chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Boostrix given by mistake instead of HepB vaccine; Inappropriate age at vaccine administration; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 1-day-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3JS9E, expiry date 18th March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th June 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 29th June 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-JUN-2022. Reporter's Comments: The patient was administered Boostrix by mistake instead of Engerix B. The Vaccine Administration Facility was the same as Primary Reporter. The reporter mentioned that all babies were listed the same. No real initials were reported. The reporter did not consented to follow up. Additional Supportive Information: The one year old patient received Boostrix instea of Engerix B, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Received pediatric dose instead of adult; Rceived pediatric dose instead of adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 52-year-old male patient who received HBV (Engerix B pediatric) (batch number 5DN72, expiry date 27th December 2022) for prophylaxis.   On 28th June 2022, the patient received Engerix B pediatric. On 28th June 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Linked case(s) involving the same patient:  US2022103250   Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's Comments: The patient received a pediatric dose of the Engerix-B vaccine instead of the adult dose of the Engerix-B vaccine. The reporter was consented to follow up. Additional supportive information: The patient received pediatric dose of the Engerix-B vaccine instead of the adult dose of the Engerix-B vaccine which led to underdose and adult use of child product.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022103250:FU1
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received HAV (Havrix 1440) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th June 2022, the patient received the 1st dose of Havrix 1440 and Havrix Pre-Filled Syringe Device. On 29th June 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's comment: The nurse/ practice manager reported that the patient received an expired Havrix dose. The reporter consented to follow-up via post. Additional Supportive Information: The patient received a dose of Havrix vaccine which was already expired, which led to expired vaccine used.
Age: 66.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received and expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 66-year-old male patient who received HAV (Havrix 1440 adult) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2022, the patient received Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 30th June 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's comment: The medical assistant reported that the patient received an expired Havrix dose. The reporter confirmed vaccine formulation by looking up batch number in database. The reporter consented to follow-up. Additional Supportive Information: The patient received a dose of Havrix vaccine which was already expired, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's Comments: The case was self-reported by the patient. The patient experiencing diarrhea approximately 24 hours after receiving first dose of Shingrix. Till the time of reporting diarrhea had not resolved. The reporter did not consent to follow up.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Accidental overdose, Incorrect dose administered
Clinical narrative: accidentally administering a pediatric dose of Engerix B to an adult; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 21-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2022, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 30th June 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's comments:  The nurse reported accidentally administered a pediatric dose of Engerix B to an adult. The reporter consented to follow up. Additional supportive information: The adult patient was accidentally administered with a pediatric dose of Engerix B which led to accidental underdose.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Middle insomnia, Neck pain, Pain in extremity
Clinical narrative: chills; feeling so poorly; woke up in the middle of the night; arm is killing her it is so sore where she got the vaccine; neck hurts; This case was reported by a consumer via call center representative and described the occurrence of chills in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 54TF4, expiry date unknown) for prophylaxis.   On 29th June 2022 11:00, the patient received the 1st dose of Shingrix. In June 2022, less than a day after receiving Shingrix, the patient experienced nocturnal awakening, pain in arm and neck pain. On 29th June 2022, the patient experienced chills and feels poorly. On an unknown date, the outcome of the chills, feels poorly, pain in arm and neck pain were not recovered/not resolved and the outcome of the nocturnal awakening was unknown.   The reporter considered the chills, feels poorly, pain in arm and neck pain to be related to Shingrix. It was unknown if the reporter considered the nocturnal awakening to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's Comment: The reporter was the patient. The patient received first dose of Shingrix yesterday (the day before reporting) around 11 am (Ante meridiem) into unspecified arm, last night around 8:30 pm (Post meridiem) patient got the worst chills.  The patient reported that the patient put three blankets on top of herself and then decided she had to go to bed because she started feeling so poorly. The chills had not resolved and patient was still having chills on and off. The patient woke up in the middle of the night.  The patient reported that her arm was killing her it was so sore where she got the vaccine, also her neck hurts.  The patient wanted to get off the phone because she felt so poorly. The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain in extremity, Rash, Skin warm, Vaccination failure
Clinical narrative: symptoms seem to reoccur/Suspected vaccination failure; Shingles/It feels like the shingles has returned; left thigh gets warm; aches thigh; Rash; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (shingles outbreak in 2018 on his left leg).   In September 2019, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, skin warm, pain in thigh and rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, skin warm, pain in thigh and rash were not recovered/not resolved.   The reporter considered the vaccination failure, shingles, skin warm, pain in thigh and rash to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's Comments: The case was self reported by the patient. The patient reported that he received both Shingrix shots and he was wondering if he could repeat the series because he indicated that he felt like the vaccine was wearing off for him and explained currently from time to time when he was walking his left thigh gets warm and aches in the area where he previously had shingles. (It felt like the shingles had returned).  The patient reported that his symptoms seem to reoccur. The patient reported that Shingrix did work for a number of years but now it had kind of dropped off. The reporter was not at home at the time of the report therefore he did not have his medical records in front of him.  The patient primary care doctor had retired.  The reporter was willing to provide the contact information if GlaxoSmithKline request it via mail or email.  The reporter indicated his records should still be at the same office since other doctors were still practicing there. The reporter consented to follow up. Additional supportive information: This case was considered as suspected vaccination failure as laboratory test confirmation for shingles was unknown.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: administered Infanrix instead of Boostrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a female patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date unknown batch number.).   On 30th June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's Comment:  The nurse practitioner stated that patient that a 29 year old patient was inadvertently administered the Infanrix vaccine instead of Boostrix at the time of reporting. Additional supportive information The patient received Infanrix vaccine instead of Boostrix, which led to wrong vaccine administered.
Age: 43.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received a dose that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 43-year-old female patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 30th June 2022, the patient received Havrix. On 30th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 30-Jun-2022 Reporters comment:  A clinical operations manager at a clinic reported that a patient received on a dose of Havrix that had expired on 24th May 2022. The reporter consented to follow up. Additional Supportive Information: The patient received Havrix which was already expired in 24th May 2022, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Nausea, Syncope
Clinical narrative: fainted, hospitalized overnight; nauseated, hospitalized overnight; Drug dose administration interval too long; This case was reported by a consumer via call center representative and described the occurrence of syncope in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included vasovagal attack. Concurrent medical conditions included artificial cardiac pacemaker user.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced syncope (serious criteria hospitalization and GSK medically significant), nausea (serious criteria hospitalization) and drug dose administration interval too long. On an unknown date, the outcome of the syncope and nausea were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the syncope and nausea to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-JUL-2022 Reporter's comments: This case was reported by the patient herself. The reporter stated that she received her first dose of Shingrix about four years prior to the reporting. About 12 hours after the dose, she felt nauseated then fainted. The reporter stated that she was hospitalized overnight for monitoring. The reporter stated that this adverse event was reported in May 2018 through Vaccine Adverse Event Reporting System (VAERS). The reporter stated that her cardiologist felt the syncope may have been due to the nausea. The reporter stated that at the time, her primary physician recommended she would not get the second Shingrix dose, the physician was now recommending her to receive second dose, and she plans to get it. The reporter stated that she had nothing else to report. The reporter consented to follow up and also, may follow up with physician. Additional Supportive Information: Vasovagal episodes was reported as Historical drug as Condition Type however the drug was not reported hence captured currently as Historical Condition. The patient plans to get 2nd dose late, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Magnetic resonance imaging breast abnormal
Clinical narrative: MRI of the breast, enlarged left lymph nodes; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th June 2022, the patient received the 1st dose of Shingrix (intramuscular). On 30th June 2022, 90 min after receiving Shingrix, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was not recovered/not resolved.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Shingrix.     Additional Information: GSK Receipt Date: 1st July 2022 Reporters Comments: The reporter was the patient. The patient was high risk group for breast cancer. The patient received Shingrix on an unknown arm. On 30th June 2022, ninety minutes after having vaccine she had a magnetic resonance imaging (MRI) of the breast. The results showed enlarged left lymph nodes.  The patient had nothing else to report. Consented to follow up was granted.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Periorbital swelling, Urticaria
Clinical narrative: swelling around one eye; hives on arms, neck and chest; This case was reported by a pharmacist via call center representative and described the occurrence of periocular swelling in a 85-year-old female patient who received Herpes zoster (Shingrix) (batch number 5H29X, expiry date 6th July 2023) for prophylaxis.   On 30th June 2022, the patient received Shingrix. On 30th June 2022, less than a day after receiving Shingrix, the patient experienced periocular swelling and hives. On an unknown date, the outcome of the periocular swelling and hives were unknown.   It was unknown if the reporter considered the periocular swelling and hives to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-JUL-2022. Reporter's Comments: The patient had hives on her arms, neck and chest. The patient also had swelling around one of her eyes. Outside phone number for GlaxoSmithKline Medical Information given for future reference and warm transfer provided. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose 21Aug2021 / 2nd dose 27Sep2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 3BE39, expiry date 8th April 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 27th September 2021, the patient received the 2nd dose of Shingrix. On 27th September 2021, 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: 01-JUL-2022 Reporter's Comments: The pharmacist reported that the patient inadvertently received second dose of Shingrix early. The pharmacist reported that the patient was not immunocompromised.  The pharmacist reported that the patient did not have any side effects.  The reporter gave permission for follow up, reported that she did not have email address to provide. The reporter consented to follow up. Additional Supportive Information: The patient received the Shingrix dose earlier than the recommended interval, which led to shortening of vaccination schedule.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF THE JNJ COVID 19 VACCINE, 24 HOURS TO 5 DAYS AFTER VIAL BEING PUNCTURED; INCORRECT PRODUCT STORAGE; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. The drug was associated with Medication error. No concomitant medications were reported. On an unspecified date, the patient experienced administration of the JNJ covid 19 vaccine, 24 hours to 5 days after vial being punctured, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of the JNJ covid 19 vaccine, 24 hours to 5 days after vial being punctured and incorrect product storage was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac pacemaker insertion
Clinical narrative: ON A PACEMAKER; This spontaneous report received from a consumer via other manufacturer (Pfizer) concerned a male of unspecified age, race and ethnicity. 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: unknown and expiry: unknown) dose was not reported, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter's brother-in-law got on a pacemaker. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of on a pacemaker was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220701757-covid-19 vaccine ad26.cov2.s-on a pacemaker. 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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: FATIGUE; ARM SORENESS AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 73 year old female. 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: 1805018 expiry: 20-JAN-2022) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced fatigue, and arm soreness at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and arm soreness at the injection site. This report was non-serious. This case, involving the same patient is linked to 20220702579.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dysgeusia, Palpitations, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; STOMACH ACHE; HEART PALPITATIONS; METALLIC TASTE/RUINED SENSE OF TASTE COMPLETELY; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 67 year old female.  The patient's height, and weight were not reported. The patient's concurrent conditions included: anxiety, sleeplessness, and antibiotics allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21 expiry: unknown), dose was not reported, 1 total administered on 11-MAY-2021 at 13:15 on left arm for prophylactic vaccination. Age at time of vaccination 65 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection and had suspected clinical vaccination failure, The patient was prescribed with non-company suspect drug Paxlovid (form of admin and route of admin were not reported, batch number: GC4035, expiry: Unknown) does not reported, administered first dose on 21-JUN-2022 for covid-19.  On 21-JUN-2022 at 22:45, patient immediately had the metallic taste side effect and it ruined sense of taste completely and had stomach ache, heart palpitations and headache.  Treatment with Paxlovid was stopped on 22-JUN-2022. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stomach ache, headache, heart palpitations, metallic taste, ruined sense of taste completely, suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint (PQC).; Sender's Comments: V0:20220706508-COVID-19 VACCINE Ad26.COV2.S-suspected 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.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient (health care professional) via other manufacturer (Pfizer ) concerned a 23 year old female.  The patient's height, and weight were not reported. Patient was other healthcare professional. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered on 12-APR-2021 for prophylactic vaccination. Age at time of vaccination 22 years old. The batch number was not reported and has been requested. Concomitant medications included Plaqnil (hydroxychloroquine phosphate) for drug use for unknown indication. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received non-company suspect vaccine Pfizer Biontech Covid-19 vaccine (tozinameran) (dose number in series 2) form of administration, route of administration, batch number and expiry were not reported), dose was not reported, start therapy date was not reported, administered on 29-OCT-2021 for prophylactic vaccination. Age at time of vaccination 22 years old. It was unknown whether patient had any adverse events following vaccination with second dose of covid-19 vaccine ad26. cov2.s (dose number in series 2). The patient additionally received non-company suspect vaccine Pfizer Biontech Covid-19 vaccine (tozinameran) (dose number in series 3) form of administration, route of administration, batch number and expiry were not reported, dose was not reported, start therapy date was not reported, administered on 30-APR-2022 for prophylactic vaccination. Age at time of vaccination 23 years old. On 07-JUN-2022, the patient tested positive for covid-19 infection and started treatment with Paxlovid (dose number in series 3). The patient was prescribed with non-company drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered first dose on 07-JUN-2022 and last dose on 11-JUN-2022 for covid-19 treatment. On 11-JUN-2022, patient tested negative with covid-19 test (dose number in series 3). From 12-JUN-2022 to 21-JUN-2022, the patient tested negative everyday (dose number in series 3). On 22-JUN-2022, the patient tested positive for 22-JUN-2022 (dose number in series 3). The action taken with tozinameran and tozinameran was not applicable. The patient had not recovered from covid-19 test positive. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID 19 VIRUS TEST POSITIVE; This spontaneous report received from a patient via a company representative concerned a female 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 prophylactic vaccination. 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, the patient experienced covid 19 virus test positive. Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid 19 virus test positive was not reported. This report was non-serious. This report was associated with product quality complaint 90000241173.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE reported; received her 1st dose of GARDASIL 9 in Aug2018, 2nd dose in Nov2019; This spontaneous report was received from a consumer and refers to a 15-year-old female patient.  The patient's medical history, historical drugs, concurrent conditions and concomitant therapies were not reported.   On an unknown date in August 2018, the patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered as prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in November 2019 the patient received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered as prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (inappropriate schedule of product administration) and at the time of reporting she has not received her 3rd dose (no adverse event).
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; HCP calling in to report that VARIVAX was administered to a patient before recognizing that the vaccine was expired.; This spontaneous report was received from a pharmacist, regarding a 41-year-old female patient. Her medical history, concurrent condition, and concomitant therapies were not reported.   On 29-JUN-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (VARIVAX) 1 time dose (dosage regimen, anatomical location, and route of administration were not provided), valid lot# 010308, expiration date: 24-MAR-2022, administered as prophylaxis (expired product administered). It was reported that the patient was unaware of this situation.  The reported stated there were no know adverse reported (no adverse event).
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (He mentioned he was vaccinated with the Pfizer and Moderna vaccines and now he has Covid) in a 69-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. Concurrent medical conditions included Blood pressure high. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (He mentioned he was vaccinated with the Pfizer and Moderna vaccines and now he has Covid). At the time of the report, COVID-19 (He mentioned he was vaccinated with the Pfizer and Moderna vaccines and now he has Covid) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. The patient had rebound and the second case was much worse than the first. The patient had not started Paxlovid and had been prescribed. The patient talked to doctor and stated he did not have all the herbal supplements he was taking and the biggest thing was the rebound. The patient would like to double check if herbal supplements would have any reaction to Paxlovid. No treatment medications were reported. Company comment: This is a spontaneous case concerning a 69-year-old, male patient with no reported medical history and with no relevant concurrent medical condition. Patient has vaccination history of receiving unknown dose number of co-suspect product BioNTech. Patient experienced the unexpected non-serious AESI event of Covid-19. The event Covid-19 occurred after the unknown dose number of mRNA-1273 and BioNTech. Patient was prescribed with Nirmatrelvir + Ritonavir (Paxlovid). No other information surrounding the event was reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2022: Non-significant live follow up: QE number was added. Sender's Comments: This is a spontaneous case concerning a 69-year-old, male patient with no reported medical history and with no relevant concurrent medical condition. Patient has vaccination history of receiving unknown dose number of co-suspect product BioNTech. Patient experienced the unexpected non-serious AESI event of Covid-19. The event Covid-19 occurred after the unknown dose number of mRNA-1273 and BioNTech. Patient was prescribed with Nirmatrelvir + Ritonavir (Paxlovid). No other information surrounding the event was reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration interrupted
Clinical narrative: Considering to give a 2nd primary dose 7 months after first primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Considering to give a 2nd primary dose 7 months after first primary dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2022, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Considering to give a 2nd primary dose 7 months after first primary dose). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Considering to give a 2nd primary dose 7 months after first primary dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was interrupted on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. No treatment medication was provided.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthritis, Interchange of vaccine products, Uveitis
Clinical narrative: Uveitis; Arthritis flare up/  Pain aggravated/ Occasional flare up in right arm of pain; interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (Uveitis) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.   On 20-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, citrate free. On an unknown date, the patient experienced UVEITIS (Uveitis) (seriousness criterion medically significant), ARTHRITIS (Arthritis flare up/  Pain aggravated/ Occasional flare up in right arm of pain) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). At the time of the report, UVEITIS (Uveitis) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown and ARTHRITIS (Arthritis flare up/  Pain aggravated/ Occasional flare up in right arm of pain) had not resolved.            No medical history was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  Company comment: This spontaneous case concerns a 63-years-old, female patient with medical history of ANKYLOSING SPONDYLITIS, who experienced the unexpected non serious AESI event of arthritis (reported as Arthritis flare up) and unexpected serious (medically significant) event of uveitis, which occurred unspecified day after third dose of mRNA-1273 vaccine. In addition, the patient previously received a different Covid-19 vaccine JANSSEN COVID-19 VACCINE (interchange of vaccine products) 2 doses prior to mRNA-1273 vaccine. Medical history of ANKYLOSING SPONDYLITIS is confounding for the event arthritis (reported as Arthritis flare up). The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63-years-old, female patient with medical history of ANKYLOSING SPONDYLITIS, who experienced the unexpected non serious AESI event of arthritis (reported as Arthritis flare up) and unexpected serious (medically significant) event of uveitis, which occurred unspecified day after third dose of mRNA-1273 vaccine. In addition, the patient previously received a different Covid-19 vaccine JANSSEN COVID-19 VACCINE (interchange of vaccine products) 2 doses prior to mRNA-1273 vaccine. Medical history of ANKYLOSING SPONDYLITIS is confounding for the event arthritis (reported as Arthritis flare up). The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness
Clinical narrative: super sick; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (super sick) and HEADACHE (headache) in a 33-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (super sick) and HEADACHE (headache). At the time of the report, ILLNESS (super sick) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported  No treatment medications were reported
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Erythema, Gait disturbance, Joint swelling, Pain
Clinical narrative: swelling in her joints including her knees; has been in tears from the pain; has touch flares on her skin; the skin was super red; had swelling in her hands and feet; couldn't walk at one point and needed to be pushed in a wheelchair; pain in her hands and feet; welt marks all over her stomach; had an itchy response; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (had an itchy response), JOINT SWELLING (swelling in her joints including her knees), PAIN (has been in tears from the pain), SKIN SENSITISATION (has touch flares on her skin) and ERYTHEMA (the skin was super red) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 049E21A and 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jun-2022, the patient experienced PRURITUS (had an itchy response) and URTICARIA (welt marks all over her stomach). On an unknown date, the patient experienced JOINT SWELLING (swelling in her joints including her knees), PAIN (has been in tears from the pain), SKIN SENSITISATION (has touch flares on her skin), ERYTHEMA (the skin was super red), PERIPHERAL SWELLING (had swelling in her hands and feet), GAIT DISTURBANCE (couldn't walk at one point and needed to be pushed in a wheelchair) and PAIN IN EXTREMITY (pain in her hands and feet). The patient was treated with TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (had an itchy response), JOINT SWELLING (swelling in her joints including her knees), PAIN (has been in tears from the pain), SKIN SENSITISATION (has touch flares on her skin), ERYTHEMA (the skin was super red), PERIPHERAL SWELLING (had swelling in her hands and feet), PAIN IN EXTREMITY (pain in her hands and feet) and URTICARIA (welt marks all over her stomach) outcome was unknown and GAIT DISTURBANCE (couldn't walk at one point and needed to be pushed in a wheelchair) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Blood test: white count was up.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Patient had some blood work done which showed that white count was up. Patient was also taking oral steroids as treatment drug.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Skin sensitisation, Urticaria
Clinical narrative: swelling in her joints including her knees; has been in tears from the pain; has touch flares on her skin; the skin was super red; had swelling in her hands and feet; couldn't walk at one point and needed to be pushed in a wheelchair; pain in her hands and feet; welt marks all over her stomach; had an itchy response; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (had an itchy response), JOINT SWELLING (swelling in her joints including her knees), PAIN (has been in tears from the pain), SKIN SENSITISATION (has touch flares on her skin) and ERYTHEMA (the skin was super red) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 049E21A and 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jun-2022, the patient experienced PRURITUS (had an itchy response) and URTICARIA (welt marks all over her stomach). On an unknown date, the patient experienced JOINT SWELLING (swelling in her joints including her knees), PAIN (has been in tears from the pain), SKIN SENSITISATION (has touch flares on her skin), ERYTHEMA (the skin was super red), PERIPHERAL SWELLING (had swelling in her hands and feet), GAIT DISTURBANCE (couldn't walk at one point and needed to be pushed in a wheelchair) and PAIN IN EXTREMITY (pain in her hands and feet). The patient was treated with TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (had an itchy response), JOINT SWELLING (swelling in her joints including her knees), PAIN (has been in tears from the pain), SKIN SENSITISATION (has touch flares on her skin), ERYTHEMA (the skin was super red), PERIPHERAL SWELLING (had swelling in her hands and feet), PAIN IN EXTREMITY (pain in her hands and feet) and URTICARIA (welt marks all over her stomach) outcome was unknown and GAIT DISTURBANCE (couldn't walk at one point and needed to be pushed in a wheelchair) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Blood test: white count was up.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Patient had some blood work done which showed that white count was up. Patient was also taking oral steroids as treatment drug.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt really sick after each shot) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (felt really sick after each shot). At the time of the report, MALAISE (felt really sick after each shot) had resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was provided. This case was linked to US-MODERNATX, INC.-MOD-2022-599999 (Linked Report). Sender's Comments: US-MODERNATX, INC.-MOD-2022-599999: Master case.