chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: chills; headache; soreness in my muscles; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, headache and muscle soreness. On an unknown date, the outcome of the chills, headache and muscle soreness were unknown.   It was unknown if the reporter considered the chills, headache and muscle soreness to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient woke up with chills, a headache and soreness in muscles. The patient asked if that was a typical reaction.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypertension, Injection site pain, Pyrexia
Clinical narrative: high blood pressure reading; had a fever; arm pain in the injected arm site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 20th November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 21st November 2020, the patient experienced fever. On 24th November 2020, the patient experienced blood pressure high. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the fever was recovered/resolved and the outcome of the blood pressure high was unknown.   It was unknown if the reporter considered the injection site pain, fever and blood pressure high to be related to Shingrix.  Additional details were provided as follows: There are no events reported with 1st dose of Shingrix. The patient received 2nd dose of Shingrix in the right arm and had arm pain in the injected arm site.  The patient reported fever and reporting a high blood pressure reading 167/102. In November 2020, fever resolved. The reporter did not consent to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Pain / at injection site; Redness / at injection site; Swelling at injection site; Shivers; Nausea; Itching; Not administered in his deltoid / below the deltoid instead; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st dose in September 2020, refer case US2020AMR233628).   On 21st November 2020, the patient received the 2nd dose of Shingrix .5 ml. On 21st November 2020, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 22nd November 2020, the patient experienced injection site pain, injection site erythema, injection site swelling, shivering, nausea and pruritus. Rechallenge with Shingrix was positive. On 23rd November 2020, the outcome of the shivering and nausea were recovered/resolved. On 24th November 2020, the outcome of the injection site pain and pruritus were recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling and vaccine administered at inappropriate site were unknown.   The reporter considered the injection site pain, injection site erythema, injection site swelling, shivering, nausea and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and next day experienced pain, redness and swelling at the injection site and reported shivers and nausea which resolved. The patient experiencing itching for 2 days and the vaccine was not administered in his deltoid and was administered below the deltoid instead, which led to vaccine administered at inappropriate site. The reporter followed up with CDC guidelines and did not consent to follow up. The reporter declined to provide HCP information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR233628:Same reporter. 1st dose
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Pain / at injection site; Redness / at injection site; Swelling at injection site; Shivers; Nausea; Itching; Not administered in his deltoid / below the deltoid instead; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st dose in September 2020, refer case US2020AMR233628).   On 21st November 2020, the patient received the 2nd dose of Shingrix .5 ml. On 21st November 2020, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 22nd November 2020, the patient experienced injection site pain, injection site erythema, injection site swelling, shivering, nausea and pruritus. Rechallenge with Shingrix was positive. On 23rd November 2020, the outcome of the shivering and nausea were recovered/resolved. On 24th November 2020, the outcome of the injection site pain and pruritus were recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling and vaccine administered at inappropriate site were unknown.   The reporter considered the injection site pain, injection site erythema, injection site swelling, shivering, nausea and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and next day experienced pain, redness and swelling at the injection site and reported shivers and nausea which resolved. The patient experiencing itching for 2 days and the vaccine was not administered in his deltoid and was administered below the deltoid instead, which led to vaccine administered at inappropriate site. The reporter followed up with CDC guidelines and did not consent to follow up. The reporter declined to provide HCP information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR233628:Same reporter. 1st dose
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: received half the vaccine; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced incorrect dose administered.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020 around 13:30, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 28 Dec 2020, during vaccine administration, the patient experienced incorrect dose administered. The pharmacist stated that the patient did not receive the full dose. The pharmacist estimated that the patient received half of the vaccine and the rest leaked out. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The event, incorrect dose administered, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a female patient who received the first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered without any associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: unknown quantity leaked out of the hub of the needle and down her arm; A spontaneous report was received from a health care facility staff member concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced incorrect dose administered.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19.   On the unknown date, during vaccine administration, the patient experienced incorrect dose administered. The health care facility staff member reported an unknown quantity leaked out of the hub of the needle and down the patient's arm. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The event, incorrect dose administered, was considered resolved.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered without any associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dosage administered
Clinical narrative: Given a first dose of the Moderna vaccine of 1ml instead of .5 ml; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was given a first dose of the Moderna vaccine of 1 mL instead of 0.5 mL.   The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 29 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection. During the administration, the pharmacist stated that the patient was given a first dose of the vaccine of 1.0 ml instead of 0.5 ml. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event was not reported.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot 011L20A), reporting Incorrect dosage administered without any associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Incorrect dose administered
Clinical narrative: Needle came off the syringe and some of the vaccine spilled out and dripped down on her arm; Needle came off the syringe and some of the vaccine spilled out and dripped down on her arm; A spontaneous report was received from a 57-year old, female nurse, who was also a patient, who received Moderna's COVID-19 vaccine and experienced needle came off the syringe and some of the vaccine spilled out and dripped down on her arm.   The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.   On 28 DEC 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On the afternoon of 28 DEC 2020, the needle came off of the syringe and some of the vaccine spilled out and dripped down the patient's arm. She was not sure if she received the full dose. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The events, needle came off the syringe and some of the vaccine spilled out and dripped down on her arm, were considered resolved on 28 DEC 2020.; Reporter's Comments: This case concerns a 57-year-old, female patient who received their first of two planned doses of mRNA-1273 (Lot-# 026L20A and expiration date-unknown), reporting an unexpected event of incomplete dose administered and exposure via skin contact. The events occurred the same day of vaccine administration. The reporter did not provide the causality assessment. The event of incomplete dose administered and exposure via skin contact was assessed as unlikely related to Moderna COVID-19 Vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine from a punctured vial kept in refrigerator more than 6 hours; A spontaneous report was received from a physician's assistant concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered vaccine from a punctured vial kept in the refrigerator more than 6 hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 28 Dec 2020, a nurse administered a vaccine from a previously punctured vial that was kept in the refrigerator for more than 6 hours. No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not reported.   The event, administered vaccine from a punctured vial kept in the refrigerator more than 6 hours, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of s patient administered a vaccine from a previously punctured vial that was kept in the refrigerator for more than 6 hours (Expired product administered)  for mRNA-1273, lot # 026L20A. There were no reported adverse events associated with this case of administered a vaccine from a previously punctured vial that was kept in the refrigerator for more than 6 hours.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediatric patient got vaccinated; A spontaneous report was received from a nurse concerning a 16-year-old, female pediatric patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, pediatric patient got vaccinated.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 28 Dec 2020, the pediatric patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 28 Dec 2020, reporter stated, she, and her 16-year-old daughter both received the Moderna COVID-19 vaccine. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The event, pediatric patient got vaccinated, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 16-year-old, female patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date -unknown), reporting an unexpected event of drug administered to patient of inappropriate age. This event occurred the same day of vaccine administration. The reporter did not provide the causality assessment for the events. The event is assessed as unrelated to Moderna COVID-19 Vaccine.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: felt it leak down her arm as needle was not tight; A spontaneous report was received from a physician concerning a 28-year old, female patient who experienced the event, felt it leak down her arm as needle was not tight.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (LOT# U25J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient received her first dose of the COVID-19 vaccine and felt it leak down her arm as the needle was not tight. The pharmacist had no idea how much leaked or how much went in. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, felt it leak down her arm as needle was not tight, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 28 year old female patient. The patient's medical history is not provided. The patient experienced an unexpected event of vaccine leaking down her arm as needle was not tight. The event occurred on 28 Dec 2020 during administration of the first dose of the COVID-19 vaccine. The sponsor considered the event as not related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Syringe leaked and she thinks she only received half of its dose; A spontaneous report was received from a dentist who was a 28-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced syringe leaked and she thinks she only received half of its dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020 at 11:30, the patient received her first of two planned doses of mRNA-1273  intramuscularly for prophylaxis of COVID-19 infection. During the administration, the syringe had a leakage and she thought she only received half of its dose. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The event, syringe leaked and she thinks she only received half of its dose was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 28-years-old, female patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date- unknown), reporting an unexpected event of Incomplete dose administered. The event of Incomplete dose administered was considered not related to Moderna COVID-19 Vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Received her first dose of Modena vaccine 24 hours after the vial had been punctured; A spontaneous report was received from a pharmacist concerning a 46-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received her first dose of Modena vaccine 24 hours after the vial had been punctured.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 24 Dec 2020, the patient received her first dose of Modena vaccine 24 hours after the vial had been punctured. The vaccine was refrigerated during the 24-hour period. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The event, received her first dose of Modena vaccine 24 hours after the vial had been punctured, was considered resolved on 24 Dec 2020.; Reporter's Comments: This case concerns a 46-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Incomplete dose received; A report was received from a consumer concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced incomplete dose received.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, approximately 0 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the patient reported that the syringe fluid leaked out onto his arm during the attempted first dose of vaccine administration, and notified the administering nurse that no liquid injected into his arm. He stated the nurse would not administer a second dose before contacting Moderna. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, incomplete dose received, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a male patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Dosed 16 year old with Moderna Vaccine; A spontaneous report was received from a physician concerning an adolescent (16 or 17 year-old) patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dosed 16 year old with Moderna vaccine.     The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unspecified date in Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for COVID-19 prophylaxis.   On an unspecified date in Dec 2020, a 16 or 17 year-old patient was dosed with the Moderna vaccine. After vaccination, there were no untoward effects and it was tolerated well. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, dosed 16 year old with Moderna vaccine, was considered resolved on an unspecified date in Dec 2020.; Reporter's Comments: This case concerns a 16-17 year-old, patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date -unknown), reporting an unexpected event of product administered to patient of inappropriate age without any associated adverse events. This event occurred the same day of vaccine administration. The reporter did not provide the causality assessment for the event. The event is assessed as not related to Moderna COVID-19 Vaccine.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site extravasation
Clinical narrative: Spurting fluid from injection site; Spurting fluid from injection site; A spontaneous report was received from a paramedic concerning a 30-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced spurting fluid from injection site.  The patient's medical history was not provided. No concomitant medications were not reported.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 28 Dec 2020, upon vaccine administration and removal of the needle, the patient experienced spurting fluid from injection site. An amount of fluid, similar to the amount of vaccine administered, was released from the patient's deltoid. It was reported this has often occured to the patient when she receives the flu vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event, spurting fluid from injection site, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 30-years-old, female subject, who experienced a non-serious unexpected event of injection site extravasation and incorrect dose administered for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of injection site extravasation and incorrect dose administered.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error, Underdose
Clinical narrative: Unclear if the patient received any of the vaccine or a partial dose; Vaccine underdose; A spontaneous report was received from a pharmacist concerning a patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced product administration error and vaccine underdose.  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) for COVID-19 prophylaxis. During the administration, the vaccine came out through the sides of the leur-lock connection between the needle and syringe. It was unclear if the patient received any of the vaccine or a partial dose.  No treatment information was reported.  The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events, product administration error and vaccine underdose, were resolved.; Reporter's Comments: This report refers to a case of product administration error and vaccine under dose for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product administration error and vaccine under dose.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna vaccine being given to a 17 year old inadvertently; A spontaneous report was received from a nurse practitioner concerning a 17-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Moderna vaccine being given to a 17 year old inadvertently with the use of mRNA-1273.    There was no medical history or concomitant medications provided.  On an unspecified date in Dec 2020 the patient received his first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date in Dec 2020, the vaccine was given to a 17-year-old inadvertently. His birthdate was missed in the vaccine clinic. The nurse practitioner followed-up with him and he was doing fine. There was no treatment information provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, Moderna vaccine being given to a 17-year-old inadvertently, was considered resolved on an unspecified date in Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273. There were no reported AEs associated with this case of product administered to patient of inappropriate age for mRNA-1273.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vial was in the refrigerator for about 12 hours, 2 patients were injected with the same vaccine vial for their first dose; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vial was in the refrigerator for about 12 hours and 2 patients were injected with the same vaccine vial for their first dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 24 Dec 2020, the patient received their first of two planned doses of mRNA-intramuscularly for prophylaxis of COVID-19 infection.  On 23 Dec 2020, eight doses were used from a vaccine vial and the vial was stored on an ice cooler between patients. When finished for the day, the punctured vial was kept in the refrigerator under the recommended temperature range.   On 24 Dec 2020, after the vial that was initially punctured at an unknown time on 23 Dec 2020, was in the refrigerator for about 12 hours, two patients were injected with same vaccine vial for their first dose. No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not reported.  The event, vial was in the refrigerator for about 12 hours and 2 patients were injected with the same vaccine vial for their first dose, was considered resolved on 24 Dec 2020.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.; Sender's Comments:  US-MODERNATX, INC.-MOD-2020-001778:Same reporter, same source, different patient
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vial was in the refrigerator for about 12 hours, 2 patients were injected with the same vaccine vial for their first dose; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was in the refrigerator for about 12 hours and 2 patients were injected with the same vaccine vial for their first dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 24 Dec 2020, the patient received their first of two planned doses of mRNA-intramuscularly for prophylaxis of COVID-19 infection.  On 23 Dec 2020, eight doses were used from a vaccine vial and was stored on an ICE cooler between patients. When finished for the day, the punctured vial was kept in the refrigerator under the recommended temperature range.   On 24 Dec 2020, after the vial was in the refrigerator for about 12 hours, two patients were injected with same vaccine vial for their first dose. No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not reported.  The event, was in the refrigerator for about 12 hours and 2 patients were injected with the same vaccine vial for their first dose, was considered resolved on 24 Dec 2020.; Reporter's Comments: This report refers to a case of product storage error for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product storage error.; Sender's Comments:  US-MODERNATX, INC.-MOD-2020-001773:Same reporter, same source, different patient
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse events reported; may have been involved in shipping temperatures outside the prescriving information; This spontaneous report was received from a 66-year-old female patient referring to herself. Her pertinent medical history, concomitant medications and drug reactions or allergies were unknown.  On 25-AUG-2020, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S036495, expiration date was not reported but upon internal review was established as 13-SEP-2021, dose of 0.5 milliliter (formulation, route of administration and anatomical location were not reported) for prophylaxis. It was reported that this vaccine may have been involved in shipping temperatures outside the prescribing information. The patient's clinic called and told her that they do not know what the temperature was or how long it had been at that temperature. She was advised to contact her physician for any direction on healthcare needs. No additional adverse events reported. A data logger was not used to capture the temperature excursion. The reporter had no knowledge of a previous temperature excursion. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: burning sensation reaction locally in arm; tender to touch arm; swollen / arm; severe reaction of red / arm; This case was reported by a physician via call center representative and described the occurrence of burning sensation in a adult patient who received Herpes zoster (Shingrix) (batch number 4Z43X, expiry date 22nd February 2022) for prophylaxis.   On 1st December 2020, the patient received the 2nd dose of Shingrix. On 1st December 2020, less than a day after receiving Shingrix, the patient experienced burning sensation. In December 2020, the patient experienced pain in arm, swelling arm and erythema of extremities. On an unknown date, the outcome of the burning sensation, pain in arm, swelling arm and erythema of extremities were unknown.   It was unknown if the reporter considered the burning sensation, pain in arm, swelling arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of at vaccination was not reported but captured as adult as per vaccine indication. The patient was vaccinated with Shingrix. The patient experienced burning sensation reaction locally in arm and provided with ice therapy then patient felt okay to go home. The patient called physician back with severe reaction of red, swollen and tender to touch arm. The physician was uncomfortable with providing patient details of adverse event. The reporter did not consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive to COVID; Tested positive to COVID; This is a spontaneous report from a contactable nurse, the patient. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Jan2021, the patient tested positive to Covid. The outcome of the event, tested positive to Covid, was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Bone pain, Condition aggravated, Fatigue
Clinical narrative: neuropathy; pain; nausea; fatigue; bone, muscle, stomach pain; bone, muscle, stomach pain; bone, muscle, stomach pain; flare; increase in joint pain from his baseline; This is a spontaneous report from a Pfizer sponsored program Accredo Xeljanz Program. A contactable nurse and contactable consumer (patient) reported that a 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization and tofacitinib citrate (XELJANZ XR), orally from 02Oct2020 at 11 mg, daily for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported.  On 19Dec2020, the patient experienced neuropathy, pain, nausea, fatigue, bone, muscle, stomach pain and flare.  In Dec2020, the patient experienced increase in joint pain from his baseline. The physician was aware. The patient was placed on unspecified steroids for the events, neuropathy, pain, nausea, fatigue, bone, muscle, stomach pain and flare which minimized symptoms. While weaning off steroids, the severity of symptoms returned. The patient was instructed by the doctor to stop taking tofacitinib citrate which was stopped on 29Dec2020. The action taken in response to the events for BNT162B2 was not applicable and for tofacitinib citrate was permanently withdrawn on 29Dec2020.  The patient reported slight improvement after stopping tofacitinib citrate.  The outcome of neuropathy, pain, nausea, fatigue, bone, muscle, stomach pain and flare was recovering and of increase in joint pain from his baseline was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information available, the reported events are most likely due to patient underlying contributory factors and unlikely that it is related to the suspect product. However due to temporal association with the vaccine, a possible contributory role of vaccine cannot be ruled out. Case will be reevaluated based on additional information during the follow-up.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Neuropathy peripheral, Pain, Rheumatoid arthritis
Clinical narrative: neuropathy; pain; nausea; fatigue; bone, muscle, stomach pain; bone, muscle, stomach pain; bone, muscle, stomach pain; flare; increase in joint pain from his baseline; This is a spontaneous report from a Pfizer sponsored program Accredo Xeljanz Program. A contactable nurse and contactable consumer (patient) reported that a 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization and tofacitinib citrate (XELJANZ XR), orally from 02Oct2020 at 11 mg, daily for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported.  On 19Dec2020, the patient experienced neuropathy, pain, nausea, fatigue, bone, muscle, stomach pain and flare.  In Dec2020, the patient experienced increase in joint pain from his baseline. The physician was aware. The patient was placed on unspecified steroids for the events, neuropathy, pain, nausea, fatigue, bone, muscle, stomach pain and flare which minimized symptoms. While weaning off steroids, the severity of symptoms returned. The patient was instructed by the doctor to stop taking tofacitinib citrate which was stopped on 29Dec2020. The action taken in response to the events for BNT162B2 was not applicable and for tofacitinib citrate was permanently withdrawn on 29Dec2020.  The patient reported slight improvement after stopping tofacitinib citrate.  The outcome of neuropathy, pain, nausea, fatigue, bone, muscle, stomach pain and flare was recovering and of increase in joint pain from his baseline was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information available, the reported events are most likely due to patient underlying contributory factors and unlikely that it is related to the suspect product. However due to temporal association with the vaccine, a possible contributory role of vaccine cannot be ruled out. Case will be reevaluated based on additional information during the follow-up.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; This is a spontaneous report from a contactable health care professional.  A 27-years-old non-pregnant  female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number= EH9899, intramuscular, in left arm on 15Dec2020 at 18:45 (at the age of 27 years-old), as a single dose for COVID-19 immunization. The patient received the vaccination at a hospital. There was no medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was not reported if the patient took any other medications in the 2 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 15Dec2020, the patient experienced an instant headache, dizziness 2 hours after the injection, nausea/vomiting/diarrhea (N/V/D), fatigue, and a fever of 100.6. The patient was not hospitalized for the reported events and no treatment was given. The clinical outcome of the events of instant headache, dizziness 2 hours after the injection, nausea/vomiting/diarrhea, fatigue, and a fever of 100.6 was recovered on an unspecified date. Since the vaccination, the patient has not been tested for COVID-19.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; This is a spontaneous report from a contactable health care professional.  A 27-years-old non-pregnant  female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number= EH9899, intramuscular, in left arm on 15Dec2020 at 18:45 (at the age of 27 years-old), as a single dose for COVID-19 immunization. The patient received the vaccination at a hospital. There was no medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was not reported if the patient took any other medications in the 2 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 15Dec2020, the patient experienced an instant headache, dizziness 2 hours after the injection, nausea/vomiting/diarrhea (N/V/D), fatigue, and a fever of 100.6. The patient was not hospitalized for the reported events and no treatment was given. The clinical outcome of the events of instant headache, dizziness 2 hours after the injection, nausea/vomiting/diarrhea, fatigue, and a fever of 100.6 was recovered on an unspecified date. Since the vaccination, the patient has not been tested for COVID-19.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, SARS-CoV-2 test, Urticaria
Clinical narrative: broke out into hives in my face and neck; short of breath; Exhaustion; This is a spontaneous report from a contactable Other Health Professional (patient). A 36-year-old female patient received first dose of BNT162B2 (Pfizer BioNTech COVID-19 EUA30, lot# EL1284), via an unspecified route of administration in left arm on 28Dec2020 08:45 at single dose for covid-19 immunization.  Medical history included Allergies: Penicillin, Bactrim (sulfamethoxazole, trimethoprim), tomatoes.  The patient's concomitant medications were not reported.  After 25 minutes of getting the first dose of the vaccine, the patient broke out into hives in face and neck. Hives continued for days. By day 3, the patient was checked into the hospital for short of breath, hives and exhaustion. A week after dose 1, the patient still had hives and slight shortness of breath. Pregnant at the time of vaccination: No. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. AE treatment: COVID test and steroids. If COVID prior vaccination: No. If COVID tested post vaccination: Yes. Covid test post vaccination: Nasal Swab on 01Jan2021, Negative result.  Facility where the most recent COVID-19 vaccine was administered: Hospital. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: NO. The outcome of all the events was not recovered. Serious: no. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: no. Seriousness criteria-Caused/prolonged hospitalization: no. Seriousness criteria-Disabling/Incapacitating: no. Seriousness criteria-Congenital anomaly/birth defect: no.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I developed Covid -19 (positive PCR) on 02Jan2021 after respecting quarantine, mask wearing, and was not onsite at work; I developed Covid -19 (positive PCR) on 02Jan2021 after respecting quarantine, mask wearing, and was not onsite at work; This is a spontaneous report from a contactable  pharmacist. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EK5130, via an unspecified route of administration at left arm from 23Dec2020 16:30 to 23Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient developed Covid-19 (positive polymerase chain reaction (PRC)) on 02Jan2021, after respecting quarantine, mask wearing, and was not onsite at work. The patient did not received treatment for the adverse events. The outcome of the events was recovering.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, C-reactive protein, C-reactive protein increased, Pain in extremity, Rash pruritic
Clinical narrative: the patient developed extreme hand and joint pain; the patient developed extreme hand and joint pain; she had an itchy rash all over her upper body; elevated CRP; This is a spontaneous report from a contactable Pharmacist. This pharmacist reported for a female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# number unknown) on 18Dec2020 for COVID-19 immunization. Medical history and concomitant drug were not reported. HCP wants to know if a patient who presented an adverse reaction to the first dose of the vaccine could receive the second one. The patient received the vaccine on 18Dec2020, and 12 days later on 30Dec2020, the patient developed extreme hand and joint pain, the patient was required to get analgesic medication up and down her arm and shoulder, patient was unable to lift her arm or do any personal care for herself 24 to 48 hours, she had an itchy rash all over her upper body, elevated CRP and those symptoms revolved in around five days. Per attached documentation, patients with a known severe allergic reaction to the vaccine should not receive a second dose, referred to the physicians diagnosed. Outcome of the event itchy rash all over her upper body, elevated CRP was recovered, for other events was unknown.  Information about lot/batch number has been requested.