chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: HEPA, HIBV, MMR
Symptoms: Extra dose administered
Clinical narrative: It had not been recorded in patient's chart that he had received these immunizations, even though there was thought by both staff and mom that they had been done, however no administration documentation.  We scheduled to do catch up on these immunizations and then it was noted after giving these again on 8/28/24 that they were given on 5/23/24 in patient's brother's chart who was there on that same day.  Mother was notified after they left of the error and that both patient's chart would be fixed appropriately and that the duplicate injection will not harm patient.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: DOCTOR PRESCRIBE BOOSTRIX IN JULY /21/2024 PATIENT PREGNANT WITH 28 WEEKS THEN HE PRESCRIBE IN AUGUST/26/2024 A SECOND BOOSTRIX  AND RSV. UNFOTUNATELLY , BOTH BOOSTRIX WHERE APLIED . AFTER THE SECOND INYECTION OF BOOSTRIX WE NOTICE THE MISTAKE BY LOOKING INFORMATION IN THE GOVERMENT DATA.  SHE HAS NO PRESENT ANY ADVERSES EVENT SHE IS NOW 34 WEEKS OF GESTETION .
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site pain, Injection site paraesthesia, Muscular weakness
Clinical narrative: 8/7/24 pt seen at Urgent Care for upper arm pain.  Patient states 2 weeks ago she got the shingles shot after she did for about a day and a half it was very painful and tender patient used warm compresses and that was helpful patient states since then that degree of pain has gone down but still is having right upper arm weakness and burning and tingling in right upper arm where injection was given.  seen by PCP on 8/28 for continued symptoms: Presenting today for follow up of her health issues. Having increased pain to right arm since the shingles vaccine just over a month ago. Persistent discomfort, but can come and go. Certain movements make it worse. Seen in UC, tried steroids but could not tolerate. No swelling or redness.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash around absomen
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Inflammation
Clinical narrative: PATIENT HAS REDNESS AND INFLAMMATION ON THE INSIDE OF HER ARM ON HER BICEP AREA
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Atrial fibrillation, Electrocardiogram
Clinical narrative: atrial fibrillation
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Mass
Clinical narrative: Mother states the vaccine was given on Monday, Wednesday she noticed some redness, and by Friday she noticed the marble sized lump. Denied any warmth to the touch.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Apparently the lic to this vaccine was withdrawn on 8/22/2024
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored vaccine administration; No additional AE; This spontaneous report was received from medical assistant and refers to a 4-year-old male. The patient's medical history, concurrent conditions and concomitant therapies were not reported. Historical vaccine was reported as measles, mumps and rubella vaccine.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, valid lot #Y004553, expiration date: 20-FEB-2026, administered for prophylaxis (dose, strength, and route of administration were not provided) which underwent temperaturee excursion of 32.4 F for 6 hours, previous temperature excursion was not reported and on 15-JUL-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) valid lot #Y003893, expiration date: 02-FEB-2026, administered subcutaneously in the left thigh for prophylaxis (dose and strength were not provided), which were improperly stored (product storage error) due to temperaturee of freezer was out of range.  No additional adverse event (AE) was reported.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Product administered after temperature excursion/vaccine was too cold for administration; This spontaneous report was received from a registered nurse referring to a 6-month-old (also reported as 7-moth-old (discrepant information)) female patient. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 28-JUN-2024, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 2003174, expiration date: 14-SEP-2025, third dose, administered orally for prophylaxis (exact dose was not provided) (product storage error). On dates between 28-JUN-2024 to 01-JUL-2024, vaccine was exposed to 12.8 degrees Fahrenheit (F) (also reported as 12.7 F) for 76 hours 50 minutes 0 seconds. It was reported that vaccine was too cold for administration. There was no previous temperature excursion. No adverse event was reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2408USA000396: US-009507513-2407USA000658: US-009507513-2408USA000406: US-009507513-2408USA000433:
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; HCP called to ask about alternative dosing schedules for a 39 yr old male for GARDASIL 9. HCP stated that the patient had received their first dose on March 6 2023, and the second dose on June 10 2024.  No other information was available.  HCP did no; This spontaneous report was received from a pharmacist refers to a 39-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 06-MAR-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), formulation: injection, 0.5 milliliter for prophylaxis (lot #, expiration date, route of administration, and anatomical location were not provided). On 10-JUN-2024, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), formulation: injection, 0.5 milliliter for prophylaxis (lot #, expiration date, route of administration, and anatomical location were not provided) (inappropriate schedule of product administration). No additional adverse event reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Assistant confirmed the patient involved did not report any medical concerns or symptoms after being administered the improperly stored dose of PROQUAD.; Medical Assistant calling to report adverse event regarding an improperly stored and administered dose of PROQUAD.  Medical Assistant stated that a dose of PROQUAD was administered after a temperature excursion occurred today, 8/9/2024.  Medical Assi; This spontaneous report as medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 09-AUG-2024, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: injection, lot # Y006769, expiration date: 24-SEP-2025, 0.5 milliliter for prophylaxis (route of administration and anatomical location were not provided).  Temperature excursion occurred on the same day (product storage error). No additional information provided. No additional adverse event reported (no adverse event).  Lot number Y006769 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), with rHA albumin status.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; an adult patient received their first dose of VARIVAX on 7/18/2024 and their second dose on 8/11/2024.; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown gender.  The patient's previous adverse drug reaction history and family adverse drug reactions were not reported. The patient's concomitant therapies, medical histories and drug allergies were not reported.  On 18-JUL-2024, the patient was vaccinated with first doe of varicella virus vaccine live (oka/merck) (VARIVAX) injection, (lot #x026789, expiration date: 14-NOV-2025), administered for prophylaxis (strength, and route of administration were not provided). On 11-AUG-2024, the patient was vaccinated with second dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, (lot #x026789, expiration date: 14-NOV-2025), administered for prophylaxis (strength, and route of administration were not provided) (Inappropriate schedule of product administration). It was confirmed no other AE occurred.
Age: 37.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; a pediatric dose of VAQTA that was administered to a 37-year-old patient yesterday,; This spontaneous report was received from a medical assistant and refers to a 37-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 15-AUG-2024, at the age of 37 years, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dose, lot #X025482, expiration date reported as 25-APR-2024, however upon internal validation was established as12-APR-2025 (conflicting information), (exact dose, route of administration, and anatomical site of vaccination were not provided) for prophylaxis (underdose). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; administered to a patient post expiry date; This spontaneous report was received from an Other Health Professional and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-NOV-2014, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, lot #0386AE, expiration date: 10-NOV-2014, administered for prophylaxis (strength, dose and route of administration were not provided) (Expired product administered). No additional AE.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: 4th dose: 12-JUL-2006; 3rd dose: 18-OCT-2005; This spontaneous report has been received from a health care professional, via an immunization record from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (# 2404USA012390), concerning a 6-month-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Historical vaccine included hepatitis B vaccine. Concomitant vaccines included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP) and measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (manufacturer unknown).  On 15-JUN-2005, the patient was vaccinated with the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection, administered for prophylaxis at a hospital (strength, dose, lot #, expiry date, and route of administration were not provided). On 17-AUG-2005, the patient was vaccinated with the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown). On 18-OCT-2005, the patient was vaccinated with the third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (Inappropriate schedule of product administration). On 12-JUL-2006, the patient was vaccinated with the fourth dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (Extra dose administered).; Sender's Comments:  US-009507513-2404USA012390:
Sex: U
Vaccine: PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP reported patient administered VAXNEUVANCE and ROTATEQ after products experienced a T/E. T/E filed: 02659842. No symptoms reported.  This case is related to AE cases: 02659845, 02659886, 02659888 and 02659891. Consent to correspond was granted.  N; HCP reported patient administered VAXNEUVANCE and ROTATEQ after products experienced a T/E. T/E filed: 02659842. No symptoms reported.  This case is related to AE cases: 02659845, 02659886, 02659888 and 02659891. Consent to correspond was granted.  N; This spontaneous report was received from medical assistant and refers to an infant patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2024, the patient was vaccinated with an improper storage dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 milliliter, lot #X022475, expiration date: 23-JAN-2026, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). Additional (on an unspecified date in 2024), the patient was also vaccinated with an improper storage dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2.0 milliliter, lot #2003161, expiration date: 01-SEP-2025, administered orally for prophylaxis (strength was not provided). It was confirmed that the vaccines were administered after an unspecified temperature excursion and no additional adverse events were reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; Inbound call from nurse calling to report administration of PROQUAD past the must use by date.  Caller states that PROQUAD had a temperature excursion on 17-MAY-2024 (see previous TE case# 02603521).  Caller states that the product was evaluated to b; This spontaneous report was received from a nurse, referring to a 4-year-old patient (gender unknown). The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  Measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: recombinant Human albumin/rHA) (PROQUAD) had a temperature excursion with temperature from 9 degree Celsius to 25 degree Celsius (exact high temperature unknown) for 6 hours 30 minutes on 17-MAY-2024. The nurse would call back with the high temperature. The product was evaluated that it must be used within 3 months of the temperature excursion, which would have been 17-AUG-2024. On 22-AUG-2024, the patient was vaccinated accidently with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: recombinant Human albumin/rHA) (PROQUAD) injection, 0.5 milliliter, once, lot #X023400, expiration date: 20-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). The nurse confirmed no symptomatic adverse events reported by patients. No additional adverse event (AE)/ product quality concern (PQC) was reported (no adverse event).
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: Received from the AE Self-Service Portal: Report submitted by Merck Employee Arm pain after the injection for G9, that lasted 2 weeks.  "Case assigned/processed by agent on 08/23/2024. See additional information provided. No additional AE/ No PQ; This spontaneous report was received from a physician via company representative referring to a 9-year-old female patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot number and expiration date not reported) for prophylaxis.         On an unknown date, the patient experienced arm pain after injection (pain in extremity), which lasted for 2 weeks.      The causal relationship between the event and the vaccine was not reported.
Age: 37.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adeverse event; 37 years old patient received PROQUAD; This spontaneous report was received from a physician regarding a 37-year-old patient of unknown gender.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. The patient's historical vaccines included varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (M-M-R II).   On 23-AUG-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) subcutaneous injection, administered as 1 dose as prophylaxis (lot number Y009106 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live [PROQUAD], expiration date reported and validated as 06-NOV-2025) (route of administration and anatomical site of injection were not provided) (Product administered to patient of inappropriate age). No additional adverse events were reported for the patient.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Incorrect product formulation administered, No adverse event, Product administration error
Clinical narrative: This patient did not report any side effects or adverse events; female patient was mistakenly administered the dialysis formulation of RECOMBIVAX HB; mistakenly administered a larger than recommended dose; This spontaneous report was received from a pharmacist concerning a 58-year-old female patient. Information regarding the patient's concurrent conditions, medical history or concomitant therapies were not reported.  On 23-JUL-2024, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (thimerosal free) (RECOMBIVAX HB) intramuscular injection 40 mcg/ml dialysis formulation at a dose of 1 milliliter intramuscularly. Lot number X024566 which has been verified to be valid, expiration date reported and validated as 01-NOV-2025. On 23-AUG-2024, when the patient returned one month later for the second dose of the series, the administration error was discovered (incorrect product formulation administered)  as the patient should have received the adult formulation (non-dialysis) dose of 10 micrograms per milliliter  for the first dose of the Hepatitis B Vaccine (Recombinant) RECOMBIVAX HB series (overdose). This patient did not report any side effects or adverse events. On the same date, the patient was administered an unspecified dose of the Hepatitis B Vaccine [Recombinant], Adjuvanted (HEPLISAV) to restart the series.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product preparation error
Clinical narrative: Used HEPLISAV-B to Reconstitute an MMR2 Vaccine and then Gave the Mixed Vaccine to the Patient; Used HEPLISAV-B to Reconstitute an MMR2 Vaccine; Initial report received on 30-Jul-2024.  A pharmacist reported that a male patient (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was used to reconstitute an  MMR II   (measles, mumps, and rubella vaccine) vaccine.  Medical history, allergies, and concomitant medications were not reported.   On 30-Jul-2024, HEPLISAV-B (Lot number 943888, expiration date 14 May-2026, and NDC 43528-0003-05) was used to reconstitute an M M-R II vaccine (no details provided) and then was administered  intramuscularly in the left deltoid. The patient did not report any further adverse effects.   No further information was available.  Company Comment The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Age: 73.0
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Received first dose of HEPLISAV-B in Dec-2023, as not received second dose yet; Initial report received on 01-Aug-2024.  A pharmacy technician in the reported that a 73-year-old female patient (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in Dec 2023 but has not received the second dose.   Medical history, allergies, and concomitant medications were not reported.   On 16-Dec-2023, the patient received the first dose of HEPLISAV-B (Lot number 941428; expiration date and NDC unknown) intramuscularly in the left arm. The patient did not receive the second dose of HEPLISAV-B due to insurance change. No adverse effects were reported.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 41.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received HEPLISAV-B as first dose, then ENGERIX as second dose; Initial report received on 02-Aug-2024.  A nurse reported that a 41-year-old male patient (race and ethnicity not provided), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and ENGERIX-B as the second dose.  Medical history and concomitant medications were not reported. The patient had no known drug allergies.  On 27-Jun-2024, the patient received dose 1 of HEPLISAV-B (Lot number 943887, expiration date 18-May-2026, NDC 43528-0003-01) intramuscularly in the right deltoid.   On an unknown date, the patient received ENGERIX-B (no details provided) as the second dose. There were no further adverse reactions.  No other information was available.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Received two doses of a hepatitis B vaccine in 24 hours; Initial report received on 06-Aug-2024.  A healthcare professional reported that a patient (race and ethnicity not provided) received two doses of a hepatitis B vaccine (not specified) for hepatitis B immunization in 24 hours.  No relevant medical history or concomitant medications were reported.   On an unknown date, the patient received a dose of an unspecified hepatitis B vaccine (Lot #, expiration date, NDC #, site, and route not reported).  Within 24 hours of receiving the dose of unspecified hepatitis B vaccine, the patient received another dose of an unspecified hepatitis B vaccine.    No other information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received Heplisav-B in Aug-2023, then Engerix B in Jan-2024; Initial report received on 06-Aug-2024.  A pharmacist reported that a patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received ENGERIX-B.  No relevant medical history or concomitant medications were reported.   On 28-Aug-2023, the patient received an unspecified dose number of a HEPLISAV-B (Lot #, expiration date, NDC #, site, and route not reported).   On an unspecified date in Jan-2024, the patient received an unspecified dose number of ENGERIX-B.  The reporter stated no other side effects were related to this.    No other information was available.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 41.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received First Dose In March, and Received Second Dose in August; Initial report received on 15-Aug-2024.  A nurse in the reported that a 41-year-old female (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received the second dose five months later.  No relevant medical history or concomitant medications were reported.   On 18-Mar-2024, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route and site not reported).  On 15-Aug-2024, 150 days after having been vaccinated with HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot# 941589, expiration date 31-Aug-2025, and NDC # 43528-003-01) intramuscularly in the right deltoid.  The patient did not come back in April for the second dose because her insurance "wasn't working."  No adverse events were reported.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 23.0
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Received First Dose, and Have Not Received Second Dose; Initial report received on 16-Aug-2024.  A consumer reported that she, a 23-year-old female (race and ethnicity not provided), received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and has not received the second dose yet.  Medical history, allergies, and concomitant medications were not reported.   On 12-Feb-2024, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, and NDC #, route and site not reported). At the time of reporting, the patient has not received the second dose of HEPLISAV-B yet.  No other information was available.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Received First Dose in April, and Have Not Received Second Dose; Initial report received on 22-Aug-2024.  A pharmacist reported that a 60-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and has not received the second dose.  Medical history and concomitant medications were not reported.  On 15-Apr-2024, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, and NDC # not reported) intramuscularly in the right deltoid. At the time of reporting, the patient has not come back in for the second dose. Reporter states that the patient has not reported any additional side effects as a result.  No other information was available.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP, HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patients were accidentally administered with pediatric dose 2 Engerix-B/Wrong dose; adult patients were accidentally administered with pediatric dose 2 Engerix-B; adult patients were accidentally administered with pediatric dose 3 Engerix-B/Wrong dose; adult patients were accidentally administered with pediatric dose 3 Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 40-year-old female patient who received HBV (Engerix B pediatric) (batch number 9474F, expiry date 27-OCT-2025) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) (batch number 9474F, expiry date 27-OCT-2025) for prophylaxis.   Previously administered products included Engerix B (received 1st dose of Engerix B on an unknown date and batch number is 29RN7 and expired on 25th February 2024).   On 05-JUN-2024, the patient received the 3rd dose of Engerix B pediatric. On an unknown date, the patient received the 2nd dose of Engerix B pediatric. On 05-JUN-2024, an unknown time after receiving Engerix B pediatric and not applicable after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: adult patients were accidentally administered with pediatric dose 3 Engerix-B/Wrong dose) and underdose (Verbatim: adult patients were accidentally administered with pediatric dose 3 Engerix-B). On an unknown date, the patient experienced adult use of a child product (Verbatim: adult patients were accidentally administered with pediatric dose 2 Engerix-B/Wrong dose) and underdose (Verbatim: adult patients were accidentally administered with pediatric dose 2 Engerix-B). The outcome of the adult use of a child product, underdose, adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt date: 15-AUG-2024 An HCP reported that a patient are accidentally administered with pediatric doses of Engerix-B.  Patient 1 received 3 Engerix-B doses so far, the last 2 doses were pediatric which led to Adult use of a child product and underdose. This is 1 of 3 linked report, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient received the first dose of Shingrix in January 2023 and had not had the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (on January 2023 received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: The patient received the first dose of Shingrix in January 2023 and had not had the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 15-AUG-2024  The reporter was the wife of the patient.  The patient received the first dose of Shingrix in January 2023 and not had the 2nd dose.  Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 78.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Injection site hypersensitivity, Pain in extremity, Paraesthesia
Clinical narrative: LEFT ARM PAIN; TWITCHING AND TINGLING UNDER THE SKIN ON LEFT UPPER ARM; SENSITIVITY AT INJECTION SITE ON LEFT UPPER ARM/SHOULDER AREA; This spontaneous report received from a patient concerned a 78 year old of unspecified sex. Initial information was processed along with the additional information received On 20-Aug-2024 and from RA on 22-Aug-2024. The patient's height, and weight were not reported. The patient's concurrent conditions included: pacemaker placement ((8-9 YEARS AGO), high blood pressure, alcoholic (A double shot of whiskey every night), and no smoking. The patient was previously treated with covid-19 vaccine ad26. cov2. s  (Dose number in series 1) for covid-19 prophylaxis.  The patient received vaccination covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number: 211A21A) dose was not reported, administered on 18-NOV-2021 to Left Arm for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers Concomitant medications included apixaban, and vitamins nos.  On an unspecified date in NOV-2021,following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced left arm pain, twitching and tingling under the skin on left upper arm, and sensitivity at injection site on left upper arm/shoulder area.(Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left arm pain, twitching and tingling under the skin on left upper arm and sensitivity at injection site on left upper arm/shoulder area was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be 90000336434- (voided)-yes. this report describes medical adverse events for the patient. there is no allegation regarding a product quality issue or product efficacy in the information reported. approval to void due to no pqc identified. based on the PQC evaluation/investigation performed.
Age: 78.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: LEFT ARM PAIN; TWITCHING AND TINGLING UNDER THE SKIN ON LEFT UPPER ARM; SENSITIVITY AT INJECTION SITE ON LEFT UPPER ARM/SHOULDER AREA; This spontaneous report received from a patient concerned a 78 year old of unspecified sex. Initial information was processed along with the additional information received On 20-Aug-2024 and from RA on 22-Aug-2024. The patient's height, and weight were not reported. The patient's concurrent conditions included: pacemaker placement ((8-9 YEARS AGO), high blood pressure, alcoholic (A double shot of whiskey every night), and no smoking. The patient was previously treated with covid-19 vaccine ad26. cov2. s  (Dose number in series 1) for covid-19 prophylaxis.  The patient received vaccination covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number: 211A21A) dose was not reported, administered on 18-NOV-2021 to Left Arm for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers Concomitant medications included apixaban, and vitamins nos.  On an unspecified date in NOV-2021,following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced left arm pain, twitching and tingling under the skin on left upper arm, and sensitivity at injection site on left upper arm/shoulder area.(Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left arm pain, twitching and tingling under the skin on left upper arm and sensitivity at injection site on left upper arm/shoulder area was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be 90000336434- (voided)-yes. this report describes medical adverse events for the patient. there is no allegation regarding a product quality issue or product efficacy in the information reported. approval to void due to no pqc identified. based on the PQC evaluation/investigation performed.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Has COVID now; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Has COVID now) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. CC2M214) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    The patient's past medical history included Kidney tumor (Patient had one kidney. Patient had tumor in kidney so one kidney had removed, tumor was cancerous, tried to save but because was so large could not save the kidney. It has probably been maybe 7 years ago.) and COVID-19 (Patient first had Covid when everybody had Covid, was sometime during holiday. Then had Covid a second time at the beginning of this year.). Previously administered products included for Product used for unknown indication: Pfizer (Dose: 1, Lot: MEN6201) on 06-Feb-2021, Pfizer (Dose: 2 and Lot: ENU199) on 09-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.   On 15-Oct-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 04-Apr-2022, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 04-Oct-2022, received fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Has COVID now). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral use) at a dose of Took 2 tablets. At the time of the report, COVID-19 (Has COVID now) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient received multiple doses of Pfizer COVID vaccine except one dose was Moderna COVID vaccine. It was unknown how many doses of Pfizer was received. Patient thought probably that she had some doses of Pfizer COVID vaccine and Moderna COVID vaccine before having Covid.  Patient had third time Covid which was really bad when patient got up and thought it was heartburn.   Patient took Paxlovid before and completed treatment. Patient had the higher dose of Paxlovid than what patient had because patient has one kidney and did not function up to par. Patient currently had Covid now and was calling enrolling for Paxlovid for a second time.   This case was linked to US-MODERNATX, INC.-MOD-2024-772730 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2024: Significant follow-up received and added secondary reporter, added suspect, updated relevant history, updated narrative. On 22-Aug-2024: Non- Significant follow-up received and updated references.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-772730:Deleted case
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Incorrect route of product administration, Weight
Clinical narrative: Vaccinated 4 times and now he currently has COVID; Route of administration: Consumer stated, "Intravenous"; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Vaccinated 4 times and now he currently has COVID) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Route of administration: Consumer stated, "Intravenous") in a 69-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (Intravenous use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Vaccinated 4 times and now he currently has COVID) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Route of administration: Consumer stated, "Intravenous"). The patient was treated with IBUPROFEN for Pain, at a dose of 800 milligram and DEXTROMETHORPHAN HYDROBROMIDE, PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE DM) at an unspecified dose and frequency. At the time of the report, COVID-19 (Vaccinated 4 times and now he currently has COVID) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Route of administration: Consumer stated, "Intravenous") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: lost almost 15 pounds.     No concomitant medications were reported.  The patient had been vaccinated 4 times and now he currently had COVID, and he had a lot of severe side effects of the COVID. He lost a lot of weight (almost 15 pounds) and had severe headaches. He did not take Paxlovid and again he had been vaccinated 4 times and he had COVID again. The patient was getting better. The clinic prescribed some pain and some nausea medication for it, and just tossed it out and that the patient was lot better. The patient had COVID a few times already even though he was vaccinated but that was the worst one by far. So, did not want to get caught without being able to get some Paxlovid, if he needed it. All the 4 vaccinations were of Moderna.  In 2022, the patient had the recent vaccine. On 14-Apr-2022, the patient had vaccination in arm but did not know which arm it was. It was reported that the lot number look like 06SKZIA because of poor handwriting on the vaccination card. The patient had no prior vaccination (4 weeks). The patient took 800 milligrams of Ibuprofen for the pain and then, Promethazine DM Sol AMN.   This case was linked to US-MODERNATX, INC.-MOD-2024-772998 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-772998:Same patient, different dose
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had COVID a few times already; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had COVID a few times already) in a 69-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (had COVID a few times already). At the time of the report, COVID-19 (had COVID a few times already) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   No concomitant medications were reported. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-772875 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-772875:Same patient, different dose
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: contracted the new covid strain; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted the new covid strain) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted the new covid strain). On 21-Aug-2024, COVID-19 (contracted the new covid strain) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Hypersensitivity, Muscle twitching, Tremor, Vomiting
Clinical narrative: Lips starts to tremble; body starts shaking; get a really full feeling like he'd eaten at an endless buffet; allergic reaction; vomited; This spontaneous case was reported by a health care professional and describes the occurrence of MUSCLE TWITCHING (Lips starts to tremble), TREMOR (body starts shaking), ABDOMINAL DISTENSION (get a really full feeling like he'd eaten at an endless buffet), HYPERSENSITIVITY (allergic reaction) and VOMITING (vomited) in an 80-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (Patient had taken the Moderna vaccine and every shot that was ever been offered. Never had any problems before.). Past adverse reactions to the above products included No adverse effect with Moderna covid-19 vaccine. Concurrent medical conditions included Chronic kidney disease.    In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced MUSCLE TWITCHING (Lips starts to tremble), TREMOR (body starts shaking), ABDOMINAL DISTENSION (get a really full feeling like he'd eaten at an endless buffet), HYPERSENSITIVITY (allergic reaction) and VOMITING (vomited). In October 2023, MUSCLE TWITCHING (Lips starts to tremble), TREMOR (body starts shaking), ABDOMINAL DISTENSION (get a really full feeling like he'd eaten at an endless buffet), HYPERSENSITIVITY (allergic reaction) and VOMITING (vomited) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that patient did not even get injection site pain. Got injection around 4pm, Had dinner around 6 to 6:30pm. Around 7 starts to get a really full feeling like he would eaten at an endless buffet. Lips starts to tremble, body starts shaking. Patient was holding remote control, but could not work it. In the ensuing 2 hours patient vomited 3 times with no warning signs beforehand. Then by 9pm it was all gone. No trembling, nothing, it was as it he would never been sick. No fever during the episode either. Reaction last 2 hours On all the other vaccines.  Treatment information was not provided.  Reporter causality was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-773070 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773070:Different patient
Sex: F
Vaccine: COVID19
Symptoms: Polymers allergy
Clinical narrative: PEG allergy; This spontaneous case was reported by a patient and describes the occurrence of POLYMERS ALLERGY (PEG allergy) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: pfizer; for Drug use for unknown indication: Miralax. Past adverse reactions to the above products included No adverse effect with Miralax and pfizer.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced POLYMERS ALLERGY (PEG allergy). At the time of the report, POLYMERS ALLERGY (PEG allergy) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       The reporter states that the patient taken all of the COVID vaccines and boosters (1 Pfizer and the majority were Moderna) and did not had any issues.  No concomitant medication was reported. The patient recently had an echocardiogram along with a stress test, and when they injected the tracer, which contained polyethylene glycol (PEG), the patient had a horrendous reaction. The reporter states that patient had a PEG allergy, however patient isn't sure if the reaction was more because of the delivery during the stress test. The reporter states that patient had taken Miralax and has never had any problems with it. It was unsure if she should continue to take the COVID vaccine. No other details were provided. Reporter causality was not reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Adrenal haemorrhage
Clinical narrative: Novavax gave me an adrenal bleed; This serious initial spontaneous safety report was received by Novavax on 25-Aug-2024 from a Consumer or other non-health professional.  An individual of an unspecified age and gender was vaccinated with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (Intramuscular) (Lot number was not provided in the report) on an unspecified date.  No medical history was reported.  No concomitant medications were reported.  On an unspecified date after vaccination, the patient experienced Novavax gave me an adrenal bleed (Adrenal haemorrhage)(Serious: Other Medically Important Condition).  At the time of reporting, the event outcome of Adrenal haemorrhage was unknown.; Sender's Comments: This individual of an unspecified age and sex experienced Adrenal haemorrhage after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula).  The event Adrenal haemorrhage was reported as serious.   Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Adrenal haemorrhage is considered Possible.