chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Immunization had previously been given - received 2nd tdap on 06/21/24. First Tdap was given on 06/04/2024
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Blood thyroid stimulating hormone, Dyspnoea, Fatigue, Graves' disease
Clinical narrative: Placed on list for 7 days. Next morning and for 8 days following, body aches, fatigue, severe headache, nausea and dry heaving. Was on menstrual cycle when vaccine administered; next day no longer discharging. Within 3 weeks, started to experience heart palpitations. Experience severe shortness of breath. Consulted doctor and given referral for cardiology. Had blood work completed by Endocrinology and 3 months later diagnosed with Graves' Disease (Hyperthyroidism).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypomenorrhoea, Nausea, Pain, Palpitations
Clinical narrative: Placed on list for 7 days. Next morning and for 8 days following, body aches, fatigue, severe headache, nausea and dry heaving. Was on menstrual cycle when vaccine administered; next day no longer discharging. Within 3 weeks, started to experience heart palpitations. Experience severe shortness of breath. Consulted doctor and given referral for cardiology. Had blood work completed by Endocrinology and 3 months later diagnosed with Graves' Disease (Hyperthyroidism).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Retching, Scan thyroid gland
Clinical narrative: Placed on list for 7 days. Next morning and for 8 days following, body aches, fatigue, severe headache, nausea and dry heaving. Was on menstrual cycle when vaccine administered; next day no longer discharging. Within 3 weeks, started to experience heart palpitations. Experience severe shortness of breath. Consulted doctor and given referral for cardiology. Had blood work completed by Endocrinology and 3 months later diagnosed with Graves' Disease (Hyperthyroidism).
Age: 5.0
Sex: F
Vaccine: COVID19, DTAPHEPBIP, MMR, COVID19, DTAPHEPBIP, MMR
Symptoms: Injection site bruising, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Mom brought child into clinic today 6/24/24 with a large red raised rash covering the whole right  deltoid area with defined edges also had a little bit of bruised area at inner edge by armpit.  Mom stated that the arm started with a little normal swelling for the first 2 days, then started itching and the rash began.  She said her daughter had been scratching at it.  Looked back up what vaccines had been given in that arm per consent form.  Vaccine administered in Right Deltoid was Pediarix.  Mom had stated that child did not have any reactions with first doses of any vaccines given on 6/13/24 prior to administering second doses of vaccines. Given information to take child to get arm looked at by a physician.
Age: 5.0
Sex: F
Vaccine: COVID19, DTAPHEPBIP, MMR, COVID19, DTAPHEPBIP, MMR
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Mom brought child into clinic today 6/24/24 with a large red raised rash covering the whole right  deltoid area with defined edges also had a little bit of bruised area at inner edge by armpit.  Mom stated that the arm started with a little normal swelling for the first 2 days, then started itching and the rash began.  She said her daughter had been scratching at it.  Looked back up what vaccines had been given in that arm per consent form.  Vaccine administered in Right Deltoid was Pediarix.  Mom had stated that child did not have any reactions with first doses of any vaccines given on 6/13/24 prior to administering second doses of vaccines. Given information to take child to get arm looked at by a physician.
Age: 5.0
Sex: F
Vaccine: COVID19, DTAPHEPBIP, MMR, COVID19, DTAPHEPBIP, MMR
Symptoms: Injection site bruising, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Redness,  swelling,  itching to R upper arm
Age: 5.0
Sex: F
Vaccine: COVID19, DTAPHEPBIP, MMR, COVID19, DTAPHEPBIP, MMR
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Redness,  swelling,  itching to R upper arm
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Device leakage
Clinical narrative: Small drip appeared to escape between barrel and needle, may have also been from needle tip prior to injection. Believed to be negligible.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Paraesthesia
Clinical narrative: That evening my arms started tingling up to the elbows, by the time I layed down that night it was an intense and constant sensation from my fingertips up to my shoulders of pins and needles like my arms had fallen asleep. I finally fell asleep and they felt the same that next morning. I read it could be a rare side effect and usually go away within a couple weeks so I waited. It took a few weeks but did gradually go away.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Arthralgia, Back pain, Bell's palsy, Eyelid disorder, Pain
Clinical narrative: Patient received vaccines on 6/21/24.  Woke up on 6/22/24 with left side face swollen, bodyaches and unable to close his left eyelid all the way.  He had trouble spitting after brushing his teeth. He was seen at Urgent Care 6/22/24 and diagnosed with Bell's Palsey. He has joint pain to knees and back.  He was started on Prednisone and is feeling better today 6/24/24.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Swelling face
Clinical narrative: Patient received vaccines on 6/21/24.  Woke up on 6/22/24 with left side face swollen, bodyaches and unable to close his left eyelid all the way.  He had trouble spitting after brushing his teeth. He was seen at Urgent Care 6/22/24 and diagnosed with Bell's Palsey. He has joint pain to knees and back.  He was started on Prednisone and is feeling better today 6/24/24.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: WHEN GRABBING VACCINE, I GRABBED THE ADULT IN ERROR AND ADMINISTERED THE VACCINE
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Home had some expired vaccine (past 30 days from thawing per manufacturer) and gave one to the resident.  Pharmacy contacted the manufacturer on behalf of the nursing home and said we would fill out VAERS.  No adverse events were reported by the patient or nursing staff.
Age: 0.08
Sex: M
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: Given PPSV23 instead of PCV15
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Decreased appetite, Fatigue, Injection site erythema, Injection site swelling, Pain
Clinical narrative: localized redness/swelling after injection through to 4 days later, body aches x1 day post injection, loss of appetite x4 days post injection, and fatigue x4 days post injection
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased activity, Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth at the site of injections the day after injection. Quadracel more noticeable then the MMRV . NO fever, no increased agitation. Client was more " calm" than usual. Pt is being seen by PCP today. 6/24/24 Dr.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, Coronary arterial stent insertion, Coronary artery disease, Dehydration
Clinical narrative: Hospitalization for Afib with RVR, COVID-19, hypomagnesemia, dehydration/hyponatremia/ metabolic acidosis, CAD s/p stent, PAD s/p LE stent, hypertension, hyperlipidemia, GERD, hypothyroidism on dates 6/14/24- 6/18/24. Treated with dexamethasone, baricitinib, Remdesivir.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Hyperlipidaemia, Hypertension, Hypomagnesaemia, Hyponatraemia
Clinical narrative: Hospitalization for Afib with RVR, COVID-19, hypomagnesemia, dehydration/hyponatremia/ metabolic acidosis, CAD s/p stent, PAD s/p LE stent, hypertension, hyperlipidemia, GERD, hypothyroidism on dates 6/14/24- 6/18/24. Treated with dexamethasone, baricitinib, Remdesivir.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hypothyroidism, Metabolic acidosis, Peripheral arterial occlusive disease, Peripheral artery stent insertion
Clinical narrative: Hospitalization for Afib with RVR, COVID-19, hypomagnesemia, dehydration/hyponatremia/ metabolic acidosis, CAD s/p stent, PAD s/p LE stent, hypertension, hyperlipidemia, GERD, hypothyroidism on dates 6/14/24- 6/18/24. Treated with dexamethasone, baricitinib, Remdesivir.
Age: 1.42
Sex: F
Vaccine: DTAP
Symptoms: Arthritis, Arthritis reactive, X-ray
Clinical narrative: REACTIVE ARTHRITIS OF THE KNEE
Age: 14.0
Sex: M
Vaccine: PNC15
Symptoms: Pain, Pain in extremity
Clinical narrative: soreness arm and pain when lifting or moving arm around.
Age: 66.0
Sex: M
Vaccine: ADEN_4_7
Symptoms: Antinuclear antibody, Blood creatine phosphokinase, Blood thyroid stimulating hormone, C-reactive protein, Dysstasia
Clinical narrative: Marked anterior thigh pain making it impossible to stand. Bending and squatting were impossible for the first 14 days. Walking was painful and very limited for weeks. Stairs were not possible for 2 months at least. There was no erythema or swelling of the knee joint.  Fatigue was also and remains a big problem. Afternoon naps are required (none prior) and after any physical exertion which is still a big problem.
Age: 66.0
Sex: M
Vaccine: ADEN_4_7
Symptoms: Fatigue, Fibrin degradation products, Gait disturbance, Increased need for sleep, Mobility decreased
Clinical narrative: Marked anterior thigh pain making it impossible to stand. Bending and squatting were impossible for the first 14 days. Walking was painful and very limited for weeks. Stairs were not possible for 2 months at least. There was no erythema or swelling of the knee joint.  Fatigue was also and remains a big problem. Afternoon naps are required (none prior) and after any physical exertion which is still a big problem.
Age: 66.0
Sex: M
Vaccine: ADEN_4_7
Symptoms: Pain, Pain in extremity, Prostatic specific antigen, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: Marked anterior thigh pain making it impossible to stand. Bending and squatting were impossible for the first 14 days. Walking was painful and very limited for weeks. Stairs were not possible for 2 months at least. There was no erythema or swelling of the knee joint.  Fatigue was also and remains a big problem. Afternoon naps are required (none prior) and after any physical exertion which is still a big problem.
Age: 66.0
Sex: M
Vaccine: ADEN_4_7
Symptoms: Somnolence
Clinical narrative: Marked anterior thigh pain making it impossible to stand. Bending and squatting were impossible for the first 14 days. Walking was painful and very limited for weeks. Stairs were not possible for 2 months at least. There was no erythema or swelling of the knee joint.  Fatigue was also and remains a big problem. Afternoon naps are required (none prior) and after any physical exertion which is still a big problem.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood glucose, Dyskinesia, Electrocardiogram, Syncope, Tremor
Clinical narrative: Pt given Bexsero and Menveo by MA. Per MA, she stepped out of the room and went to sit down to her desk when mother of child came out of room asking for help.   MOC states patient had fainted and had some limb movements.  At around 11:40am I entered room pt was laying down sating he felt hot, I dimmed light and provided pt with Icepack and placed under neck and around forehead.  While taking EKG and orthostatic vitals pt was trembling but stated he felt "okay"
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Patient stated pharmacist administered in the left arm that has caused persistent and worsening pain on whole left warm
Age: 83.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Cellulitis
Clinical narrative: Patient reports that she got cellulitis in the arm and received antibiotics.  Patient had existing tattoo and wanted vaccine in that arm.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse evemt; Caller reported vaccines were administered after temperature excursions; This spontaneous report was received from Other Health Professional and refers to a patient of unspecified age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 24-MAY-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #X023403, verified to be a valid lot number with expiration date: 03-APR-2025 (dose, strength, and route of administration were not provided).  The caller reported that the was administered after temperature excursion, at a temperature of 48.4F, during a time frame of 58 minutes. No previous temperature excursion was reported. No other information was provided. No additional adverse events were reported.   ; Sender's Comments:  US-009507513-2406USA004946: US-009507513-2406USA004898: US-009507513-2406USA004803: US-009507513-2406USA004757:
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: A female patient "passed out" after receiving her first dose of GARDASIL 9.; This spontaneous report was received from other health professional and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in December 2023, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, route of administration and anatomical location were not provided).  On an unspecified day in December 2023 (reported as about 6 months ago), the patient "passed out" (loss of consciousness) after receiving her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). At the time of reporting, the outcome of the event was not provided. No additional information provided.  The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the event of loss of consciousness was reported as not applicable.   The causal relationship between the event of loss of consciousness and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.   Upon internal review, the event of passed out was determined to be medically significant.  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: RVX
Symptoms: Deafness unilateral
Clinical narrative: This vaccine caused my mother to lose the hearing in one ear; This serious case was reported by a consumer via interactive digital media and described the occurrence of hearing loss unilateral in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced hearing loss unilateral (Verbatim: This vaccine caused my mother to lose the hearing in one ear) (serious criteria GSK medically significant). The outcome of the hearing loss unilateral was not reported.   The reporter considered the hearing loss unilateral to be related to RSV vaccine.     The company considered the hearing loss unilateral to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 17-JUN-2024 This case was reported patient child via (social media) interactive digital media.; Sender's Comments: Deafness unilateral  is an unlisted event which is considered unrelated to GSK vaccine RSV vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; has a really bad case of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: has a really bad case of shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-JUN-2024 This case was reported by a patient's wife via (social media) interactive digital media. The shot was not a guarantee, the patient got the shots 2 years ago and right now (at the time of reporting) had a really bad case of shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. The case was linked with case US2024AMR075571 and US2024AMR078163 reported by the same reporter for different patients.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingles vaccine. US-GLAXOSMITHKLINE-US2024AMR075571:same reporter US-GSK-US2024AMR078163:same reporter, sisters case
Sex: U
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administration outside of the recommended age; they had been administering Kinrix as the first dose in the DTap-IPV vaccination series for children; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received DTPa-IPV (Kinrix) (batch number 34MS9, expiry date 13-FEB-2026) for prophylaxis.   On an unknown date, the patients received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration outside of the recommended age) and inappropriate schedule of vaccine administered (Verbatim: they had been administering Kinrix as the first dose in the DTap-IPV vaccination series for children). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of 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: 14-JUN-2024 A nurse reported that they had been administering Kinrix as the first dose in the DTap-IPV vaccination series for children that have emigrated and wanted to know if what they are doing was correct which led to Inappropriate schedule of vaccine administered. They also stated during the phone call that some of the children were three to seven years of age but did not give specific information for any of the children which led to Inappropriate age at vaccine administered. They mentioned that groups of female children received the dose and this case was filed for that collective group.  The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: frozen Shingrix administered to the patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-JUN-2024, the patient received Shingrix. On 17-JUN-2024, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: frozen Shingrix administered to the patient). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 17-JUN-2024 The reporter was calling to report that one of the froze Shingrix vaccine and a nurse at this thawed a dose of the frozen Shingrix and administered it to the patient which led to incorrect storage of drug. The reporter had no patient demographics to provide. The reporter did not have the lot number, expiry date, route of administration or location of administration for the Shingrix to provide. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late 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 a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received his first dose in 2022).   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: late dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 18-JUN-2024 The patient received his first Shingrix dose in 2022 and had late 2nd dose.  The consumer was at the doctor's office at the time of the call for a second dose of Shingrix. No further information was known. Did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   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: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-JUN-2024 The pharmacist had a patient who took their first dose of Shingrix in 2019 and did not return for second dose. She was asking for her second dose now in 2014, 5 years later. Did she need to restart the series questioned the reporter. The Healthcare professional disconnected the chat before able to get any additional information. No email or mailing address provided. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site pruritus
Clinical narrative: Caller also said that prior to that she got all vaccinations and had a problem with itching with site injections; allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Caller also said that prior to that she got all vaccinations and had a problem with itching with site injections) and HYPERSENSITIVITY (allergic reaction) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer Covid-19 vaccine (Patient had no reaction to Pfizer.) on 10-Nov-2023. Past adverse reactions to the above products included No adverse effect with Pfizer Covid-19 vaccine. Concurrent medical conditions included Diabetes and Blood pressure high.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Caller also said that prior to that she got all vaccinations and had a problem with itching with site injections) and HYPERSENSITIVITY (allergic reaction). At the time of the report, VACCINATION SITE PRURITUS (Caller also said that prior to that she got all vaccinations and had a problem with itching with site injections) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported. Treatment medications were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: We assisted in his father's passing because of our covid-19 bioweapon vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (We assisted in his father's passing because of our covid-19 bioweapon vaccine) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.  Company Comment: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the serious (due to medically significant) fatal unexpected, event of death, which occurred on an unknown date and with unknown latency after a dose of SPIKEVAX NOS (SPIKEVAX NOS) vaccine. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of SPIKEVAX NOS (SPIKEVAX NOS) vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2024: Live follow-up received and added no new information.; Reported Cause(s) of Death: Unknown cause of death
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Palpitations
Clinical narrative: heart racing; upper left hand chest pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing), CHEST PAIN (upper left hand chest pain) and CHILLS (chills) in a 12-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jun-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 21-Jun-2024, the patient experienced PALPITATIONS (heart racing), CHEST PAIN (upper left hand chest pain) and CHILLS (chills). At the time of the report, PALPITATIONS (heart racing), CHEST PAIN (upper left hand chest pain) and CHILLS (chills) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter causality was not reported. It was unknown if the patient experienced any additional symptoms/events.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: ended up coming down with COVID about two years ago; ended up coming down with COVID about two years ago; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (BNT162B2), 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) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "recovered" and all described as "ended up coming down with COVID about two years ago". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Reporter was, joyfully surprised when both Pfizer and Moderna on came out with their messenger RNA-based vaccines and his wife(patient) and he were two of the first people to get it for a couple of reasons. His wife and he both ended up coming down with COVID about two years ago. They went right on the pax [Paxlovid]. Four days later- it tired reporter out - four days later, you know, we were healthy again. So they had been very good in terms of keeping up with our boosters. They had got a new vaccine based in place. They were usually first in line to get it. This do the flu vaccine them on the same day. Did not thinking there would be any complications, but just deciding, let they go ahead and keep them both isolated. Reporter heard that the two shots sort of had like differential side effects. So coming down with it and going ahead and having the two basically on different days this last year, which reporter wife did as well at his urging, was the right way to do it.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Drug ineffective; COVID-19; Vaccine brand=Pfizer / biontech, 07Jun2022, Vaccine dose number=4, Vaccine brand other=Moderna, 13Dec2022, Vaccine dose number=5; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 23Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 24Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 07Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Dec2022 as dose 5 (booster), single), in left arm and on 06Oct2023 as dose 6 (booster), single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Dec2022, outcome "unknown", described as "Vaccine brand=Pfizer / biontech, 07Jun2022, Vaccine dose number=4, Vaccine brand other=Moderna, 13Dec2022, Vaccine dose number=5"; COVID-19 (medically significant) with onset Jun2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Jun2024, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 09Jun2024 to 13Jun2024.
Sex: F
Vaccine: COVID19
Symptoms: Dysphemia, Impaired work ability, Malaise, Tremor
Clinical narrative: lost the ability to work; visibly shaking hands; stuttered voice; didn't feel well at all / had not feel well since injection; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient received BNT162b2 (BNT162B2), on 12Apr2021 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: MALAISE (non-serious) with onset 12Apr2021, outcome "not recovered", described as "didn't feel well at all / had not feel well since injection"; IMPAIRED WORK ABILITY (non-serious) with onset 12Apr2021, outcome "not recovered", described as "lost the ability to work"; DYSPHEMIA (non-serious) with onset 12Apr2021, outcome "not recovered", described as "stuttered voice"; TREMOR (non-serious) with onset 12Apr2021, outcome "not recovered", described as "visibly shaking hands". It was unknown if therapeutic measures were taken as a result of impaired work ability, tremor, dysphemia, malaise.  Additional information: Very upset. Stood up in Pfizer sponsored event and voiced the adverse events.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 21Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (PRIMARY SERIES COMPLETE), for COVID-19 IMMUNIZATION; Comirnaty (1st booster), for COVID-19 IMMUNIZATION, reaction(s): "hair loss". The following information was reported: ALOPECIA (non-serious) with onset Oct2023, outcome "recovered", described as "Hair loss". Additional information: Consumer stated, "I wanted to report a side effect from the Pfizer vaccine (Clarified as Pfizer Covid Vaccine). I experienced hair loss two times with two vaccines and I am wondering if I tried another vaccine, if perhaps I would not experience that." When paraphrased the concern, consumer stated, "I have had it more than that but I know for certain two times it caused hair loss." Consumer stated, "I was not sure how many times it caused hair loss but there were two specific times that I knew that." Lab tests "No." Consumer stated, "The last shot that I had was 9/21/23(Clarified as September/21/2023) and I would say two weeks later and it lasted approximately 3 months." Still experiencing was "No. I am not.". When clarified hair loss due to Covid vaccine/Booster shot/Comirnaty 12, consumer stated, "The booster shot."  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400198930 Same Reporter, Patient, AE/Different Product.;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 38-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "MALS (post surgery)" (unspecified if ongoing); "MALS (post surgery)" (not ongoing); "Celiac artery stent" (not ongoing), notes: from complications of MALS; "asthma" (unspecified if ongoing); "known allergies: Penicillins" (unspecified if ongoing); "known allergies: steri strip adhesive" (unspecified if ongoing); "known allergies: nickel" (unspecified if ongoing); "known allergies: cobalt" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jun2024, outcome "recovered" (15Jun2024); DRUG INEFFECTIVE (medically significant) with onset Jun2024, outcome "recovered" (15Jun2024). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jun2024) Negative, notes: Covid test after 5 days of negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 10Jun2024 to 15Jun2024   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high bmi" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2024, outcome "recovered" (Jun2024) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2024) Negative, notes: negative day 3 of treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 08Jun2024 to 13Jun2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug Ineffective; COVID-19; This is a spontaneous report received from an Other HCP.  A 39-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm 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 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: COVID-19 (medically significant) with onset Jun2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Jun2024, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 12Jun2024 to 16Jun2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: slight soreness on arm; tired; This Initial case was previously missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 17Jun2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Physician and a Consumer or other non HCP, Program ID.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6203) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: with intermittent O2 use; "Asthma" (unspecified if ongoing); "slightly blood pressure" (unspecified if ongoing); "Past hx of alcohol use disorder" (unspecified if ongoing); "Long term smoking history" (unspecified if ongoing), notes: 50 plus pack year hx. The patient's concomitant medications were not reported. Past drug history included: Albuterol inhaler; Steroid inhaler; O2, reaction(s): "COPD". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "slight soreness on arm"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tired".  Additional information: Side effect to the vaccine was slight soreness on arm and at 24th or so got really tired.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400096881 same patient, different vaccine dose/event;
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Pain in extremity, SARS-CoV-2 test
Clinical narrative: slight soreness on arm; tired; This Initial case was previously missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 17Jun2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Physician and a Consumer or other non HCP, Program ID.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 2, single (Lot number: ER2613) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: COPD with intermittent O2 use; "Asthma" (unspecified if ongoing); "slightly blood pressure" (unspecified if ongoing); "smoking history" (unspecified if ongoing), notes: her long term smoking history/ Active smoking of cigarettes, 50 plus pack year hx; "alcohol use disorder" (unspecified if ongoing); "immunological protection was lacking" (unspecified if ongoing); "slightly blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Albuterol inhaler; Steroid inhaler, notes: Albuterol inhaler; O2, reaction(s): "COPD". Vaccination history included: BNT162b2 (DOSE 1, Lot number: EN6203), administration date: 26Feb2021, for COVID-19 Immunization, reaction(s): "slight soreness on arm", "tired". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 18Mar2021, outcome "unknown", described as "slight soreness on arm"; FATIGUE (non-serious) with onset 18Mar2021, outcome "unknown", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter is a retired family physician and continue to do part-time public health. Patient is reporter sister. She gets regular medical care through her primary care provider and pulmonologist. It seems likely that her immunological protection was lacking. This may be secondary to her past alcohol use disorders (she has been sober for 8 years), her long term smoking history, and her COPD. Other medical condition or taking any other medications, consumer stated, "I do have slightly blood pressure and that's it." The patient was not receive any other vaccines on the same date as the Pfizer vaccine. The patient has not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. Patient has past hx of e toh use disorder (sober for 8 years). Pfizer ER2613 Expiration Date was 21Jul. Only side effect to all vaccines was slight soreness on arm and at 24th or so hr. got really tired.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400096881 same patient, different vaccine dose/event;
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: slight soreness on arm; tired; The Initial case was previously missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 17Jun2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Physician and a Consumer or other non HCP, Program ID.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "slightly blood pressure" (unspecified if ongoing); "intermittent O2 use" (unspecified if ongoing), notes: COPD with intermittent O2 use; "etoh use disorder" (unspecified if ongoing), notes: Patient has past hx of etoh use disorder, Past hx of alcohol use disorder; "long term smoking history/Active smoking of cigarettes" (unspecified if ongoing), notes: long term smoking history/Active smoking of cigarettes, 50 plus pack year hx; "inhaler" (unspecified if ongoing), notes: Steroid inhaler, Albuterol inhaler. The patient's concomitant medications were not reported. Past drug history included: Steroid inhaler; Albuterol inhaler; O2 for COPD, notes: COPD with intermittent O2 use. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: EN6203), administration date: 26Feb2021, when the patient was 62-year-old, for Covid-19 Immunization, reaction(s): "tired", "slight soreness on arm"; BNT162b2 (DOSE 2, SINGLE, Batch/Lot number: ER2613, Ex-21Jul), administration date: 18Mar2021, when the patient was 62-year-old, for Covid-19 Immunization, reaction(s): "tired", "slight soreness on arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Oct2021, outcome "unknown", described as "slight soreness on arm"; FATIGUE (non-serious) with onset 12Oct2021, outcome "unknown", described as "tired".  Additional information: Only side effect to all vaccines was slight soreness on arm and at 24th or so hr. got really tired.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: slight soreness on arm; tired; This is a spontaneous report received from a Physician and a Consumer or other non HCP.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2022 as dose 4 (booster), single (Lot number: FF4984) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "slightly blood pressure" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Alcohol use disorder" (unspecified if ongoing), notes: She has been sober for 8 years; "Long term smoking history" (ongoing), notes: active smoking of Cigarette/50 plus pack year. The patient's concomitant medications were not reported. Past drug history included: Intermittent o2 use for COPD; Albuterol inhaler. Vaccination history included: BNT162b2 (Dose 1, Batch/Lot Number: EN6203), administration date: 26Feb2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Batch/Lot Number: ER2613, Ex-21Jul), administration date: 18Mar2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (Dose 3 (Booster), Batch/Lot Number: FF2587), administration date: 12Oct2021, when the patient was 63-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2022, outcome "unknown", described as "slight soreness on arm"; FATIGUE (non-serious) with onset Apr2022, outcome "unknown", described as "tired".  Additional information: Only side effect to all vaccines was slight soreness on arm and got really tired.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400096881 same patient/drug, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 1, single (Lot number: HG4629), in right arm for covid-19 immunisation. The patient's relevant medical history included: "hyponatremia" (unspecified if ongoing), notes: Hospital diagnosis hyponatremia. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), 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 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 11Jun2024 to 14Jun2024.