chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 2 month old female patient with milk protein allergy but this had not been confirmed. The patient's medical history included mucous in stools that looked like egg white, when the patient ws 3 weeks old (approximately in 23-JAN-2013). The pharmacist reported that on 05-MAR-2012 the patient was vaccinated with ROTATEQ, suspension 2, dose 1, oral. There were not concomitant medications. The pharmacist reported that on 06-MAR-2013 her daughter had been experiencing mucous in her stool. She has been irritable and screaming often. She also has been pulling her legs up to her chest. On 06-MAR-2013 a faecal occult blood test came back positive. The pharmacist reported that on 10-MAR-2013 her daughter had 5 loose stools. The pediatrician told the pharmacist to feed her daughter NUTRAMIGEN. At the time of the report, the outcome of faecal occult blood test positive, loose stools, pulling legs up to chest, irritability, screaming and mucous in stools was reported as not recovered/not resolved. The patient's mother sought medical attention by speaking to physician. The patient was treated with NUTRAMIGEN. Additional information has been requested.
On 12/13/22, 12 Pfizer Bivalent boosters were administered at two vaccination sites.  The two loose unpunctured vials had expiration dates of 12/09/22.  The vaccine had expired 4 days earlier, expirations are on the boxes and not vials so nurse was unaware.  Call to HCP, told to complete VAERS and call manufacturer. If not viable: follow CDC guidelines which is to notify client and re-vaccinate in 8 weeks.  Pfizer requested data logger temps and calibration certificate as well as event details. Per Pfizer, we are within the 75 days of stability assessment.
Shoulder area of vaccine site with severe but localized large area of circular erythema with fever 2 cm dia area of induration and minimal bruising.
Myalgia, Fever, NauseaVomiting, HIVES; SWELLING/REDNESS AT INJECTION SITE Narrative:  Other Relevant History:
pt recv vax in 1995 & 29SEP96 pt devel shingles;pt recovered;
April 10 - I only had mild pain at injection site; no impact to activities. At 9:40 PM that evening, I started feeling feverish, pain, itching at the injection site (continued for about 6 days); muscles aches (ongoing) headache, nausea, and uncontrollable chills. And I was not able to do anything the next day and that was the 11th. I l also got my period that day. The 12th, my period became a geyser - I never had a period like that before - I was bleeding a lot for about 5 days (my period didn't last longer than  a normal  period though) ; and I still had some muscle aches (they continued through the 12th). So I gave my PCP a call and went in, and she told me to watch it (she didn't know I had been vaccinated. I've had an ongoing headache this week: on Wednesday (the 21st) - for 22 hours non-stop and Thursday (the 22nd I had another one on Thursday - it was about 6 or 7 hours).
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 04-DEC-2014 the patient was vaccinated with an expired dose of ZOSTAVAX lot # K000455, expiry date: 30-OCT-2014, 0.65 ml subcutaneously. No adverse events were reported. Additional information has been requested.
Redness, warm, swelling, pain to upper arm of injection site. Area was reported by patient to cover 3/4 length of upper arm. Patient developed malaise for 1.5 days.
redness at site of injection; swollen at site of injection; itchy at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness at site of injection), INJECTION SITE SWELLING (swollen at site of injection) and PRURITUS (itchy at site of injection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ERYTHEMA (redness at site of injection), INJECTION SITE SWELLING (swollen at site of injection) and PRURITUS (itchy at site of injection). At the time of the report, ERYTHEMA (redness at site of injection), INJECTION SITE SWELLING (swollen at site of injection) and PRURITUS (itchy at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment was provided.
I had fever, chills and extreme stomach spasms that lasted for 6 to 7 hours.
This spontaneous report was received from a registered pharmacist concerning a patient of unknown age and gender. On 08-APR-2013, the patient was vaccinated with an expired dose of ZOSTAVAX (lot number and expiry date reported as 672676/0069AE and 03-APR-2013 respectively, dose and route unspecified) by a physician. No concomitant mediations were reported. No adverse event was reported. Additional information has been requested.
08/24/18: The evening after getting vaccine in left deltoid employee stated arm felt warm and turned red and muscle swelled up (bicep). Saturday 8/25/18 upper arm was swollen, red and warm to touch. Saw on Monday 8/27/18 bicep area swollen - not deltoid area. Less swollen than over the weekend.
Sept 8,2021- I had head congestion and I thought it was allergies, my older dad had the same symptoms. My mom was in hospice and was dealing with that. I was exhausted. My head was hurting. My dad and fever that Sunday and I took him ER and positive with COVID-19. Sept 14, my dad was doing bad and went to doctor and was diagnosed COVID-19. Got the monoclonal infusion on Sept 17,2021. Didn't have a high fever. I still have issues - my legs hurt after the infusion - my joints in my ankles, bones and muscles hurt Friday - Sunday. I felt sick and slept and took ibuprofen and Sunday, my legs were better but some days my legs are crazy painful, was sweating badly - like 2-3 weeks.
At 4:30 am 2/23/08 she developed nausea, abdominal cramping and dizziness that slowly resolved and was gone by midnight of the next day. Patient reported reaction when she came in for her 3rd HPV.
Patient received a single dose of Pfizer on 05/07/21, unbeknownst, the patient received a single dose of Moderna on 03/17/2021 at a different facility, No adverse events were noted. At the time we were taking patients at their or their caregiver's word during screening questions. In current state anyone who does not arrive with a vaccine card is searched in system to verify eligibility. This patient was eligible to receive Pfizer from us by age.
Varicella given in left arm. 2 cm long by 2.5 cm wide reddened area.
No additional AE information reported.; temperature excursion; This spontaneous report was received from a medical assistant, referring to a 6-month-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.  On 05-JUN-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (single dose unspecified, lot # T033812, expiration date: 29-DEC-2021) orally for prophylaxis. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 1 hour (product storage error). No previous temperature excursion was reported. No additional adverse event information reported.
11:30 pm 03-30-21 chills and diaphoresis developed, then nausea and vomiting, elevated BP and blood sugars. Then low blood sugars in am. Transported by EMS ambulance to ER, given 700 RL IV, Fentanyl and Phenergan IV. In ER, Zofran, Phenergan IV, vomiting continued, admitted. Labs revealed elevated Calcium, Lactate, and Triponin. IV of RL continued, Phenergan, Zofran and Benadryl.  Vomiting continued, O2 off for 48 hours and becoming confused intermittently.  PT walking in hall, began retaining oral meds 03-31-21 and sips liquids, Lactate and Triponin decreased. O2 at 1 liter back on. No other cause found. Has lost weight and is weaker. Nausea and pain continued, but DC to home 04-01-21.
5-10 min S/P vaccine administration, noted by RN staff pt exhibited pruritic raised area on face b/L & upper chest. Provider informed. Administered Benadry 12.5mg/5mL 2.5 mL PO @ 1605 7/5/19
heartburn; This spontaneous case was reported by a patient and describes the occurrence of DYSPEPSIA (heartburn) in a 53-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu on 25-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu.    On 17-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 18-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced DYSPEPSIA (heartburn). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) at an unspecified dose and frequency. At the time of the report, DYSPEPSIA (heartburn) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events. Patient Took tums otc. There were no lab data/results available.
My Mom had an an allergic reaction four hours after receiving her first dose of the Pfizer Covid 19 vaccine. Her face swelled up and became red....worse on the right side than the left...her eyes were swollen as well. It lasted this way for four days....it is a little better now, but her face is still a little swollen (seven days after shot). She had a headache on and off and felt tired (which we understand is not an allergic reaction, but rather an immune response). Her family physician suggested taking antihistamines before her second shot. Needless to say, we are apprehensive about what the outcome from the second shot will be like for her.
COVID Positive Patient (s/p 2 Pfizer doses 5/5/21 & 7/2/21)  - admit 3/2/22 w/ covid & has been on a vent ever since; found to have LV thrombus (ddimer 8223)
On March 29, 2023, I went to the ER for pain in the lower right quadrant of my abdomen. I was diagnosed with Acute Diverticulitis. I was released the same night.
First dose / about 3 years ago and did not receive second dose due to other issues and then COVID happened; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about 3 year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The case was reported by the consumer. The patient  inquired about getting a second dose of Shingrix. He stated that received first dose of Shingrix about 3 years ago and did not receive second dose due to other issues and then COVID happened, which led to incomplete course of vaccination. The patient's doctor said to go ahead and get the second dose as soon as possible, but his pharmacist said he need to restart the series.  The patient wanted to clarify whether restarting the vaccine series was necessary.  The reporter gave a consent to follow up with HCP but did not have HCP's email address or a fax number.  The reporter did not have a personal fax number. No further information was reported.
Pain in the upper arm with limited mobility beginning within 24 hours. No visible swelling or redness.
Initial report reported by consumer on 18 November 2013. A 20 year old female, medical history and concomitant unknown, received dose of Flu vaccine (Lot#, vaccination site was unknown). Patient think vaccination was given intramuscular but she was not sure. It was reported that she experienced injection site pain and the pain travelled through her shoulder blade. Patient was recovered from the event on next day. Documents held by sender: none.
06/29/2004 - Pt received MMR vaccine. 07/09/2004 - Discomfort, fever. 07/10/2004 - Cough, Coryza, Conjunctivitis. 07/11/2004 - Generalized papular rash.  Tx - symptomatic tx.
Vaccine administered beyond use date after the thawprocess; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thawprocess) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thawprocess). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thawprocess) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The patient had no adverse reactions after the administration of vaccine. Medical facility was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process. Patient got Moderna with vaccine Ndc code 80777-0273-99.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
/24/23  I had low blood pressure, body aches, my bones ached, headache, chills, runny nose, but no fever.  I took an at home COVID test and it was positive. It felt like flu symptoms.  I called my doctor. She prescribed Paxlovid which I began taking it that day. It helped with the symptoms, but I ended up with a yeast infection.   The side effects of Paxlovid were a little rough.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with expired RECOMBIVAX HB (lot # 666601/1315Z; expired date: 09-OCT-2012) intramuscularly on 10-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No known adverse effects reported. Additional information has been requested.
Received the vaccine on day 15 after the first vaccine.    Experienced pain at injection site.  Fever, nausea, severe fatigue, headache and severe body aches.  Lasted approx 12 to 14 hours.
Extremely lathargic, cannot move without running out of breath. Has a very difficult time breathing and she is unable to do ANYTHING
Pt recv vax on 12/9/97; within 1/2 hr pt exp tight throat & breathing difficulties
Someone reported getting covid after being fully vaccinated; Someone  reported getting covid after being fully vaccinated; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection, Batch/ Lot number: Not reported), via an unspecified route of administration on an unspecified date as dose 2, single and dose 1 via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that, reported getting COVID after being fully vaccinated on an unspecified date. The patient experienced positive sars-cov-2 test. The patient underwent lab tests and procedures which included sars-cov-2 test: yes on an unspecified date.  (Since the vaccination, has the patient been tested for COVID-19 Yes). The outcome of the event reported as unknown.
Patient developed blood clot after vaccine booster shot; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: THROMBOSIS (medically significant), outcome "recovered", described as "Patient developed blood clot after vaccine booster shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported events 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
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 21-NOV-2018, the patient was vaccinated with improperly stored M-M-R II (lot # N024698, expiration date 08-SEP-2019) and VAQTA (lot # R013859, expiration date 14-JUN-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). The sterile diluent used to reconstitute M-M-R II was properly stored. No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Anosmia - Lost sense of smell within days of booster shot. Not sure of exact date but, I have no recollection of smelling anything in the month of September so, I lost my sense of smell within days of the 08/25/22 injection date. I had not head trauma, injuries, or infections  at the time of the injection or thereafter to account for the loss of smell that followed.
Immediately following immunization patient developed widespread hives with facial swelling (peak approx. 1 hour after vaccine). Resolved after dose of BENADRYL.
Left hip and joints is bothering me and my left leg is like sore; left hip and the joints, it really hurts; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration on 10Feb2021 (at the age of 80-year-old) as single dose in left arm for COVID-19 immunisation. The patient's medical history included insertion of cardiac pacemaker put into his body on the left side on 04Feb. Concomitant medications were his regular medication and blood pressure pills, which included losartan 50 mg one daily, atorvastatin 80 mg one daily, aspirin 81 mg, carvedilol 12.5 taken 2 daily. The patient took first dose of BNT162B2 (Lot Number: EK4176) on via an unspecified route of administration 20Jan2021) as single dose for COVID-19 immunisation. On an unspecified date, the patient's left hip and joints bothered and his left leg was like sore, left hip and the joints, it really hurts him. The patient enquired if its natural that happens or what's going on because it comes and goes but in his left hip and the joints really hurts.. The patient went for lab work at the hospital where he was two weeks ago, but result was unknown. Outcome of the event was unknown.
no other AE; temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about their concurrent conditions, concomitant therapies or medical history provided.  On 12-MAR-2021, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) dose/frequency: 1, lot # T027118, expiration date 07-FEB-2022, recombinant human albumin (rHA) (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was stored in a temperature of 13.5 Fahrenheit degrees (F) for 40 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No additional adverse event was reported.  Follow-up information has been received from the medical assistant and an office manager on 30-MAR-2021 and on 28-MAY-2021. The date of vaccination was additionally reported as between 04-MAR-2021 and 25-MAR-2021 by the medical assistant and details of the facility where the patient was vaccinated were provided. As of 28-MAY-2021, no further information was available as the office manager stated she was not familiar with the case and the medical assistant has no longer been working in the facility.  This is one of several reports from the same reporter.
After receiving shot patient was standing waiting for husband.   She had an immediate headache, felt dizzy, had lower back pain and pain in the right clavicle area.  Patient was seated in a chair.  EMS was called.  Symptoms started to improve slightly before EMS arrived.  EMS found patient had an elevated BP.  Symptoms improved and patient declined going to hospital with EMS.  Patient left shortly after EMS left the pharmacy.
12/29/06 Hep B vaccine given 4 days later the patient reports immediate Nausea and light headedness, presents now with C/O arm and neck pain. 01/09/07 seen by
Patient has been diagnosed with aplastic anemia with thrombocytopenia.  No genetic abnomalities or PNH on testing.  Unclear if this is related to the Janssen COVID immunization at this time.  No treatment started.  Will be monitoring over time for recovery.  PF4 Aby test pending
Two weeks and one day after receiving the Moderna COVID-19 vaccine, my hand curled up towards my shoulder and became unusable. Shortly after, it appeared that my muscles we deteriorating and I lost strength. I was tested for a stroke and nothing was found.
24 hrs post immun, pt devel high grade fever of 105 w/no relief from APAP; advised by local MD, pts mom provided constant bath, which lowers t102; had petit mal sz w/rolling of eyeballs & stiffening x 15 seconds;
Severe headaches still happening  Severe joint pain still happening  Chills still happening  3rd day and not going away
My adverse event started on 03/06/2023 in the early evening. I wasn't feeling well. No fever and I had no body aches. On 03/08/2023 I did a home COVID-19 test which was positive. I developed cough, sore throat, and body aches. On 03/09/2023 I called my doctors office and did a telehealth the same day.  The nurse  prescribed me with Paxlovid and  also advised me to take Tylenol.  I did home COVID-19 test again on 03/16/2023 which was negative.
Rash started on face, neck and hands then spread to her trunk and legs. This was present by 11am the day following the vaccine. Rash is not itchy. No other symptoms.
Vaccine was given to a Pt. that was under 4 yrs. of age.
Swelling at injection, no redness. No complaints of pain at present time. No temperature change at injection site, afebrile, ice pack applied 650 mg PO TYLENOL. Follow up call at 430 PM. States increased tenderness, and decreased swelling.