chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair falling out after second dose; This is a spontaneous case received from a contactable consumer (patient himself). An 84-year-old male patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: EN6207) via an unspecified route of administration in left arm on 01Apr2021 10:00 (age at vaccination 84-year-old) as single dose for COVID-19 immunization. The patient medical history was reported as none. Concomitant medication was not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number: EN6207) on 14Mar2021, on left arm for COVID-19 immunization. On an unspecified date on Apr2021, the patient stated that his hair started failing out a couple weeks after second dose. The outcome of the event was reported as not recovered.   No follow-up attempts are needed. No further information was expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: (Batch/Lot Number: ER8727; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration, administered in Arm Left on 24Mar2021 at 14:25 (at the age of 49-years-old) as dose 1, single for covid-19 immunisation. History of all previous immunizations with the Pfizer vaccine considered as suspect was none. The patient medical history and concomitant medications were not reported. Patient History was none. Family Medical History Relevant to AE was none. The patient experienced hair loss on 28Mar2021. Reporter seriousness for the event was unspecified. She commented she works in Phlebotomy. She commented she filed a E-report online on 22Apr2021 and has not heard or received a response from anyone. She further clarified she completed a VAERS report online. She confirmed she has not complete a safety report with Pfizer directly yet.  She clarified the adverse event experienced as hair loss. She noticed it in the morning before noon. Her second dose she received on 14Apr2021, Lot: ER8729 Exp: 31Jul2021, administered in left arm. Her appointment for second shot was at 2:30 PM. She also added, she was using a skin cream that at first thought could have been the cause of the hair loss. However, her Dermatologist said it was not it because this skin cream is supposed to help hair loss. She did not have name of skin cream to provide. Vaccination Facility Type- Hospital. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. The event did not cause Emergency Room. She visted Physician's Office. She went to Dermatologist. She was going through injections in her head now as treatment. Prior Vaccinations within 4 weeks was none. AEs following prior vaccinations was reported as no. She wanted to know what usually is the next step when something like this happen. She was requesting or wanting follow-up about. She mentioned she just wanted someone to contact her and follow-up directly regarding this. No additional details provided. She wanted to speak to someone directly. Outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss after both doses; This is a spontaneous report from a contactable consumer (patient herself).  A 35-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: er8736, expiration date was not reported), via an unspecified route of administration, in left arm on 23Apr2021 at 09:30 AM (at the age of 35-years-old) as dose 1, single and patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history included irritable bowel syndrome (IBS) and eczema. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patients concomitant medications were not reported. The patient had not received any other vaccine within 4 weeks and had not received other medications in two weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 26Apr2021, the patient had experienced hair loss after both doses. Patient had not received any treatment for the event reported. The outcome of the event was recovering. Follow up attempts are needed. Further information has been requested.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Losing her hair after her second vaccine; This is a spontaneous report from a contactable consumer. and a non-contactable consumer (friend). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, expiry date: unknown), via an unspecified route of administration on 05May2021 as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history included covid-19. The patient's concomitant medications were not reported. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, it was unknown that the patient been tested for COVID-19. The patient has previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, expiry date: unknown), via an unspecified route of administration on unspecific date as DOSE 1, SINGLE for covid-19 immunization. On 06May2021, the patient was losing her hair after her second vaccine. The event was resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the event was unknown. The outcome of the event was unknown.  Follow-up attempts are completed. No further information was expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: swelling, redness, warmth of the arm; swelling, redness, warmth of the arm; swelling, redness, warmth of the arm; This is a spontaneous report from a contactable physician. A 76-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown) via intramuscular route of administration in the left arm on 18May2021 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, hyperlipidemia, osteopenia and chronic kidney disease (CKD). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient had received any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), buspirone (MANUFACTURER UNKNOWN) and atenolol (MANUFACTURER UNKNOWN) all for an unknown indication on an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on 27Apr2021 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. On 18May2021, the patient experienced swelling, redness and warmth of the arm. It was reported that the swelling and warmth had resolved, but there was still extensive erythema involving perhaps 25% of the skin surface of the upper arm. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of swelling, redness and warmth of the arm and included treatment with ibuprofen (MANUFACTURER UNKNOWN) and reassurance. The clinical outcome of the events swelling and warmth of the arm was recovered on an unknown date in May2021; redness was recovering at the time of this report.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Menstruation delayed, Pain
Clinical narrative: Body aches; Super late period; Tired; Headache; This is a spontaneous report from a contactable consumer (patient).  A 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration, in left arm on 29Apr2021 at 08:15 (at the age of 32-years-old) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: unknown) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient had not received any other vaccines within four weeks prior to the COVID vaccine. On 30Apr2021 at 08:00, the patient had experienced body aches, super late period, tired and headache. Therapeutic measures were not taken as a result of the events reported. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: Difficulty breathing; Fast heart beat; Dizziness; Diarrhea; Vomiting; Arm pain; Nausea; This is a spontaneous report from a contactable consumer (Patient). A 73-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 26May2021 at 10:00 (at the age of 73-year-old), as dose 1, single in left arm for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received unspecified concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26May2021 at 11:00, the patient experienced difficulty breathing, fast heart beat, dizziness, diarrhea, vomiting, arm pain and nausea. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab test and procedure which included heart rate: fast, on 26May2021 at 11:00. The clinical outcome of all the events was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: Difficulty breathing; Fast heart beat; Dizziness; Diarrhea; Vomiting; Arm pain; Nausea; This is a spontaneous report from a contactable consumer (Patient). A 73-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 26May2021 at 10:00 (at the age of 73-year-old), as dose 1, single in left arm for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received unspecified concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26May2021 at 11:00, the patient experienced difficulty breathing, fast heart beat, dizziness, diarrhea, vomiting, arm pain and nausea. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab test and procedure which included heart rate: fast, on 26May2021 at 11:00. The clinical outcome of all the events was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, SARS-CoV-2 test
Clinical narrative: It felt like she was hit with a foam baseball bat in the lower back; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 10Mar2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 17Feb2021 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021, the patient reported that it felt like hit with a foam baseball bat in the lower back. Therapeutic measures were not taken as a result of this event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On an unknown date, the patient underwent nasal swab (SARS-CoV-2 test) and the test result was negative. The clinical outcome of the event lower back pain was recovered on an unknown date in 2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Flatulence, Lethargy, Nausea
Clinical narrative: Ongoing Stomach cramps; Nausea; bloating; lethargy; foul smelling gas; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is 2nd of three reports.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced ongoing stomach cramps, nausea, bloating, lethargy, foul smelling gas on an unspecified date. The outcome of all events stomach cramps, nausea, bloating, lethargy, foul smelling gas was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Lethargy, Product administered at inappropriate site, Rash
Clinical narrative: Rash on torso which extended to the legs; weakness, loss of pressure in hands; Generally lethargic, super slow; super slow and joint pains; Anatomical Location:Leg Left; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: was not reported) via an unspecified route of administration in the left leg on 14May2021 at 14:00 (at the age of 56-years-old) as dose 2, single dose for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. The patient received unspecified normal medication within two weeks of vaccination. The patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of bnt162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: was not reported) via unspecified route of administration in the left leg on 23Apr2021 at 10:00 as dose 1, single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 20May2021 at 16:00, the patient experienced rash on torso which extended to the legs, weakness, loss of pressure in hands, generally lethargic, super slow and joint pains. On 19May2021, the patient underwent SARS-CoV-2 test through nasal swab and the test result was negative. The event resulted in doctor visit twice. The clinical outcome of the event rash on torso which extended to the legs, weakness, loss of pressure in hands. generally lethargic, super slow and joint pains was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Rash on torso which extended to the legs; weakness, loss of pressure in hands; Generally lethargic, super slow; super slow and joint pains; Anatomical Location:Leg Left; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: was not reported) via an unspecified route of administration in the left leg on 14May2021 at 14:00 (at the age of 56-years-old) as dose 2, single dose for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. The patient received unspecified normal medication within two weeks of vaccination. The patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of bnt162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: was not reported) via unspecified route of administration in the left leg on 23Apr2021 at 10:00 as dose 1, single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 20May2021 at 16:00, the patient experienced rash on torso which extended to the legs, weakness, loss of pressure in hands, generally lethargic, super slow and joint pains. On 19May2021, the patient underwent SARS-CoV-2 test through nasal swab and the test result was negative. The event resulted in doctor visit twice. The clinical outcome of the event rash on torso which extended to the legs, weakness, loss of pressure in hands. generally lethargic, super slow and joint pains was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: my hair is falling out. I have long brown hair, I began to notice 3 days after the vaccine that my hair brush was Very full, its been coming out heavily every day since. It looks very thin around my t; This is a spontaneous report from a contactable consumer or other non hcp (herself). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 20May2021 (Batch/Lot Number: EW0176) as dose 1, single (age at vaccination 35-year-old) for covid-19 immunisation. Medical history included drug known allergies: Sulfa from an unknown date and unknown if ongoing. Concomitant medication(s) included citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced my hair is falling out. i have long brown hair, i began to notice 3 days after the vaccine that my hair brush was very full, its been coming out heavily every day since. it looks very thin around my temples. And the hair is everywhere I look. on 23May2021. No treatment was received. The outcome for event was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia
Clinical narrative: My arm is also getting g numb and itsgetting worse; After the shot I have been having problems with my head . The back of my head feels heavy at times have pain and sometimes feels like its going to explode.; This is a spontaneous report from a contactable consumer (patient herself).  A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route, administered in Arm Right on 12Apr2021 12:30 (at the age of 50-years-old) as dose 1,single for COVID-19 immunization. The patient medical history was not reported. It is not known if the patient had any allergies to medications, food, or other products. The patient received other unspecified medications within two weeks of the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13Apr2021, patient experienced my arm is also getting numb and its getting worse, after the shot i have been having problems with my head the back of my head feels heavy at times have pain and sometimes feels like its going to explode. Problems with her head. The back of her head felt heavy at times, had pain and sometimes felt like it was going to explode. The patient's arm was also getting numb and it was getting worse. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events arm was also getting numb and problems with head and the back of head felt heavy at times have pain were not recovered at the time of this report.       No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Tongue discolouration, Tongue eruption
Clinical narrative: Tongue is discolored and has rash like appearance; Tongue is discolored and has rash like appearance; This is a spontaneous report from a contactable consumer (patient). A 13-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EP7533) via an unspecified route of administration on 22Jun2021 at 08:45 (at the age of 13-years-old) in left arm as a single dose for covid-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0168) via an unspecified route of administration on 13Jul2021 at 08:45 (at the age of 13-years-old) in left arm as a single dose for covid-19 immunization. Medical history included eczema from an unknown date and unknown if ongoing. There were no concomitant medications. Known allergies were reported as unknown. No other vaccine in four weeks and no other medications in two weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. The patient reported that his tongue was discoloured and had rash like appearance on an unknown date in 2021. The event resulted in doctor or other healthcare professional office/clinic visit. Treatment was reported as unknown. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was received on 14-Sep-2021 from a physician via Regulatory Authority (reference number: SEQW21-02255) and concerned a patient of an unspecified age and gender.  The patient's medical history and concomitant medications were unknown.  On an unspecified date in 2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was P100249167.  On an unspecified date in 2020, an unknown amount of time after receiving Afluria Quadrivalent, the patient experienced hives.  The outcome of the event was unknown.  The reporter did not provide a causality assessment.  The reporter assessed the event as non-serios.  Company comment: The event of hives is considered as unassessable to Afluria Quadrivalent.; Sender's Comments: The event of hives is considered as unassessable to Afluria Quadrivalent.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave Moderna vaccine to a 17 year old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave Moderna vaccine to a 17 year old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave Moderna vaccine to a 17 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave Moderna vaccine to a 17 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported. T  he treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Follow-up received and added suspect product administration date, batch number, route of administration, anatomical Location and reporter  added.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatotoxicity, Pruritus
Clinical narrative: itching; hepatotoxicity; This spontaneous case was reported by a consumer and describes the occurrence of HEPATOTOXICITY (hepatotoxicity) and PRURITUS (itching) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004m204 and 025l20a) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-May-2021, the patient experienced HEPATOTOXICITY (hepatotoxicity) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PRURITUS (itching) (seriousness criterion hospitalization). On 22-May-2021, HEPATOTOXICITY (hepatotoxicity) was resolving. At the time of the report, PRURITUS (itching) had not resolved.            Concomitant medication not provided.  Treatment drug included ANTIHISTAMINE ALLERGY RELIEF.  Company Comment: This case concerns a 30-year-old female patient with unknown medical history, who experienced the unexpected serious events of hepatotoxicity and pruritis. The events occurred 90 days after receiving the second dose of mRNA-1273 vaccine. The rechallenge is not applicable. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Further information has been requested.; Sender's Comments: This case concerns a 30-year-old female patient with unknown medical history, who experienced the unexpected serious events of hepatotoxicity and pruritis. The events occurred 90 days after receiving the second dose of mRNA-1273 vaccine. The rechallenge is not applicable. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Further information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; a patient was administered with a dose of PNEUMOVAX 23 that was improperly stored; This spontaneous report was received from a nurse, 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 18-AUG-2021, the patient was vaccinated with improper stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (0.5 ml, lot # T009743, expiration date 27-JAN-2022, strength and route were not provided) for prophylaxis (product storage error). The vaccine administered experienced temperature excursions of 30.6 Degree Fahrenheit for 26 hours and 14 minutes. There was previous temperature excursion: below 36 Degree Fahrenheit with an average of 34.9 Degree Fahrenheit for 1 hour 54 minutes; above 47 Degree Fahrenheit with an average of 48.6 Degree Fahrenheit for 21 hours. No additional information provided. No additional adverse event(AE) was reported.  This is one of three reports received from the same reporter (2108USA006446 and 2108USA006442). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T009743; expirationdate: 27-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2108USA006446: US-009507513-2108USA006442:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 01-SEP-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 milliliter, 1 dose, subcutaneously, lot # T016990, expiration date 11-NOV-2021 (dose number and vaccination site were not provied) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion of 9.9 degrees Fahrenheit for 2 hours and 11 minutes on 14-SEP-2021 and to the temperature excursion of 6.6 degrees Fahrenheit for 59 minutes on 15-SEP-2021. There was a previous temperature excursion, 7.3 degrees Fahrenheit for 37 minutes on 25-JUL-2021.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: First one kicked my rear end; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal 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 feeling abnormal. On an unknown date, the outcome of the feeling abnormal was recovered/resolved.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot and it had kicked his/her rear end. For 2nd dose tolerance refer case US2021AMR197871.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR197871:same reporter, same patient, different dose, 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Injection site pain, Musculoskeletal pain, Pain
Clinical narrative: got shot, have shingles/Suspected vaccination failure; had shingles; painful shot; pain in my rear; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, injection site pain and pain. On an unknown date, the outcome of the vaccination failure, shingles, injection site pain and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, injection site pain and pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had shingles got shot which was painful, had shingles again and pain in rear. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: got shot, have shingles/Suspected vaccination failure; had shingles; painful shot; pain in my rear; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, injection site pain and pain. On an unknown date, the outcome of the vaccination failure, shingles, injection site pain and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, injection site pain and pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had shingles got shot which was painful, had shingles again and pain in rear. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shot 4 years ago and just got Shingles now; Just horrible pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain 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 had the shot 4 years before the date of reporting and just got Shingles now. There were no rash or blisters but just horrible pain. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and lab test confirmation was unknown at the time of reporting.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Headache, Influenza like illness
Clinical narrative: pain and soreness at the site of injection; she had nausea; Fever; Chills; No appetite; Headache; No energy; she had flu like symptoms; This case was reported by a consumer via and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 29th August 2021, 5 hrs after receiving Shingrix, the patient experienced injection site pain. On 30th August 2021, the patient experienced nausea, fever, chills, appetite absent, headache and loss of energy. On an unknown date, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the injection site pain, nausea, fever, chills, appetite absent, headache, loss of energy and influenza-like symptoms were recovered/resolved.   The reporter considered the injection site pain, nausea, fever, chills, appetite absent, headache and loss of energy to be related to Shingrix. It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient had first shot of Shingrix intramuscularly in her right arm and had flu like symptoms for 3 days. Five hours after receiving the shot patient experienced pain and soreness at injection site. In the morning following the shot patient had nausea, fever, chills, no appetite, headache, and no energy that lasted for 72 hours. The patient received the shot 3 weeks ago and all her symptoms had thus resolved. The patient declined follow up with her healthcare professional. The reporter did not consent to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pyrexia
Clinical narrative: pain and soreness at the site of injection; she had nausea; Fever; Chills; No appetite; Headache; No energy; she had flu like symptoms; This case was reported by a consumer via and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 29th August 2021, 5 hrs after receiving Shingrix, the patient experienced injection site pain. On 30th August 2021, the patient experienced nausea, fever, chills, appetite absent, headache and loss of energy. On an unknown date, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the injection site pain, nausea, fever, chills, appetite absent, headache, loss of energy and influenza-like symptoms were recovered/resolved.   The reporter considered the injection site pain, nausea, fever, chills, appetite absent, headache and loss of energy to be related to Shingrix. It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient had first shot of Shingrix intramuscularly in her right arm and had flu like symptoms for 3 days. Five hours after receiving the shot patient experienced pain and soreness at injection site. In the morning following the shot patient had nausea, fever, chills, no appetite, headache, and no energy that lasted for 72 hours. The patient received the shot 3 weeks ago and all her symptoms had thus resolved. The patient declined follow up with her healthcare professional. The reporter did not consent to follow up.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: exposure to freezing temperatures; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 48-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number KN5VR, expiry date 16th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th September 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 case details were reported as follows: The pharmacist called due to their discovery that the patient was inadvertently administered on 16th September 2021 the vaccine that was in the temperature excursion, which led to incorrect storage of drug. The pharmacist was informed that the vaccine should be discarded due to exposure to freezing temperature 31.5 degree Fahrenheit for 13 hours. The reporter did not consent to follow up. This was 1 of 7 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021198147:same reporter US-GLAXOSMITHKLINE-US2021198139:same reporter US-GLAXOSMITHKLINE-US2021198148:same reporter US-GLAXOSMITHKLINE-US2021198144:same reporter US-GLAXOSMITHKLINE-US2021198142:same reporter
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo reconstituted with sterile water; Menveo reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 20th September 2021, the patient received Menveo. On 20th September 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided are as follows: The nurse reported that the patient received a dose of Menveo lyophilized powder reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Fatigue, Flushing, Gait disturbance
Clinical narrative: NEUROPATHY IN BOTH FEET THAT WENT UP HER LEGS/FINGERS AND HANDS; FEELING FLUSHED IN THE FACE; BODY ACHES; DIFFICULT TO WALK; SORE THROAT; SEVERE BONE PAIN; WORSE PAIN IN LEGS AND HIPS; FEELING FEVERISH; HEADACHE; WEAKNESS; FEELING VERY TIRED; SEVERE PAIN IN BOTH MUSCLE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included chemotherapy performed on an unspecified date in NOV-2020, patient had no known allergies as pre-existing medical conditions, The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported,1 total, administered on 14-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 14-SEP-2021, about 4 hours post vaccination, patient felt flushed in the face and feverish, although patient did not have a fever. Patient complained of a headache that would come and go for 2 days. Patient stated she had neuropathy in both feet that went up her legs and lasted over 24 hours, as well as neuropathy in her fingers and hands that was still persisted. Patient stated she had body aches described as both muscle and bone pain, that was so severe that it was difficult to walk. The pain begun 20 hours after the injection and lasted over 24 hours, and was worse in the legs and hips. Patient reported that 3 hours after the injection, she felt very tired, which lasted approximately 48 hours, as well as weakness that was associated with the body pain. Patient also experienced a sore throat. Patient compared the feeling to her chemotherapy treatment in NOV-2020. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, severe bone pain, worse pain in legs and hips, and severe pain in both muscle on SEP-2021, and headache, and feeling very tired on 16-SEP-2021, had not recovered from neuropathy in both feet that went up her legs/fingers and hands, and the outcome of feeling flushed in the face, feeling feverish, weakness, sore throat and difficult to walk was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210935168-COVID-19 VACCINE AD26.COV2.S-neuropathy in both feet that went up her legs/fingers and hands. 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).