chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RSV
Symptoms: Malaise, Pain
Clinical narrative: sick; quite a bit of pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 27-JAN-2024, the patient received Arexvy. In JAN-2024, an unknown time after receiving Arexvy, the patient experienced sickness (Verbatim: sick) and pain (Verbatim: quite a bit of pain). The outcome of the sickness and pain were not reported.   It was unknown if the reporter considered the sickness and pain to be related to Arexvy.     It was unknown if the company considered the sickness and pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-JAN-2024 This case was reported by a patient via interactive digital media. The patient had the vaccine 3 full days prior to the reporting date and had been sick and in quite a bit of pain. The patient want to know if the symptoms were (illegible text). The follow-up could not be possible as no contact details were available.
Age: 68.0
Sex: F
Vaccine: RVX
Symptoms: Anxiety, Arthralgia, Fatigue, Fibromyalgia, Injected limb mobility decreased
Clinical narrative: inability to raise her left arm; woke up with pain; developed fatigue; polyarthralgia; polymyalgia; SED rate of 58; anxiety; insomnia; fibromyalgia; This non-serious case was reported by a physician via sales rep and described the occurrence of injected limb mobility decreased in a 68-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   In NOV-2023, the patient received RSV vaccine (left arm) and Influenza vaccine (right arm). On an unknown date, 1 day after receiving RSV vaccine, the patient experienced injected limb mobility decreased (Verbatim: inability to raise her left arm), pain (Verbatim: woke up with pain), fatigue (Verbatim: developed fatigue), polyarthralgia (Verbatim: polyarthralgia), polymyalgia (Verbatim: polymyalgia), elevated sedimentation rate (Verbatim: SED rate of 58), anxiety (Verbatim: anxiety), insomnia (Verbatim: insomnia) and fibromyalgia (Verbatim: fibromyalgia). The patient was treated with gabapentin, allopurinol (Elavil) and modafinil. The outcome of the injected limb mobility decreased, pain, polyarthralgia, polymyalgia, elevated sedimentation rate and fibromyalgia were not reported and the outcome of the fatigue, anxiety and insomnia were not resolved.   It was unknown if the reporter considered the injected limb mobility decreased, pain, fatigue, polyarthralgia, polymyalgia, elevated sedimentation rate, anxiety, insomnia and fibromyalgia to be related to RSV vaccine.     It was unknown if the company considered the injected limb mobility decreased, pain, fatigue, polyarthralgia, polymyalgia, elevated sedimentation rate, anxiety, insomnia and fibromyalgia to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 30-JAN-2024 The physician was also a patient who self reported this case. The patient received the RSV vaccine and she was unsure of which RSV vaccine she received. The next day she woke up with pain and inability to raise her left arm, developed fatigue, polyarthralgia, polymyalgia, SED rate (erythrocyte sedimentation rate) of 58. The patient did receive the flu shot in her right arm the same day. Now currently (at the time of reporting), the patient had fatigue, anxiety and insomnia. The patient was being treated with gabapentin 300 mg, and Elavil 10 mg and Modafanil for excessive day time fatigue. Clinically patient had an acute onset of fibromyalgia. It was unknown if the reporter considered the pain, injected limb mobility decreased, fatigue, polyarthralgia, polymyalgia, anxiety, insomnia, fibromyalgia and elevated sedimentation rate to be related to Influenza vaccine. The reporter did not consent to follow-up.
Age: 68.0
Sex: F
Vaccine: RVX
Symptoms: Insomnia, Myalgia, Pain, Red blood cell sedimentation rate increased
Clinical narrative: inability to raise her left arm; woke up with pain; developed fatigue; polyarthralgia; polymyalgia; SED rate of 58; anxiety; insomnia; fibromyalgia; This non-serious case was reported by a physician via sales rep and described the occurrence of injected limb mobility decreased in a 68-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   In NOV-2023, the patient received RSV vaccine (left arm) and Influenza vaccine (right arm). On an unknown date, 1 day after receiving RSV vaccine, the patient experienced injected limb mobility decreased (Verbatim: inability to raise her left arm), pain (Verbatim: woke up with pain), fatigue (Verbatim: developed fatigue), polyarthralgia (Verbatim: polyarthralgia), polymyalgia (Verbatim: polymyalgia), elevated sedimentation rate (Verbatim: SED rate of 58), anxiety (Verbatim: anxiety), insomnia (Verbatim: insomnia) and fibromyalgia (Verbatim: fibromyalgia). The patient was treated with gabapentin, allopurinol (Elavil) and modafinil. The outcome of the injected limb mobility decreased, pain, polyarthralgia, polymyalgia, elevated sedimentation rate and fibromyalgia were not reported and the outcome of the fatigue, anxiety and insomnia were not resolved.   It was unknown if the reporter considered the injected limb mobility decreased, pain, fatigue, polyarthralgia, polymyalgia, elevated sedimentation rate, anxiety, insomnia and fibromyalgia to be related to RSV vaccine.     It was unknown if the company considered the injected limb mobility decreased, pain, fatigue, polyarthralgia, polymyalgia, elevated sedimentation rate, anxiety, insomnia and fibromyalgia to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 30-JAN-2024 The physician was also a patient who self reported this case. The patient received the RSV vaccine and she was unsure of which RSV vaccine she received. The next day she woke up with pain and inability to raise her left arm, developed fatigue, polyarthralgia, polymyalgia, SED rate (erythrocyte sedimentation rate) of 58. The patient did receive the flu shot in her right arm the same day. Now currently (at the time of reporting), the patient had fatigue, anxiety and insomnia. The patient was being treated with gabapentin 300 mg, and Elavil 10 mg and Modafanil for excessive day time fatigue. Clinically patient had an acute onset of fibromyalgia. It was unknown if the reporter considered the pain, injected limb mobility decreased, fatigue, polyarthralgia, polymyalgia, anxiety, insomnia, fibromyalgia and elevated sedimentation rate to be related to Influenza vaccine. The reporter did not consent to follow-up.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2 doses of pediarix in September 2023 with in 2 weeks of each dose; This non-serious case was reported by a nurse via sales rep and described the occurrence of drug dose administration interval too short in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Concomitant products included Pediarix.   In SEP-2023, the patient received the 2nd dose of Pediarix. In SEP-2023, an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too short (Verbatim: 2 doses of pediarix in September 2023 with in 2 weeks of each dose). The outcome of the drug dose administration interval too short 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: 01-FEB-2024 Reporter from clinic reported that pediatric patient was given 2 doses of Pediarix in September of 2023 within 2 weeks of each dose. Reporter wanted information regarding the follow up to this patient The reporter consented to follow-up. The patient received 2nd dose of Pediarix vaccine, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, Exposure during pregnancy
Clinical narrative: Patient pregnant while boostrix was administered; Boostrix expired dose administered; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 24-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4547C, expiry date 18-NOV-2023) for prophylaxis.   On 29-JAN-2024, the patient received Boostrix. On 29-JAN-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Boostrix expired dose administered). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Patient pregnant while boostrix was administered). The outcome of the expired vaccine used and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Boostrix): 33 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Last Menstrual Period Date: 11-JUN-2023 Estimated Delivery/Due date: 31-MAR-2024 Pregnancy Outcome: Pregnancy was ongoing   Additional Information: RA Receipt Date: 30-JAN-2024 The healthcare professional reported a 31 week pregnant patient administered expired Boostrix, which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: received only adjuvant of Arexvy; received only adjuvant of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) (batch number G75S4, expiry date 05-JUL-2025) for prophylaxis.   On 31-JAN-2024, the patient received Arexvy. On 31-JAN-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: received only adjuvant of Arexvy) and inappropriate dose of vaccine administered (Verbatim: received only adjuvant of Arexvy). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 31-JAN-2024 The pharmacist reported via chat that a patient in long term care facility received only the Arexvy adjuvant, the vaccine was not reconstituted which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. At the time of reporting, no further doses have been administered. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up. The case is linked with case US2024AMR016554, reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2024AMR016554:Same reporter/product
Age: 1.25
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: administration of a third dose in an infant; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 15-month-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number a2l45, expiry date 30-JUN-2023) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT) and INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT).   On 31-JAN-2024, the patient received the 3rd dose of Fluarix Quadrivalent 2023-2024 season. On 31-JAN-2024, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced extra dose administered (Verbatim: administration of a third dose in an infant). The outcome of the extra dose administered was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 31-JAN-2024 The Nurse inquired about Fluarix and what information was available about any information about the administration of a third dose in an infant which led to extra dose administered. They provided information about vaccine, patient and event. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Deviation from the rapid schedule; 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 37-year-old female patient who received HAB (Twinrix) (batch number H7RF2, expiry date 17-JAN-2026) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 19-JAN-2024, the patient received the 2nd dose of Twinrix. On 19-JAN-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Deviation from the rapid schedule). The outcome of the drug dose administration interval too long 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: 01-FEB-2024 The Pharmacist contacted and inquiring about Twinrix and asked for information available about any information about the administration of Twinrix when there was a deviation of the normal accelerated schedule. Information about the event, vaccine and patient was given.  The Vaccine Administration Facility was the same as Primary Reporter. The patient received 2nd doses after the recommended schedule, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 25.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an expired dose of Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAB (Twinrix adult) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 11-OCT-2023, the patient received Twinrix adult. On 11-OCT-2023, an unknown time after receiving Twinrix adult, the patient experienced expired vaccine used (Verbatim: received an expired dose of Twinrix). 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: 01-FEB-2024 The reporter was a pharmacy student who stated a female patient received an expired dose of Twinrix which led to expired vaccine used. According to the reporter, he was not aware of any side effects reported by the patient. The reporter did not consent to follow up.
Age: 73.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Nurse practitioner reports a floor nurse inadvertently administered a pediatric dose of Havrix to an adult patient yesterday; Nurse practitioner reports a floor nurse inadvertently administered a pediatric dose of Havrix to an adult patient yesterday; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 73-year-old female patient who received HAV (Havrix 720) (batch number 2x2ej, expiry date 14-OCT-2024) for prophylaxis.   On 01-FEB-2024, the patient received Havrix 720. On 01-FEB-2024, an unknown time after receiving Havrix 720, the patient experienced accidental underdose (Verbatim: Nurse practitioner reports a floor nurse inadvertently administered a pediatric dose of Havrix to an adult patient yesterday) and adult use of a child product (Verbatim: Nurse practitioner reports a floor nurse inadvertently administered a pediatric dose of Havrix to an adult patient yesterday). The outcome of the accidental underdose and adult use of a child product 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: 02-FEB-2024 The reporter reported that a floor nurse inadvertently administered a pediatric dose of Havrix to an adult patient the day before reporting, which led to underdose and adult use of a child product. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Administered after expiration date; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 65-year-old male patient who received HBV (Engerix B) (batch number T020448, expiry date 13-APR-2023) for prophylaxis.   Previously administered products included Engerix B (had receive 1st dose of Engerix B) and Engerix B (had receive 2nd dose of Engerix B).   On 01-FEB-2024, the patient received the 3rd dose of Engerix B. On 01-FEB-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Administered after expiration date). 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: 02-FEB-2024 The pharmacist inquiring about Engerix-B and what information was available about information about that the administration of Engerix-B after the expiration date.  Partial information about vaccine, event, patient were given. The patient was received the Engerix B vaccine after the expiration date, which led to expired vaccine used. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient had been administered only the first dose of Shingrix in 2020; This non-serious case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had been administered only the 1st dose in 2020).   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: patient had been administered only the first dose of Shingrix in 2020). The outcome of the incomplete course of vaccination was unknown.   Additional Information: RA Receipt Date: 02-FEB-2024 The Vaccine Administration Facility was the same as Primary Reporter. No additional adverse event information was reported. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: received dose 1 Energix B in September; This non-serious case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a 45-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on September 2023).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: received dose 1 Energix B in September). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-Feb-2024 The reporter had a questions around Twinrix dosing schedule when the patient was already received one dose of Energix B.  The reporter started that he or she had a 45 year old patient that received dose 1 Energix B in September, due to a late notice traveler he ordered in Twinrix and do not had any Energix B or adult Hep A on hand.  The reporter stated that he or she was sure he will be ok being vaccinated for hep A as well.  The patient had no prior doses on file of that and the reporter cannot found literature on how many doses of twinrix he will need if two or if they are even compatible. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: SORE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: covid-19 prophylaxis. The patient was previously treated with covid-19 vaccine nrvv ad26 (JNJ 78436735) (dose number in series 1).The patient received covid-19 vaccine ad26.cov2.s ) (dose number in series 2).(suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sore (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from an Other HCP. Other Case identifier(s): US-MODERNATX-MOC20231107000138.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID". Clinical course: Patient had COVID in Aug2023 and wondering how long after COVID can receive the Spikevax.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported events Drug ineffective and COVID-19 cannot be ruled out, based on the limited information currently available.
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Blood test, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: States swelling at injection site, hives, and fever.  States was given steroids at Hospital.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Joint swelling, Peripheral swelling, Pruritus, Rash
Clinical narrative: Per patient began feeling itching the night after receiving the vaccine. The itching then progressed into a rash with severe itching and then swelling of the legs and ankles. This continued on for some time. She contacted her doctor who confirmed that he believed it to be an allergic reaction to the vaccine. The rash progressed and moved to both legs. The doctor prescribed 1. Medrol dosepak 2. Clindmycin and triamcinolone cream.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Per patient began feeling itching the night after receiving the vaccine. The itching then progressed into a rash with severe itching and then swelling of the legs and ankles. This continued on for some time. She contacted her doctor who confirmed that he believed it to be an allergic reaction to the vaccine. The rash progressed and moved to both legs. The doctor prescribed 1. Medrol dosepak 2. Clindmycin and triamcinolone cream.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Computerised tomogram normal, Headache, Influenza virus test negative, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: Severe frontal headache, noted within an hour of vaccination. Seen at ER, given analgesics. Headache eventually resolved.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Customers came to request newest COVID vaccine Spikevax. Graduate intern billed insurance and it went through and gave it to them. When Pharmacist went to them, found that patient already had the COVID shot this season already, just the different manufacturer, Comirnaty, in Sept 2023
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: pt had received a 23-24 high dose flu shot already on 10/19/2023
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Skin rash welts terrible itch.  Cortisone cream. Medrol dose pac. Resolving after 3 mos.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Customer came to request newest COVID vaccine Spikevax. Graduate intern billed insurance and it went through and gave it to her. When Pharmacist went to it, found that patient already had the COVID shot this season already, just the different manufacturer, Comirnaty, in Oct  2023.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: I don't know if this is related.  I developed a dry, red rash behind both knees and inner thighs about 2 weeks ago.   It burns when I apply any type of lotion, cream or prescription.  Anti-itch creams did not help.   Sought medical attention on 2/8/24.  Triamcinolone was prescribed.   It has only been 24 hours, so I don't have any relief yet.
Age: 93.0
Sex: F
Vaccine: RSV
Symptoms: Sudden death
Clinical narrative: Sudden Death
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death in a 46-year-old male recipient of Pfizer-Biontech. DOSE1 DATE 03/28/2021 LOT#ER6955, DOSE2 DATE 04/20/21 LOT#ER8737. COD not stated or ascertained online. Facility stamp on vax card was deceased recipient a resident of county?
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death of a 54-year-old female. DOSE#1 Date 03/12/2021 LOT#011A21A unable to ascertain subsequent DOSE info through source
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Online report of 59-year-old male that died at home. Copy of vax card online DOSE1 DATE 03/03/2021 LOT# 030A21A, any subsequent doses can't be confirmed through source. Facility stamp on card unsure of entity that inoculated
Age: 24.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Feeling hot, Nausea
Clinical narrative: Nause's, felt hot then, dizzy and patient lied down had water, ice cream...sitting up and talking did have TB test today.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Heart rate decreased
Clinical narrative: patients heart rate dropped to 62 bpm. She was given oxygen and completely recovered in the office.; This spontaneous report was received from a physician and refers to an 11-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2024 (reported as last week), the patient was vaccintated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection; and meningococcal vaccine a/c/y/w conj (crm197) (MENVEO), both administered as vaccination (immunisation) (strengths, doses, vaccination schemes, injection sites, lot numbers, expiration dates, and routes of administration were not provided).  On the same date, the patient's heart rate dropped to 62 bpm (heart rate decreased). She was given oxygen and completely recovered in the office.  The causal relationship between the event heart rate decreased and the suspect vaccines was not provided.
Age: 30.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Confirmed no symptoms or side effects reported/ No additional AE/no PQC; A dose of PROQUAD given to a 30 year old patient on 4JAN2024; This spontaneous report has been received from a medical assistant, regarding a 30-years-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 04-JAN-2024, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, at a dose of 0.5 milliliters once as prophylaxis (lot number: W026317, which was determined to be valid, with an expiration date on 18-FEB-2024), which its sterile diluent (strength, route and anatomical location of administration were not reported) (Inappropriate age at vaccine administration).  The reporter was inquiring if the vaccination needed to be repeated.   No additional adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional AE, no PQC; Caller is a nurse transferred requesting information on expired VAQTA (adult) that was administered to a patient. Product expired 12/27/2023 and was administered 2/7/2024. Product had TE on 12/2/2023 of 9.4C for 5 hours 26 minutes. See report; Product had TE on 12/2/2023 of 9.4C for 5 hours 26 minutes; This spontaneous report was received from nurse concerning an adult patient of unknown gender and age.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 02-DEC-2023, the vaccine had a temperature excursion (product storage error) of 9.4C for 5 hours 26 minutes   On 07-FEB-2024, the patient was vaccinated with an expired vaccine of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 milliliter, (lot #W023489, has been verified to be valid, expiration date: 27-DEC-2023) (anatomical location and route was not reported) administered for prophylaxis (strength, and route of administration were not provided). No Adverse event reported.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site cellulitis, Product preparation error
Clinical narrative: Nurse handling the vaccine with no clean hands or the vial was not properly handled; Cellulitis at the injection site; This is a spontaneous report received from a consumer from medical information team, Program ID.  A 16-year-old female patient received meningococcal serogroup B conjugate vaccine (TRUMENBA), on 31Jan2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 16 years intramuscular, in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE CELLULITIS (non-serious) with onset 31Jan2024, outcome "not recovered", described as "Cellulitis at the injection site"; PRODUCT PREPARATION ERROR (non-serious) with onset 31Jan2024, outcome "not recovered", described as "Nurse handling the vaccine with no clean hands or the vial was not properly handled". Therapeutic measures were taken as a result of vaccination site cellulitis. The well check appointment told it was necessary vaccination. The patient's mother was wanting to know if specifically, cellulitis is listed as an adverse reaction for Trumenba. The patient experienced cellulitis after taking the vaccination - cellulitis at the injection site. The patient was still taking antibiotics but have not completed the course yet. It was for the left arm. They were very upset this happened. It seemed more and more clear that it was the fault of the office nurse handling the vaccine with no clean hands or the vial was not properly handled. The patient's mother wanted to find out if the reaction the patient experience from one of the vaccines manufactured by Pfizer is written somewhere in a list of possible reactions. She is not able to find it anywhere and wanted to see if Pfizer is able to tell her its possible reaction or if it was mishandled by the doctor's office. All possible reactions were queried online even if they are rare to Trumenba. Cellulitis is not one of effects listed in clinical research. They were trying to find out where they go from there. They wanted to figure out next steps if there is one. This should not have happened to the patient.  Causality for "nurse handling the vaccine with no clean hands or the vial was not properly handled" and "cellulitis at the injection site" was determined associated to device constituent of meningococcal serogroup B conjugate vaccine (malfunction).  The information on the batch/lot number for meningococcal serogroup B conjugate vaccine will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old 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 included: "Asthma" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), Various Pfizer and Moderna), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid treatment from 01Jan2024 to 05Jan2024).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years 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; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 20Jan2024 to 24Jan2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: The caller got the initial 2 doses of the Pfizer COVID Vaccine/ He confirmed he did get COVID, a mild case, with no fever, it wasn't that bad; The caller got the initial 2 doses of the Pfizer COVID Vaccine/ He confirmed he did get COVID, a mild case, with no fever, it wasn't that bad/Congestion/Headache; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 63-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in arm and in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 60 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "I take a Blood Pressure medication" (ongoing). Concomitant medication(s) included: LISINOPRIL/HCTZ taken for blood pressure abnormal (ongoing). Vaccination history included: Flu shot (DOSE NUMBER UNKNOWN, SINGLE), for Influenza immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "The caller got the initial 2 doses of the Pfizer COVID Vaccine/ He confirmed he did get COVID, a mild case, with no fever, it wasn't that bad"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "The caller got the initial 2 doses of the Pfizer COVID Vaccine/ He confirmed he did get COVID, a mild case, with no fever, it wasn't that bad/Congestion/Headache". The patient underwent the following laboratory tests and procedures: Computerised tomogram: Unknown results, notes: for my chest area for my lung; SARS-CoV-2 test: Unknown results. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19. Clinical course: Patient confirmed he did get COVID, a mild case, with no fever, it wasn't that bad. He rested and drank plenty of fluids. Reporter stated, he got one shot in the left arm and one shot was in the right arm as anatomical Location. He would just got his normal Flu shot. He did not know if it was from Pfizer Flu shot. No, other vaccines administered on the same date. No Other vaccinations four weeks prior to COVID Vaccine.  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-PV202400018570 same reporter/patient/drug, different events;
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Prostate cancer
Clinical narrative: The caller got the initial 2 doses of the Pfizer COVID Vaccine/ He confirmed he did get COVID, a mild case, with no fever, it wasn't that bad; The caller got the initial 2 doses of the Pfizer COVID Vaccine/ He confirmed he did get COVID, a mild case, with no fever, it wasn't that bad/Congestion/Headache; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 63-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in arm and in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 60 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "I take a Blood Pressure medication" (ongoing). Concomitant medication(s) included: LISINOPRIL/HCTZ taken for blood pressure abnormal (ongoing). Vaccination history included: Flu shot (DOSE NUMBER UNKNOWN, SINGLE), for Influenza immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "The caller got the initial 2 doses of the Pfizer COVID Vaccine/ He confirmed he did get COVID, a mild case, with no fever, it wasn't that bad"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "The caller got the initial 2 doses of the Pfizer COVID Vaccine/ He confirmed he did get COVID, a mild case, with no fever, it wasn't that bad/Congestion/Headache". The patient underwent the following laboratory tests and procedures: Computerised tomogram: Unknown results, notes: for my chest area for my lung; SARS-CoV-2 test: Unknown results. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19. Clinical course: Patient confirmed he did get COVID, a mild case, with no fever, it wasn't that bad. He rested and drank plenty of fluids. Reporter stated, he got one shot in the left arm and one shot was in the right arm as anatomical Location. He would just got his normal Flu shot. He did not know if it was from Pfizer Flu shot. No, other vaccines administered on the same date. No Other vaccinations four weeks prior to COVID Vaccine.  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-PV202400018570 same reporter/patient/drug, different events;
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Prostrate cancer; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 60 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "I take a Blood Pressure medication" (ongoing). Concomitant medication(s) included: LISINOPRIL/HCTZ taken for blood pressure abnormal (ongoing). Vaccination history included: Flu shot (DOSE NUMBER UNKNOWN, SINGLE), for Influenza immunisation; Bnt162b2 (DOSE 1, SINGLE, Anatomical Location: Arm), administration date: Mar2021, when the patient was 60 years old, for COVID-19 immunisation. The following information was reported: PROSTATE CANCER (medically significant) with onset 2023, outcome "unknown", described as "Prostrate cancer". The patient underwent the following laboratory tests and procedures: Blood test: (2023) Prostrate cancer, notes: for pre-surgery; Computerised tomogram: (unspecified date) Unknown results, notes: for my chest area for my lung. Clinical course: Patient had 'simulation' done in a couple of weeks. He just gave a check-up and took blood samples and stuff like that.  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-202400034922 same reporter/patient/drug, different dose/events;
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Prostate cancer
Clinical narrative: Prostrate cancer; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 60 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "I take a Blood Pressure medication" (ongoing). Concomitant medication(s) included: LISINOPRIL/HCTZ taken for blood pressure abnormal (ongoing). Vaccination history included: Flu shot (DOSE NUMBER UNKNOWN, SINGLE), for Influenza immunisation; Bnt162b2 (DOSE 1, SINGLE, Anatomical Location: Arm), administration date: Mar2021, when the patient was 60 years old, for COVID-19 immunisation. The following information was reported: PROSTATE CANCER (medically significant) with onset 2023, outcome "unknown", described as "Prostrate cancer". The patient underwent the following laboratory tests and procedures: Blood test: (2023) Prostrate cancer, notes: for pre-surgery; Computerised tomogram: (unspecified date) Unknown results, notes: for my chest area for my lung. Clinical course: Patient had 'simulation' done in a couple of weeks. He just gave a check-up and took blood samples and stuff like that.  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-202400034922 same reporter/patient/drug, different dose/events;
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Janssen Dose Number: 2; This is a spontaneous report received from a Consumer or other non HCP.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose 3 (booster), single (Lot number: GJ3277) at the age of 42 years, in left arm for covid-19 immunisation; COVID-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 10Apr2021 as dose 1, single (Lot number: 202A21A), in left arm and on 29Nov2021 as dose 2, single (Lot number: 6855194), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Nov2022, outcome "unknown", described as "Janssen Dose Number: 2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment from 22Dec2023 to 26Dec2023.  No follow-up attempts are possible.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: COVID-19 vaccine moderna (Dose 3 (booster), single, Anatomical location: right arm), administration date: 12Sep2023, when the patient was 74-year-old, for COVID-19 immunisation; Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures (Paxlovid from 25Jan2024 to 29Jan2024) were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 at 11:00 as dose 1, single (Lot number: 4G4675) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 5 (BOOSTER), SINGLE at 03:00 PM, Batch/lot number: w5342, Anatomical location: Right arm), administration date: 19Nov2022, when the patient was 51-year-old, for Covid-19 Immunisation; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 26Jan2024 to 31Jan2024.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: he has COVID; he has COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "illness" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "he has COVID". Clinical course: It was reported that the patient had different illness aside from COVID, he had chronic COVID and he had four vaccine (unspecified COVID Vaccine) and he did not know and his wife did not know why he had COVID.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.