chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (lot# L014458, expiration date 11-FEB-2017, dose, dose# and route unknown). No adverse symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Patient was given Moderna vaccine booster given instead of Pfizer.  Patient did not experience any side effects or adverse reaction.
Flu vaccine adminstered but not needed; patient previously received seasonal flu vaccine 9/16/2023
Within 10 minutes, post vax, pt developed an irregular border 50mm to 60mm circular, pale redness noted around the injection site on right and left arms. Redness continued to intensify. At 16:50, they were 50 cent-sized. Bright red area to definite border, 10-15mm wheal at both injection sites. At 16:55, gave 4.5ml Benadryl po and at 17:10 the redness and wheal had decreased slightly. At 17:40, only slight redness remained on each arm, wheal had disappeared. Discussed danger signs, swelling of lips or face, difficulty breathing and instructed to call 911 if occured. Benadryl sent home with mom. Instructed to observe arms closely, give 1/2 to 1 tsp if needed in 4-6 hours.
Information has been received from a nurse concerning a 7 year (estimated, age unit was not provided) old patient with an allergy to unspecified medication who on 30-NOV-2001 was vaccinated with VARIVAX vaccine (Oka/Merck) (lot # 639780/0579L). In July 2008, the patient developed full blown chickenpox. Subsequently, the patient recovered. The patient was seen by a physician. Additional information has been requested.
Approximately 12 hours post vax pt developed burning sensation, itching on trunk  and upper extremities, heat to neck. Also developed swelling in face and itching and burning in ears. Complained of feeling numbness in head. Symptoms lasted approximately 1 hour. Pt developed shortness of breath for 15 minutes.
I had a heart attack. One stent was used on the date of the attack and another stent added in June of 2021.
Legs were yellow; sore throat; Lost my voice; Fever of 109F; could not raise body from floor becasue joints were hurting; could not raise her body from the floor because her joints were hurting; legs felt like jelly legs; This spontaneous case was reported by a consumer and describes the occurrence of HYPERPYREXIA (Fever of 109F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history given). Concomitant products included QUETIAPINE FUMARATE (SEROQUEL).   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced GAIT DISTURBANCE (could not raise body from floor becasue joints were hurting) and ARTHRALGIA (could not raise her body from the floor because her joints were hurting). On 14-Apr-2021, the patient experienced HYPERPYREXIA (Fever of 109F) (seriousness criterion medically significant), YELLOW SKIN (Legs were yellow), OROPHARYNGEAL PAIN (sore throat) and APHONIA (Lost my voice). On an unknown date, the patient experienced ASTHENIA (legs felt like jelly legs). At the time of the report, HYPERPYREXIA (Fever of 109F), GAIT DISTURBANCE (could not raise body from floor becasue joints were hurting), YELLOW SKIN (Legs were yellow), OROPHARYNGEAL PAIN (sore throat), APHONIA (Lost my voice) and ASTHENIA (legs felt like jelly legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Additional medications listed are: "blood pressure meds, cholesterol meds, antidepressants, anti-seizure meds".  Company Comment  This case concerns a 65-year-old female with a serious unexpected event of hyperpyrexia, and nonserious unexpected oropharyngeal pain, aphonia, asthenia, gait disturbance, yellow skin, and expected arthralgia. Event onset 3 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
A nurse reported that a 12 month old female inadvertently received a dose of Pnu-Imune 23 instead of Prevnar on 6/19/01 and subsequently developed an injection site reaction characterized by a "quarter sized" area of redness and tenderness. The injection site reaction resolved after a week. No further information was available at the date of this report. Information was received which identified that this child also received an injection of Hep-B (mfr unk) on 6/19/01.
1st vaccine (03/26/21): skin rash, poison ivy like reaction across back (but not arm) began spreading 3 days after getting the vaccine and took 3 weeks to heal. Have retraced my steps and don?t think there is anything other than the vaccine that skin came in contact with.  2nd vaccine (04/16/21): upper abdominal pain / stomach pain at night. Not super severe but have never felt anything like it before.
I started getting symptoms of a runny nose, cough and congestion. I took a COVID-19 test that was positive. I contacted my doctor. I was prescribed Paxlovid and an inhaler. My symptoms are getting better today. I had to stop taking my blood pressure medication due to taking Paxlovid.
pain in muscle; regular feelings of the flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "pain in muscle"; INFLUENZA (non-serious), outcome "unknown", described as "regular feelings of the flu".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
VACCINE EXPIRED PER SITE VISIT 8/12/22. SHIPPING LABEL HAS DATE OF 12/31/2069
Shortly after receiving the shot, the next day or so started getting a fever. Fever lasted a few months. Lost somewhere around 35 pounds. Had to be admitted to the ER and sent in for many more tests over the last year
A non-serious event of expired product administered was received from a nurse concerning a 14-year-old female. No medical or drug history was provided. FluMist was administered on 03-Jan-2008. The FluMist expired seven days earlier on 27-Dec-2007. Eighteen days post exposure to the expired FluMist, the patient had not experienced ill effects. No additional dosing is indicated. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. The reporter also reported another patient that was exposed to expired product, case MEDI-0006378.
reactions; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (reactions) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reactions). At the time of the report, VACCINATION COMPLICATION (reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. No treatment information were provided.
TINGLING AND NUMBNESS FROM LEFT ELBOW DOWN TO HALF OF LEFT HAND INCLUDING PINKY, RING FINGER AND PART OF MIDDLE FINGER.  THIS STARTED 5-10 MINUTES AFTER INJECTION; PAIN INCREASED OVER NEXT 24HRS AND THEN STABALIZED. PAIN INCREASES WHEN WORKING OR OTHERWISE USING HAND. 10 DAYS HAVE PASSED AND NO IMPROVEMENT BUT NO WORSENING AFTER INITIAL 24HRS. DOCTOR INDICATED IT MAY BE ULNAR NERVE RELATED.
No adverse effect; patient was administered a dose of improperly stored PROQUAD; This spontaneous report was received from a medical assistant refers to a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 22-AUG-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S003863, expiry date:08-AUG-2020, anatomical location and route was not reported) for prophylaxis (product storage error). The vaccine was exposed to a temperature range of -14 C to-10 C ( -14.4C) for a time frame of 18 minutes which was due to calibration for data-logger. There were no previous temperature excursions noted. No adverse effect reported. No PQC was filed.
Information has been received from a nurse practitioner through a pregnancy registry concerning a 29 year old female with asthma and a possible Tylenol allergy, who on 01-APR-2008 and 05-MAY-2008 was vaccinated with VARIVAX (Merck). Concomitant therapy included Advair and Mucinex. The patient is pregnant with LMP of 01-APR-2008 and an EED of 22-JAN-2009. No adverse effect reported. Pregnancy test fetal ultrasound was performed. There was no product quality complaint. Follow up information received on 27-FEB-2009 from an initial and a outcome pregnancy questionaries. The patient had a live born normal female on 23-JAN-2009, who weighed 7+6 LBS. There were no complications during pregnancy and during labor. It was also reported that there were no infections or illness during pregnancy and no concurrent medical conditions. During the pregnancy the patient's primary glucose was elevated. During the pregnancy the patient had a tertiary glucose tolerance test (GTT) within normal limits. Four ultrasounds test were performed to the patient, the first one on 24-JUN-2008, the second one on 31-JUL-2008, the third one on 02-SEP-2008 and the fourth one on 16-NOV-2008, all of them within normal limits. No further information is available.
On 01/27/21 at 8:30 pm started to feel chills that continued to intensify into the evening hours. Reports at 11:30pm felt feverish but unable to check temperature.  On 01/28/21 at 0445 began to experience sweats, fatigue, and nausea. Reports one episode of vomiting occurred around this time. Around 12:00pm on 01/18/21 symptoms of headache started and progressed into the evening. Took temperature at 7:30pm it was 99.9 degrees F.  On 01/29/21 symptoms were improving but reports still feeling very fatigued.
7AUG95 pt got AM vax later that PM mom states face became edematous, & pt was c/o itching on back first then all over; low grade temp; 8AUG95 pt went to pediatrician & dx of vax rxn made;
Fever, chills, headache, extreme joint pain. Lasted six hours until I took Tylenol.  I took Tylenol every six hours for 24 hours, was very tired with body and joint aches.
Significant maculo-papular diffuse rash eruption 12 days after vaccine administration.
next day lt arm became infected MD gave oral ATB next day infection had spread then given IV ATB for 2 days;have had many problems since;
Soft ball size lymph node in arm pit. Same side as injection/lymph node is still enlarged; Soft ball size lymph node in arm pit. Same side as injection. Very painful; vaccine received within 4 weeks PRIOR: Pfizer - Right arm/25Jul2021; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 40-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 25Jul2021 (at the age of 40-year-old) as dose 1, single; dose 2 via an unspecified route of administration, administered in arm right on 08Aug2021 at 12:00 PM (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient medical history was reported as none. Patient had no known allergies. The patient concomitant medication included omeprazole (received medication in two weeks) taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. On 08Aug2021 at 12:00 PM, the patient experienced vaccine received within 4 weeks prior: Pfizer - right arm/25Jul2021. On 08Aug2021 at 16:00 (04:00 PM), the patient experienced soft ball size lymph node in arm pit, same side as injection/lymph node is still enlarged; soft ball size lymph node in arm pit, same side as injection, very painful. Adverse event: Soft ball size lymph node in arm pit. Same side as injection. Very painful for about a week starting the night I received the vaccine. I'm currently on day 13 and the lymph node is still enlarged, but only to the size of a golf ball. The patient did not receive treatment for the events. Outcome of the events lymph nodes enlarged, lymph node pain was not recovered and outcome of remaining event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Left upper thigh with 2 cm area of inflammation with mild central induration.  No warmth to the touch and no drainage.  Rest of leg intact.  Mild tenderness to touch
Patient experienced stroke 17 days post Covid vaccine. She had also had lumbar decompression/fusion surgery earlier on the day of the stroke. She had a history of lower extremity DVT managed on Eliquis prior to admission.
Myalgia Narrative: after 1st dose :day 1 and 2- sore arm; day 3 sore arm and fatigue day 4 resolved
Developed lesions on (L) hand, wrist, (R) ear, neck, chest, hair 6/17/14. On 6/18/14 (L) ear developed lesions. Looks like chickenpox, itchy - not painful. Contacted PCP who ordered Acyclovir 800mg 5x day x 7 days.
mom stated pt was limp approx 24-30 hrs p/vax; mom also stated pt perked-up p/feeding, no color change noted by parent but extremities were col; mom did not notify MD because of improvement;
Feeling unwell, Dizzy, Blood pressure very high, I was prescribed a beta blocker by my doctor.
Patient came in to Public Health to receive her second dose of Moderna monovalent.  The patient was given a covid vaccine that had  expired on 03/12/2023.  Nurses contact a representative regarding the vaccine; someone will reach out to Public Health and advise us on what to do.
WITHIN AN HOUR MY TONGUE STARTING TINGLING AND THEN MY THROAT SLIGHTLY SWELLED UP. TOOK BENADRYL AND SYMPTOMS LESSENED. HOWEVER AS SOON AS MEDICINE WORE DOWN THE SWELLING RETURNED. ITS BEEN 16 HOURS SINCE VACCINATION AND STILL FEELING SWELLING.
Breakthrough case admission after 2 vaccines 9/25/22 Lot# EN6207;  Pfizer 4/5/21 Lot# Ew0150
Jan 20 2011 5 pm Call from hosp/med ctr. Mother accompanied infant to ER. Resp difficulty infant had cardiac arrest. Expired. Infant had been sleeping in parent bed with his father.
Pt telephoned 1/08/09 and stated that she had spoken with her friend who had a reaction to the Tetanus vaccine, and she wanted to report that she had a reaction as well. She had a Tdap on September 9, and developed knee pain in October. She did report a history of joint pain in her ankles 2 yrs previously. Is currently being treated with anti-inflammatory medication. Advised that this was unlikely to be a vaccine reaction, but that this would be reported at her request.
administered an expired pentacel with no reported adverse event; Initial information received on 23-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4-month-old male patient who was administered an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [PentaceL (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine live reassort oral 5V (Rotateq) and Vaxudence for Prophylactic vaccination.  On 16-Oct-2023, the patient received a dose 2 of 0.5 ml total dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength: unknown) (lot: UJ786AA, expiry date: 12-Oct-2023) via intramuscular route in the right thigh for Immunization and administered an expired pentacel with no reported adverse event (expired product administered) (latency: same day).      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 the 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.
pt recv vax 11OCT96 & pt exp large rash on stomach that looked like small chickenpox;
Pt states on 5/28/14 got a Td vaccine, late at night. Presents general arthralgia, nausea, fever, headache and 1 day after pain, redness, swelling of left arm.
p/vax pt exp T101 & redness to lt arm w/area of edema; tx w/methylprednisolone, cephalexin & benadryl
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on 27-SEP-2014 the patient was vaccinated with improperly stored PNEUMOVAX 23 (strength, route not reported). The reporter mentioned that temperature excursion involved was found to be unsupported excursion with in-house stability data. No adverse symptoms reported. The outcome of administered improperly stored PNEUMOVAX and no adverse symptoms reported is unknown. No product quality complaint was involved. This case is linked to the case 1409USA015044 via same reporter link. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received SHINGRIX for prophylaxis. In October 2018, the patient received SHINGRIX. In October 2018, 1 day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The case was reported by patient's husband. The patient received vaccine on left arm. The patient experienced sore arm for a couple of days. The reporter consented to follow up. The caller also experienced a bad reaction that put her down for a few days and called the Risk Compliance to report in detail. The case has been linked with case US2018167868 reported by the same reporter.
Red, warm swollen site of injection. Advised ice, antihistamine, TYLENOL/ADVIL.
Client received Covid19 vaccine, Janssen at pop up clinic. Client reported he had not yet received any Covid19 vaccines. Dose was administered and when data entry occurrred later that day, staff realized that client had previously received both J&J and Pfizer. Client notified. No adverse reaction.
face was covered with hives; body now has hives all over; Head started to itch; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: Er8730), via unspecified route of administration in the left arm on 27Mar2021 at 08:15 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy from unknown date. Patient received magnesium (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), both for unspecified indication from unknown dates within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 12:15, 4 hours after the vaccination, the patient experienced head start to itch and within next 15 minutes, patients face was covered with hives and in next hour had hives all over body. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures taken as a result of hives and itching that included treatment with Benadryl. The clinical outcome of the event of hives and itching was resolving, at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Swelling at injection site; inflammation around injection site; This is a spontaneous report from a contactable physician, the patient. This 29 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose  1 , single dose via intramuscular route of administration in the left arm on 23Dec2020 at 02:15 PM (at the age of 29 years-old) for COVID-19 vaccination. It was unknown if the patient was pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  There was no relevant medical history reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown) dose 2, single dose via  intramuscular route of administration in the left arm on 08Jan2021 at 11:00 AM and experienced headache, nausea, pain at the injection site, fever/chills, bodyache, fatigue, tingling/numbness at injection site, shoulder stiffness, altered taste and inappropriate schedule of vaccine. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On an unknown date, the patient experienced swelling at injection site and inflammation around injection site. The events were reported as non-serious. The patient was not treated for swelling at injection site and inflammation around injection site. The clinical outcome of swelling at injection site and inflammation around injection site was unknown.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Information of lot/batch number has been requested.
Within 5 minutes of receiving the shot, he got very pale, and very dizzy, and collapsed. His heart rate dropped, I kept yelling to him to keep him alert and not to pass out. His eyes kept rolling, this was horrific to see my son like this. This eppisode lasted 15 minutes!!!!!We were at the doctors when this occured. After 1/2 he was able to sit up, though he was very weak. Please let us know if there were others that had this problem witht his batch?