chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Administered Menveo reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 14-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva652a, expiry date 28th February 2023) and (batch number amva652a, expiry date unknown) for prophylaxis.   On 26th July 2022, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 26th July 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's Comments: The pharmacist technician reported on 27th July 2022 that a patient was administrated with Menveo on 26th July 2022.  The vaccine was reconstituted with sterile water.  No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The patient was vaccinated with Menveo which was reconstituted with sterile water, which led to Wrong solution used in drug reconstitution.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, Overdose, Product administered to patient of inappropriate age
Clinical narrative: adolescent received Havrix 1440; adolescent received Havrix 1440; received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 16-year-old female patient who received HAV (Havrix 1440) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 26th July 2022, the patient received the 1st dose of Havrix 1440 1 ml. On 26th July 2022, unknown after receiving Havrix 1440, the patient experienced overdose, adult product administered to child and expired vaccine used. On an unknown date, the outcome of the overdose, adult product administered to child and expired vaccine used were unknown.   Additional Information: GSK receipt date: 27-Jul-2022 Reporter's comment: A pharmacy intern reported that an adolescent patient received an expired Havrix 1440 dose one day before the reporting the day. The reporter specifically stated it was Havrix 1440 but did not confirm if it was a PFS or SDV. The reporter consented to follow-up via email. Additional supportive information: An adolescent patient received an expired dose of Havrix 1440, which led to  overdose, adult product administered to child and expired vaccine used.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: boostrix expired 28JAN2022, administred 27JUL2022; 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 DTPa (Reduced antigen) (Boostrix) (batch number 374LV, expiry date 28th June 2022) for prophylaxis.   On 27th July 2022, the patient received Boostrix. On 27th July 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: 27-Jul-2022 Reporter's comment: The health care professional reported that on the day of reporting an expired dose of Boostrix was administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up via phone. Additional supportive information: The patient received an expired dose of Boostrix, which led to expired vaccine used.
Sex: U
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: receiving expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Rota (Rotarix lyophilized formulation) (batch number 3A333, expiry date 16th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 27th July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 27th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 27-Jul-2022 Reporter's comment: The nurse practitioner reported that on the day of reporting a patient received an expired dose of Rotarix. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Rotarix, which led to expired vaccine used.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 3A333, expiry date 16th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 25th July 2022, the patient received the 1st dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 25th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 27-Jul-2022 Reporter's comment: The office manager stated that an expired dose of Rotarix was administered to a patient. The reporter consented to follow-up via postal. Additional supportive information: The patient received an expired dose of Rotarix, which led to expired vaccine used. The case was linked with case US2022111765, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022111765:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on 6/10/2021, has not received second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in right arm on 10th June 2021 of batch number 44DX0 and 28th October 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27-JUL-2022 Reporter's comment: The pharmacist reported that at the time of reporting the patient had not receive the second dose of the Shingrix vaccine. The reporter consented to follow-up. Additional supportive information: Till the reporting the patient did not receive the second dose of Shingrix vaccine, which led to incomplete course of vaccination.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 3A333, expiry date 16th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 27th July 2022, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 27th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 27-Jul-2022 Reporter's comment: The office manager stated that an expired dose of Rotarix was administered to a patient. The reporter consented to follow-up via postal. Additional supportive information: The patient received an expired dose of Rotarix, which led to expired vaccine used. The case was linked with case US2022111764, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022111764:Same reporter
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue, Underdose
Clinical narrative: administered 0.25mL due to incorrect reconstitution technique; administered 0.25mL due to incorrect reconstitution technique; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 61-year-old patient who received Herpes zoster (Shingrix) (batch number H7AT2, expiry date 28th August 2023) for prophylaxis.   On 27th July 2022, the patient received Shingrix (intramuscular) .25 ml. On 27th July 2022, unknown after receiving Shingrix, the patient experienced underdose and inappropriate reconstitution technique. On an unknown date, the outcome of the underdose and inappropriate reconstitution technique were unknown.   Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's Comments: The health care professional (HCP) reports that 2 patients were administered 0.25mL of Shingrix by the pharmacist due to incorrect reconstitution technique. The reporter consented to follow up. Additional Supportive Information: The patient was administered 0.25mL of Shingrix by the pharmacist due to incorrect reconstitution technique, which led to under dose and inappropriate reconstitution technique. This case is 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022111775:Same reporter
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue, Underdose
Clinical narrative: administered 0.25mL due to incorrect reconstitution technique; administered 0.25mL due to incorrect reconstitution technique; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 71-year-old patient who received Herpes zoster (Shingrix) (batch number H7AT2, expiry date 28th August 2023) for prophylaxis.   On 27th July 2022, the patient received Shingrix (intramuscular) .25 ml. On 27th July 2022, unknown after receiving Shingrix, the patient experienced underdose and inappropriate reconstitution technique. On an unknown date, the outcome of the underdose and inappropriate reconstitution technique were unknown.   Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's Comments: The health care professional (HCP) reports that 2 patients were administered 0.25mL of Shingrix by the pharmacist due to incorrect reconstitution technique. The reporter consented to follow up. Additional Supportive Information: The patient was administered 0.25mL of Shingrix by the pharmacist due to incorrect reconstitution technique, which led to under dose and inappropriate reconstitution technique. This case is 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022111772:Same reporter/Same case
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: LOST MORE TO THE VAX; This spontaneous report received from a consumer via a company representative via social media (J&J corporate social media account) concerned multiple patients. The patients weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, multiple people were lost due to vaccine and died from an unknown cause. It was unknown whether an autopsy was performed or not. The reporter reported that, "I've lost some to the flu and lost more to the vax..check your news sources". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220752266 and 20220749737.; Sender's Comments: V0: 20220749758 -covid-19 vaccine ad26.cov2.s -LOST MORE TO THE VAX. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: MYOCARDITIS; This spontaneous report received from a consumer via a company representative via social media (J&J Corporate social media) concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown ) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, 2 patients had myocarditis. As per reporter already had it for 3 days. my husband works in homes. over 3,000 now. NEVER SICK. my jabbed daughter. 3 times. 2 very serious causing pneumonia. too many side effects. 2 friends with myocarditis. one had a stroke. one a clot. 2 now with kidney issues. A niece miscarried twice. a young 38 year old friends daughter died of a heart attack. you along with the medical industry were programmed to push it. we ARENT DYING. now several have "cold symptoms" You need to listen to the whistle blower nurses..the Drs who have records. The insurance companies paying out for too many young. funeral directors saying the same. we have a lot of customers in all sorts of occupations. they all realize this is making pharma money along with politicians who invested and affecting too many jabbed. The studies are coming out. I hope some day you can see that the therapeutics are what works. now people are losing their immunity to everything. cancers coming back of course another scare will be here just in time for elections but ask yourself. why cant you sue pharma for death or side effects. Why are the millions of illegals coming in not jabbed. Soon you will be overwhelmed with polio, measles. whatever they have brought in along with jab side effects.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of myocarditis was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220750085, 20220750167, 20220750301, 20220752074 and 20220752219.; Sender's Comments: V0: 20220750036- covid-19 vaccine ad26.cov2.s-myocarditis. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Hyperaesthesia teeth, Loose tooth, Suspected COVID-19, Syncope
Clinical narrative: COVID-19 INFECTION; UPPER RIGHT TEETH EXTREMELY LOOSE; UPPER RIGHT TEETH EXTREMELY SENSITIVE; VOMITING; DEHYDRATION; FAINTNESS; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa allergy, and migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin were not reported, batch number: unknown, expiry: unknown) 1 in total, dose, start therapy date were not reported, administered to left arm for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, the patient experienced covid-19 infection. The patient was treated with the suspect drug Paxlovid (form of administration and route of administration were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered from 13-Jul-2022 to 16-JUL-2022 for treatment of COVID-19. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient received concomitant medication: Anti-Nausea (unspecified drug). On 13-JUL-2022, the patient experienced faintness, dizziness, vomiting, and dehydration and visited Emergency Room (ER). The patient was treated with fluids for dehydration. The patient reported that, she quit the paxlovid treatment after 3 of the 5 courses. On 18-JUL-2022, 2 days after quitting paxlovid, the patient experienced upper right teeth extremely loose and sensitive, felt like they were about to come out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable, and with paxlovid was drug discontinued. The patient was recovering from faintness, dehydration, upper right teeth extremely loose, upper right teeth extremely sensitive, and vomiting, and the outcome of covid-19 infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220752059-COVID-19 VACCINE AD26.COV2.S- faintness. The event(s) has a 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: Vomiting
Clinical narrative: COVID-19 INFECTION; UPPER RIGHT TEETH EXTREMELY LOOSE; UPPER RIGHT TEETH EXTREMELY SENSITIVE; VOMITING; DEHYDRATION; FAINTNESS; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa allergy, and migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin were not reported, batch number: unknown, expiry: unknown) 1 in total, dose, start therapy date were not reported, administered to left arm for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, the patient experienced covid-19 infection. The patient was treated with the suspect drug Paxlovid (form of administration and route of administration were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered from 13-Jul-2022 to 16-JUL-2022 for treatment of COVID-19. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient received concomitant medication: Anti-Nausea (unspecified drug). On 13-JUL-2022, the patient experienced faintness, dizziness, vomiting, and dehydration and visited Emergency Room (ER). The patient was treated with fluids for dehydration. The patient reported that, she quit the paxlovid treatment after 3 of the 5 courses. On 18-JUL-2022, 2 days after quitting paxlovid, the patient experienced upper right teeth extremely loose and sensitive, felt like they were about to come out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable, and with paxlovid was drug discontinued. The patient was recovering from faintness, dehydration, upper right teeth extremely loose, upper right teeth extremely sensitive, and vomiting, and the outcome of covid-19 infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220752059-COVID-19 VACCINE AD26.COV2.S- faintness. The event(s) has a 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: U
Vaccine: COVID19, COVID19
Symptoms: Malaise
Clinical narrative: NOT FEELING VERY WELL; This spontaneous report received from a patient concerned a 73 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: bells palsy (30 years ago) when the patient was 42 or 43 years old and other pre-existing medical conditions included: The patient didn't have any problems at all. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient was not feeling well and just not up to and patient have been driving himself crazy on the telephone right away (dose number in series: 1). On an unspecified date OCT-2021, patient received booster dose, covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, 1 total administered for covid-19 prophylaxis It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s (dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not feeling very well was not reported. This report was non-serious.; Sender's Comments: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Suspected COVID-19, Therapeutic product effect decreased
Clinical narrative: SICK; SYMPTOMS RETURNED; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, emphysema, autoimmune disease, and hypothyroidism. The patient was pregnant at the time of vaccination. The patient previously received with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin was not reported, and batch number: 1805020, expiry: Unknown) dose was not reported, 1 total, administered on 06-MAR-2021 at 10:45 on left arm for covid-19 prophylaxis.  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 patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin was not reported, and batch number: 1822809, expiry: Unknown) dose was not reported, 1 total, administered on 02-NOV-2021 at 10:30, on right arm for covid-19 prophylaxis. Age at time of vaccination 61 years old. Concomitant medications included opioids used for allergy, ascorbic acid/calcium carbonate/calcium pantothenate/calcium phosphate/chromium/cyanocobalamin/folic acid/magnesium carbonate/magnesium hydroxide/manganese gluconate/nicotinic acid/potassium bicarbonate/potassium carbonate/potassium phosphate dibasic/pyridoxine hydrochloride/quercetin/riboflavin sodium phosphate/sodium bicarbonate/sodium phosphate/thiamine hydrochloride/thioctic acid/zinc ascorbate and guaifenesin used for unknown indication. The patient was prescribed with treatment drug Paxlovid (form of admin and route of admin were not reported, batch number: unknown, expiry: Unknown) dose not reported, administered first dose on 07-JUL-2022 and last dose on 12-JUL-2022 for covid-19 treatment .  On 11-JUL-2022 at 07:00, the patient experienced sick and had suspected covid-19 infection, the reporter started feeling better after finishing the Paxlovid and six days later symptoms returned and were worse than the original symptoms (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with Paxlovid drug discontinued. The patient had not recovered from sick, symptoms returned and suspected covid-19 infection. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Hypokinesia
Clinical narrative: LOSS OF USE OF THEIR ARM; CHILLS; HEADACHE; This spontaneous report received from a consumer who heard of multiple (unspecified) patients of an unspecified age, sex, race and ethnicity.   The patient's weight, height, and medical history were not reported. The patients received primary dose with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patients received first booster with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The patients received second booster with non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) or another approved covid-19 vaccine (unspecified manufacturer), (Dose number in series 3), (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported.  On an unspecified date, after second booster, the patients experienced loss of use of their arm, chills, and headache (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The outcome of the chills, headache and loss of use of their arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20220744486.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 37 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of the report. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total, administered on right arm on 17-MAR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 35 years old. Concomitant medications included (Synthroid) levothyroxine sodium and metformin for unknown indication.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient also received booster dose of non-company suspect vaccine Pfizer Covid-19 Vaccine (tozinameran) (Dose number in series 2) (form of admin, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, administered on right arm on 03-DEC-2021 for covid-19 prophylaxis.  On an unspecified date in 2022, the patient experienced suspected covid-19 infection (early symptoms of covid-19) (Dose number in series 2) and received non company suspect paxlovid (form of administration and route of administration were not reported, batch number: unknown and expiry: unknown) dose was not reported, administered from 29-JUN-2022 till 03-JUL-2022 for covid-19 treatment. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran was not applicable and paxlovid was discontinued. The patient had not recovered from suspected covid-19 infection. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a 59 year old female patient reporting on herself. The patient's height, and weight were not reported. The patient's concurrent conditions included: migraine, and ibuprofen allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, 1 total administered to left arm on 28-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 58 years old. No concomitant medications were reported. The batch number was not reported and has been requested.  It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s (dose number in series: 1). The patient received, non-company suspect vaccine elasomeran (Moderna covid-19 vaccine)(dose number in series: 2) ( form of admin, route of admin, and batch number and expiry were not reported) dose was not reported, administered to left arm on 30-OCT-2021 for covid-19 prophylaxis. No concomitant medications were reported.  On an unspecified date in JUL-2022, the patient was treated with non-company suspect drug Paxlovid (route of administration, batch number and expiry were not reported) dose and frequency were not reported for covid-19 treatment which was lasted after 5 days course in JUL-2022. On 18-JUL-2022, after recommended 5 day dose of Paxlovid and a week later patient started to have same covid symptoms, Fatigue, runny nose, sweats/chills (Suspected covid-19 infection) (dose number in series: 2) The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and with Paxlovid was drug discontinued on JUL-2022. The patient recovered from suspected covid-19 infection on 21-JUL-2022. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: RECEIVED VACCINE DOSE THAT WAS IN A TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a 47 year old male. 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: 202F21A expiry: UNKNOWN) dose was not reported, administered on 26-JUL-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 47 years old. No concomitant medications were reported. On 26-JUL-2022, the patient experienced received vaccine dose that was in a temperature excursion, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received vaccine dose that was in a temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220759250. This report was associated with product quality complaint:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 10-May-2022 and administered on 20-Jun-2022 and 05-Jul-2022.; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-May-2022 and administered on 20-Jun-2022 and 05-Jul-2022.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     It was unknow if the patient had ever been diagnosed or tested positive for COVID-19.  Patient did not had any acute illnesses at the time of vaccination and up to one month before.  Patient did not had any allergies.  Concurrent medical conditions included Type 2 diabetes mellitus and Obesity.    On 20-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 20-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-May-2022 and administered on 20-Jun-2022 and 05-Jul-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-May-2022 and administered on 20-Jun-2022 and 05-Jul-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that they looked it up and said 15-Oct-2022 and now they read and said it's only good for 30 days when they received it. Reporter confirmed the vials were in refrigerated storage. Reporter wanted to know if there was a hard cut off for the 30 days.  Patient had received booster dose of Moderna vaccine.  Date the vial was initially stored in the refrigerator was on 10-May-2022.  Date of administration of vaccine was on 20-Jun-2022.  Vial did not undergo any temperature excursions.  It was reported that patient did not had any adverse effects. .  Patient was informed of the expiration error and her dose had full efficacy even though it had past its use by date.  It was unknown if the event caused the patient to seek medical care.  It was unknown if patient had experienced any similar event in the past.  No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2022: Follow up received significant information: Address of reporter has been updated, Patient demographics added. Medical history added. Suspect product details updated. Event onset date added and verbatim updated for event expired vaccine used. I-narrative updated
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Heavy menstrual bleeding
Clinical narrative: menstrual flooding/one of the heaviest periods experienced; sitting uncomfortably; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (menstrual flooding/one of the heaviest periods experienced) and DISCOMFORT (sitting uncomfortably) 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.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced HEAVY MENSTRUAL BLEEDING (menstrual flooding/one of the heaviest periods experienced) and DISCOMFORT (sitting uncomfortably). At the time of the report, HEAVY MENSTRUAL BLEEDING (menstrual flooding/one of the heaviest periods experienced) and DISCOMFORT (sitting uncomfortably) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. It was reported that after receiving first dose of a COVID-19 vaccine in early 2021, 10 days later found patient sitting uncomfortably in a work meeting during one of the heaviest periods patient had experienced. The patient had what was often called menstrual flooding. The patient would not have thought to connect the experience to the Moderna dose patient had received, were it not for the patients graduate student who had the worst cramps of life after COVID-19 vaccination. Patient had not experienced similarly intense symptoms after the second dose. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines were stored after CDC expiry date; Vaccine administered past 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered past 30-day use by date) and PRODUCT STORAGE ERROR (Vaccines were stored after CDC expiry date) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 021F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered past 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored after CDC expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered past 30-day use by date) and PRODUCT STORAGE ERROR (Vaccines were stored after CDC expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  CDC expiry date was reported as 26-Mar-2022 (lot no- 021F21A).   Date Stored in Standard Freezer for the lot 021F21A was 2 degrees F high, -1 degrees F low on 30-Nov-2021.  No treatment medication was reported.  This case contains information for the second of 45 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-571126 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-571126:Master case
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Paraesthesia oral, Trichoglossia
Clinical narrative: got the Booster dose, and three hours later, she got a fuzzy tongue; and prickly lips; thinks this was an allergic; This spontaneous case was reported by a patient and describes the occurrence of TRICHOGLOSSIA (got the Booster dose, and three hours later, she got a fuzzy tongue), PARAESTHESIA ORAL (and prickly lips) and ALLERGY TO VACCINE (thinks this was an allergic) 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 25-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2022, the patient experienced TRICHOGLOSSIA (got the Booster dose, and three hours later, she got a fuzzy tongue), PARAESTHESIA ORAL (and prickly lips) and ALLERGY TO VACCINE (thinks this was an allergic). At the time of the report, TRICHOGLOSSIA (got the Booster dose, and three hours later, she got a fuzzy tongue), PARAESTHESIA ORAL (and prickly lips) and ALLERGY TO VACCINE (thinks this was an allergic) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills
Clinical narrative: I had chills; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (I had chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 030L20A and 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported. No allergies were reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (I had chills). At the time of the report, CHILLS (I had chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The patient experienced chills after administer of first dose, second dose and third dose of Moderna.  The outcome was reported as recovered on an unknown date, and the symptoms were improved.  No treatment medication was provided.   This case was linked to MOD-2022-614384 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Diarrhoea, Erythema, Inappropriate schedule of product administration, Incorrect route of product administration
Clinical narrative: I had chills; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (I had chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 030L20A and 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported. No allergies were reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (I had chills). At the time of the report, CHILLS (I had chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The patient experienced chills after administer of first dose, second dose and third dose of Moderna.  The outcome was reported as recovered on an unknown date, and the symptoms were improved.  No treatment medication was provided.   This case was linked to MOD-2022-614384 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: I had chills; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (I had chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 030L20A and 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported. No allergies were reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (I had chills). At the time of the report, CHILLS (I had chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The patient experienced chills after administer of first dose, second dose and third dose of Moderna.  The outcome was reported as recovered on an unknown date, and the symptoms were improved.  No treatment medication was provided.   This case was linked to MOD-2022-614384 (Patient Link).
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose 21 days after 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 21 days after 1st dose) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1414b) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1 and Lot number FT 9142.) on 01-Jul-2022. Past adverse reactions to the above products included No adverse event with Pfizer.    On 22-Jul-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 21 days after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 21 days after 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Patient received first dose of Pfizer and second dose of Moderna vaccines within 21 days timeline. No treatment medication was provided.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was first punctured on 06-Jul-2022 and was stored in fridge post puncture; Patient was administered with the dose more than 12 hours of post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with the dose more than 12 hours of post puncture) and PRODUCT STORAGE ERROR (The vial was first punctured on 06-Jul-2022 and was stored in fridge post puncture) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 060A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jul-2022 at 7:25 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Jul-2022 at 7:25 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with the dose more than 12 hours of post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 06-Jul-2022 and was stored in fridge post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with the dose more than 12 hours of post puncture) and PRODUCT STORAGE ERROR (The vial was first punctured on 06-Jul-2022 and was stored in fridge post puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the vial was initially stored in the refrigerator on 29-Jun-2022 and the date and time vial was first punctured was on 06-Jul-2022 at 7:49.The vial had not undergone any temperature excursions and the total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was Less than 30/45 minutes  No treatment medications were reported.  This case contains information for the 1st patient out of 2 patients described by the reporter.   This case was linked to MOD-2022-615591 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2022-615591:2nd patient