chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Pfizer booster 3 weeks prior to arrival. States tested + for Covid 3 days prior. Acute shortness of breath while attempting to do daily pushups late on 2/4. Came into ER w sats in low 90s but able to ambulate without assistance. Sats drop to 80s while walking
My arm was itchy this morning and now a big, hot ball has appeared.  It is visible through my shirt.  I can feel it growing.  I have also been having strange pains and feelings on the left side of my body (in my neck, arm, leg).
Information has been received from a physician concerning a female patient who on 08-JUN-2007 "ten days ago", was vaccinated with a first dose of Gardasil. On 08-JUN-2007, the patient fainted after getting injection site Gardasil. The physician also reported that the patient felt dizzy and was sick to the stomach after the injection. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
This initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 08 out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
extremely migraine; muscle aches from head to tow; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (extremely migraine), MYALGIA (muscle aches from head to tow) and NAUSEA (nausea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 22-Feb-2021, the patient experienced MIGRAINE (extremely migraine), MYALGIA (muscle aches from head to tow) and NAUSEA (nausea). At the time of the report, MIGRAINE (extremely migraine), MYALGIA (muscle aches from head to tow) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Swelling 7 1/2 x 6 cm on L upper arem, very red and warm to touch. Advised cold pack, topical hydrocortisone and see MD if worsens over weekend.
Concern comes from a pulmonary Embolism  and DVT diagnosed within a week of the first shot.  Realize this could be a coincidence, I have no history of clots.
hot or warm to touch injection site; migraine; slightly difficult to move injected arm, can only move it one foot; rash is around the injection site; Bad Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (hot or warm to touch injection site), MIGRAINE (migraine), HYPOKINESIA (slightly difficult to move injected arm, can only move it one foot), VACCINATION SITE RASH (rash is around the injection site) and HEADACHE (Bad Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included TOPIRAMATE (TOPAMAX), ATENOLOL, ATORVASTATIN, LORAZEPAM, CELECOXIB (CELEBREX) and GABAPENTIN for an unknown indication.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced INJECTION SITE WARMTH (hot or warm to touch injection site), MIGRAINE (migraine), HYPOKINESIA (slightly difficult to move injected arm, can only move it one foot), VACCINATION SITE RASH (rash is around the injection site) and HEADACHE (Bad Headache). The patient was treated with OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (hot or warm to touch injection site), MIGRAINE (migraine), HYPOKINESIA (slightly difficult to move injected arm, can only move it one foot) and VACCINATION SITE RASH (rash is around the injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. Permian, Amebic injection for migraine once a month is the other concomitant medications reported by reporter. Migraine medications are the other treatment medication reported by reporter. Permian,Amebic injection for migraine once a month is the other concomitant medications reported by reporter.   This case was linked to MOD21-026479 (E2B Linked Report).; Sender's Comments:  MOD21-026479:
Patient presented to clinic to get second dose of Moderna COVID 19 vaccine however was given Pfizer COVID 19 vaccine by RN
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
Pt received Varivax on 6-8-08. Presented to my office on 6-17-08 with herpes rash.
pt recv vax 12FEB96 & pt devel a rash;no further details were provided
completed a hepatitis B series and blood work showed no immunity; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a male patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, more than 2 years after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient completed Hepatitis B of unknown brand series in 1999. Last week from the date of reporting, the patient's blood work done for a transporter position which showed no immunity for Hepatitis B. The reporter consented to follow up.
This case was reported by a consumer via call center representative and described the occurrence of increased intraocular pressure in a 81-year-old male patient who received BOOSTRIX for prophylaxis. The patient's past medical history included intraocular pressure high (8 years before the reporting date), glaucoma, eye operation and cataract extraction (after surgeries eye pressure had been 11 and 13 for the past 2-3 years). On 7th March 2019, the patient received BOOSTRIX (intramuscular). On 13th March 2019, 6 days after receiving BOOSTRIX, the patient experienced increased intraocular pressure. On an unknown date, the outcome of the increased intraocular pressure was unknown. The reporter considered the increased intraocular pressure to be related to BOOSTRIX. Additional details were provided as follows: This case was reported by the patient's wife. The patient received BOOSTRIX on the left arm. The patient pressure in his eyes had jumped up from 13 to 23 in one aye and 26 in the other eye. The eye doctor and pharmacist thought that the increased pressure was due to the vaccine and he was supposed to return in 3 months for another check. The emergency room visit was required. Lab Comments: The patient's eye pressure jumped from 13 in each eye up 23 in one eye and 26 in the other eye.
Room spinning; Flu like symptoms; Positional dizziness; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Room spinning), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS POSTURAL (Positional dizziness) and DIZZINESS (Dizziness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE in April 2021. Past adverse reactions to the above products included Dizziness with JANSSEN COVID-19 VACCINE.    On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VERTIGO (Room spinning), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS POSTURAL (Positional dizziness) and DIZZINESS (Dizziness). At the time of the report, VERTIGO (Room spinning), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS POSTURAL (Positional dizziness) and DIZZINESS (Dizziness) outcome was unknown.            No concomitant medication was provided. No treatment information was provided.
CDC reports: 5yo child developed fever to 103, local rxn at inject site, hypotonic episode, excessive sleep & would not eat or drink following immun. Duration of illness 1 1/2 days.
COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a 43 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-JAN-2022, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.
Ten days post vaccination client had a large local reaction (area red and swollen) at the injection site.  Two days later client had shortness of breath with difficulty in breathing.  On 08/15/2007 client presented to her allergist because the symtoms persisted.  Dr put the client on two inhalers and Singular. Client revisited the Dr. on 08/31/2007 for persist cough and was placed on Leviquin 500mg for 12 days.  Client states she is better but not a 100%.  Dr will be doing a Varicella titer soon.
For 1-3 days patient had fever + swelling at injection site (improved with ice). Patient has experienced "Charlie horse" in arm + numbness/tingling in fingers. Not constant only when moves arm certain way
sore arm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9263, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 04Feb2021 (age at vaccination was 60 years) as dose 2, single for COVID-19 immunization. The patient's medical history included none (Patient's Medical History (including any illness at time of vaccination) No Family Medical History Relevant to AE(s): None) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. AE following prior vaccinations was none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL3246, Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 14Jan2021 at 14:00 as dose 1, single for COVID-19 immunization. Patient received third dose on 29Sep2021. On Feb2021, after second dose patient experienced sore arm. The outcome of the events was unknown.  Follow-up attempts have been completed and no further information is expected.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A male patient received the 4th dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in arm for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st, 2nd and 3rd dose of the COVID-19 vaccine (manufacturer unknown), for COVID-19 immunization. Reportedly, vaccination site pain occurred in the spot where they did the shot; his arm hurt a bunch. Maybe two hours later, he woke up again and his arm still hurt a bunch; outcome: unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
received their first 2 doses of Engerix-B 5 months apart; 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 38-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B (received first dose 5 months apart on 14th March 2023 of batch number C44K4).   On 25-AUG-2023, the patient received the 2nd dose of Engerix B. On 25-AUG-2023, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: received their first 2 doses of Engerix-B 5 months apart).  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: 25-Aug-2023 A pharmacist wished to know how to proceed.  Partial information about event, vaccine and patient was given.  The Vaccine Administration Facility was the same as Primary Reporter. Did not consent to follow-up. The patient received second dose of Engerix-B later than the recommended interval, which led to lengthening of vaccine schedule.
Got shots at 9 a.m. Was swelled in right thigh p.m. of 2/26. At a.m. of 2/27 had more swelling, redness and heat at inject site. Was red and 4 x 4 in. large. Improvement with ice packs and Motrin.
Headache, Sedation, Myalgia, Fever, Pain @ injection site Narrative:
Mother calling to report child developed "pus" running from injection site.  Mother took child to Dr. and child was placed on antibiotics.  All information was given to clerk.  Mother has declined to return all requests for follow up information.
Hours after receiving my second Moderna Covid vaccine on March 5, 2021 I began experiencing the following symptoms: - Extreme ongoing, debilitating fatigue which to the date of this submitted report has been resistant to treatment. - Spike in depression & Anxiety - Increased brain fog and struggles concentrating  - Spike in lack of motivation generally - Increased irritability, frustration, aggression, and impatience toward others. - Began having suicidal thoughts
Patient was fine in the time period immediately after the injection. However, beginning 1/14/19 patient reported flu-like symptoms. These symptoms included chills, fever, nausea, body aches and her eyes burning. She reports that these symptoms lasted 4-5 days. She reported this reaction to the pharmacy on 1/24/19.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 6 (booster), single (Lot number: GJ5342), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing); "wasp bites" (unspecified if ongoing); "Metastatic sweat gland carcinoma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient received COVID 19 anti viral treatment with Paxlovid form 01Oct2023 to 05Oct2023. No follow-up attempts are possible. No further information is expected.
Migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "Migraine". Therapeutic measures were taken as a result of migraine.  Additional information: Patient had taken tylenol for her migraine before the 2nd dose. Wanted to know what other pain relievers she can take because tylenol isn't effective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 11-SEP-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # T011167 with expiration date 27-MAY-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
pt recvd vax & exp chest tightness p/each dose; on f/u reporting facility indicated pt never returned for 3rd dose of vax & no further details are available;
Broke out in rash under her breast / Rash Resolved; This case was reported by a physician via sales rep and described the occurrence of rash in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the physician for her mother. The age at vaccination was not reported. The patient received shingles vaccine last year and broke out in rash under her breast. The reporter did not consent to follow up.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant medications were reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient received additional booster dose. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Significant follow up received: age group and case narrative updated.
Irritability/crying for 3-4 days after immunization with Pediarix and Hib. Tactile warmth.
expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  (removed from freezer 10-14-21 into refrigerator and never opened before today and temperature never compromised )
Vomiting about 8 hours after vaccine given up until 12 hours after.  Unclear whether vaccine related or just standard food poisoning.