chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects are being reported.; beyond the age of 45 years old and received GARDASIL 9; This spontaneous report has been received from a male patient beyond the age of 45 years old, referring to himself. Information about medical history, concurrent conditions and concomitant therapies were not provided.      On 19-SEP-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product administered to patient of inappropriate age) (strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. No adverse effect was reported.
A rash developed one week after shot starting on my legs and arms and has spread to my upper legs, chest, back etc.
DIFFICULTY WALKING; PAIN IN ALL JOINTS; This spontaneous report received from a patient concerned a male of unspecified age. 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, 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 patient experienced difficulty walking, and pain all in joints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the difficulty walking and pain in all joints was not reported. This report was non-serious.
Vaccine given after use date/Expired vaccine given; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given after use date/Expired vaccine given) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given after use date/Expired vaccine given). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given after use date/Expired vaccine given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment medications were reported.  It was reported that the HCP was trying to figure out whether the patient should be re-administered with another dose. The HCP did not know if the vial had undergone any temperature excursions and regarding date of vial initially stored in the refrigerator.
Seen in urgent care 1/17/11. Varicella vaccine 1/3/11. 2 days ago, 1/15 red, raised area on right arm which increased in size. Prior to redness, itchy. Size 3cm x 2cm. Treated for cellulitis at site 1/19/11 with LEVAQUIN.
no adverse event; an expired dose of PROQUAD was administered to a patient; This spontaneous report was received from a medical assistant regarding a 5 year old patient. No information regarding concurrent conditions, drug allergies or reactions, medical history or concomitant medications was provided.  On 04-MAY-2021 the patient was administered an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) rHA 0.5 ml  for prophylaxis (lot S035108  with expiration date reported and verified as valid on 03-MAY-2021) (expired product administered). No temperature excursions or additional adverse events were reported.
Suspected vaccination failure; 15 people / experienced shingles; This case was reported by a consumer via media and described the occurrence of  suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received Shingles vaccine and experienced shingles. 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 unknown at the time of reporting. This case was one of the 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088476: US-GLAXOSMITHKLINE-US2021AMR088499: US-GLAXOSMITHKLINE-US2021AMR088499: US-GLAXOSMITHKLINE-US2021AMR088498:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088500:Original Case : US2021AMR088476
Reaction was local, on left thigh of MMR site, about 5cm with erythema. No induration.
injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lymphoma.   On 20th February 2023, the patient received the 1st dose of Shingrix (intramuscular). On 20th February 2023, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Additional Information: GSK Receipt date: 21-FEB-2023 Reporter comment: The reporter was the patient. The patient received her first Shingrix dose and experienced injection site pain. Nothing else was reported. The reporter did not consent to follow up
She received the 2nd dose of the COVID vaccine (Pfizer) on 9/30. Beginning on 10/3, she started complaining of constant, sharp, left lateral chest pain. The pain does not radiate. Minimal aggravation with position. It is not worse with deep breaths or chest wall palpation. She also had a fever with TMax 102F. She was trying to manage symptoms at home with Tylenol, Gas-X and Alka Seltzer, but pain persisted so she presented to ED on 10/3.
Fever, fatigue, headache, swollen soar arm and woke up in the middle of the night with racing heart.
Patient states felt fine after immunization having mild discomfort on first day- she states then on 11/5/18 in afternoon she started getting jabbing pains in site where shot was given (she said felt like needle poking her). She said this pain came every 30 minutes. She states no fever, rash, itching, swelling, or redness. She took TYLENOL and used ice pack which helped minimally. She came in to report this to pharmacy on 11-6-18 and said the pain is still there but now just dull pain. We examined her arm and no sign of redness, rash or inflammation or bruising. She states no fever or itching. We told her to continue with ice and TYLENOL and if pain continues to call MD to get examined. We told her we would report this to VAERS website and will follow up and check on her in next day.
7 days post vax pt was hosp & dx w/pneumonia;cult reportedly showed no growth;@ the date of this report pt remained hosp & required mechanical ventilation;
Severe headache, body ache, elevated fever beginning around 11:30pm day of vaccine.  Tylenol taken on morning of 2/17/2021 helped reduce fever and headache.  Fatigue a factor the remainder of the day.   24 hrs. later (2/18) all symptoms were gone and normal activities resumed.
Sudden infant death. Patient received vaccine in the morning. Found dead at around 9pm after he was put in bed at 7pm.
Shingles/Nerve pain/Lot of pain/Rash under arm; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles/Nerve pain/Lot of pain/Rash under arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced HERPES ZOSTER (Shingles/Nerve pain/Lot of pain/Rash under arm). The patient was treated with LYSINE at an unspecified dose and frequency and VALACYCLOVIR [VALACICLOVIR] at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles/Nerve pain/Lot of pain/Rash under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided by the reporter. Treatment: Lysine, Valacyclovir. Patient stated  she received 1st dose of moderna covid-19 vaccine on 27Apr2021 on her right arm and due for her 2nd dose on 25May2021. She stated that she began with rash under her arm around 10May2021 and got lot of pain. On 20May2021 she visited dermatologist and they have told her that she had shingles and put her on medication. Nerve pain has subsided on 24May2021 and going away. She wanted to know if it would be okay to receive 2nd dose as she was on medication and whether shingles is the common side effect of vaccine. When she spoke to her HCP regarding this, they recommended to speak with moderna  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
bilateral humming/whooshing sound in his ears following his Pfizer BioNTech Covid-19 booster dose; This is a spontaneous report received from contactable reporter(s) (Physician).  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete manufacturer unknown), for Covid-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "bilateral humming/whooshing sound in his ears following his Pfizer BioNTech Covid-19 booster dose". Therapeutic measures were not taken as a result of tinnitus. Additional information: The patient will visit an ENT on 29Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient presented to the ED on 3/15/21 and was subsequently hospitalized with NSTEMI. She also presented to the ED on 4/14/21 with chest heaviness.
Severe stomach pain; Diarrhea; Nausea; My back, shoulders, and neck to hurt; My back, shoulders, and neck to hurt; My back, shoulders, and neck to hurt; Nightmares; Yeast infection; Feel like my bones are trying to come out of my body/Brain feels bigger than my skull/ Chest fullness like heart trying to come out of chest; Chest fullness like heart trying to come out of chest; Stomach bloating; This is a spontaneous report from a contactable consumer. A 45-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/ Lot number: not reported), second dose via an unspecified route of administration administered in left arm on 28Feb2021 (at the age of 45-year-old) as a single dose for COVID-19 immunisation at hospital. Medical history included immune system disorder, Von willebrand's disease, high blood pressure, arthritis, allergies: Latex and related foods, all from an unknown date and unknown if ongoing. Concomitant medications received within two weeks of vaccination included duloxetine hydrochloride (CYMBALTA); levetiracetam (KEPPRA); lisinopril (LISINOPRIL); lisdexamfetamine mesilate (VYVANSE), all taken for an unspecified indication, start and stop date were not reported. The patient previously took paroxetine (PAXIL), blood pressure medication with Diuretic, Penicillin, and experienced drug hypersensitivity. Historical vaccine given to patient previously was dose 1 received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunisation in hospital and experienced slight rash. The patient was not diagnosed with COVID, prior vaccination. The patient did not receive other vaccine in four weeks of vaccination. The patient has not been tested for COVID, post vaccination. It was reported that on 01Mar2021, the patient experienced severe stomach pain with diarrhea and nausea, feel like her bones are trying to come out of her body (she wishes she had a zipper to release the aliens) caused her back, shoulders, and neck to hurt, nightmares, yeast infection with 2nd, brain felt bigger than her skull, chest fullness like heart trying to come out of her chest, and stomach bloating. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. As a corrective therapy patient took fluids and Zofran for the events. On 08Mar2021, the patient underwent lab tests and procedure which included Nasal Swab SARS-CoV-2 test; result negative, post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
10/3 Patient noticed L arm was red, warm while at routine PCP visit. MD said to call if redness increases. 10/4 Patient called BOH states redness now has decreased intensity, is improving - no treatment given.
Patient reported redness at injection site that spread to her torso.  Also complained of possible swelling in back of throat.  The pharmacy was notified of these events 3 days post injection.
patient under age 18 had received Flublok, no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of an unknown age who received a dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot number not reported via unknown route in unknown administration site.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to Inappropriate age at vaccine administration.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on the batch number was requested.
Developed dermatographia two weeks after reducing vaccine.   If I touch or scratch my skin it becomes red for approx. 30 minutes.
On 01/22/2016 patient presented with a vesicular rash on the right thigh, it "spread: to the back (right side) to the right knee consistent with shingles.
Vaccines were stored after beyond use date and CDC expiry date; Vaccine was administered after beyond use date and CDC expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and CDC expiry date) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and CDC expiry date) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and CDC expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and CDC expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and CDC expiry date) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and CDC expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the vial was stored in standard freezer for the lot 068H21A with 2 degrees F high -1 degrees F low on 04-Jan-2022.  The beyond use date and CDC expiry date was reported as 02-Apr-2022.  No treatment information was provided by the reporter.  This case contains information for the eighth of 45 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-571126 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-571126:Master Case
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 21-DEC-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # K011004 and expiry date: 07-NOV-2015) which was improving stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of-58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Patient dizzy after 10 minutes. Called patient M.D. office. Told patient to relax at home and call if problems + call M.D. in AM
Lithium toxicity; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter has read viable reports of son man, another with 2 people who got lithium toxicity after receiving the vaccine on unknown date. The reporter also after over a decade on lithium, no changes had lithium toxicity. It was horrifying, delusions, physical, mental. Seizures, kidney injury, pancreatitis. No doctor knew what was happening, family was called in about reporter long-term care, possibly death. The consumer doesn't know if this vaccine had any part or not, if it was, consumer want to be able to help, the doctors, and others with this. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101077401 Same reporter/ drug/ event for different patients;US-PFIZER INC-202101077402 Same reporter/ drug/ event for different patients
Pt fainted per mother. She fell down. She was given juice and protein bars. She felt better. I was told that the pt has not had anything to eat almost all day & she was afraid of needles.
PATIENT CAME TO PHARMACY TWO DAYS POST VACCINATION FROM 10/2/17- DELTOID AND SURROUNDING AREA WAS SWOLLEN AND WARM MORE USUAL.
presented to the emergency room a tonight with the 2-3 day history of worsening shortness of breath associated with cough and brownish sputum production.  He denies fever or chills.  The shortness of breath progressively got was during this time frame.  He also gives a 2-3 day history of nausea, vomiting and diarrhea and unable to keep for liquids or solids down.  He denies abdominal pain, melena or hematochezia.     He presented and respiratory distress on BiPAP support.   He received intravenous Lasix 80 mg upon arrival to the emergency department.  Subsequently live auricle investigations revealed a profound hyponatremia with a serum sodium of 111 and hence received 500 mL of...  Tested positive on 12/03/2021 presented to the emergency room tonight with the 2-3 day history of worsening shortness of breath associated with cough and brownish sputum production.  He denies fever or chills.  The shortness of breath progressively got was during this time frame.  He also gives a 2-3 day history of nausea, vomiting and diarrhea and unable to keep for liquids or solids down.  He denies abdominal pain, melena or hematochezia.     He presented and respiratory distress on BiPAP support.   He received intravenous Lasix 80 mg upon arrival to the emergency department.  Subsequently live auricle investigations revealed a profound hyponatremia with a serum sodium of 111 and hence received 500 mL of intravenous sodium chloride fluid challenge.  He also received the duo neb. in view of the profound hyponatremia he is being evaluated to be admitted to the intensive care unit for closer monitoring.  During his stay in the emergency department he has been weaned off the BiPAP support and currently on 3 L of oxygen via nasal cannula.  Incidentally he claims that he was vaccinated for COVID-19, 6 months ago with 2 dose regimen but he is not sure what type of vaccine it was.
R deltoid, the next day at 4pm, pt noticed edema and warmth at site.
side effects from second dose included chills, fatigue, muscle aches; fatigue; muscle aches; This is a spontaneous report from a contactable consumer. This 33-year-old female consumer reported that the patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, LOT number: EL3247), via an unspecified route of administration in left arm on 16Feb2021 11:00 (Age at vaccination: 33-year-old). Patient previously received first dose of BNT162B2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT number: EL3247) via an unspecified route of administration in left arm on 26Jan2021 11:00 (Age at vaccination: 33-year-old). The patient concomitantly received parenteral vitamins in two weeks. The patient does not have any known allergies.The patient was not tested positive either before or after vaccination. After receiving the second dose the patient had chills, fatigue, and muscle aches on 16Feb2021 23.00. The outcome of these events was reported as recovered.
1) immediate pain 1/2 through injection - fully dissipated within 5 minutes. Felt great all day. 2) Fever conditions (chills, body aches) about 10 hours later and pain in both shoulders that evening (difficulty sleeping).  Next day feeling lethargic due to rough night`sleeping (?) and/or body's response to vaccine