chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My mother in law received the vaccine 4-5 months ago. She caught Covid and died; My mother in law received the vaccine 4-5 months ago. She caught Covid and died; Just couldn't breathe; A little cough; This is a spontaneous report received from a contactable consumer via Pfizer sponsored program. The caller is calling on behalf of her deceased Mother-in-law. A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiration Date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history included COPD from an unknown date and unknown if ongoing, Bypass (She had bypass 19 years ago) from an unknown date and unknown if ongoing. The reporter stated that " I don't know what else was she taking." The patient's concomitant medications were not reported. Reporter wants to know if Pfizer was giving a placebo or the actual vaccine. She believes her mother-in-law had received a placebo vaccine. My mother-in-law received the vaccine 4-5 months ago. She caught Covid and died (2021). The doctor confirmed she did not have any antibodies. We all had been exposed to her. We are currently in quarantine. My father-in-law is 80 years old and was nervous. He was wondering why did he take the vaccine if it did not protect his wife or him. Reported doctor had basically tested her and they had found no antibodies. At the moment she was nervous because her father-in-law lived with them and they were both quarantined and he was 80 years old. Reporter stated they said she had no antibodies like she never got the vaccine. Reporter stated I do not know the name of antibody Test, but the hospital did it and they said she had no antibody at all. Date of Death: Reporter stated, I am not sure my father-in-law did knows exactly when they got vaccinated but it was 3 or 5 months ago. Reporter stated, "No, she went to the hospital on Thursday evening, and she had been on the ventilator like 3 hours later and she died on Saturday morning 2 O'clock. She had no fever, she had a little cough not major stuff, it was like flu the fever and usual cough she did not had any of that. She had no flu, she just couldn't breathe (2021). Anatomical Site of Administration: Reporter stated, I just know that she received it 4 months ago. The patient underwent lab tests and procedures which included antibody test: no antibody at all, Covid-19: positive on 2021 (She caught Covid and died). Therapeutic measures were taken as a result of my mother in law received the vaccine 4-5 months ago. she caught covid and died, just couldn't breathe. The patient died on 10Jul2021. An autopsy was not performed. The outcome of events just couldn't breathe  and cough was unknown, while other events was fatal.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: My mother in law received the vaccine 4-5 months ago. She caught Covid and died
fatigue, arm soreness, extreme dizziness, nausea, flushing. Recurred after 2 weeks. Brain fog that lasted weeks.
Patient reports she received the Moderna Bivalent booster at approximately 1:30pm on 9/26/22.  By approximatley 7:00pm the same evening she began not feeling well with muscle aches, headache, difficulty sleepingand increased joint pain (more than typical for her), chills, then feeling hot.  Reports symptoms progressively got worse of the next few days and she did not feel back to herself until Monday, October 3, 2022.  She reports she did not contact her PCP or receive any other medical care during this time.  Reports no adverse symptoms after receiving any other COVID-19 vaccines.
HEART BEATING LIKE CRAZY; CELLS REJECTING THE FOREIGN MATERIAL, FEEL IT COMING OUT OF MY SKIN; SHADOWS DANCE IN VISION; WHOLE BODY HURTS; GUT FEELS HEAVY; BODY FEELS 5-10 DEGREES COLDER; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced heart beating like crazy, cells rejecting the foreign material, feel it coming out of my skin, shadows dance in vision, whole body hurts, gut feels heavy, and body feels 5-10 degrees colder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body feels 5-10 degrees colder, shadows dance in vision, whole body hurts, cells rejecting the foreign material, feel it coming out of my skin, heart beating like crazy and gut feels heavy was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Low grade fever HA Induration at injection site with redness and warmth Antibiotics prescribed by PCP after a phone call with the patient  for possible cellulitis
Breakthrough Covid-19 First Dose 2/23/2021 84-year-old male brought in via EMS for generalized weakness and fever, tested positive for COVID in ED. His main concerns are the chills, alternating with fever, and the generalized weakness associated with this symptoms over the last couple of days according to his statement.
An expired Covid-19 pfizer vaccine was administered to the patient on 4/18/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient on 5-10 and she does not plan to get revaccinated.
diffuse urticarial rash which devel w/in 24 hrs of vax; no resp sx; no other findings;
Patient called Clinic call center reporting generalized rashes covering 20% of his body. Patient denies any other symptoms at this time. PAtient is not in respiratory distress. Patient declined scheduling with Medical Center provider and stated will reach out to PCP for advice today.
At time of vaccine on , had a fishy/metal taste in her mouth, which lasted till bedtime.  First day, arm was sore, not red or swollen. Next few days had severe fatigue, muscle pain, swollen lymph nodes in neck.  Next day, 2/13after vaccine when woke up, had a white coated tongue which lasted one day. That evening, her tongue swelled up which lasted about a week. Pt saw doctor at medical center on Feb 15. He advised you to take Tylenol and 2 benedryl day of vaccine and he wrote her a script for an EPI pen for after the vaccine and to use as needed.
Pt had vaccination at city site.  Waitied 15 min after shot and was cleared to go.  Reported to wife that he was very thristy, so they stopped at a convenience store on the way home.  While there, he felt worse and asked to go to the Emergency room.  They chose Methodist to enter.  Pt went to triage and while at triage, had syncopal episode, then full arrest.  After short course of CPR and defib, he had ROSC.  Was taken to cath lab for intervention (stents) and is now in ICU.
DTaP #5 given right thigh 11/27/02. Seen in clinic 11/29/02 10cm erythematous, warm to touch, 3cm induration around injection site. Very fussy with N/V x 5 on arm of 11/29/02, low PO, poor sleep. Using hot compress, motrin
This case was reported by a consumer and described the occurrence of injection site pain in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were unknown. It was unknown if the reporter considered the injection site pain and tiredness to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. After vaccination with SHINGRIX, the patient was tired and had injection site pain. For tolerance to 2nd dose refer US2018GSK226545.
Approximately 17 days after receiving my booster dose of Pfizer vaccine I started to have severe low back pain with the L>R side. This lasted for 4-5 days and then I developed a rash over the area. I was not thinking of Shingles so did not go in to be seen until October   20th  where it was confirmed to be herpes zoster.
Runny nose beginning at 12:30 PM Nov 9, 2009 progressing to headache, lethargy, loss of appetite, paranasal sinus pressure, runny nose, and sore throat by 9:00 pm Nov 9, 2009.  The severity of these symptoms increased over night and persist as of the time this adverse event report was submitted.
Injection site red pepper 4 cm nausea-fever, myalgias, headache. Tx: Ice, TYLENOL, ondansetron
SYMPTOMS- excessive vomiting, high fever/ chills , back pain;   TREATMENT - diagnosed with Idiopathic Necrotizing Acute Pancreatitis Developed blood clots(SMB Thrombosis) , esophageal ulcers/ internal bleeding, internal fluid sacs retention (+25lbs- abdominal and thoracic,) jaundice. Required insulin injections; oxygen nasal cannula; nasogastric tube; TPN Central line and Physical Therapy to regain legs mobility   TIME COURCE - One Hospital 8 Days; Another Hospital  - 22 Days ED, ICU(20 days), Stepdown; Rehab Center -  9 Days
Interchange of vaccine product; No symptoms; Inappropriate schedule; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. The reporter described that on an unknown date, the patient was vaccinated a series of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, route, lot # and expiry date were not reported) for prophylaxis, it was reported that on 07-FEB-2020, the patient vaccinated  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot # and expiry date were not reported) for prophylaxis (Circumstance or information capable of leading to medication error and wrong product administered). No symptoms experienced.
Symptoms and Signs: Right thigh is tender to touch, swelling and redness. Time Course: The symptoms were noticed on the night of 9/10/13. Treatment: Bactrim and Clindamycin for 7 days.
suspcted Vaccination failure; was free from shingles up until last week when she developed a case.; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 7PS9E, expiry date 10th September 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 7295J, expiry date 17th October 2021) for prophylaxis.   The patient's past medical history included shingles.   On 22nd November 2019, the patient received the 2nd dose of Shingrix. On 20th September 2019, the patient received the 1st dose of Shingrix. In November 2020, between 1 and 2 years after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional details were provided as follows: The patient had frequent cases of shingles prior to receipt of her Shingrix.  After vaccination, the patient was free from shingles up until last week when she developed a case. This case was considered to be a suspected vaccination failure case, as laboratory confirmation for shingles was unknown.
This case was reported by a consumer via other manufacturer and described the occurrence of tingling sensation in a elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included drug allergy (allergic to DEMORAL). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced tingling sensation and pruritus. On an unknown date, the outcome of the tingling sensation and pruritus were unknown. It was unknown if the reporter considered the tingling sensation and pruritus to be related to SHINGRIX. Additional details were provided as follows: This case was reported via Merck National Service Center. The age at vaccination was not reported, the patient was in her 80's. Shortly after receiving Shingrix, the patient felt tingling and itching between her fingers. In addition the patient said she is allergic to DEMORAL and asked if the vaccine contained that product. No further adverse event information was provided. For tolerance to next dose, refer case US2018GSK211136, reported by same reporter for same patient.
Vaccine was given on 01/24/2022; expiration date 01/23/2022.  Unable to contact individual to have them revaccinated per manufacturer.
Lab confirmed covid; Lab confirmed covid; shortness of breath; low O2; This is a spontaneous report from a contactable Other Health Care Professional.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included ocrelizumab (OCREVUS) taken for unspecified indication start and stop date were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date, it was reported that patient experienced COVID after 1 month of second  vaccine (both Pfizer) which was Lab confirmed covid. Both with medically significant illness, neither required hospitalization one went to ER for shortness of breath and low O2. The patient underwent lab tests and procedures which included sars-cov-2 test positive: confirmed on an unspecified date. The outcome of events was unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.; Sender's Comments: As per the information provided in the narrative, the causal association between the suspect drug and the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
shingles at 10 day post 2nd dose, COVID arm and rash 2 days post second dose, peripheral neuropathy 12 days post second dose, pain syndrome at 15 days post second dose administration. I am still recovering
Sunday night had flu-like symptoms, skin and tongue felt funny. Extreme light and sound sensitivity but no migraine pain, just discomfort. Monday-Tuesday felt extremely lethargic, slept most of the days. Wednesday my brain felt more alert but my body still felt funny, and the sound sensitivity was gone but the light sensitivity was still there. Was able to do some exercise. Each day has improved but now it?s Friday night and I continue to feel skin and light sensitivities.
Rash - severely large pustules - mostly small bumps on upper torso front & back felt weak - almost flu-like.
Heart palpitations exactly 2 weeks after getting the moderna vaccine, this is still ongoing, I've been put on beta blockers, ans currently awaiting a heart monitor and may have to go on medication to dampen down the nervous system.
1 patient received Moderna Covid-19 vaccine that had undergone a temperature excursion and was administered prior to knowing the viability of the vaccine.; Patient received moderna vaccine that underwent a temperature excursion; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (1 patient received Moderna Covid-19 vaccine that had undergone a temperature excursion and was administered prior to knowing the viability of the vaccine.), POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (1 patient received Moderna Covid-19 vaccine that had undergone a temperature excursion and was administered prior to knowing the viability of the vaccine.), POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (1 patient received Moderna Covid-19 vaccine that had undergone a temperature excursion and was administered prior to knowing the viability of the vaccine.), POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (1 patient received Moderna Covid-19 vaccine that had undergone a temperature excursion and was administered prior to knowing the viability of the vaccine.) and POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna vaccine that underwent a temperature excursion).    Concomitant product use was not provided by the reporter.  No information available about the patient's primary series of Moderna COVID-19 vaccine.  The patient received Moderna COVID-19 vaccine that underwent a temperature excursion and was administered prior to knowing the viability of the vaccine.  Vaccine expiration date was not known. Patient did not remember which arm they received the vaccine in. This dose was a booster dose.   No other adverse events were reported.  Treatment information was not provided.
Received vaccine on 11/4.  On 11/5, developed fever of less than 102 degrees, which lasted for two days, along with body aches.  also developed cellulitis at injection site on left upper thigh.  Site became swollen, red, very sore and made mucsle ache and leg weak when attempting to stand.  Fever resolved in two days, but cellulitis covered a patch of skin 3" by 7" across top of thigh, then going down side of outer thigh another 3" by 7" down.  Area was very tender to touch, swollen, itchy, and sore.  The redness and swelling and itch lasted until 11/10, and soreness until 11/14.  Redness gradually faded.  I did return to my doctor for consultation regarding the cellulitis to see if medical intervention was necessary.  He decided to hold off on antibiotics to see if condition resolved on its own.  It is now okay, with only slight soreness, but no redness or itch as of 11/20
Pt is 36 yo male with PMH of renal transplant 2/2 IgA nephropathy, CKD IIIa, OSA, GERD, morbid obesity who presented with cough and shortness of breath on 4/25/2021. He was found to have COVID-19 pneumonia and AKI. He is s/p Pfizer dose #1 vaccination on 2/23/2021 and dose #2 vaccination on 3/16/2021. He is immunosuppressed on mycophenolate, prednisone and balatacept monthly which may have affected immunogenicity to vaccine. Pt admitted and completed 10 day course of remdesivir. Also received dexamethasone. Improved VTE score of 1 so did not meet criteria for prophylactic Eliquis. Difficulty in weaning patient off of O2. Was discharged on 5/5/2021 on 4L oxygen and will follow up with Pulmonary as outpatient.
FEELING SMOTHERED FROM THE HEAT; CHILLS; A SEVERE HEADACHE; FEVERISH; This spontaneous report received from a patient concerned a 75 year old. 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: 043H21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 08-APR-2021, the subject experienced feeling smothered from the heat. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced a severe headache. On 08-APR-2021, the subject experienced feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling smothered from the heat, and chills on 09-APR-2021, had not recovered from a severe headache, and the outcome of feverish was not reported. This report was non-serious.
dizziness that lasted about 10 minutes/Dizzy; headache like someone hit me in the center of my head; Real weak; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 70-year-old female patient received second dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 2, single on an unspecified date in Feb2021 for covid-19 immunisation (at the age of vaccination 70-year-old). The patient's medical history included flu and her head was so heavy. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single for covid-19 immunisation. Patient had the second shot on Sunday. On next day in Feb2021, patient experienced dizziness that lasted about 10 minutes/ still dizzy/ real dizzy caused her to lay across bed but then it went away. This went on for 5 minutes and today, about 60 minutes ago, when got up, she had a headache in the center of her head and took 2 extra strength tylenol and it went away in Feb2021. In Feb2021, patient was also real weak. Patient wanted to know if this could be the flu or a side effect from the vaccine. She read where the headache could be a side effect but did not read anything about dizziness. Patient stated that she took a lot of other medicine so if could be those too. No further details provided. Therapeutic measures were taken as a result of headache with tylenol. At the time of this report, outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Approximately 30 minutes post injection experienced left jaw numbness lasting approximately 2 hours. Experienced left ear tingling and bitter taste in mouth lasting approximately 5 minutes.  Experienced left sciatic numbness lasting approximately 10 minutes.  No treatment.  Self-resolved.
Stabbing Chest pains from a few hours after shot until about 24 hours after.