chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Muscle soreness; Headache; Diarrhea; Tiredness; Swollen lymph nodes in armpit; This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number N3755, expiry date 26th June 2023) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose was received on Jun 2022, refer case US2022AMR142462).   On 3rd October 2022, the patient received the 2nd dose of Shingrix. On 4th October 2022, 1 days after receiving Shingrix, the patient experienced muscle soreness, headache, diarrhea, tiredness and axillary lymph nodes enlarged. On an unknown date, the outcome of the muscle soreness, headache, diarrhea, tiredness and axillary lymph nodes enlarged were not recovered/not resolved.   It was unknown if the reporter considered the muscle soreness, headache, diarrhea, tiredness and axillary lymph nodes enlarged to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR142462   Additional Information: GSK Receipt Date: 04-Oct-2022 Reporter's comment: The patient self-reported this case. The patient received the second dose of Shingrix and experienced muscle soreness, headache, diarrhea, tiredness, and swollen lymph nodes in armpit.  The reporter consent to follow-up.; Sender's Comments:  US-GSK-US2022AMR142462:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on Nov/2021, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that patient had not had the second dose of Shingrix vaccine almost 1 year post 1st dose of Shingrix vaccine. The reporter was unable to provide any additional details regarding adverse event. Healthcare professional given permission for safety team to follow up. Adverse event contained all reported information. The reporter did consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administrated with less than two months after dose one; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's comment: Physician reported that a patient was administrated with Shingrix with less than two months after dose one. No adverse event was reported. No patient's identifiers, lot number, expiration date and vaccination date were provided. The reporter consented to follow-up. Additional Supportive Information: The patient received 2nd dose of Shingrix earlier than the recommended interval, which led to shortening of vaccination schedule.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: shingles; pain in left arm; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) (batch number Ms5hc, expiry date 8th July 2023) for prophylaxis.   On 2nd August 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2022, 4 days after receiving Shingrix, the patient experienced shingles and pain in arm. On an unknown date, the outcome of the shingles and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the shingles and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-Oct-2022 Reporter's comment: The pharmacist reported an adverse event for Shingrix. The patient received the first shot of Shingrix. The pharmacist stated that the patient experienced with pain in left arm about 4 days after the vaccination.  The patient went to the physician and they said he had shingles.  The patient still reports pain in the left arm.  The pharmacist was not sure if the patient had lesions or just pain with the Shingles.  The reporter did not consent to follow-up. Less than 2 months,the patient experienced shingles.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse reaction, Herpes zoster, Incomplete course of vaccination
Clinical narrative: Shingles; first dose approximately 4 years, has not received second; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's comment: The RPH(registered pharmacist) called on behalf of patient. The patient received first dose of Shingrix approximately 4 years ago(from the date of reporting) and had not received the second dose.  The reporter reported that the patient was currently experiencing active case of Shingles.  The reporter also reported that the patient was experiencing an adverse reaction to the first dose of Shingrix, but did not provide any details regarding the adverse reaction.  The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose January 2022; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's comment: Pharmacist called to ask for information about a patient who received the first dose of Shingrix in January 2022. The reporter asked if it was correct to administer the second dose. The reporter did not provide information about the lot number and expiration date of the first dose of Shingrix administered to the patient. The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Off label use, SARS-CoV-2 test
Clinical narrative: COVID-19; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 05-OCT-2022. The patient's weight, height, and medical history were not reported. On an unspecified date in 2021, the patient was previously treated with elasomeran (Moderna covid-19 vaccine) (Dose number in series 1) (Form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered for covid-19 prophylaxis.  On an unspecified date in 2021, the patient experienced pericarditis with the following vaccination elasomeran (Moderna covid-19 vaccine) (Dose number in series 1). The patient had pericarditis twice but did not specify the timing of the two incidences. The patient had received first booster with covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, 1 total administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s (Dose number in series 2). The patient received second booster with covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, 1 total administered on an unspecified date in APR-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. The drug was associated with Off label dosing frequency (Dose number in series 3). No concomitant medications were reported.  On an unspecified date in MAY-2022, after receiving second booster with covid-19 vaccine ad26.cov2.s, the patient had Covid-19 and also experienced symptoms phlegm and tiredness (Dose number in series 3). Laboratory data included: three confirmatory tests that the patient had were all negative (2 negative at home tests and 1 negative PCR test) (Covid-19) (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 and off label dosing frequency was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000254110. The suspected product quality complaint has been confirmed to be voided (this report describes adverse events for the patient. Based on information obtained during outreach, the reporter stated they did not have any positive covid test/diagnosis. Since there is no positive confirmatory test for covid, there is no product quality issue reported) based on the PQC evaluation/investigation performed.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test, Thrombosis, Vaccination failure
Clinical narrative: WHOLE CLOTTING; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via another pharmaceutical company (Moderna) concerned a male of an unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: penicillin allergy, and concurrent conditions included: blood pressure spikes up when in stress. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, the patient experienced whole clotting (dose number in series 1) and had decided to take Moderna for his booster dose. The patient received Non-company suspect vaccine included: elasomeran (Moderna covid-19 vaccine) (dose number in series 2) (form of admin, route of admin were not reported, batch number: 022T(?)21A, expiry: unknown) dose was not reported, administered on 22-JAN-2022 for covid-19 prophylaxis. Concomitant medications included lisinopril for blood pressure spikes up when in stress. On 22-JAN-2022, the patient experienced revaccination with different covid-19 vaccine (dose number in series 2). On 27-AUG-2022, the patient had symptoms and tested positive for covid-19 and experienced confirmed covid-19 infection (dose number in series 2) and had confirmed clinical vaccination failure (dose number in series 1). On 06-SEP-2022 or 07-SEP-2022, Laboratory data included: COVID-19 virus test Negative. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure, revaccination with different covid-19 vaccine and whole clotting was not reported. This report was serious (Other Medically Important Condition). This report was associated with Product quality complaint: 90000254398. Sender's Comments: V0: 20221009696-covid-19 vaccine ad26.cov2.s- Confirmed Clinical Vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.  20221009696-covid-19 vaccine ad26.cov2.s-  Whole clotting- The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: LOT OF PEOPLE DIED OF BLOOD CLOTS; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number, and expiry were not reported) dose was not reported, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, reporter reported that " A lot of people died of blood clots" from the J&J vaccine, it was a common issue. On an unspecified date, the patients died from blood clots. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was fatal. This report was serious (Death).; Sender's Comments: V0- 20221010172 -covid-19 vaccine ad26.cov2.s-Lot of people died of blood Clots. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOTS
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT GIVEN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190 expiry: 24-SEP-2022) dose was not reported, administered on 06-OCT-2022 for covid-19 prophylaxis. The drug was associated with Medication error. No concomitant medications were reported.  On 06-OCT-2022, the patient experienced patient given expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient given expired vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: LITTLE BIT SLEEPY; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced little bit sleepy, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little bit sleepy, and the outcome of fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: PEOPLE KILLED BY VACCINE; This spontaneous report received from a consumer via a company representative via social media concerned a multiple patients of an unspecified race and ethnic origin. Initial information was processed along with the additional information received on 10-OCT-2022. The patient's weight, height, and medical histories were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 in total, dose, start therapy dates were not reported for covid-19 prophylaxis. 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 patients died. Cause of death was not reported. As per reporter, "I know peoples who were killed by your covid vaccine". It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This report was associated with product quality complaint: 90000254593. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria since this report states the reporter knows of people killed by vaccination. This reports patient death with no product quality issue reported therefore it does not require a quality investigation) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20221013757- covid-19 vaccine ad26.cov2.s- people killed by vaccine. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Abnormal dreams, Feeling abnormal, Panic disorder
Clinical narrative: PANIC; NOT THE SAME PERSON MENTALLY SPEAKING; DREAMS OF DEAD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced panic, not the same person mentally speaking, and dreams of dead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the panic, not the same person mentally speaking and dreams of dead was not reported. This report was non-serious. This report was associated with product quality complaint: 90000254615
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Ear infection, Influenza, Off label use, Suspected COVID-19
Clinical narrative: LOST 20 POUNDS; EAR INFECTION; PINK EYE; FLU SYMPTOMS; SUSPECTED COVID-19 INFECTION; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via another pharmaceutical company concerned a 68 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma (took a shot (Unspecified) for it). The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 in total was administered on 26-AUG-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 in total was administered on 17-OCT-2021 for covid-19 prophylaxis which was an off label dosing frequency (Dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 67 years old. No concomitant medications were reported. On 25-DEC-2021, following vaccination with booster dose of covid-19 vaccine ad26.cov2.s, the patient had a severe case of Covid-19 with the symptoms of cough and terrible sore throat which was suspected covid-19 infection (Dose number in series 2), and lasted for one month. The patient received treatment medications (dates unspecified) which included: prednisone and an antibiotic (Unspecified). On an unspecified date, the patient lost 20 pounds and experienced ear infection, pink eye, and flu symptoms (Dose number in series 2). It was reported that Covi-19 was terrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on an unspecified date in JAN-2022, and the outcome of lost 20 pounds, ear infection, pink eye, off label dosing frequency and flu symptoms was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: LOST 20 POUNDS; EAR INFECTION; PINK EYE; FLU SYMPTOMS; SUSPECTED COVID-19 INFECTION; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via another pharmaceutical company concerned a 68 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma (took a shot (Unspecified) for it). The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 in total was administered on 26-AUG-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 in total was administered on 17-OCT-2021 for covid-19 prophylaxis which was an off label dosing frequency (Dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 67 years old. No concomitant medications were reported. On 25-DEC-2021, following vaccination with booster dose of covid-19 vaccine ad26.cov2.s, the patient had a severe case of Covid-19 with the symptoms of cough and terrible sore throat which was suspected covid-19 infection (Dose number in series 2), and lasted for one month. The patient received treatment medications (dates unspecified) which included: prednisone and an antibiotic (Unspecified). On an unspecified date, the patient lost 20 pounds and experienced ear infection, pink eye, and flu symptoms (Dose number in series 2). It was reported that Covi-19 was terrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on an unspecified date in JAN-2022, and the outcome of lost 20 pounds, ear infection, pink eye, off label dosing frequency and flu symptoms was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Pain
Clinical narrative: UNSPECIFIED AUTOIMMUNE DISORDER WAS BEING MADE WORSE; PAIN WAS MADE WORSE; This spontaneous report received from a consumer via other manufacturer Novavax concerned a 59-year-old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient's concurrent conditions included: unspecified autoimmune disorder and pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total, administered on 09-APR-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 59 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced unspecified autoimmune disorder was being made worse, and pain was made worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unspecified autoimmune disorder was being made worse and pain was made worse was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20221016458- covid-19 vaccine ad26.cov2.s-unspecified autoimmune disorder. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Date of positive COVID-19 test: April or May 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Date of positive COVID-19 test: April or May 2022) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21a, 040B21A and 047A21A) for COVID-19 vaccination.     Concomitant products included MONTELUKAST SODIUM (SINGULAIR), LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (Date of positive COVID-19 test: April or May 2022). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Date of positive COVID-19 test: April or May 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient did not had allergies. Patient did not have history related to mentioned AE and both acute and chronic illnesses at the time of vaccination. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. In Apr or May-2022, patient had COVID positive test or diagnosis. Patient did not have hospitalization due to COVID-19   This case was linked to MOD-2022-656961 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Burning sensation, Fear, Pruritus, Sleep disorder
Clinical narrative: In the middle of the night, while I was asleep, I was awoken because my feet were intensely burning and itching. I do not have any other conditions except for Asthma and have never experienced this before. The burning and itching lasted for hours and were very intense and scary.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Crying, Emotional distress, Erythema, Oropharyngeal pain
Clinical narrative: Patient received vaccines at 1225 as ordered.  Patient remained in room for 30 minutes post monitoring due to history of anaphylaxis to eggs.  RN continued to check in on patient and MOC.  1255: RN noticed patient sitting on the bed looking very upset. Patient was scratching and MOC consoling. RN assessed and noted small, red, circular hives noted on back and neck. RN immediately brought CPNP to bedside for further assessment.  1300: Patient began coughing and stated his throat was hurting. NP listened to lung sounds and noted wheezing + called MD to bedside. IM Epi given to right thigh and patient placed on continuous pulse ox. Patient crying and hives spreading to face.  1303: RN gave PO benadryl as ordered. Breathing exercises completed with patient and patient tolerated PO benadryl well. Patient maintaining O2 sats 95% - 98% on room air. Wheezing continued, but breath sounds and hives improving.  1312: RN and NP continued monitoring closely at bedside and transferred patient + MOC safely to ED with second Epi pen dose on hand.  1320: Patient sitting up in wagon, continues to report throat hurting, but NAD and calm, breathing normally, awake and alert at this time. Hives fully subsided from face and decreased on back. Patient is no longer wheezing or coughing at this time. Patient checked in to ED; report given to ED RN by NP, and patient brought back to ED room safely with ED RN and MOC.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria, Wheezing
Clinical narrative: Patient received vaccines at 1225 as ordered.  Patient remained in room for 30 minutes post monitoring due to history of anaphylaxis to eggs.  RN continued to check in on patient and MOC.  1255: RN noticed patient sitting on the bed looking very upset. Patient was scratching and MOC consoling. RN assessed and noted small, red, circular hives noted on back and neck. RN immediately brought CPNP to bedside for further assessment.  1300: Patient began coughing and stated his throat was hurting. NP listened to lung sounds and noted wheezing + called MD to bedside. IM Epi given to right thigh and patient placed on continuous pulse ox. Patient crying and hives spreading to face.  1303: RN gave PO benadryl as ordered. Breathing exercises completed with patient and patient tolerated PO benadryl well. Patient maintaining O2 sats 95% - 98% on room air. Wheezing continued, but breath sounds and hives improving.  1312: RN and NP continued monitoring closely at bedside and transferred patient + MOC safely to ED with second Epi pen dose on hand.  1320: Patient sitting up in wagon, continues to report throat hurting, but NAD and calm, breathing normally, awake and alert at this time. Hives fully subsided from face and decreased on back. Patient is no longer wheezing or coughing at this time. Patient checked in to ED; report given to ED RN by NP, and patient brought back to ED room safely with ED RN and MOC.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, FLUC4
Symptoms: Incorrect product formulation administered
Clinical narrative: Requested bivalent vaccine, received monovalent.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, FLUC4
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: Requested bivalent vaccine, received monovalent.
Age: 87.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt received Pfizer bivalent vaccine as first dose in the series instead of the regular Pfizer.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event, Vaccine was freezed and then thaw before using. Per CDC that was incorrect so we need to report as not good and notify our patients.
Age: 60.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Catheterisation cardiac abnormal, Electrocardiogram abnormal, Pericarditis
Clinical narrative: Pericarditis
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Asthenia, Back pain, Bone scan normal, C-reactive protein normal, Enterovirus test positive
Clinical narrative: Following well child visit and vaccinations 9/2021 developed higher fever along with developing profound fatigue, decreased energy, and headache whose only positive test was initially for rhinovirus/enterovirus on 10/5 done in the setting of fevers, who has had since that time a variable/waxing-waning course with most prominent symptoms of fatigue (and some reported post-exertional malaise), ongoing intermittent temperatures/fevers (100s-103s) with many repeated inflammatory lab checks both during and between fevers (ESR/CRP/CBC) which have been normal, and more recently with issues of back pain and shin pain who overall has findings and negative studies suggestive of CFS/ME like illness.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Fatigue, Full blood count normal, Headache, Human rhinovirus test positive, Inflammatory marker test
Clinical narrative: Following well child visit and vaccinations 9/2021 developed higher fever along with developing profound fatigue, decreased energy, and headache whose only positive test was initially for rhinovirus/enterovirus on 10/5 done in the setting of fevers, who has had since that time a variable/waxing-waning course with most prominent symptoms of fatigue (and some reported post-exertional malaise), ongoing intermittent temperatures/fevers (100s-103s) with many repeated inflammatory lab checks both during and between fevers (ESR/CRP/CBC) which have been normal, and more recently with issues of back pain and shin pain who overall has findings and negative studies suggestive of CFS/ME like illness.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Magnetic resonance imaging spinal normal, Malaise, Pain in extremity, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: Following well child visit and vaccinations 9/2021 developed higher fever along with developing profound fatigue, decreased energy, and headache whose only positive test was initially for rhinovirus/enterovirus on 10/5 done in the setting of fevers, who has had since that time a variable/waxing-waning course with most prominent symptoms of fatigue (and some reported post-exertional malaise), ongoing intermittent temperatures/fevers (100s-103s) with many repeated inflammatory lab checks both during and between fevers (ESR/CRP/CBC) which have been normal, and more recently with issues of back pain and shin pain who overall has findings and negative studies suggestive of CFS/ME like illness.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Requested bivalent vaccine, received monovalent.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Pain, Rhinorrhoea
Clinical narrative: I had a headache, body aches, runny nose, and cough. I tested positive positive for COVID-19. I spoke to my doctor and prescribed me medication.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had a headache, body aches, runny nose, and cough. I tested positive positive for COVID-19. I spoke to my doctor and prescribed me medication.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Requested bivalent vaccine, received monovalent.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event occurred, this submission is to document a 48 year old female received a Shingrix vaccine, which is not indicated until she is 50 years old per agency guidelines.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event, Vaccine was freezed and then thaw before using. Per CDC that was incorrect so we need to report as not good and notify our patients.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Requested bivalent vaccine, received monovalent.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: No adverse event, Vaccine was freezed and then thaw before using. Per CDC that was incorrect so we need to report as not good and notify our patients.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Requested bivalent vaccine, received monovalent.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event, Vaccine was freezed and then thaw before using. Per CDC that was incorrect so we need to report as not good and notify our patients.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: Started feeling sciatic nerve pain in left side of body, mainly with arm and foot.  Episodes were intermittant.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling to area, low site of injection, warmth, redness, hard area, square looking raised redenned area, pain
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event, Vaccine was freezed and then thaw before using. Per CDC that was incorrect so we need to report as not good and notify our patients.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient was seen in our office on 10/12/22 for covid-19 vaccination and received a dose of Pfizer COVID-19 vaccine for 6m to 4 year olds. However, on re-examination of her vaccination record after vaccination,  it was noticed that the patient already received two doses of Moderna  COVID-19 vaccine for 6m to 5 year olds, which she received at an outside pharmacy. Therefore, the patient received an additional dose of COVID-19 vaccination in error. Patient received an influenza vaccination today in addition to the Pfizer COVID-19 vaccine.  I called and spoke with the patient's mother and and disclosed the vaccination error on 10/12/22 at approximately 3:20 PM. I also after spoke with a representative from the CDC and provided mother with a list of common side effects to monitor/call for based on their recommendations. At the time of the phone call, mother did not disclose any side effects. I discussed with mother that I will call the family for an update and advised for family to call at any time if side effects are experienced and offered for family to return to office for further discussion and/or evaluation in the next week.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia, Sciatica
Clinical narrative: Started feeling sciatic nerve pain in right side of body, mainly with arm and foot.  Called Dr and she said they were nerve symptoms. Has a history of Nerve Pain, Dr. advised to take prescribed Muscle Relaxers. Was told to give it time and see if it resolved and it did.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Paraesthesia oral
Clinical narrative: Patient stated her tongue felt tingly. She took a dose of 25mg of liquid benadryl. Within a minute, the atient stated it was no longer tingling. She also stated she gets nervous with shots and may just be worked up. She stated she had the initial moderna series and had no problem. The patient waited an additional 15 minutes and stated she felt nothing concerning at that time. She denied any oral swelling or difficulty breathing.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event, Vaccine was freezed and then thaw before using. Per CDC that was incorrect so we need to report as not good and notify our patients.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Gait inability, Immunisation reaction, Pain in extremity
Clinical narrative: Pt. called the pharmacy 10-12-22 and said she wanted to be sure she did the right thing in letting us know she experienced an adverse effect from her yearly flu shot.  She had the shot on 10-08-22 and said that about 24 hours later she had left leg  (especially upper part of leg) and left knee pain.  She took several doses of Tylenol and Aleve throughout the next few days.  She said she was unable to walk. The pain resolved by 10-11-22 and she was again able to walk.  She routinely walks 3 miles per day for exercise.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neuralgia, Pain in extremity, Sciatica
Clinical narrative: Felt left finger nerve pain with back stiffness. Sciatic pain in both feet.  Didn't see Dr. Tried to relieve pain with exercise.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered
Age: 9.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Expired product administered
Clinical narrative: Vaccine was pulled from our fridge with a BUD date of 10/31 and administered. Later that day we received a notice from our corporate that the lot used was short-dated by the manufacturer and expired on 9/30 regardless of when it was placed in our fridge.
Age: 14.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest pain, Electrocardiogram abnormal, Palpitations
Clinical narrative: Patient reported heart palpitations and mild chest pain in the week following the booster, so we went to our primary care doctor. They did an EKG in the office and told us that it showed signs of pericarditis. They told us that unless he felt additional pain, we did not need to treat but should monitor him for any shortness of breath. We do not yet know if it has resolved. We have an appointment 6 weeks out for a follow up EKG.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received communication from Home Office that vaccine could be potentially short-dated and expired at the time of administration
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Muscle spasms, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: After dose 1 and dose 2 of my  initial vaccines I  started having  pain in my lower part of the body   including legs, limbs,  arms, lower back, toes and muscles cramps.  I never had this pain before.  It wasn't severe . As time went by after getting my 3rd dose the pain increased  I went to  my doctor to tell him that it is very painful. My doctor told me that there is nothing to worry about the pain is not related to the vaccine. He just told me to relax and the pain will go away by it's own.  I never had this pain before so, I decided to see an Orthopedic because my toes was hurting . The Orthopedic  prescribed me diclofenac  and also advised me to take Tylenol as needed .
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Vaccine administered for second time by mistake. Patient reports no signs or symptoms of adverse events
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Injury, Nervous system disorder, Reflex test normal
Clinical narrative: Saw Dr and was given a brief Neurological Reflex test with Normal results; Dr thinks my nerve problems could have exacerbated the injury I had in 2009.
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mechanical urticaria, Urticaria
Clinical narrative: Acute urticaria with dermatographism x 21 days and ongoing, onset 12 days after receiving Moderna bivalent booster. Took ceterizine 2x daily for two weeks, then took ceterizine 2x plus famotidine 1x for one week.  Plan is to add hydroxyzine 4x daily, plus ceterizine, plus famotidine. If urticaria and dermatographism does not resolve, will take presnisone in addition to antihistamines as described.
Age: 1.08
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Expired product administered
Clinical narrative: No adverse event, It was an administration error, MMR was given on 10/10/22 and after it was given, expiration date was noted as 10/08/2022, so it had expired 2 days prior to being given.  Father was contacted and child is fine, no adverse event occurred. No clinic visit was required but patient will receive MMR again at next visit age 15 months, father is agreeable, as a result of this error, extra training was conducted at todays staff meeting for preventing future administration errors
Age: 31.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Menstruation delayed
Clinical narrative: Delayed in menstrual cycle by 8 days
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: NO ADVERSE.  Reporting administration error only.  Patient was given expired vaccine.  FK5618 expired on 08/31/2022 according to Pfizer website.  But, vial with that LOT# was given to patient on 09/09/2022.  Pfizer had no guidance.  Per CDC administration errors algorithm, patient was rescheduled for re-vaccination.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered his second dose of COVID-19 Pfizer BioNTech for ages 5-11 years (NDC: 59267-1055-04) on 10/07/2022, and the Lot number (FL2757)used expired on 9/30/2022.
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Joint swelling, Pain in extremity
Clinical narrative: Sever arm pain that dissipated within 36 hours. Persistent  pain and swelling in left ankle that continues as of date/time of report
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Asthenia, Cardiac disorder, Depression, Fear
Clinical narrative: Just assuming this is one adverse event, not multiple Woke up at 2AM thirsty; got up got water felt weak got back to bed. Discovered my oxygen reading on a pulse oximiter was 77 and pulse was 79. My understanding is I shouldn't have been walking with that reading but I was. Was too weak to work the rest of the week. For the next three weeks my pulse was over 100 for walking around the house. oxygen reading was over 94 and thus I didn't note the exact value. I sought some help after the second week and got an answer of I think the vaccine set your covid recovery back.  I seemed to get better, went on my scheduled vacation for middle of September, found I was still much weaker than my normal self, came back, and slowly lost ground. I'm weaker now and am on over the counter sleep aid melatonin. I struggle to get enough sleep, I struggle to get work done. My heart surges at the slightest provocation, and my stress handling is completely shot.  I have actually been afraid to go into the doctor's office because my primary care physician originally thought it was depression, which I can disprove to myself and made multiple attempts to have it treated by mental health. It is probable I have depression, but that's not the primary cause here.