chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Neck Stiffness; Neck soreness; This case was reported by a pharmacist via call center representative and described the occurrence of stiff neck in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th June 2022, the patient received the 2nd dose of Shingrix. In June 2022, less than a week after receiving Shingrix, the patient experienced stiff neck and neck pain. On an unknown date, the outcome of the stiff neck and neck pain were not recovered/not resolved.   It was unknown if the reporter considered the stiff neck and neck pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Jun-2022 Reporter's Comments: The pharmacist reported this case for himself.  The patient reported he received the second dose of the Shingrix vaccine and had been experiencing neck stiffness/soreness. No other information was given during encounter. The reporter denied giving information.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via eye contact, Occupational exposure to product
Clinical narrative: part of diluent sprayed into eye; part of diluent sprayed into eye; This case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while preparing product for administration in a female patient who received Herpes zoster (Shingrix) (batch number 54TF4, expiry date unknown) for prophylaxis.   On 28th June 2022, the patient received Shingrix. On 28th June 2022, unknown after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration and exposure via eye contact. On an unknown date, the outcome of the occupational exposure while preparing product for administration and exposure via eye contact were unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: The reporter reported that, when she was going to draw up Shingrix diluent in syringe, the needle popped off and part of the diluent sprayed into her right eye.  She had rinsed with water and reported that she would continue to do so throughout the day. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, when she was going to draw up Shingrix diluent in syringe, the needle popped off and part of the diluent sprayed into her right eye, which led to occupational exposure while preparing product for administration and exposure via eye contact.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Muscular weakness, Pyrexia
Clinical narrative: soreness at the injection site; chills; fever; weakness of the arms and legs; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd June 2022, the patient received the 1st dose of Shingrix. In June 2022, less than a month after receiving Shingrix, the patient experienced injection site pain, chills, fever and weakness of limbs. On an unknown date, the outcome of the injection site pain, chills and fever were recovered/resolved and the outcome of the weakness of limbs was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, chills, fever and weakness of limbs to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Jun-2022 Reporters Comments: The case was self-reported by the patient. The patient received first dose of Shingrix vaccine and experienced soreness at the injection site, chills and fever. The patient reported that he later began to experience weakness of the arms and legs. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Swelling face, Tenderness
Clinical narrative: swollen, puffy face; pain; tiredness; This case was reported by a nurse via call center representative and described the occurrence of facial swelling in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th June 2022, the patient received Shingrix. On 27th June 2022, less than a day after receiving Shingrix, the patient experienced facial swelling, pain and tiredness. On an unknown date, the outcome of the facial swelling, pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the facial swelling, pain and tiredness to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comments: The nurse reported that the patient received a dose of Shingrix and developed swollen, puffy face, pain and tiredness. The reporter did not provide lot number and expiration date. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given too early; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: The case was submitted via online. The reporter asked should a patient receive another Shingrix shot if their 2nd one was given too early or was the series completed at that point. The patient received 1st dose Shingrix on 9th June and 2nd dose received on 28th June. No further details provided. The reporter consented to follow up. Additional supportive information: The patient received the 2nd dose of Shingrix earlier than the recommended interval, which led to shortening of vaccination schedule. The year of occurrence of the event was not provided as per source document.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in non-vaccinated arm (Right Arm)/like he has been hit with a 20 lb brick; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: The case was received on afterhours voicemail box. The pharmacist reported that the patient was vaccinated with Shingrix vaccine in left arm but patient was reporting that his right arm was sore, like he had been hit with a 20 lb brick. No additional details at time of reporting. The reporter consented to follow up.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received a dose that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 34-year-old female patient who received HAV (Havrix 1440) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 29th June 2022, the patient received Havrix 1440. On 29th June 2022, unknown after receiving Havrix 1440, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's comments:  The reporter stated that the patient received a dose of Havrix 1440 EL.U that had expired on 18th June 2022. The reporter consented to follow up. Additional Supportive Information: The reporter stated that a patient received an expired dose of Havrix 1440 which led to, expired vaccine used.
Age: 8.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 8 years old received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received DTPa-IPV (Kinrix) (batch number YC97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  This report was made by GSK without prejudice and did not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 29-Jun-2022. Reporter's Comments: The physician assistant reported that an 8 years old patient received a Kinrix dose. The reporter consented to follow up. Additional Supportive Information: The 8 years old patient received a Kinrix dose, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose of Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 29th June 2022, the patient received Havrix. On 29th 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 Reporter's Comments: The pharmacist reported that a patient received expired dose of Havrix vaccine on 29th June 2022 which was expired on 18th June 2022 inadvertently. The reporter consented to follow up. Additional supportive information: The patient received Havrix which was already expired in 18th June 2022, which led to expired vaccine used.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: patient received on 27Jun2022 a dose of Boostrix that had expired on 21Jun2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3E52S, expiry date 21st June 2022) for prophylaxis.   On 27th June 2022, the patient received Boostrix. On 27th June 2022, unknown after receiving Boostrix, 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 Reporter's Comments: Medical assistant reported a patient received a dose of Boostrix on 27th Jun 2022 that had expired on 21st Jun 2022.  Conset to follow up was granted. Additional supportive information: As patient received expired vaccine which led to expired vaccine used.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient received a 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 9Y92A, expiry date 28th June 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On 28th June 2022, the patient received the 3rd dose of Shingrix. On 28th June 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 1st July 2022 Reporter's Comments: Consent to follow up was granted via postal. Additional supportive information: As patient received 3rd dose of Shingrix, which led to extra dose administered. This case was linked with US2022101097 reported by same reporter for patient's husband.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022101097:same reporter, other patient
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient forget to get his second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2nd October 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-JUL-2022 Reporter's Comments: The pharmacist reported that the patient forget to get his second dose of Shingrix. The pharmacist was unable to provide further information. The data regarding Shingrix was no longer in system. The VAERS details reported for 1st dose of Shingrix. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure, Weight
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; BLOATING; GAINED WEIGHT; WEIGHT LOSS OF 5 OR SO POUNDS; This spontaneous report received from a patient via other company (AbbVie) concerned an elderly female. Initial information was processed with additional information received on 29-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis, and psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis, and psoriatic arthritis. No concomitant medications were reported.  On an unspecified date, the patient had felt the side effects such as bloated and fatigues and gained weight when the patient started Skyrizi and had never felt sick. The patient tested positive for covid-19 (suspected covid-19 infection and suspected clinical vaccination failure) and afterwards received a negative result. In 2022, the patient had a weight loss of 5 or so pounds. Laboratory data (dates unspecified) included: COVID-19 virus test negative, and had positive (the physician thought it was a false positive result). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with risankizumab was not reported. The patient recovered from suspected covid-19 infection, bloating, and gained weight, and the outcome of suspected clinical vaccination failure and weight loss of 5 or so pounds was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complain: 90000238693.; Sender's Comments: V0:20220658464-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased, Weight increased
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; BLOATING; GAINED WEIGHT; WEIGHT LOSS OF 5 OR SO POUNDS; This spontaneous report received from a patient via other company (AbbVie) concerned an elderly female. Initial information was processed with additional information received on 29-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis, and psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis, and psoriatic arthritis. No concomitant medications were reported.  On an unspecified date, the patient had felt the side effects such as bloated and fatigues and gained weight when the patient started Skyrizi and had never felt sick. The patient tested positive for covid-19 (suspected covid-19 infection and suspected clinical vaccination failure) and afterwards received a negative result. In 2022, the patient had a weight loss of 5 or so pounds. Laboratory data (dates unspecified) included: COVID-19 virus test negative, and had positive (the physician thought it was a false positive result). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with risankizumab was not reported. The patient recovered from suspected covid-19 infection, bloating, and gained weight, and the outcome of suspected clinical vaccination failure and weight loss of 5 or so pounds was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complain: 90000238693.; Sender's Comments: V0:20220658464-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Sjogren's syndrome
Clinical narrative: SJOGREN'S SYNDROME; COVID-19; This spontaneous report received from a patient via other manufacturer (Company) concerned a 3 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis flare ups, and sjogren's syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, and expiry: unknown) dose was not reported, 1 total, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number: 1159243 expiry: UNKNOWN, batch number: 1160362 expiry: UNKNOWN) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. Age at time of vaccination 27 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced sjogren's syndrome, and covid-19. The physician believed that the vaccine trigger sjogren's syndrome. Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from covid-19, and the outcome of sjogren's syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220658612-Covid-19 vaccine ad26.cov2.s - Sjogren's syndrome. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: ANAPHYLAXIS; This solicited report received from a consumer via study with ongoing routine monitoring concerned a 39 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: anaphylactic reactions and The patient was not pregnant at the time of vaccination. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, 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 (1 day after vaccination), the patient experienced anaphylaxis. The patient was seen to establish care with an Internal Medicine physician. During visit patient brought up reaction to J and J vaccine (one day after receiving) starting with symptoms that had been experienced with other anaphylactic reactions in the past. No physician notes were found about the reaction at the time that it happened as the patient stated that benadryl (Treatment medications diphenhydramine hydrochloride) helped. Physician documented that their visit was focused on patient's unfortunate reaction to the J and J vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylaxis was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and anaphylaxis as related and the company causality between covid-19 vaccine ad26.cov2.s and anaphylaxis as related. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220660352-COVID-19 VACCINE AD26.COV2.S -Anaphylaxis. This event(s) is labeled and is therefore considered potentially related.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 66 year old male.  Initial information was processed along with additional information on 01-JUL-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: lung cancer (missing1/4 of lung for years). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: unknown) dose was not reported, 1 total administered on right arm on 09-MAR-2021 for prophylactic vaccination. Patient did not receive the booster shot. Age at time of vaccination 65 years old. No concomitant medications were reported.  Since 21-JUN-2022, the patient was feeling sick, had bad cough and headache. On 26-JUN-2022, he tested positive for Covid-19 (unspecified test) (confirmed covid-19 infection) which led to confirmed clinical vaccination failure. The headache was recovering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220702322. This report was associated with product quality complaint: 90000240649.; Sender's Comments: V0: 20220702424-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative from social media concerned a unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. On an unspecified date, the patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series: 1). On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 25-JUN-2022, the patient started feeling sick (dose number in series 2). On 28-JUN-2022, major symptoms started (suspected covid-19 and suspected clinical vaccination failure) (dose number in series 2). On 01-JUL-2022, Laboratory data included: SARS-CoV-2 test Positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint number: 90000240790.; Sender's Comments: V0-20220705993-covid-19 vaccine ad26.cov2.s-suspected clinical vaccine failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient through other manufacturer (Pfizer) concerned a 27 year old, female The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy with codiene and propofol, and the patient was not pregnant at the time of reporting and the patient stated she was taking other medication or products within 2 weeks of starting covid-19 treatment (Paxlovid). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered to right arm for prophylactic vaccination. The batch number was not reported and has been requested.  The patient additionally received non-company suspect vaccine Moderna Covid-19 vaccine (elasomeran) (dose number in series 2) (form of administration, route of administration, batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total, administered to right arm for prophylactic vaccination. Concomitant medications included amoxicillin trihydrate/clavulanate potassium, carbidopa monohydrate/levodopa, levomefolic acid, and sapropterin dihydrochloride. On 13-JUN-2022, the patient was treated with non-company suspect drug Paxlovid (route of administration not reported, batch number: FY0319 and expiry were not reported) dose and frequency were not reported for covid-19 treatment and last administered on 17-JUN-2022. On JUN-2022, after non company suspect drug paxlovid treatment (for covid-19) laboratory data included: COVID-19 virus test Negative.  On 21-JUN-2022, three days after non company suspect drug paxlovid treatment symptoms returned despite of isolation, the patient had suspected covid-19 infection (dose number in series 2) and suspected clinical vaccination failure (dose number in series 1). On same day laboratory data included: COVID-19 virus test Positive (strong). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number requested.; Sender's Comments: V0: 20220706776-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORENESS AT INJECTION SITE FOR A FEW DAYS; This spontaneous report received from a consumer concerned a male of unspecified age.  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced soreness at injection site for a few days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of soreness at injection site for a few days was not reported. This report was non-serious. This case, from the same reporter is linked to 20220707811.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On 11-Aug-2021, the patient received first dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: In the second dose she had a bad reaction to the vaccine; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (In the second dose she had a bad reaction to the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (In the second dose she had a bad reaction to the vaccine). At the time of the report, IMMUNISATION REACTION (In the second dose she had a bad reaction to the vaccine) outcome was unknown.            No concomitant product reported by reporter. No treatment medication reported by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: had pain in my injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (had pain in my injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (had pain in my injection site). At the time of the report, VACCINATION SITE PAIN (had pain in my injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported.  The patient had pain in injection site for about two or three days but not more than that. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Weight increased
Clinical narrative: Weight gain; Dizziness; Headache; This spontaneous case was reported by a patient and describes the occurrence of WEIGHT INCREASED (Weight gain), DIZZINESS (Dizziness) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) tablet for an unknown indication.    Previously administered products included for Drug use for unknown indication: Methotrexate, Gabapentin, Singulair, Baclofen and Covaryx. Past adverse reactions to the above products included No adverse event with Baclofen, Covaryx, Gabapentin, Methotrexate and Singulair. Concurrent medical conditions included Allergy to antibiotic (Erythromycin), Drug allergy (Hydroxychloroquine sulfat), Drug allergy (Lisinopril) and Ankylosing spondylitis.   On 03-Aug-2021, the patient started TOFACITINIB CITRATE (XELJANZ XR) (Oral) at an unspecified dose once a day. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WEIGHT INCREASED (Weight gain), DIZZINESS (Dizziness) and HEADACHE (Headache). At the time of the report, WEIGHT INCREASED (Weight gain), DIZZINESS (Dizziness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The patient second dose of Moderna COVID-19 Vaccine was scheduled for 10-Sep-2021.  Patient believed headache, dizziness, and weight gain was from Moderna COVID-19 Vaccine and not Xeljanz.  No treatment medication was reported.   Reporter did not allow further contact
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Received Pfizer COVID Vaccine after receiving first dose of Moderna; Received First dose of Moderna; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received First dose of Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Pfizer COVID Vaccine after receiving first dose of Moderna) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prevention.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Prevention.    Concurrent medical conditions included Allergy (diagnosed allergies), Immunocompromised, Respiratory disorder NOS, Chromosomal abnormality NOS, Endocrine disorder (endocrine abnormalities (including diabetes)), Diabetes (endocrine abnormalities (including diabetes)) and Obesity.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) .3 milliliter. On 03-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received First dose of Moderna). On 10-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Pfizer COVID Vaccine after receiving first dose of Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received First dose of Moderna) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Pfizer COVID Vaccine after receiving first dose of Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported. In Apr-2021, the patient went to receive his first dose of Moderna vaccine and at that time, he was told that the clinic would not give the second dose because it was out of the EUA. Hence the patient received his first dose of Moderna vaccine on 03-Apr-2021. Then he went to a Pfizer clinic and informed them that he had not gotten any of the vaccine yet and he was administered the Pfizer COVID Vaccine between 10:00 - 13:00 on 10-Aug-2021. This was his second dose. The patient mentioned that he was fine and did not have any issues. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Quite ill for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Quite ill for 24 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Quite ill for 24 hours). At the time of the report, ILLNESS (Quite ill for 24 hours) had resolved.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2021-599534, MOD-2021-599535 (Patient Link). Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Quite ill for 24 hours; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Quite ill for 24 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Quite ill for 24 hours). At the time of the report, ILLNESS (Quite ill for 24 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-599494, US-MODERNATX, INC.-MOD-2021-599535 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-599494:cross link (Reporter's Daughter case) US-MODERNATX, INC.-MOD-2021-599535:MOD-2021-599535 (Same reporter)
Sex: U
Vaccine: COVID19
Symptoms: Dysphagia
Clinical narrative: The patient who took the Moderna Covid vaccine and reported trouble swallowing afterwords; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (The patient who took the Moderna Covid vaccine and reported trouble swallowing afterwords) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPHAGIA (The patient who took the Moderna Covid vaccine and reported trouble swallowing afterwords). At the time of the report, DYSPHAGIA (The patient who took the Moderna Covid vaccine and reported trouble swallowing afterwords) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rashes that go and appear somewhere else; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH PRURITIC (itchy rashes that go and appear somewhere else) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure abnormal (has been ongoing for 15-20 years) and Blood cholesterol abnormal (has been ongoing for 15-20 years).    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced RASH PRURITIC (itchy rashes that go and appear somewhere else). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency; RANITIDINE HYDROCHLORIDE (ZANTAC) at an unspecified dose and frequency and ALUMINIUM HYDROXIDE, MAGNESIUM TRISILICATE, SODIUM ALGINATE (PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (itchy rashes that go and appear somewhere else) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication included patient was taking medication for blood pressure and cholesterol. Dosage text was reported as unknown dose and shot on her hand was unknown. Reporter seriousness for Allegra-Stated that it was not working for the rash: Unspecified. Patient was told to take some allergy medication and stated that it was not working for the rash. Reporter stated that patient had the rash a week after the vaccine. Therapy dates and if the dose was changed in response to the event not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: First dose of the COVID-19 vaccine: itching at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (First dose of the COVID-19 vaccine: itching at the injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (First dose of the COVID-19 vaccine: itching at the injection site). On 01-Mar-2021, VACCINATION SITE PRURITUS (First dose of the COVID-19 vaccine: itching at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient ethnicity was reported as Other  No patient history was reported and no investigation assessment was reported. No concomitant medication was provided It was reported that for first dose patient had experienced typical reaction like itching at the injection site for few minutes and then fine. Treatment information was not reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: he had no reaction to the first dose, other than typical reactions like itching at the injection site for a few minutes and then they were fine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PRURITUS (he had no reaction to the first dose, other than typical reactions like itching at the injection site for a few minutes and then they were fine) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetic. Concomitant products included INSULIN for Diabetes.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PRURITUS (he had no reaction to the first dose, other than typical reactions like itching at the injection site for a few minutes and then they were fine). In March 2021, VACCINATION SITE PRURITUS (he had no reaction to the first dose, other than typical reactions like itching at the injection site for a few minutes and then they were fine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient ethnicity reported as (withheld).  Concomitant medication included medication for blood pressure daily. Patient never had any reactions to these medications prior to vaccination  No treatment medication was reported.