chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, MENB, MENB, MNQ, MNQ, RV1, TDAP
Symptoms: Product storage error
Clinical narrative: stored at 0.4C x 42 hours; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) (batch number 2Y393, expiry date 30-APR-2027) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number TH9NR, expiry date 31-JAN-2027) for prophylaxis, Men ACWY-CRM NVS (Menveo) (batch number E4A39, expiry date 30-JUN-2025) for prophylaxis, Men ACWY-CRM NVS (Menveo) (batch number KX3LM, expiry date 31-JUL-2025) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) (batch number 7CZ47, expiry date 16-JAN-2026) for prophylaxis, DTPa (Infanrix) for prophylaxis, HBV (Engerix B) for prophylaxis and Rota (Rotarix liquid formulation) for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero, Menveo, Menveo, Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix B and Rotarix liquid formulation. On 08-JUL-2024, an unknown time after receiving Bexsero, Bexsero, Menveo, Menveo, Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix B and Rotarix liquid formulation, the patient experienced incorrect storage of drug (Verbatim: stored at 0.4C x 42 hours). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-JUL-2024 Medical Assistant requested stability data for Bexsero, Menveo (2-vial), Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B, Rotarix (liq) stored at 0.4C x 42 hours.  No signs of freezing/slushing.  Temperature excursion started on July 8, 2024 and not found until July 12, 2024.  The vaccines used in patients, which led to incorrect storage of product. Consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Blister, Erythema, Herpes zoster, Neuralgia
Clinical narrative: Suspected vaccination failure; shingles (left upper back)/has had 2 breakthrough cases of shingles; nerve pain ( left upper back); pink; blisters "feels raw" left upper back; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (when she was 17 and had it a few times throughout her young adult life) and post herpetic neuralgia (fingertip nerve pain when she was 17 years). Previously administered products included Zostavax (received Zostavax on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles (left upper back)/has had 2 breakthrough cases of shingles), post herpetic neuralgia (Verbatim: nerve pain ( left upper back)), erythema (Verbatim: pink) and blister (Verbatim: blisters "feels raw" left upper back). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure was unknown and the outcome of the shingles, post herpetic neuralgia, erythema and blister were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, erythema and blister to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles, post herpetic neuralgia, erythema and blister to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 15-JUL-2024 The patient self-reported this case for herself. The patient she received 2 Shingrix (2 to 6 months apart) in 2017.  The patient received the one time dose (Zostavax) before that.  The patient reported that, she has had 2 breakthrough cases of shingles.  It affected the patient's left upper back which she states was "raw" pink and blisters.  The patient was prescribed pills for 10 days (valacyclovir) and ointments.  The patient had not finished the pills till the time of reporting.  The patient reported that, the pain had not gone away, she believes it was nerve pain.  The patient also mentioned she had shingles when she was 17 and had it a few times throughout her young adult life.  Back then the patient stated it affected her fingertips, the patient had recovered from that.  The reporter did not consented to follow up.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix (1st and 2nd dose).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin erosion, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles (left upper back)/has had 2 breakthrough cases of shingles; nerve pain ( left upper back); pink; blisters "feels raw" left upper back; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (when she was 17 and had it a few times throughout her young adult life) and post herpetic neuralgia (fingertip nerve pain when she was 17 years). Previously administered products included Zostavax (received Zostavax on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles (left upper back)/has had 2 breakthrough cases of shingles), post herpetic neuralgia (Verbatim: nerve pain ( left upper back)), erythema (Verbatim: pink) and blister (Verbatim: blisters "feels raw" left upper back). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure was unknown and the outcome of the shingles, post herpetic neuralgia, erythema and blister were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, erythema and blister to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles, post herpetic neuralgia, erythema and blister to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 15-JUL-2024 The patient self-reported this case for herself. The patient she received 2 Shingrix (2 to 6 months apart) in 2017.  The patient received the one time dose (Zostavax) before that.  The patient reported that, she has had 2 breakthrough cases of shingles.  It affected the patient's left upper back which she states was "raw" pink and blisters.  The patient was prescribed pills for 10 days (valacyclovir) and ointments.  The patient had not finished the pills till the time of reporting.  The patient reported that, the pain had not gone away, she believes it was nerve pain.  The patient also mentioned she had shingles when she was 17 and had it a few times throughout her young adult life.  Back then the patient stated it affected her fingertips, the patient had recovered from that.  The reporter did not consented to follow up.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix (1st and 2nd dose).
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal pain upper, Chest pain, Dyspnoea, Immediate post-injection reaction, Impaired driving ability
Clinical narrative: couldn't think; couldn't drive; couldn't breath; chest pain; stomach pain; stung; hardness at injection site; sleepy for 2 days; This serious case was reported by a consumer via call center representative and described the occurrence of difficulty thinking in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included heart murmur.   On 11-JUL-2024, the patient received Arexvy (left arm). On 11-JUL-2024, immediately after receiving Arexvy, the patient experienced injection site stinging (Verbatim: stung). On 12-JUL-2024, the patient experienced difficulty breathing (Verbatim: couldn't breath), chest pain (Verbatim: chest pain) and stomach pain (Verbatim: stomach pain). In JUL-2024, the patient experienced difficulty thinking (Verbatim: couldn't think) (serious criteria GSK medically significant), injection site induration (Verbatim: hardness at injection site), driving ability disturbed (Verbatim: couldn't drive) and sleepiness (Verbatim: sleepy for 2 days). In JUL-2024, the outcome of the difficulty thinking and driving ability disturbed were resolved and the outcome of the sleepiness was resolved (duration 2 days). The outcome of the injection site induration was not resolved and the outcome of the injection site stinging, difficulty breathing, chest pain and stomach pain were resolved.   It was unknown if the reporter considered the difficulty thinking, injection site induration, injection site stinging, difficulty breathing, chest pain, stomach pain, driving ability disturbed and sleepiness to be related to Arexvy.     The company considered the difficulty thinking to be unrelated to Arexvy. It was unknown if the company considered the injection site induration, injection site stinging, difficulty breathing, chest pain, stomach pain, driving ability disturbed and sleepiness to be related to Arexvy.   Additional Information: GSK receipt date: 15-JUL-2024 The reporter stated that she received Arexvy and immediately the injection stung, which created a hardness that was almost gone but still there in left arm..  She stated the next morning she woke up, couldn't breath and had chest and stomach pain (recovered) which she thought was having a heart attack. She stated she had a history of heart murmurs.  She stated for 2 days after injection she was very sleepy.  She could not drive and could not think.  She stated that all the symptoms are going away except for the hardness in left arm.; Sender's Comments: Mental impairment is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Injection site induration, Injection site pain, Mental impairment, Somnolence
Clinical narrative: couldn't think; couldn't drive; couldn't breath; chest pain; stomach pain; stung; hardness at injection site; sleepy for 2 days; This serious case was reported by a consumer via call center representative and described the occurrence of difficulty thinking in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included heart murmur.   On 11-JUL-2024, the patient received Arexvy (left arm). On 11-JUL-2024, immediately after receiving Arexvy, the patient experienced injection site stinging (Verbatim: stung). On 12-JUL-2024, the patient experienced difficulty breathing (Verbatim: couldn't breath), chest pain (Verbatim: chest pain) and stomach pain (Verbatim: stomach pain). In JUL-2024, the patient experienced difficulty thinking (Verbatim: couldn't think) (serious criteria GSK medically significant), injection site induration (Verbatim: hardness at injection site), driving ability disturbed (Verbatim: couldn't drive) and sleepiness (Verbatim: sleepy for 2 days). In JUL-2024, the outcome of the difficulty thinking and driving ability disturbed were resolved and the outcome of the sleepiness was resolved (duration 2 days). The outcome of the injection site induration was not resolved and the outcome of the injection site stinging, difficulty breathing, chest pain and stomach pain were resolved.   It was unknown if the reporter considered the difficulty thinking, injection site induration, injection site stinging, difficulty breathing, chest pain, stomach pain, driving ability disturbed and sleepiness to be related to Arexvy.     The company considered the difficulty thinking to be unrelated to Arexvy. It was unknown if the company considered the injection site induration, injection site stinging, difficulty breathing, chest pain, stomach pain, driving ability disturbed and sleepiness to be related to Arexvy.   Additional Information: GSK receipt date: 15-JUL-2024 The reporter stated that she received Arexvy and immediately the injection stung, which created a hardness that was almost gone but still there in left arm..  She stated the next morning she woke up, couldn't breath and had chest and stomach pain (recovered) which she thought was having a heart attack. She stated she had a history of heart murmurs.  She stated for 2 days after injection she was very sleepy.  She could not drive and could not think.  She stated that all the symptoms are going away except for the hardness in left arm.; Sender's Comments: Mental impairment is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: patient miss the dose, he miss the 6 month window; first was on August-2023 and the second on October-2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Concurrent medical conditions included immunocompromised and hepatic disease. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   In OCT-2023, the patient received the 2nd dose of Twinrix. On an unknown date, the patient received the 3rd dose of Twinrix. In OCT-2023, an unknown time after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: first was on August-2023 and the second on October-2023). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: patient miss the dose, he miss the 6 month window). The outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-JUL-2024 and 16-JUL-2024 The patient was immunocompromised with a prior condition of liver disease, this was the reason physician indicated Twinrix vaccination. The pharmacist reported that a patient received 1st dose of Twinrix in August 2023 and second dose in October 2023. The reporter was ask if a patient missed the dose, she miss the six months window, they did not had to restart. The reporter just want to take some kind of guidance if they had to restart the series or should go ahead an re-administer. She did not provide the specific dates for this, and also, she did not had the batch number or expiration date of the previous vaccines. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination.
Age: 40.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: shorter interval between dose 2 and 3; late 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 40-year-old female patient who received HAB (Twinrix) (batch number 429JJ, expiry date 01-APR-2026) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX).   On 12-JUL-2024, the patient received the 3rd dose of Twinrix. On 14-MAR-2024, the patient received the 2nd dose of Twinrix. On 14-MAR-2024, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: late 2nd dose). On 12-JUL-2024, the patient experienced drug dose administration interval too short (Verbatim: shorter interval between dose 2 and 3). The outcome of the drug dose administration interval too short and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-JUL-2024 The other health professional (medical assistant) reported that, a patient received her 1st dose of Twinrix on 11-JAN-2024 and received 2nd dose of Twinrix longer than the recommended interval which led to lengthening of vaccination schedule. The patient received 3rd dose of Twinrix shorter than the recommended interval which led to shortening of vaccination schedule. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number HH44K, expiry date 17-MAY-2026) and (batch number D243K, expiry date 17-MAY-2026) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 07 July 2023) and Havrix (1st dose received on 07 July 2023). Concomitant products included HEPATITIS A VACCINE INACT (HAVRIX 1440).   On 15-JUL-2024, the patient received the 2nd dose of Shingrix. On 15-JUL-2024, an unknown time after receiving Shingrix and an unknown time after receiving HAVRIX 1440, the patient experienced drug dose administration interval too long (Verbatim: late 2nd dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 15-JUL-2024 The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: not getting the second Shingrix dose until up to a year after first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: not getting the second Shingrix dose until up to a year after first dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 16-JUL-2024 The pharmacist called to ask about the efficacy of Shingrix if second dose was administered more than 6 months after first dose. The pharmacist mentioned in the past having patients that were not getting the second Shingrix dose until up to a year after first dose, which led to lengthening of vaccination schedule. At the time of call, pharmacist did not have any specific patient or dosing details.  The reporter consented to follow up.; Sender's Comments:  US-GSK-US2019147645:Same reporter / different patient
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix was administered to a 2 month old patient; vaccine to be given was Pediarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 12-JUL-2024, the patient received Kinrix. On 12-JUL-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 2 month old patient) and wrong vaccine administered (Verbatim: vaccine to be given was Pediarix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-JUL-2024 Nurse called to report Kinrix was administered to a 2 month old patient, before the recommended age which led to inappropriate age at vaccine administration Intended vaccine to be given was Pediarix which led to wrong vaccine administered Patient initials and lot number asked and declined. This vaccine was patient first dose for dtap and ipv.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Expired dose of Priorix was administered to a male patient; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a male patient who received MMR (Priorix) (expiry date 21-JUN-2024) for prophylaxis.   On 16-JUL-2024, the patient received Priorix. On 16-JUL-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Expired dose of Priorix was administered to a male patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUL-2024 Expired dose of Priorix was administered to a male patient which led to expired vaccine used. Physician does not have any more details on the patient but agrees to follow up if needed by email.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: received a vaccine for hepatitis b over a year ago, wanted to know if she had to restart the entire series or if she could administer Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B vaccine (received 1st dose over a year ago, on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination (Verbatim: received a vaccine for hepatitis b over a year ago, wanted to know if she had to restart the entire series or if she could administer Engerix-B). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-JUL-2024 The pharmacist reported that a patient received a vaccine for Hepatitis B over a year ago and the patient being uncertain of which vaccine was administered and wanted to know if she had to restart the entire series or if she could administer Engerix-B.  They did not have any information about the vaccine, event or patient other than what was provided. Till the time of reporting, the patient did not receive 2nd dose of Hepatitis B, which led to incomplete course of vaccination.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Vaccines administered to a unknown number of patients after being exposed to multiple temperature excursions from 22-APR-2024 through approximatly 14-JUN-2024; This spontaneous report was received from a physician concerning a 4-year-old female patient. Her concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 23-APR-2024, she was vaccinated with improperly stored vaccines of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, administered on the patient's left arm, lot number X0110531, which was determined to be an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX), expiration date 11-APR-2025 (dosage regimen was not reported), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) injection, administered on the patient's left arm, lot number W028734 with expiration date 08-SEP-2024 (dosage regimen was not reported), and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX), administered on the patient's right arm, lot number 5AY2J with expiration date 10-JUN-2024 (dosage regimen and indication were not reported). Varicella virus vaccine live (Oka/Merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) were administered as prophylaxis (Product storage error). No additional adverse event was reported (No adverse event).; Sender's Comments:  US-009507513-2406USA005882:
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: inadvertently administered a dose of Pediarix; This dose made the patient's fourth dose of hepatitis b and inactivated polio; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number X9EP5, expiry date 09-MAR-2026) for prophylaxis.   Co-suspect products included HAV (Havrix 1440 adult) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   On 18-JUL-2024, the patient received Pediarix and Havrix 1440 adult. On 18-JUL-2024, an unknown time after receiving Pediarix and Havrix 1440 adult, the patient experienced wrong vaccine administered (Verbatim: inadvertently administered a dose of Pediarix) and extra dose administered (Verbatim: This dose made the patient's fourth dose of hepatitis b and inactivated polio). The outcome of the wrong vaccine administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUL-2024 and 19-JUL-2024  Nurse reported that a 15 month old female patient was supposed to receive a DTaP dose but was inadvertently administered a dose of Pediarix. This dose made the patient's fourth dose of hepatitis b and inactivated polio which led to wrong vaccine administered and extra dose administered. The patient was inadvertently administered an adult dose of Havrix which led to wrong vaccine administered. This was the patient's first Hepatitis A dose.; Sender's Comments:  US-GSK-US2024090745:Case created in error, deleted
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Malaise, Pain in extremity
Clinical narrative: not feeling well; Light-headed, dizzy/patient felt like going to pass out; arm pain; headache; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (not feeling well), DIZZINESS (Light-headed, dizzy/patient felt like going to pass out), PAIN IN EXTREMITY (arm pain) and HEADACHE (headache) in a 25-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: HPV (Human papillomavirus) on 15-Jul-2024. Past adverse reactions to the above products included No adverse event with HPV (Human papillomavirus).    On 15-Jul-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 15-Jul-2024, the patient experienced MALAISE (not feeling well), DIZZINESS (Light-headed, dizzy/patient felt like going to pass out), PAIN IN EXTREMITY (arm pain) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (not feeling well), DIZZINESS (Light-headed, dizzy/patient felt like going to pass out), PAIN IN EXTREMITY (arm pain) and HEADACHE (headache) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available.  Patient received two vaccinations at 11:00 AM. By 2:00 PM patient started feeling arm pain, light-headed, dizzy, and started getting a headache. By 2:30 PM patient felt like was going to pass out. Slept from 3-7:30 PM. Patient woke up still not feeling well. Patient took Tylenol which helped the headache, but not the arm pain. It was unknown if the patient experienced any additional symptoms/events.   Medication details and reason for taking the medicine was Tylenol 1 extra strength pill.
Sex: M
Vaccine: PNC20
Symptoms: Malaise, Productive cough
Clinical narrative: Coughing and coughing out mucus, lots of it and it has not gone away; It is disturbing, it is like I have Pneumonia; Started getting sick; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: Unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCTIVE COUGH (non-serious), outcome "recovering", described as "Coughing and coughing out mucus, lots of it and it has not gone away; It is disturbing, it is like I have Pneumonia"; ILLNESS (non-serious), outcome "recovering", described as "Started getting sick". Therapeutic measures were taken as a result of productive cough.  Additional information: About three weeks ago, patient took the vaccine at the VA hospital, the Prevnar 20 conjugate pneumococcal Pneumonia vaccine and ever since he had been having a strange side effect that he had not read about anywhere. Consumer stated, "72 hours after I got the vaccine, I started coughing and coughing out mucus, lots of it and it has not gone away yet. I have told my doctor a couple of times, I said I think this has got something to do with the Prevnar. He (Doctor) said no, it is a coincidence, you picked up something, a virus or something. Have not had any fever, just this cough and I took expectorant and I keep coughing this stuff up especially when I am asleep, I cough up all this mucus and swallow it and spit it out. It is disturbing, it is like I have Pneumonia."
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, FLUX, RVX, COVID19, FLUX, RVX
Symptoms: COVID-19, Investigation, SARS-CoV-2 test, Vaccination failure, Weight
Clinical narrative: she came up positive for covid today; she came up positive for covid today; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 63-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY RTU FOR XBB.1.5), on 04Oct2023 as dose 1, single (Lot number: HD9876) at the age of 62 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), on 04Oct2023 as dose number unknown, single) for covid-19 immunisation; rsv vaccine (RSV VACCINE), on 04Oct2023 as dose number unknown, single) for immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 04Oct2023 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "rash was on her trunk" (unspecified if ongoing), notes: it looked like she had an allergic reaction to medication; "Guillain Barre" (unspecified if ongoing); "leptomeningeal metastases" (unspecified if ongoing); "swelling of the meninges" (unspecified if ongoing), notes: swelling in her meninges of her brain; "swelling of the meninges" (unspecified if ongoing), notes: swelling in her meninges of her brain; "metastatic brain cancer" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "she is allergic to Bactrim". Vaccination history included: BNT162b2 (dose 1, single lot# EN6201), administration date: 05Mar2021, when the patient was 60-year-old, for covid-19 immunization; BNT162b2 (dose 2, single lot # ER2613), administration date: 05Apr2021, when the patient was 60-year-old, for covid-19 immunization; moderna (dose 3, single lot number 058H21A), administration date: 02Dec2021, when the patient was 60-year-old, for covid-19 immunization; moderna (dose 4, single lot number 061F22A), administration date: 17Oct2022, when the patient was 61-year-old, for covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jul2024, outcome "unknown" and all described as "she came up positive for covid today". The patient underwent the following laboratory tests and procedures: test: (07Nov2023) swelling in the meninges; SARS-CoV-2 test: (19Jul2024) positive; Weight: (unspecified date) 100 pounds, notes: States her weight is right around 100 pounds. Additional information: The patient came up positive for covid today and her doctor had called in Paxlovid that the insurance company flagged as having some high reaction or bad reaction to atovaquone but had previously taken that and stopped taking it in May.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400220361 same patient, different vaccine dose number and events;
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, FLUX, RVX, COVID19, FLUX, RVX
Symptoms: Brain oedema, Gait inability, Rash, SARS-CoV-2 test
Clinical narrative: she came up positive for covid today; she came up positive for covid today; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 63-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY RTU FOR XBB.1.5), on 04Oct2023 as dose 1, single (Lot number: HD9876) at the age of 62 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), on 04Oct2023 as dose number unknown, single) for covid-19 immunisation; rsv vaccine (RSV VACCINE), on 04Oct2023 as dose number unknown, single) for immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 04Oct2023 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "rash was on her trunk" (unspecified if ongoing), notes: it looked like she had an allergic reaction to medication; "Guillain Barre" (unspecified if ongoing); "leptomeningeal metastases" (unspecified if ongoing); "swelling of the meninges" (unspecified if ongoing), notes: swelling in her meninges of her brain; "swelling of the meninges" (unspecified if ongoing), notes: swelling in her meninges of her brain; "metastatic brain cancer" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "she is allergic to Bactrim". Vaccination history included: BNT162b2 (dose 1, single lot# EN6201), administration date: 05Mar2021, when the patient was 60-year-old, for covid-19 immunization; BNT162b2 (dose 2, single lot # ER2613), administration date: 05Apr2021, when the patient was 60-year-old, for covid-19 immunization; moderna (dose 3, single lot number 058H21A), administration date: 02Dec2021, when the patient was 60-year-old, for covid-19 immunization; moderna (dose 4, single lot number 061F22A), administration date: 17Oct2022, when the patient was 61-year-old, for covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jul2024, outcome "unknown" and all described as "she came up positive for covid today". The patient underwent the following laboratory tests and procedures: test: (07Nov2023) swelling in the meninges; SARS-CoV-2 test: (19Jul2024) positive; Weight: (unspecified date) 100 pounds, notes: States her weight is right around 100 pounds. Additional information: The patient came up positive for covid today and her doctor had called in Paxlovid that the insurance company flagged as having some high reaction or bad reaction to atovaquone but had previously taken that and stopped taking it in May.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400220361 same patient, different vaccine dose number and events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergic reaction to excipient, Hypersensitivity
Clinical narrative: I had the same allergic reaction after receiving Pfizer COVID vaccine, the Comirnaty; allergy to Polyethylene glycol; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; polyethylene glycol [macrogol] (POLYETHYLENE GLYCOL [MACROGOL]). The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE; LIPITOR taken for hyperlipidaemia, stop date: 17Jul2024. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "I had the same allergic reaction after receiving Pfizer COVID vaccine, the Comirnaty"; ALLERGIC REACTION TO EXCIPIENT (non-serious), outcome "unknown", described as "allergy to Polyethylene glycol". Therapeutic measures were taken as a result of hypersensitivity, allergic reaction to excipient. Additional information: in the past whenever patient get a COVID shot or a booster she have to take Prednisone prior to getting the injection because that also contain Polyethylene glycol. Patient had the same allergic reaction after receiving Pfizer COVID vaccine, the Comirnaty. She have several doses, have had multiple doses of Comirnaty.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400220501 same patient, different dose and event;US-PFIZER INC-2021330189 same patient, different dose and event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I had the same allergic reaction after receiving Pfizer COVID vaccine, the Comirnaty; allergy to Polyethylene glycol; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; polyethylene glycol [macrogol] (POLYETHYLENE GLYCOL [MACROGOL]). The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE; LIPITOR taken for hyperlipidaemia, stop date: 17Jul2024. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "I had the same allergic reaction after receiving Pfizer COVID vaccine, the Comirnaty"; ALLERGIC REACTION TO EXCIPIENT (non-serious), outcome "unknown", described as "allergy to Polyethylene glycol". Therapeutic measures were taken as a result of hypersensitivity, allergic reaction to excipient. Additional information: in the past whenever patient get a COVID shot or a booster she have to take Prednisone prior to getting the injection because that also contain Polyethylene glycol. Patient had the same allergic reaction after receiving Pfizer COVID vaccine, the Comirnaty. She have several doses, have had multiple doses of Comirnaty.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400220501 same patient, different dose and event;US-PFIZER INC-2021330189 same patient, different dose and event;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: 2020 (unspecified if ongoing), notes: in the hospital the first time for eight days. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". It was reported that the patient only got COVID one other time and already had the vaccine so it wasn't as strong, right now it was bad (as reported).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Myocardial Infarction; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2024-NVX-US-00344.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 19Feb2021 as dose number unknown, single (Lot number: EN6201) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "LUPUS" (not ongoing), notes: LUPUS (Lupus erythematosus) (Asked but Unknown - Asked but Unknown) (Continuing: No). The patient's concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 03Mar2021, outcome "not recovered".
Age: 21.0
Sex: U
Vaccine: COVID19
Symptoms: Type 1 diabetes mellitus
Clinical narrative: type 1 diabetes; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 21-year-old patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 21 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TYPE 1 DIABETES MELLITUS (medically significant) with onset 2021, outcome "unknown", described as "type 1 diabetes". The clinical course was reported as follows: "At the age of 21 years old I developed type 1 diabetes after receiving one of the original rounds of the COVID vaccine in 2021.  I work in medicine, I have no family history of type 1 diabetes or any history of thyroid disease or any antibodies. So my question is, would it be a possibility I received type 1 diabetes from the vaccine". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: just got Covid for the first time; just got Covid for the first time; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose number unknown; Manufacturer unknown), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "just got Covid for the first time". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient specified she will only take the Pfizer boosters and have had all that have been available. Paxlovid had kept her from having serious problems.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "not recovered". The event "headache" required physician office visit.  Additional information: The patient reported ongoing headache for 2 years and half ago after second dose of Pfizer COVID vaccine. The patient visited several doctors and specialist.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: how sick I got from my last Covid shot; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "how sick I got from my last Covid shot". Additional information: patient age was unknown, it was reported "elderly" as age group at the time of report. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: left only a tiny bit sore.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PAIN (non-serious), outcome "unknown", described as "left only a tiny bit sore.". Additional information: patient stated that had both shots together last September at the same time and was left only a tiny bit sore.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Dizziness, Fatigue, Pain
Clinical narrative: ache; feel dizzy; tired; down in the dumps; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An adult female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "ache"; DIZZINESS (non-serious), outcome "unknown", described as "feel dizzy"; FATIGUE (non-serious), outcome "unknown", described as "tired"; DEPRESSED MOOD (non-serious), outcome "unknown", described as "down in the dumps".  Additional information: The reporter stated,  "Covid-19 shot makes you feel dizzy, aching, tired and just down in the dumps". The reporter considered the events were caused by the suspect product.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.