chrisvoncsefalvay/vaers-outcomes huggingface dataset:
OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via a social media via a company representative concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 in total, dose 1 administered for covid-19 prophylaxis. On an unspecified the patient experienced penis got bigger (Dose number in series 1). The outcome of penis got bigger was not reported. The patient had received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 in total, dose 2 administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 in total, dose 3 administered for covid-19 prophylaxis which was an off label dosing frequency (Dose number in series 3). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that "Janssen please bring a covid booster back to market, im a healthcarehero and i had 3 jandj shots and the only side effect i had was my penis got bigger. I refuse to take a mrna vaccine. If yall dont want a [redacted] to lose his job please make a new omicron/flu booster". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20220909146 (Dose number in series 1).
Rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
From 3/24/2021 @8pm until 3/26/2021 @7pm sore arm headache fever chills muscle and joint aches
feel cold; feel like that i have fever; Headache; Body ache; Feeling tired; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced feel cold, feel like that i have fever, headache, body ache and feeling tired. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Jan2023 as dose 4 (booster), single (Lot number: GJ6742) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (dose 1, single, Lot: EL3249), administration date: 23Jan2021, when the patient was 75-year-old, for COVID-19 Immunization; BNT162b2 (dose 2, single, Lot: EN6201), administration date: 13Feb2021, when the patient was 75-year-old, for COVID-19 Immunization; BNT162b2 (dose 3 (booster), single, Lot: FE3592), administration date: 23Oct2021, when the patient was 76-year-old, for COVID-19 Immunization, reaction(s): "Tinnitus". The following information was reported: TINNITUS (non-serious), outcome "not recovered". Additional information: The patient received his 3rd dose of the Pfizer Covid vaccine, which was his first booster dose on 23Oct2021, and 3-5 days later he got tinnitus in both ears. He has spoken to his primary care doctor, and even had another booster dose on 10Jan2023 (Lot: GJ6742). He spoke to a hearing doctor but nobody seemed to care or saying anything about it. He stated the side effects were on the news all the time and a doctor mentioned that tinnitus could be a side effect of the vaccine. He saw the hearing doctor shortly after the tinnitus began and was told that other veterans have complained about it as well. The hearing doctor sent him home with a music machine to use for the tinnitus. The patient clarified that the doctor told him that other people said that they got tinnitus after getting the vaccine but did not know what manufacturer's product those other patients received. The patient did not have other vaccinations within four weeks prior to the first administration date of the suspect vaccine and did not have family medical history relevant to the adverse events; Sender's Comments: Linked Report(s): PFIZER INC-202300056289 Same patient/drug/event, different doses.
Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 0051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2023, SARS-CoV-2 test: (Positive) Home test. On an unknown date, SARS-CoV-2 test: (Positive) Home test.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient tested positive for Covid, but he did not have a whole lot of symptoms. Reporter does not know when the patient got COVID, but he had minimal symptoms on 09-Aug-2023, when they both tested positive.  The patient had 2 positive home tests.  Doctor prescribed Paxlovid.   This case was linked to US-MODERNATX, INC.-MOD-2023-738502 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2023: Live follow-up information received included Reference numbers added from PQC Document.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738502:Case for Wife
had the vaccine, shingles anyway/suspected vaccination failure; shingles; stabbing pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix.  Additional details were provided as follows:  The patient self-reported this case.                                        The age at vaccination was not reported. The patient got the Shingrix vaccine and had shingles anyway. Stabbing pain was unbearable . The patient asked futher guidance on this. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not available. The follow-up would not possible as no contact details were available.
Severe diarrhea 10x/day reduce PO intake pt was admitted though ER at hospital with IV hydration. 01/16/07 Received medical records from hospital which reveal patient admitted 12/9/06-12/10/06 with diarrhea & poor feeding since receiving vax.  Dehydrated on exam & by labs.  Rehydrated overnight then given oral challenge which was tolerated.  No further diarrhea & d/c home to be seen by PCP in 1-2 days.  FINAL DX: Gastroenteritis.
Swelling of the lymph nodes on the side of the injection - left - under the arm and on the side of her breast; Soreness in the lymph nodes on the side of the injection - left - under the arm and on the side of her breast; Pain on the injection site/Discomfort; Itching in the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Pain on the injection site/Discomfort), VACCINATION SITE PRURITUS (Itching in the injection site), VACCINATION SITE LYMPHADENOPATHY (Swelling of the lymph nodes on the side of the injection - left - under the arm and on the side of her breast) and LYMPH NODE PAIN (Soreness in the lymph nodes on the side of the injection - left - under the arm and on the side of her breast) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain on the injection site/Discomfort) and VACCINATION SITE PRURITUS (Itching in the injection site). On 23-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swelling of the lymph nodes on the side of the injection - left - under the arm and on the side of her breast) and LYMPH NODE PAIN (Soreness in the lymph nodes on the side of the injection - left - under the arm and on the side of her breast). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN (Pain on the injection site/Discomfort), VACCINATION SITE PRURITUS (Itching in the injection site), VACCINATION SITE LYMPHADENOPATHY (Swelling of the lymph nodes on the side of the injection - left - under the arm and on the side of her breast) and LYMPH NODE PAIN (Soreness in the lymph nodes on the side of the injection - left - under the arm and on the side of her breast) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
eye lid infection; This is a spontaneous report from a contactable consumer reported for her husband. An 86-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Pfizer product; Batch/lot number: EL3246) via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunization. Medical history included pulmonary embolism (PE) diagnosed 3 years ago, treated at (university name) hospital for about 3 weeks and the clot was gone and he went back to his normal routine. Other products were reported as no. Caller stated she and her husband got the first dose of the Covid vaccine 2 weeks ago today, 11Jan2021, stated they were scheduled to get 2nd dose next week 01Feb2021. Caller stated her husband had developed, unrelated to vaccine, an eye lid infection on 18Jan2021 with outcome of not resolved, stated he went to doctor had been treating it with topical antibiotics and anti-inflammatory eye drops, infection was improving but persistent, doctor wanted to put him on an oral antibiotic, they were very reluctant to do so, stated that they considered doxycycline but they read not to be taken with vaccines, stated he would not take that one, caller wanted to know did he need to ride the infection out and possibly end up with an incision and drainage or if he can take an antibiotic. Stated the main concern was that could an antibiotic possibly diminish the efficacy of either the first or second doses of the Covid vaccine and wanted to know if this was possible. Stated her husband was a retired orthopedic surgeon.; Sender's Comments: Eyelid infection is considered unrelated to the vaccine use representing a coincidental skin/ subcutaneous infectious condition.
Hospitalization: 10/23/22 - 10/27/22 Presentation to the ED: SOB, ADMITTED FOR SEPSIS.  COVID + date: 10/23/22 Treatment: STEROID NEBULIZER. Discharge to: HOME W/ HOME HEALTH SERVICES.
i was ok until the next day. i was drowsy i couldnt get out of bed, my stomach was hurting and diheerra, loss of appitete  a blockage  saw dr from heart
2-3 days after vaccine developed flu like symptoms, then progressive fatigue. 5-7 days later rise in creatinine noticed in a Urgent care. Pt underwent to kidney biopsy bc rapid renal function deterioration. Biopsy showed severe Anti GBM (Godd Pasture disease). Pt currently on dialysis and plasmapheresis, without signs of improvement.
Cellulitis left upper arm. Cllindamycin 300 mg IM, TMP/SMZ DS BID x 10 D, DURICEF 1 gm BID x 10 D.
Seven days following the first dose of vaccination, the patient developed red, puffy inflammation at the injection site. It was itchy, but did subside after 3 - 4 days.
Patient received vaccine (FLUVIRIN) 11/8/14. Reported rash below injection site and itching all over" on 11/9/14.
she had an outbreak of a rash on her spine about 2 inches long and also on the back of her neck that appears to be shingles; This spontaneous report was received from a female patient regarding herself. The patient's concurrent conditions included thyroid issues and heartburn. The patient's medical history, drug reactions or allergies were not reported.  Concomitant therapy included levothyroxine and unspecified heartburn medicine.  On an unknown date in 2006, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX), (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis.  On 17-OCT-2019, the patient had an outbreak of a rash on her spine about to 2inces long and on the back of her neck that appears to be shingles (herpes zoster). The patient also reported that she was having headaches, as well, as pain in her shoulders and neck. The patient sought medical attention by speaking with her physician and she was treating the rash with unspecified cream, the pain was treated with ice and for the infection, she was being treating with acyclovir and acetaminophen (TYLENOL) for the headaches.  At the time of the report, the patient did not recovered from the herpes zoster.  The relatedness between the event of herpes zoster and therapy with zoster vaccine live(ZOSTAVAX) was not reported.
she got a cyst on the side where she got her shot right above her collar bone; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Apr2021 (Lot number: ER8729, Expiration Date: 31Jul2021) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (ongoing), notes: she had this condition since 2018 or 2019, she thinks 2019. Concomitant medication(s) included: ARIMIDEX taken for breast cancer, start date: Jan2020 (ongoing); PRAVASTATIN taken for blood cholesterol (ongoing); HYDROCHLOROTHIAZIDE (ongoing). The following information was reported: CYST (non-serious) with onset 11Apr2021, outcome "not recovered", described as "she got a cyst on the side where she got her shot right above her collar bone".  Additional Information: Patient reported she has no clue when she started Pravastatin medication, that she has maybe been on it for about 3 or 4 years. Hydrochlorothiazide is her water pill and that she has been on it for maybe 3 years, 4 years. She says she is not heavy at all, she is thin, 145 pounds, 5ft 7in. She reported she has had Breast cancer condition since 2018 or 2019, she thinks 2019. she was a nurse assistant, home health aid, medical assistant, all of the above. The last one she did was a home health aide. Patient declines to provide her address to receive paper mail but consents to a phone call follow up if needed. she doesnt like to use email. Does not provide email. she just got it on Friday, 09Apr2021. Patient reported, it was Sunday morning when she noticed the cyst. She reports that it is movable. She is unsure what the seriousness of the cyst is, that it might have been the way she slept, maybe the necklace she wore, that with cancer you notice every little thing. She reported she might go today, call her primary doctor to see what she should do. She said she should have called him before she called us. She reported no one in her family, had cancer, it is not hereditary, she doesnt know how she got it, it was only stage 1 at the time. No prior vaccination done within 4 weeks. No adverse events prior to vaccination.  No follow-up attempts are possible. No further information is expected.
FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and headache. This report was non-serious.
redness and warmth around the injection site; soreness, redness and warmth around the injection site; warmth around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th August 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced soreness, redness and warmth around the injection site. The reporter consented to follow up.
abscess inj site encompassing entire shoulder area;drained & treated w/ATB;resolved;10MAY94 f/u 3 days p/inj the area got indurated & red; a week p/it became fluctuant & then it was incised;purulent exudate came out, approx 1cc;seen in ER
crown fell out; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH LOSS (crown fell out) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced TOOTH LOSS (crown fell out). At the time of the report, TOOTH LOSS (crown fell out) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment details were reported.  Action taken with mRNA-1273 in response to the event was not applicable.
A Pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent with no adverse event; 0.7 ml of Fluzone HD was administered to the patient with no adverse event; A Pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent with no adverse event; Initial information received on 15-Nov-2020 regarding an unsolicited valid non-serious case received from an other health professional (pharmacy manager) via call center.  This case is linked to cases 2020SA323787, 2020SA323795, 2020SA323872, 2020SA324116, 2020SA323616 and 2020SA323597 (same reporter).  This case involves a 11 year old male patent for whom it was reported that a pharmacist was supposed to give fluarix, however accidentally grabbed and administered influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] (wrong product administered, Inappropriate age at vaccine administration) on 13-Nov-2020 (batch number: UJ555AA and expiration date: 30-Jun-2021) at a dose of 0.7 ml once via intramuscular route in the left arm for prophylactic vaccination (overdose).  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event wrong vaccine administered, Inappropriate age at vaccine administration and that it was an overdose (latency: same).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: this suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module VI of the good Pharmacovigilance practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Headache, Myalgia, CHILLS; FATIGUE; SORE ARM Narrative:
Herpes zoster diagnosis at ED. She was previously vaccinated with 2 doses of varicella vaccine. Painful rash in one dermatome. She also reported a history of varicella in 2009.