chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, SARS-CoV-2 test, Sensitive skin
Clinical narrative: Fever of 100 degrees; headache; soreness/sensitivity to touch on arm at site of injection/sensitivity at injection site; soreness/sensitivity to touch on arm at site of injection/sensitivity at injection site; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EP6955, Expiration date was not reported), via intramuscular in arm left on 24Mar2021 at 11:00 AM (at the age of 46-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history was reported as none. Allergies to medications, food, or other products was reported as no. The patient's concomitant medications received within 2 weeks of vaccination included ongoing spironolactone, 1x/day (150mg/day, 15+ years ago), from an unspecified date in Mar2021, taken for acne. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3247, Expiration date was not reported), via intramuscular in arm left on 04Mar2021 at 11:45 AM (at the age of 46-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. On 24Mar2021 at 23:00, the patient experienced fever of 100 degrees, headache, soreness/sensitivity to touch on arm at site of injection/sensitivity at injection site. All developed overnight after receiving second dose in the late morning. The symptoms developed 12 hours after 2nd dose. They were pretty steady during the next 18 hours with little variation in fever, severity of headache, etc and then all symptoms suddenly stopped at 05:00 pm the following day (on 25Mar2021). The reporter considered the seriousness of the events as non-serious. Treatment was not received for the events. On 03Feb2021, the patient underwent lab tests and procedures which included COVID-19 test, resulted as negative and body temperature, resulted as 100 Centigrade, fever of 100 degrees on 24Mar2021. The outcome of the events was recovered on 25Mar2021 at 17:00.  No follow-up attempts are needed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fever of 100 degrees; headache; soreness/sensitivity to touch on arm at site of injection/sensitivity at injection site; soreness/sensitivity to touch on arm at site of injection/sensitivity at injection site; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EP6955, Expiration date was not reported), via intramuscular in arm left on 24Mar2021 at 11:00 AM (at the age of 46-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history was reported as none. Allergies to medications, food, or other products was reported as no. The patient's concomitant medications received within 2 weeks of vaccination included ongoing spironolactone, 1x/day (150mg/day, 15+ years ago), from an unspecified date in Mar2021, taken for acne. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3247, Expiration date was not reported), via intramuscular in arm left on 04Mar2021 at 11:45 AM (at the age of 46-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. On 24Mar2021 at 23:00, the patient experienced fever of 100 degrees, headache, soreness/sensitivity to touch on arm at site of injection/sensitivity at injection site. All developed overnight after receiving second dose in the late morning. The symptoms developed 12 hours after 2nd dose. They were pretty steady during the next 18 hours with little variation in fever, severity of headache, etc and then all symptoms suddenly stopped at 05:00 pm the following day (on 25Mar2021). The reporter considered the seriousness of the events as non-serious. Treatment was not received for the events. On 03Feb2021, the patient underwent lab tests and procedures which included COVID-19 test, resulted as negative and body temperature, resulted as 100 Centigrade, fever of 100 degrees on 24Mar2021. The outcome of the events was recovered on 25Mar2021 at 17:00.  No follow-up attempts are needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (the patient). A 56-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Mar 24, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. In Mar 2021, patient experienced body ache, headache and fever. She had her 1st shot of the Pfizer COVID-19 vaccine on Mar 24, 2021; and experienced headache and body ache. She wanted to know if this was normal and how long it will last. The outcome of the events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: It is still red and swollen at the injection site; It is still red and swollen at the injection site; It is warm to the touch; there is still a lump; it is red and sore; This is a spontaneous report from a contactable consumer. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205) via an unspecified route of administration on arm left 13Mar2021 13:15 (age at vaccination 70-years-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included alprazolam (XANAX); lorazepam (LORAZEPAM), Vitamins, Unspecified sleeping medicines. The caller stated she had the first dose of this vaccine on 13Mar2021 in her left shoulder. On 14Mar2021, patient stated that it is still red and swollen at the injection site, it is warm to the touch, there is still a lump there and it is red and sore. Consumer asked if this is normal and how long she should expect it to last. She is due for her next dose on 03Apr2021 and said she will get it in the other arm. Reporter states that no medical conditions, she is healthy. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Malaise, Pyrexia, SARS-CoV-2 test
Clinical narrative: Headache; General unwell feeling; Pain in the left arm where the vaccine was injected; High fever (98); This is a spontaneous report from a contactable consumer. This 39-Year-old male consumer (patient) reported that:  A 39-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: el3247), via unspecified route of administration in left arm in 24Mar2021 at 13: 45 (at the age of 39-years-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Patient has no known allergies. Concomitant medication included finasteride (FINASTERIDE) taken for an unspecified indication, start and stop date were not reported; ascorbic acid, calcium gluconate, proteins nos, silicon dioxide, colloidal, zinc gluconate (IMEDEEN [ASCORBIC ACID; CALCIUM GLUCONATE; PROTEINS NOS; SILICON DIOXIDE, COLLOIDAL; ZINC GLUCONATE]) taken for an unspecified indication, start and stop date were not reported and both medications were received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was tested for COVID-19 post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: el3247), via unspecified route of administration in left arm in 01Mar2021 10:30 (at the age of 39-years-old) as dose 1, single for COVID-19 immunization. On 24Mar2021 at 23:30 patient experienced pain in the left arm where vaccine was injected, high fever (98) and later after 12 hours on 25Mar2021 at 01:45 had headache, general unwell feeling. The patient did not receive any treatment for AEs. The patient underwent lab tests and procedures which included body temperature: 98 on 24Mar2021, sars-cov-2 test (Nasal swab): negative on Dec2020, sars-cov-2 test (Nasal swab): negative on Jan2021 and sars-cov-2 test (Nasal swab): negative on Feb2021. The clinical outcome of the events was recovering.   Query: The Regulatory Agency recently received the attached report submitted by you. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines.  Response: Awareness Date: 24Mar2021 (As the patient, it is when I became aware of the reported events).  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Headache; General unwell feeling; Pain in the left arm where the vaccine was injected; High fever (98); This is a spontaneous report from a contactable consumer. This 39-Year-old male consumer (patient) reported that:  A 39-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: el3247), via unspecified route of administration in left arm in 24Mar2021 at 13: 45 (at the age of 39-years-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Patient has no known allergies. Concomitant medication included finasteride (FINASTERIDE) taken for an unspecified indication, start and stop date were not reported; ascorbic acid, calcium gluconate, proteins nos, silicon dioxide, colloidal, zinc gluconate (IMEDEEN [ASCORBIC ACID; CALCIUM GLUCONATE; PROTEINS NOS; SILICON DIOXIDE, COLLOIDAL; ZINC GLUCONATE]) taken for an unspecified indication, start and stop date were not reported and both medications were received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was tested for COVID-19 post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: el3247), via unspecified route of administration in left arm in 01Mar2021 10:30 (at the age of 39-years-old) as dose 1, single for COVID-19 immunization. On 24Mar2021 at 23:30 patient experienced pain in the left arm where vaccine was injected, high fever (98) and later after 12 hours on 25Mar2021 at 01:45 had headache, general unwell feeling. The patient did not receive any treatment for AEs. The patient underwent lab tests and procedures which included body temperature: 98 on 24Mar2021, sars-cov-2 test (Nasal swab): negative on Dec2020, sars-cov-2 test (Nasal swab): negative on Jan2021 and sars-cov-2 test (Nasal swab): negative on Feb2021. The clinical outcome of the events was recovering.   Query: The Regulatory Agency recently received the attached report submitted by you. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines.  Response: Awareness Date: 24Mar2021 (As the patient, it is when I became aware of the reported events).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Mar 2, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient called and asked if she can still get the second dose appointment on Mar 23, 2021 because she had allergies last week (Mar 2021). She stated it's not severe, but the day prior, it was terrible. She took Claritin that day and on the day of the report. The outcome of the event: unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: really bad rash on her chest and upper neck/her chest has become, and her neck is raised red bumps and very itchy; really bad rash on her chest and upper neck/her chest has become, and her neck is raised red bumps and very itchy; really bad rash on her chest and upper neck/her chest has become, and her neck is raised red bumps and very itchy; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's daughter). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Jan2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced really bad rash on her chest and upper neck/her chest has become, and her neck was raised red bumps and very itchy. Verbatim and Event Description: (Name) the patient's daughter called on behalf of the patient regarding an adverse reaction the patient experienced after taking the Pfizer-BioNTech COVID-19 Vaccine During the call caller stated. Reporter mother got the COVID shot from Pfizer in January, end of January she developed a really, really bad rash on her chest and upper neck, have you had any complaints about that. She got it in the end of January and her chest has become, and her neck is raised red bumps and very itchy. Outcome of all the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, body aches, fever (~102F), head ache; Sore arm, body aches, fever (~102F), head ache; Sore arm, body aches, fever (~102F), head ache; Sore arm, body aches, fever (~102F), head ache; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP 6955 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 23Mar2021 at 12:15 PM (age at vaccination: 50 years), as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history was not reported. The patient did not have any known allergies and allergies to medications, food, or other products. Concomitant medication included colecalciferol (VITAMIN D). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL 3247 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 04Mar2021 at 01:15 PM (age at vaccination: 50 years), as a single dose for COVID-19 immunization. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks. On 24Mar2021 at 12:30 AM, the patient experienced sore arm, body aches, fever (~102F), headache. The patient did not received any treatment for the events. The patient underwent lab test and procedure included temperature with ~102F on 24Mar2021. Outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer, reported for a female patient. A female patient, of an unspecified age, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on Mar 18, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient previously received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on Feb 24, 2021, single dose, for COVID-19 immunization. Reportedly, she is experiencing adverse events: aches, fever and fatigue (after receiving the second vaccine) on an unspecified date. Created manual AE form. She also wanted to know if she can take pain relievers. The outcome of the events unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Somnolence, Swelling
Clinical narrative: she felt a surge from the injection site on her left arm which went up to her shoulder, her neck, her face, and then her brain.; pain; swelling; take a nap; Felt the injection travel up her arm, into her neck, and into her brain, she could feel it moving; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6208 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 13Mar2021 at 10:40 AM (age at vaccination: 70 years), as a single dose for COVID-19 immunization. The patient was taking covid vaccine because she didn't want to get infected and infect anyone else. Vaccine was not administered at military facility. The patient's medical history was not reported. Concomitant medication included paracetamol (TYLENOL). The patient did not receive any vaccine prior vaccinations (within 4 weeks). The patient mentioned that she received the 1st dose of the vaccine on her left arm last 13Mar2021. She mentioned that everything went well and there were no problems. She got home and about half an hour later she lied down and she felt a surge from the injection site on her left arm which went up to her shoulder, her neck, her face, and then her brain on an unspecified date. She wanted to take a nap because she got up early, she wasn't tired from the vaccine. The patient felt the injection travel up her arm, into her neck, and into her brain, she could feel it moving. It happened so quickly then went away and the patient felt it move into her brain and asked was it a clot, was it the medicine itself. The patient has been walking and has been fine. This happened in the left arm, the same arm that the vaccine was given in. She described it as like a marble moving up inside her arm. It went away eventually and she was feeling fine now. She did not expect that feeling, not like the pain and swelling she initially felt on her injection site which was normal to her, just like when getting a flu shot. She took one Tylenol for the pain and swelling and it went away. She mentioned that there was nothing wrong after that and would just like to report it. She was also asking if she should take the 2nd shot. The adverse events did not require a visit to emergency room and physician's office. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fever 101 degrees; Headache; Severe muscle aches/pain; Nausea; Tiredness; Injection site pain; Chills; Severe muscle aches/pain; After my first and second vaccinations my sinus congestion and seasonal allergies completely disappeared; This is a spontaneous report from a contactable consumer (patient). A 61 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955) via an unspecified route, administered in Right arm on 24Mar2021 at 09:45 (61-year-old at vaccination) at a Dose 2, Single for Covid-19 immunization. The patient was non-pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. The patient's medical history included Hashimotos thyroiditis, high cholesterol, dry eye, Seasonal allergies, Nasal polyps. The patient had known allergies to sulfur antibiotics. The patient had experienced rash while on sulfur antibiotics. The patient's concomitant medication(s) included levothyroxine sodium (SYNTHROID); liothyronine; pravastatin; ciclosporin (RESTASIS) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not the patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198) via an unspecified route, administered in Right arm on 03Mar2021 at 08:30 (61-year-old at vaccination) at a Dose 1, Single for Covid-19 immunization. No adverse effect but a positive outcome. After her first and second vaccinations her sinus congestion and seasonal allergies completely disappeared. After first dose she noticed complete clearing of nasal passages (she had nasal polyps) and she have not needed any seasonal allergy medicine this spring. Felt absolutely fantastic. On 24Mar2021 at 23:00, the patient had experienced fever 101 degrees, headache, severe muscle aches/pain, nausea, tiredness, injection site pain, chills. Lasted 6 hours only. The patient underwent lab tests and procedures which included body temperature: 101 degrees on 24Mar2021. o treatment received for the resulted events. The reporter consider seriousness of events as non-serious. The outcome of the events was recovered on 25Mar2021.  No follow-up attempts are needed. No further information was expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Therapeutic response unexpected, Vaccination site pain
Clinical narrative: Fever 101 degrees; Headache; Severe muscle aches/pain; Nausea; Tiredness; Injection site pain; Chills; Severe muscle aches/pain; After my first and second vaccinations my sinus congestion and seasonal allergies completely disappeared; This is a spontaneous report from a contactable consumer (patient). A 61 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955) via an unspecified route, administered in Right arm on 24Mar2021 at 09:45 (61-year-old at vaccination) at a Dose 2, Single for Covid-19 immunization. The patient was non-pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. The patient's medical history included Hashimotos thyroiditis, high cholesterol, dry eye, Seasonal allergies, Nasal polyps. The patient had known allergies to sulfur antibiotics. The patient had experienced rash while on sulfur antibiotics. The patient's concomitant medication(s) included levothyroxine sodium (SYNTHROID); liothyronine; pravastatin; ciclosporin (RESTASIS) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not the patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198) via an unspecified route, administered in Right arm on 03Mar2021 at 08:30 (61-year-old at vaccination) at a Dose 1, Single for Covid-19 immunization. No adverse effect but a positive outcome. After her first and second vaccinations her sinus congestion and seasonal allergies completely disappeared. After first dose she noticed complete clearing of nasal passages (she had nasal polyps) and she have not needed any seasonal allergy medicine this spring. Felt absolutely fantastic. On 24Mar2021 at 23:00, the patient had experienced fever 101 degrees, headache, severe muscle aches/pain, nausea, tiredness, injection site pain, chills. Lasted 6 hours only. The patient underwent lab tests and procedures which included body temperature: 101 degrees on 24Mar2021. o treatment received for the resulted events. The reporter consider seriousness of events as non-serious. The outcome of the events was recovered on 25Mar2021.  No follow-up attempts are needed. No further information was expected.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AEs reported; administered VAQTA that expired; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 03-SEP-2021, the patient was vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) (0.5 ml, lot # T014590, expiration date 15-APR-2021; strength and route were not provided) for prophylaxis (expired product administered).  The hepatitis a vaccine, inactivated (VAQTA) did not have any temperature excursions. No additional adverse event reported.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: No additional AE's were reported; first dose on 24Sep202 l of his ROT ATEQ vaccine at six months old which was at 27weeks old; This spontaneous report as received from a consumer (patient's mother) and refers to a 6-month-old male patient. The patient's drug reactions, allergies and concomitant medication were not reported. His concurrent conditions included reflux.   On 24-SEP-2021, at 27-weeks-old, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (exact dose, lot # and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). It was stated that he did not get the vaccine at 2 and 4 month appointment because of reflux. The patient had not had any additional doses yet. It was also reported that the reporter was trying to get in touch with her pediatrician to see what they need to do. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Second shot kicked my butt for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for an unknown indication.   Previously administered products included Shingles vaccine (patient received 1st dose on an unknown date and did not experience anything).   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient experienced nothing with first shot but the second shot had kicked his/her butt for 3 days.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Restlessness
Clinical narrative: Fever; Chills; severe body pain/ Couldn't sit still.; Couldn't sit still'; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, chills, general body pain and restlessness. On an unknown date, the outcome of the fever, chills, general body pain and restlessness were recovered/resolved.   The reporter considered the fever, chills, general body pain and restlessness to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient had bad reaction to the shingles vaccine, fever, chills and severe body pain. The patient stated that he/she could not sit still, he/she was not prepared for that. The patient stated that the fever, chills, severe body pain and could not sit still gone by the next morning and he/she felt great. The patient stated he/she was so terrified to get the second shot after that, so patient waited till the last minute and got the shot prepared for worst and nothing happened, she/he thanks god so glad did it. The follow up would not possible as contact details was not available.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blepharospasm, Eye pain, Pain, Pain in extremity
Clinical narrative: Sore Scalp; eye twitching, eye spasms; pain behind her eye.; Hives; left marks on her skin.; Side pain; having pain in her back and down her sides; pain in her big left toe and pain in both thumbs; itchy patch on her back; This case was reported by a consumer via call center representative and described the occurrence of scalp pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2021, the patient received the 1st dose of Shingrix (intramuscular). In June 2021, less than a month after receiving Shingrix, the patient experienced itching and pain in toe. In September 2021, the patient experienced back pain and pain localized. On an unknown date, the patient experienced scalp pain, blepharospasm, eye pain, hives and skin disorder. On an unknown date, the outcome of the scalp pain, blepharospasm, hives and skin disorder were unknown and the outcome of the eye pain, back pain and pain localized were not recovered/not resolved and the outcome of the itching and pain in toe were recovered/resolved.   It was unknown if the reporter considered the scalp pain, blepharospasm, eye pain, hives, itching, back pain, pain in toe, skin disorder and pain localized to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient for herself. The patient received the dose in her left arm. One to two weeks after the vaccine, she reported an itchy patch on her back.  A few weeks later at the end of June she started experiencing pain in her big left toe and pain in both thumbs which went away after a week or two.  After the ain in her toe and thumbs, she started experiencing symptoms in her eyes which included eye twitching, eye spasms, and pain behind her eye. The patient went to an eye doctor for this issue but at the time did not realize it could be vaccine related and the doctor was not sure why she was experiencing it either. The eye pain was still present at the time of reporting. A month before reporting, the caller reported that she started having pain in her back and down her sides which was also unresolved.  The patient also reported having hives 3 weeks after her Shingrix that left marks on her skin. She experienced another episode of hives around the first of August.  Patient was referred to her Health Care professional and was provided the phone number for MI for her doctor to call if there are furthe concerns. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Pruritus, Skin disorder, Urticaria
Clinical narrative: Sore Scalp; eye twitching, eye spasms; pain behind her eye.; Hives; left marks on her skin.; Side pain; having pain in her back and down her sides; pain in her big left toe and pain in both thumbs; itchy patch on her back; This case was reported by a consumer via call center representative and described the occurrence of scalp pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2021, the patient received the 1st dose of Shingrix (intramuscular). In June 2021, less than a month after receiving Shingrix, the patient experienced itching and pain in toe. In September 2021, the patient experienced back pain and pain localized. On an unknown date, the patient experienced scalp pain, blepharospasm, eye pain, hives and skin disorder. On an unknown date, the outcome of the scalp pain, blepharospasm, hives and skin disorder were unknown and the outcome of the eye pain, back pain and pain localized were not recovered/not resolved and the outcome of the itching and pain in toe were recovered/resolved.   It was unknown if the reporter considered the scalp pain, blepharospasm, eye pain, hives, itching, back pain, pain in toe, skin disorder and pain localized to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient for herself. The patient received the dose in her left arm. One to two weeks after the vaccine, she reported an itchy patch on her back.  A few weeks later at the end of June she started experiencing pain in her big left toe and pain in both thumbs which went away after a week or two.  After the ain in her toe and thumbs, she started experiencing symptoms in her eyes which included eye twitching, eye spasms, and pain behind her eye. The patient went to an eye doctor for this issue but at the time did not realize it could be vaccine related and the doctor was not sure why she was experiencing it either. The eye pain was still present at the time of reporting. A month before reporting, the caller reported that she started having pain in her back and down her sides which was also unresolved.  The patient also reported having hives 3 weeks after her Shingrix that left marks on her skin. She experienced another episode of hives around the first of August.  Patient was referred to her Health Care professional and was provided the phone number for MI for her doctor to call if there are furthe concerns. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna COVID-19 vaccine were administered on 29Sep2021 and they had expired on 28Sep2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine were administered on 29Sep2021 and they had expired on 28Sep2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.   No Medical History information was reported.  On 29-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine were administered on 29Sep2021 and they had expired on 28Sep2021). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine were administered on 29Sep2021 and they had expired on 28Sep2021) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Inappropriate schedule of product administration, Off label use
Clinical narrative: FEELING A LITTLE BIT GOOFY AND DULL; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight was 101.4 kilograms, and height was not reported. The patient's concurrent conditions included: pulmonary arterial hypertension. The patient received epoprostenol sodium (powder for solution for infusion, intravenous drip, batch number: MM257M01P1 expiry: 30-SEP-2022) dose and frequency were not reported from 25-OCT-2018 for pulmonary arterial hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/ lot numbers. Concomitant medications included ambrisentan, and warfarin.  On an unspecified date, the patient experienced feeling a little bit goofy and dull, off label use, and inappropriate schedule of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of epoprostenol sodium was not changed. The outcome of the feeling a little bit goofy and dull, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, with frequency time 1 total, 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 had a blood clot and died from the blood clot. It was unknown if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died from blood clot. This report was serious (Death).; Sender's Comments: V0: 20211009011-COVID-19 VACCINE AD26.COV2.S-blood clot. This event(s) is considered unassessable. 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).; Reported Cause(s) of Death: BLOOD CLOT
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Death, Hypotension
Clinical narrative: DEATH; LOW BLOOD PRESSURE; This spontaneous report received from a consumer concerned a 69 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, expiry: 30-OCT-2021) dose was not reported, 1 total, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUN-2021,  the patient experienced low blood pressure issues since vaccination, was known visited on 02-OCT- 2021. Laboratory data included: Blood pressure (NR: not provided) low. On 04-OCT-2021 after an appointment was missed patient friends went to patient house where patient was found on floor beside bed. The patient died from unknown cause of death. An autopsy was not performed at time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 04-OCT-2021, and the outcome of low blood pressure was not reported. This report was serious (Death).; Sender's Comments: V0: 20211011543-COVID-19 VACCINE AD26.COV2.S-death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: HIGH BLOOD PRESSURE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: low blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 high blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of high blood pressure was not reported. This report was non-serious. This case, from the same reporter is linked to 20211012327 and 20211011386.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED DOSES OF THE VACCINE WERE ADMINISTERED; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-SEP-2021, the patient experienced expired doses of the vaccine were administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired doses of the vaccine were administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211011801, 20211012209, 20211012114 and 20211012383. This report was associated with product quality complaint : 90000196306.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: 02-OCT-2021) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042l20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and METOPROLOL for an unknown indication.    On 21-Jan-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 PAIN IN EXTREMITY (Pain in the arm). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the arm) had not resolved.        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.   This case was linked to MOD-2021-335494 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered to 5 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 5 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 5 patients). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 5 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow-up received, includes no new information. On 01-Oct-2021: Follow-up received, includes no new information.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: sore injection site arm; felt tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt tired) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt tired). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-336832, MOD-2021-336855 (Patient Link).