Patient reported the day after receiving first dose she noticed muscle spasms in the area of the vaccine. These happen occassionally even one month after the dose.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Systemic: Lymph Node Swelling-Medium
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Cardiac stress test, Neuropathy peripheral
Clinical narrative: Developed angina on exertion about two weeks after the second shot. This cleared in about 6 weeks. Have had a low grade peripheral neuropathy for many years that is well-controlled.  This was exacerbated by after the second shot. This cleared in about 6 months.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Mouth swelling, Pruritus, Rash, Rash pruritic
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Delayed allergic reaction. Itchy rash on chest, neck and eyelid. Eyelids moderately swollen.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swelling of eyelid, Swollen tongue, Type IV hypersensitivity reaction
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Delayed allergic reaction. Itchy rash on chest, neck and eyelid. Eyelids moderately swollen.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at injection site-medium; Site: Swelling at injection site-medium.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Headache-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient reported Numbness in one of her legs. It started 2/20, the day after the vaccine. The numbness is temporary. She states that it comes on and her leg is numb for a period of time and then the feeling of numbness goes away. That has occurred multiple times on 02/20. Patient also has mild headache and mild soreness at the injection site. Patient plans to follow up with physician or go to the urgent care.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: Skin on fingertips rubbing off.  Not to the point of fingers actually bleeding.  Ongoing.  Don't know what brand of flu shot she received about a week after the booster (third) shot.  I just picked one.  Again, we were travelling and just stopped at a pharmany.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Atrioventricular block complete, Balance disorder, Borrelia test, Bradycardia, Cardiac pacemaker insertion
Clinical narrative: Shortness of breath, nausea, disequilibrium. Diagnosed in intensive care at Hospital with complete heart block bradycardia (approx 30 beats a minute). MRI showed no inflammation. No faults found with catheter investigation via groin. After 10 days in intensive care I was moved to different hospital for a pacemaker. Sensation of disabling disequilibrium has not ceased. Ear doctor found no problem with inner ear. Brain scan tomorrow.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Catheter placement, Dyspnoea, Echocardiogram, Electrocardiogram abnormal, Intensive care
Clinical narrative: Shortness of breath, nausea, disequilibrium. Diagnosed in intensive care at Hospital with complete heart block bradycardia (approx 30 beats a minute). MRI showed no inflammation. No faults found with catheter investigation via groin. After 10 days in intensive care I was moved to different hospital for a pacemaker. Sensation of disabling disequilibrium has not ceased. Ear doctor found no problem with inner ear. Brain scan tomorrow.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging normal, Nausea
Clinical narrative: Shortness of breath, nausea, disequilibrium. Diagnosed in intensive care at Hospital with complete heart block bradycardia (approx 30 beats a minute). MRI showed no inflammation. No faults found with catheter investigation via groin. After 10 days in intensive care I was moved to different hospital for a pacemaker. Sensation of disabling disequilibrium has not ceased. Ear doctor found no problem with inner ear. Brain scan tomorrow.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mechanical urticaria, Rash pruritic, Skin abrasion, Urticaria
Clinical narrative: Highly prurtic rash, worse BLE but has some BUE involvement, no face or neck involvement; sudden onset within last half-hour Scattered red, raised welts that converge in some areas into large plaques BLE and buttocks; dematographism with excoriation noted BLE; minor involvement BUE with patchy redness  Dx: Urticaria; Treated with diphenhydramine hcl 25mg 2 caps po in office and Dexamethasone 8mg IM in office Recheck by phone 2/15/2022 with patient reporting resolution of symptoms.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Mood swings
Clinical narrative: I've had the same timing and pre menstrual symptoms for 5 years. After getting my booster both the timing of my period and the PMS symptoms have changed. My period started 2 weeks earlier than normal and has continued on that cycle for 2 months. My PMS symptoms have gotten more noticeable as well (mood swings). No other changes in life style, diets, and medications have occurred so the booster is the only variable.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Condition aggravated, Pain in extremity, Rheumatoid arthritis, Skin induration
Clinical narrative: Cellulitis- softball size, continues to grow, hard, warm (hot) to the touch.  Started with sore arm Friday night, but Saturday night is was described as above. Marked it and took ibuprofen. It continued growing outside of marks and I was seen at the ED.  Given IM shot of antibiotics and oral as well.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Cellulitis- softball size, continues to grow, hard, warm (hot) to the touch.  Started with sore arm Friday night, but Saturday night is was described as above. Marked it and took ibuprofen. It continued growing outside of marks and I was seen at the ED.  Given IM shot of antibiotics and oral as well.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Diarrhoea, Fear, Impaired work ability
Clinical narrative: Extreme vertigo with nausea, diarrhea and vomiting lasting 2-3 days.  Required a telephone consult with doctor's office and medication to reduce vertigo. Unwell for about 2 weeks.  Unable to work for almost a week,  Weakness persisting for about a month. Lingering anxiety from extreme vertigo episodes and fear of it returning.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Malaise, Nausea, Vertigo, Vomiting
Clinical narrative: Extreme vertigo with nausea, diarrhea and vomiting lasting 2-3 days.  Required a telephone consult with doctor's office and medication to reduce vertigo. Unwell for about 2 weeks.  Unable to work for almost a week,  Weakness persisting for about a month. Lingering anxiety from extreme vertigo episodes and fear of it returning.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, Back pain, Chest discomfort, Chest pain, Feeling of body temperature change
Clinical narrative: Patient reports this particular episode of chest pain started yesterday (2/19) around 12?noon. He reports that it initially started as "jolts" of pain, some "sharp and dull". He reports that he woke up this morning with a "tight" chest pain. He reports that he has also had "hot and cold sweats" all morning. Patient reports that this is not a burning pain, and does not feel like GERD or heartburn. He denies anything making this pain better or worse. Patient denies any nausea. He does note a lower?mid back pain that he has not had before as well.