chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Right hand hand was red; Right hand swelling; 4 days after my bivalent booster dose my right hand started to hurt; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Right hand hand was red), PERIPHERAL SWELLING (Right hand swelling) and PAIN IN EXTREMITY (4 days after my bivalent booster dose my right hand started to hurt) in an 84-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     Concomitant products included DILTIAZEM for an unknown indication.    On 19-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Sep-2022, the patient experienced ERYTHEMA (Right hand hand was red), PERIPHERAL SWELLING (Right hand swelling) and PAIN IN EXTREMITY (4 days after my bivalent booster dose my right hand started to hurt). The patient was treated with DICLOFENAC DIETHYLAMINE (VOLTAREN [DICLOFENAC DIETHYLAMINE]) for Pain in hand, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Right hand hand was red), PERIPHERAL SWELLING (Right hand swelling) and PAIN IN EXTREMITY (4 days after my bivalent booster dose my right hand started to hurt) was resolving.            Patient had 1st Dose of Moderna COVID-19 vaccine on 02-Jan-2021 with Lot number 011L20A. Patient had 2nd Dose of Moderna COVID-19 vaccine on 29-Jan-2021 with Lot number 029K20A. Patient had 1st Booster Dose on 07-Aug-2021 with Lot number 042B21-2A. Patient had 2nd Booster Dose on 04-APR-2021 with Lot number of 042S21. Patient placed treatment medication on the hand and that reduced the pain. After application of treatment medication on right hand, Patient felt a lot better (ninety percent better). Patient hand swelling and redness in hand was not all gone, but it was much better now. Patient stated that the redness in hand was fading.   This case was linked to MOD-2021-214543 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Live follow up was received on 26-Sep-2022. I-Narrative Supplement was updated.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Today, a dose of 0.25mL of the new Moderna Covid-19 Bivalent was given to a patient, instead of the 0.5mL dose.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Today, a dose of 0.25mL of the new Moderna Covid-19 Bivalent was given to a patient, instead of the 0.5mL dose.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Today, a dose of 0.25mL of the new Moderna Covid-19 Bivalent was given to a patient, instead of the 0.5mL dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Today, a dose of 0.25mL of the new Moderna Covid-19 Bivalent was given to a patient, instead of the 0.5mL dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Today, a dose of 0.25mL of the new Moderna Covid-19 Bivalent was given to a patient, instead of the 0.5mL dose.).    No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: given bivalent booster for the 1st dose primary series; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (given bivalent booster for the 1st dose primary series) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (given bivalent booster for the 1st dose primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (given bivalent booster for the 1st dose primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (given bivalent booster for the 1st dose primary series).    No concomitant medication information provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Patient had a slight headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Patient had a slight headache) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Patient had a slight headache). At the time of the report, HEADACHE (Patient had a slight headache) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: After first dose patient experienced a very very little fatigue during 48 hours; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (After first dose patient experienced a very very little fatigue during 48 hours) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve replacement (Recent change in status such as improvement or worsening: same). Concurrent medical conditions included Enlarged prostate (Condition was worsening.) since 1990, Blood pressure high (Recent change in status such as improvement or worsening: same) and High cholesterol (Recent change in status such as improvement or worsening: same). Concomitant products included WARFARIN, ATORVASTATIN and HYDROCHLOROTHIAZIDE, LISINOPRIL (ZESTORETIC) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced FATIGUE (After first dose patient experienced a very very little fatigue during 48 hours). On 31-Jan-2021, FATIGUE (After first dose patient experienced a very very little fatigue during 48 hours) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient did not have any allergies related to medications, food and other products. Patient never tested positive or diagnosed with COVID. After first dose patient experienced a very very little fatigue during 48 hours.   This case was linked to MOD-2022-651167, MOD-2022-651184 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received first dose on 24Apr2021 and second dose on 22Jul2021.; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 24Apr2021 and second dose on 22Jul2021.) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 026L20A) for COVID-19 prophylaxis.     The patient's past medical history included Tinnitus, Cancer (cancer twice) and Shoulder arthritis. Concurrent medical conditions included Type 2 diabetes mellitus and Asthma (taking medication/ inhalers for the asthma.).   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 24Apr2021 and second dose on 22Jul2021.) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 24Apr2021 and second dose on 22Jul2021.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            It was reported that patient took medication and inhaler for asthma.  No treatment medication were provided.   This case was linked to MOD-2022-651284, MOD-2022-651253 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Constipation, Eating disorder, Functional gastrointestinal disorder, Immune system disorder, Muscle spasms
Clinical narrative: thymus spasm; took the immune response/their immune system was unable to deal with something they normally have.; all intestinal functions stopped; 100% constipation/utter shut down; stopped eating/just eating liquids; cold from hell/the cold was affecting his lungs; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (thymus spasm), IMMUNE SYSTEM DISORDER (took the immune response/their immune system was unable to deal with something they normally have.), FUNCTIONAL GASTROINTESTINAL DISORDER (all intestinal functions stopped), CONSTIPATION (100% constipation/utter shut down) and EATING DISORDER (stopped eating/just eating liquids) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient do not having any medical conditions or being on any medication prior to the vaccine.     On 27-Jan-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2022, the patient experienced NASOPHARYNGITIS (cold from hell/the cold was affecting his lungs). On an unknown date, the patient experienced MUSCLE SPASMS (thymus spasm), IMMUNE SYSTEM DISORDER (took the immune response/their immune system was unable to deal with something they normally have.), FUNCTIONAL GASTROINTESTINAL DISORDER (all intestinal functions stopped), CONSTIPATION (100% constipation/utter shut down) and EATING DISORDER (stopped eating/just eating liquids). At the time of the report, MUSCLE SPASMS (thymus spasm), IMMUNE SYSTEM DISORDER (took the immune response/their immune system was unable to deal with something they normally have.), FUNCTIONAL GASTROINTESTINAL DISORDER (all intestinal functions stopped), CONSTIPATION (100% constipation/utter shut down) and EATING DISORDER (stopped eating/just eating liquids) outcome was unknown and NASOPHARYNGITIS (cold from hell/the cold was affecting his lungs) was resolving.            Patient received Bivalent booster dose. No concomitant medications was reported. On the 21-Sep-2022 they had a orthopedic appointment and everything was just fine. Patient says the events are starting to recover. Patient tried different laxatives and enemas for the intestinal stop. Patient had to go on nebulizer because the cold was affecting his lungs, patient has taken different herbal approaches like tea, honey and ephedra.  Patient don't think its the vaccine that caused the cold but took the immune response.   This case was linked to MOD-2022-651522, MOD-2021-032238 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: thymus spasm; took the immune response/their immune system was unable to deal with something they normally have.; all intestinal functions stopped; 100% constipation/utter shut down; stopped eating/just eating liquids; cold from hell/the cold was affecting his lungs; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (thymus spasm), IMMUNE SYSTEM DISORDER (took the immune response/their immune system was unable to deal with something they normally have.), FUNCTIONAL GASTROINTESTINAL DISORDER (all intestinal functions stopped), CONSTIPATION (100% constipation/utter shut down) and EATING DISORDER (stopped eating/just eating liquids) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient do not having any medical conditions or being on any medication prior to the vaccine.     On 27-Jan-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2022, the patient experienced NASOPHARYNGITIS (cold from hell/the cold was affecting his lungs). On an unknown date, the patient experienced MUSCLE SPASMS (thymus spasm), IMMUNE SYSTEM DISORDER (took the immune response/their immune system was unable to deal with something they normally have.), FUNCTIONAL GASTROINTESTINAL DISORDER (all intestinal functions stopped), CONSTIPATION (100% constipation/utter shut down) and EATING DISORDER (stopped eating/just eating liquids). At the time of the report, MUSCLE SPASMS (thymus spasm), IMMUNE SYSTEM DISORDER (took the immune response/their immune system was unable to deal with something they normally have.), FUNCTIONAL GASTROINTESTINAL DISORDER (all intestinal functions stopped), CONSTIPATION (100% constipation/utter shut down) and EATING DISORDER (stopped eating/just eating liquids) outcome was unknown and NASOPHARYNGITIS (cold from hell/the cold was affecting his lungs) was resolving.            Patient received Bivalent booster dose. No concomitant medications was reported. On the 21-Sep-2022 they had a orthopedic appointment and everything was just fine. Patient says the events are starting to recover. Patient tried different laxatives and enemas for the intestinal stop. Patient had to go on nebulizer because the cold was affecting his lungs, patient has taken different herbal approaches like tea, honey and ephedra.  Patient don't think its the vaccine that caused the cold but took the immune response.   This case was linked to MOD-2022-651522, MOD-2021-032238 (Patient Link).
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Flushing, Pallor, Rash, Rash macular
Clinical narrative: baby developed facial flushing/rash to face/head only. Erythematous macular areas that blanched; baby developed facial flushing/rash to face/head only. Erythematous macular areas that blanched; baby developed facial flushing/rash to face/head only. Erythematous macular areas that blanched; baby developed facial flushing/rash to face/head only. Erythematous macular areas that blanched; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-Jul-2022 with the following VAERS Primary ID 2222724-1. The original narrative from the sender is the following:  Baby developed facial flushing/rash to face/head only. Erythematous macular areas that blanched/ had normal interaction, normal respiratory exam and continued to act normally. heart rate and 02 sat remained normal, redness/rash resolved over 15 min. Mom and grandmother noted he had now had a flushing reaction like this to precious vaccines and the vaccines were the exact same at his 2 and 4 moth well child exams.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13
Symptoms: Urticaria
Clinical narrative: About 10-15 min after vaccines on the way out patient developed defuse urticaria to face and chest; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2302595-1. The original narrative from the sender is the following:  About 10-15 min after vaccines on the way out patient developed defuse urticaria to face and chest.  8 mg  dexamethasone given and monitored in office with resolution of urticaria after about 45 min.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "defuse urticaria to face and chest".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMR
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Wrong product administered
Clinical narrative: Vaccine given in error; No adverse reaction to vaccine; This non-serious case was received during the Reporting System monitoring on 12-JUL-2022 with the following Primary ID 2307076-1. The original narrative from the sender is the following:  Vaccine given in error. Order was for Varicella (Varivax) which was misread and Dtap IPV HIb HepB (Vaxelis) administered. Pt had no adverse reaction to vaccine and will receive correct vaccine during 15 month well child check.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Vaccine given in error".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Irritability, Pyrexia
Clinical narrative: irritability; Fever Tmax 104; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2307092-1. The original narrative from the sender is the following:  Fever Tmax 104 and irritability.
Sex: F
Vaccine: DTPPVHBHPB, HIBV, PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: While checking inventory that Pediarix was documented as given, but vaxelis was actually adminstered; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2312794-1. The original narrative from the sender is the following:  No adverse reaction was reported. It was discovered on 6/1/2022 while checking inventory that Pediarix was documented as given, but Vaxelis was actually administered.  Baby received 2 doses of Hib in error. Mother/guardian of child was telephoned on 6/1/2022, at number provided in patient's record, but message "not accepting calls" was received. Her voice mail box was full, so no message was left.
Sex: F
Vaccine: DTPPVHBHPB, HIBV, PNC13
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Wrong product administered
Clinical narrative: While checking inventory that Pediarix was documented as given, but vaxelis was actually adminstered; Received 2 doses of Hib in error; No adverse reaction was reported; This non-serious case was received during the Reporting System monitoring on 12-JUL-2022 with the following Primary ID 2312795-1. The original narrative from the sender is the following:  No adverse reaction was reported. It was discovered on 6/1/2022 while checking inventory that Pediarix was documented as given, but Vaxelis was actually administered.  Baby received 2 doses of Hib in error. Mother/guardian of child was telephone on 6/1/2022, at number provided in patient's record, but message ""not accepting calls"" was received. Her voice mail box was full, so no message was left.
Age: 1.92
Sex: M
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: His vaccine sites on his thighs were indurated, itching, and erythematous.; His vaccine sites on his thighs were indurated, itching, and erythematous.; His vaccine sites on his thighs were indurated, itching, and erythematous.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2260423-1. The original narrative from the sender is the following:  Patient received vaccines listed above on 26-APR-2022.  He presented to the clinic 02-MAY-2022.  His vaccine sites on his thighs are indurated , itching, and erythematous.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported event "His vaccine sites on his thighs are indurated , itching, and erythematous."  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Vaccination error
Clinical narrative: Thought I needed to give the patient vaxelis. Misunderstood the NP orders.; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2290529-1. The original narrative from the sender is as below:  Thought I needed to give the patient vaxelis. Misunderstood the NP orders. Child didn't have no reaction or distress after the vaccine was administered. Pt mother was aware of the vaccine given.
Sex: M
Vaccine: DTAPIPVHIB, DTPPVHBHPB, PNC13, RV5
Symptoms: Extra dose administered
Clinical narrative: Patient  came in  for  6 month shots and received pentacel and variax  together  = to  double doses  of  tdap ipv and him; This non-serious spontaneous case was received during the Reporting System monitoring on 12-JUL-2022 with the following Primary ID 2292667-1. The original narrative from the sender is as below:  Patient  came in  for  6 month shots and received Pentacel and variax  together = to  double doses of tdap ipv and him.  Current illness reported as not applicable.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Crying
Clinical narrative: Inconsolable crying; This spontaneous safety report with reference number 02205662 and 02205656 was received by the partner on 15-JUL-2022 and forwarded on 15-JUL-2022 from a physician.  The reporter did not provide the causality assessment between Vaxelis and inconsolable crying.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: No adverse event
Clinical narrative: no adverse reactions noted at visit; This non-serious case was received during the Reporting System monitoring on 12-JUL-2022 with the following Primary ID 2342230-1. The original narrative from the sender is as below:  No adverse reactions noted at visit.  Current illness was reported as none.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Urticaria; This non-serious spontaneous case was received during the Reporting System monitoring on 12-JUL-2022 with the following Primary ID 2317412-1. The original narrative from the sender is as below:  Pt. had the above vaccines, awakened 24hrs later with hives over entire body, went to ER and received steroids and antihistamine. Resolved within 2 days. Mom had also given regular whole milk the same day as shots because of the formula shortage. Possible reaction to milk
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PPV, RVX
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever 105F after VAXELIS vaccine and vomiting; Fever 105F after VAXELIS vaccine + vomiting; This non-serious spontaneous Safety Report, with reference numbers 02208144/02208142, was received on 19-JUL-2022 and forwarded on 20-JUL-2022 from a physician.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "fever".  No further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 07-SEP-2022 and forwarded on 09-SEP-202. Additional information was received on 12-SEP-2022.  The case is maintained as non-serious.   The reporter assessed the causal relationship between Vaxelis and the reported events "Fever 105F after Vaxelis vaccine and vomiting" as related.  Further information is expected to clarify patient's duration of hospitalization.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC, RV5
Symptoms: Injection site induration, Injection site swelling, Peripheral swelling
Clinical narrative: Leg is also swollen; Bump at the injection site. Bump is hard; This spontaneous safety report, with reference number 2022SA261502, was received on 21-JUL-2022, from a health care professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the events: "Bump at the injection site. Bump is hard" and "Leg is also swollen".  Further information is expected.  For reference purposes the case is linked to MCM-003723 (parent case/ same reporter).
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB, DTPPVHBHPB
Symptoms: No adverse event
Clinical narrative: Both Vaxelis and Pentacel was given to patient at 2 month visit; No adverse reactions were reported.; This non-serious spontaneous safety report with reference number #2022SA321965 was received by a partner on 04-AUG-2022 and forwarded on 05-AUG-2022 from a physician.  The causal relationship between Vaxelis and the reported event "Both Vaxelis and Pentacel was given to patient at 2 month visit; No adverse reactions were reported" is assessed as not applicable due to the nature of the event.  Further information is expected.
Age: 0.5
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Pyrexia
Clinical narrative: High fever (fever was greater than or equal to 102 degrees); This non-serious spontaneous safety report, with reference number 2022SA294152 was received by a partner on 19-JUL-2022 and forwarded on 24-AUG-2022 from a physician.   The reporter did not assess the causal relationship between Vaxelis and the reported event of "High fever (fever was greater than or equal to 102 degrees)".  No further information is expected.  NON SIGNIFICANT FOLLOW UP INFORMATION was forwarded by the partner with reference number: 2022SA354686 on 26-AUG-2022. The case is maintained as non-serious.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of "High fever (fever was greater than or equal to 102 degrees)".   Further information is expected.  For reference purposes, this case is linked to MCM-003948 (same reporter).
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Pyrexia
Clinical narrative: Fever; This non-serious spontaneous safety report with reference number 2022SA351274 was received by a partner on 23-AUG-2022 from a health care professional, and forwarded on 24-AUG-2022.  The reporter did not provide an assessment of the causal relationship between Vaxelis and "Fever".   No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Nurse calling for TE evaluation on refrigerated products state 3 doses of Vaxelis in PFS involved in this excursion have been administered to patients; This spontaneous safety report, with interaction number 02237963, was received by the partner on 01-SEP-2022 and forwarded to Agency on 02-SEP-2022, from a health professional.  Due to the nature of the event, the causality between the event "Nurse calling for TE evaluation on refrigerated products state 3 doses of Vaxelis in PFS involved in this excursion have been administered to patients; VAXELIS :Temperature/Time frame (48.2F) for 6 hours 40 minutes", and Vaxelis was not applicable.  Further information is expected.  For reference purposes cases is linked to: MCM-003974 and MCM-003975.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Nurse calling for evaluation on refrigerated products states 3 doses of VAXELIS in PFS involved in this excursion have been administered to patients; This spontaneous safety report, with interaction number 02237963 (case# 02238021), was received by the partner on 01-SEP-2022 and forwarded on 02-SEP-2022, from other health professional.  Due to the nature of the event, the causality between the event "Nurse calling for evaluation on refrigerated products states 3 doses of VAXELIS in PFS involved in this excursion have been administered to patients; VAXELIS :Temperature/Time frame (48.2F) for 40 minutes", and Vaxelis was not applicable.  Further information is expected.  For reference purposes, cases is linked to MCM-003999 and MCM-003974 (same reporter).
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Nurse calling for TE evaluation states 3 doses of VAXELIS in PFS involved in the excursion have been administered to patients; This non-serious spontaneous safety report reference #02238017/ interaction #02237963 was received by a partner on 01-SEP-2022 from a Nurse, and forwarded on 02-SEP-2022.  Due to the nature of the event, the causality between Vaxelis and the reported event of "Nurse calling for TE evaluation states 3 doses of VAXELIS involved in the excursion have been administered to patients" was not applicable.  Further information is expected.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Pyrexia
Clinical narrative: fever that was "100.4F or a little higher"; This non-serious spontaneous Safety Report, with reference numbers 02239599/02239593, was received by partner on 02-SEP-2022 and forwarded to Agency on 05-SEP-2022 from a Nurse.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "fever".  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Cough, Feeling abnormal, Pyrexia, Vomiting
Clinical narrative: Cough; 102.4F Fever; Vomiting; Seemed a bit fuzzy; This non-serious spontaneous safety report, with case number 02239608/02239593, was received by partner, on 02-SEP-2022 and forwarded to agency on 05-SEP-2022 from a consumer.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Fuzzy, Cough, Fever, and Vomiting".  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PPV
Symptoms: Crying, Diarrhoea, Pyrexia
Clinical narrative: Crying excessively; He got diarrhea five times; High fever; This non-serious spontaneous safety report with reference number # 02222997( Interaction # 02222985) was received by a partner on 23-AUG-2022 and forwarded on 20-SEP-2022 from a physician.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events of "He got diarrhea five times, high fever and crying excessively".  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Pyrexia
Clinical narrative: Parent reported that their baby had a fever for about a week; This non-serious spontaneous safety report, with reference number 02250753, was received by a partner on 20-SEP-2022 and forwarded on 21-Sep-2022, from a Health Professional via employee.   The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Parent reported that their baby had a fever for about a week".  No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Poor quality product administered, Product administration error
Clinical narrative: Muscle ache; Fatigue; The vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. Vaccine that was administered to 5 patients while the vaccine was expired.; The vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. Vaccine that was administered to 5 patients while the vaccine was expired.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 2022, outcome "unknown" and all described as "The vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. Vaccine that was administered to 5 patients while the vaccine was expired."; MYALGIA (non-serious), outcome "unknown", described as "Muscle ache"; FATIGUE (non-serious), outcome "unknown".  Additional information: Caller was asking about the gray cap vaccine. The vaccine was expired and was administered to 5 patients. Caller mentioned that she was going to report this to VAERS and wants to check on what to do next. She said that this vaccine has an expiration date of 15Jun2022. Caller said at least that helps with one patient and all the patients were similar. No one of the 5 really had adverse reaction to the expired doses though 3 did report they had several days of side effects - so they thought event though expired that the vaccine had some effect on their sometimes muscle aches, fatigue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (18Aug2022): This is a spontaneous follow-up report received from a contactable Other-HCP. Program ID. Updated information included: Reporter information updated (Address, city, state added. Phone Number updated for primary reporter).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (26Sep2022): New information received from the same contactable other HCP. Updated information includes new events (Fatigue, muscle ache).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201070713 Same reporter/drug/event, different patient;US-PFIZER INC-202201093830 Same reporter/drug/event, different patient;US-PFIZER INC-202201098081 Same reporter/drug/event, different patient;
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: Tested Positive for Covid 19 after having 5 doses of the Pfizer Covid 19; Tested Positive for Covid 19 after having 5 doses of the Pfizer Covid 19; Extreme Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH6964) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Continuing: Yes. Concomitant medication(s) included: FINASTERIDE (ongoing); TAMSULOSIN (ongoing); QVAR taken for asthma (ongoing). Vaccination history included: BNT162b2 (first dose; lot: EK9231), administration date: 11Jan2021, when the patient was 70-year-old, for Covid-19 Immunization; BNT162b2 (second dose; lot:: EL9262), administration date: 01Feb2021, when the patient was 70-year-old, for Covid-19 Immunization; BNT162b2 (first booster dose; lot: EW0185), administration date: 29Aug2021, when the patient was 70-year-old, for Covid-19 Immunization; BNT162b2 (second booster dose; lot: FJ9943), administration date: 04Apr2022, when the patient was 71-year-old, for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 20Sep2022, outcome "not recovered", described as "Extreme Dizziness"; OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "Tested Positive for Covid 19 after having 5 doses of the Pfizer Covid 19". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2022 at 14:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 78 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mitrovalve prolapse" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Known allergies: demerol, reaction(s): "Known allergies: Demerol". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Sep2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19; began COVID 19 treatment PAXLOVID from 09Sep2022 to 13Sep2022. Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 14:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 81 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Jan2021 at 12:00 as dose 1, single (Lot number: EL1283), on 01Feb2021 at 13:00 as dose 2, single (Lot number: EL9264), in left arm, on 29Aug2021 at 16:00 as dose 3 (booster), single (Lot number: EW01n) and on 08Mar2022 at 14:30 as dose 4 (booster), single (Lot number: FK9895), in right arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid removed 2009", start date: 2009 (unspecified if ongoing), notes: otherwise good health for age. Concomitant medication(s) included: LEVOXYL; ATENOLOL; SIMVASTATIN, stop date: 08Sep2022; OCUVITE [ASCORBIC ACID;BETACAROTENE;COPPER;TOCOFERSOLAN;ZINC], start date: 24Aug2022; BAUSCH&LOMB, start date: 24Aug2022; MATURE MULTIVITAMINS and Kirkand. Past drug history included: Naproxyn, reaction(s): "Allergies: naproxyn". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: Other medical history: Mild asthma. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Treatment of COVID-19; (22Sep2022) Positive, notes: Reoccurrence of symptoms at day 10 - 6 days after completing Paxlovid regimen. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient was not taken other medication within 2 weeks. The patient had no known allergies. Paxlovid was taken as treatment for COVID 19 with start date was 12Sep2022, treatment stop date was 16Sep2022. Reoccurrence of symptoms at day 10 to 6 days after completing Paxlovid regimen.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Ear infection, Rash
Clinical narrative: Slight rash" from ear drops/Rash on her neck and chin, and also a slight rash on "My chest and tummy; Ear infection; She was not sure if it is an allergy or not; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team, Program ID: The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization; Bnt162b2 (Dose 2, single), for COVID-19 Immunization. The following information was reported: EAR INFECTION (non-serious) with onset Sep2022, outcome "unknown"; DRUG HYPERSENSITIVITY (non-serious) with onset Sep2022, outcome "unknown", described as "She was not sure if it is an allergy or not"; RASH (non-serious) with onset Sep2022, outcome "recovered" (Sep2022), described as "Slight rash" from ear drops/Rash on her neck and chin, and also a slight rash on "My chest and tummy". Therapeutic measures were taken as a result of rash, ear infection.  Additional information: She recently was prescribed eardrops for an ear infection. She developed a "slight rash" from ear drops, (Neomycin Polymyxin), 10th day taking the ear drops she stopped using them because she noticed a rash on her neck and chin, and also a slight rash on her chest and tummy. She took Benadryl and it went away. She was not sure if it is an allergy or not, and she had an appointment with an allergist to find out.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Wrong product administered
Clinical narrative: About 5 days after vaccine came down with ear ache; Other vaccine same date dose number=4, lot number=fk9894; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: gh9694) at the age of 73 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 08Sep2022 as dose 4 (booster), single (Lot number: fk9894) at the age of 73 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Heart failure" (unspecified if ongoing); "CKD" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: COVID-19 vaccine (Primary immunization complete; Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 08Sep2022, outcome "unknown", described as "Other vaccine same date dose number=4, lot number=fk9894"; EAR PAIN (non-serious) with onset 13Sep2022, outcome "recovering", described as "About 5 days after vaccine came down with ear ache". The event "about 5 days after vaccine came down with ear ache" required physician office visit. Therapeutic measures were taken as a result of ear pain.  Additional information: The patient had no other vaccine in four weeks and was taking multiple other medications in two weeks. The patient received Amoxicline 870mg as treatment for the events. The patient had no COVID prior vaccination, was not tested for COVID post vaccination, and had no known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 34 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 14Jan2021 as dose 2, single (Lot number: EL1283), in left arm and on 25Sep2021 as dose 3 (booster), single (Lot number: 301558A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "OSA" (unspecified if ongoing), notes: OSA with CPAP; "CPAP" (unspecified if ongoing), notes: OSA with CPAP; "GERD" (unspecified if ongoing), notes: Well controlled GERD on medications. Concomitant medication(s) included: CLARITINE, stop date: 12Sep2022; PRILOSEC [OMEPRAZOLE MAGNESIUM], stop date: 12Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (23Sep2022) Positive, notes: Positive antigen test; (25Sep2022) Positive, notes: Positive antigen test. Continued positive antigen tests now 2 days out from initial rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 14Sep2022 to 19Sep2022.; Sender's Comments: Based on the information currently available, a lack of efficacy with COVID 19 vacccines in this patient cannot be completely excluded.