chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 hours after the injection he developed pain in his left upper extremity which was not injected. The following morning he awoke with numbness and tingling in the right ring and small fingers as well; The following morning he awoke with numbness and tingling in the right ring and small fingers/numbness and tingling radiating up to the hypothenar area and to the forearm; The following morning he awoke with numbness and tingling in the right ring and small fingers/numbness and tingling radiating up to the hypothenar area and to the forearm; extreme pain in right hand; Medial and antecubital elbow pain too.; This is a spontaneous report from a contactable physician.  A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: ER8735), via intramuscular route, administered in Right arm on 28Apr2021 at 19:00 as dose 1, single (at the age of 77-years-old), for covid-19 immunization. Medical history was not reported. It was unknown if the patient had known allergies or not. The patient was taking unspecified prescribed concomitant medications (Other medications in two weeks: prescription medications). It was unknown if patient was administered with other vaccine in four weeks. It was stated that, on an unspecified date in 2021, 02 hours after the injection, the patient developed pain in his left upper extremity which was not injected. The following morning, unknown date in 2021, he woke with numbness and tingling in the right ring and small fingers as well as extreme pain in right hand and medial and antecubital elbow pain too. It was described that ring and small numbness and tingling radiating up to the hypothenar area and to the forearm. The events were reported as serious with seriousness criteria as hospitalization (from unknown date in 2021 to unknown date in 2021). No. of days for hospitalization were 5. Adverse events also resulted in: doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not have covid prior vaccination and had not tested for covid post vaccination. No treatment was received for the events. The outcome for all the events was reported as not recovered, at the time of report.  No FU attempts possible. No further information expected.; Sender's Comments: Based on the available information in the case, the causal association between the events pain in extremity, hypoesthesia, paresthesia, arthralgia  and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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.
Extreme body temperature fluctuating; severe dizziness; passed out for 5 seconds (as a result fell to the  floor and caused severe bruising - possible concussion sustained)
mom reported in AM of 5NOV pt had temp of 103 @ 9PM not c/o anything specific;acting well by next AM;temp of 103.2 3AM the next noc;6NOV c/o sore throat;was on amoxil prior to vax;prolonged URI sx;
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 08-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# R006216 and expiration date 28-AUG-2019) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
patient presented with a large rash. it extended down interior and exterior portions of right arm. It occured on the day of the vaccine. Patients rash also extended from the injection site about 8 to 9 inches down bilaterally.
PATIENT RECEIVED THE FLUZONE VACCINE IN UPPER LEFT DELTOID AND PFIZER BOOSTER (THIRD DOSE) IN LOWER LEFT DELTOID. PATIENT DID NOT INDICATE ANY REACTIONS WITH FIRST TWO DOSES OF PFIZER OR ANY FAINTING FROM PREVIOUS VACCINES. I TOLD PATIENT TO WAIT IN SEATED AREA IN FRONT OF PHARMACY FOR 15 MINUTES, SAME AS PREVIOUS DOSES. I CONTINUED WITH MY VACCINE APPOINTMENTS AND SHORTLY AFTER GIVING THE PATIENT HIS VACCINES, A CUSTOMER CAME TO THE PHARMACY TO ASK FOR HELP, A WOMAN CUSTOMER WAS SHOUTING FOR HELP IN THE STORE PARKING LOT. I IMMEDIATELY CALLED FOR STORE MANAGEMENT TO ASSIST THE CUSTOMER (I WAS UNAWARE AT THE TIME THAT THIS PATIENT WAS THE ONE NEEDING HELP AS THE CUSTOMER SAID IT WAS A WOMAN CUSTOMER SHOUTING FOR HELP). AFTER MANAGEMENT WENT OUT TO THE PARKING LOT TO ASSIST THE CUSTOMER, MANAGEMENT INFORMED ME THAT IT WAS MY PATIENT. PATIENT HAD PASSED OUT IN THE PARKING LOT. PATIENT TOLD MANAGEMENT THAT THEY GET NERVOUS WITH NEEDLES AND JUST RECEIVED THE VACCINES. PATIENT DID NOT WANT ANY MEDICAL ASSISTANCE AND DID NOT WANT US TO CALL 911. PATIENT WAS INFORMED TO WAIT AND I WOULD COME OUT TO ASSIST PATIENT BACK INSIDE THE STORE TO ASSURE HE DID NOT NEED FURTHER MEDICAL ASSISTANCE. PATIENT DID NOT WANT TO WAIT AND DROVE AWAY AS MANAGEMENT WAS COMING INTO THE PHARMACY TO GET ME.  I CALLED PATIENT TO FOLLOW UP WITH THEM TO ASSURE THEY WERE OKAY AND PATIENT THEN TOLD ME THEY SOMETIMES GET NERVOUS WITH NEEDLES AND AS HE WAS SITTING IN HIS CAR IN THE PARKING LOT, HE PASSED OUT AND HIS SON RAN TO GET A CUSTOMER TO ASK FOR HELP. PATIENT TOLD ME THIS REACTION DOES SOMETIMES HAPPEN BUT NOT ALL THE TIME. PATIENT WAS THEN INFORMED AGAIN TO WAIT IN THE SEATED WAITING AREA IN FRONT OF THE PHARMACY FOR 15 MINUTES NEXT TIME TO ASSURE HE IS OKAY.
This spontaneous report was received from a Registered Nurse reporting on herself. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. Nurse reported she cut an unspecified finger (limb injury) on an unspecified hand while reporting a Product Quality Complaint on a broken Luer lock on a PNEUMOVAX 23 syringe (syringe issue). Nurse did not want to report the incident stating she was reporting it as a paper cut. At the time of the report, the outcome of syringe issue and limb injury was unknown. The reporter did not mention the causality assessment between events and PNEUMOVAX 23.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. In July 2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number, expiration date, dose and route of administration were not reported). Concomitant therapies included a dose of tetanus toxoid vaccine (manufacturer unknown) administered the same day. On an unknown date in 2015, reported as "an unspecified time after being administered both vaccines", the patient experienced hives. The outcome of urticaria and the relatedness between the hives and the PNEUMOVAX 23 were unknown. Additional information has been requested.
Shortly after vaccination on 9/9/03, mother noticed facial grimacing and blank look on face periodically. Next appointment 11/3/03, patient noted to have frequent tics and seizures and mild developmental delay. Referred to neurology. EEG confirmed seizure. Has had extensive work up since then. Medical Record received on 12/29/2004 states pt experienced epilepsy and ataxia. Follow up 03/03/05: Patient has not recovered from adverse event(s), he still has presistnet seizure disorder. Follow up: persistent seizures, speech and motor develomemtal delay.
Pfizer Covid vaccine - Covid; Pfizer Covid vaccine - Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 65-year-old male patient received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Insulin dependent diabetic" (unspecified if ongoing), notes: Insulin dependent diabetic. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer Covid vaccine - Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: this patient and patient from report 1 tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Covid vaccine for all 4 doses. States her first dose was 30Jan2021 and she believes her 2nd dose was 20Feb2021, she thought they did it 3 weeks after the 1st dose. States the 1st booster was Sep2021, she thought the 12th or something, and her 2nd booster was Apr2022. States she got all doses in her left arm. Caller states her husband was a 65 year old diabetic and he said he felt like he was 31, he felt that good and he thought there was a steroid in it.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A few days after injections, noticed when I lift my arm, lift items or stretch, now get a pinched/pulling sensation in the palm of my left hand.
SOB Narrative: Pt reported itching and SOB at 1247. BP 134/88 HR 71 SAT 99% RA. RRT called at 1253, cetirizine 10mg PO AT 1253, epi-pen administered at1253, diphenhydramine 50mg IM at 1257. Pt was then transported to ED. While in ED, given nebs and 125mg solumedrol. Intermittent chest tightness, given albuterol inhaler with good response. Patient was discharged with prednisone 40mg x5 days, cetirizine 10mg x5 days, famotidine 20mg x5 days, albuterol inhaler upon resolution of wheezing.
Given a Heplisav-B Vaccine Yesterday While It was Out of Temperature Range; Initial Report Received on 27-May-2022  A registered nurse reported that a 27-year-old male patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was out of temperature range.  No medical history at the time of vaccination was reported.   Concomitant medications at the time of vaccination were reported as unknown.  On 26-May-2022, the patient received a dose of HEPLISAV-B that was out of temperature range between 0°C and 1°C (Lot # 935843, expiration date 08-Oct-2022, NDC # and route unknown) in the right deltoid. The patient did not experience any adverse reactions.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
w/in 5min post vax inc 120 pulse;heaviness in chest radiating down arm;220/106;rx 02;sx decrease in 20min;chest tightness;numbness around lips, very exhausted;
extremely dizzy; Can't get up and walk/ can barely walk; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extremely dizzy), GAIT DISTURBANCE (Can't get up and walk/ can barely walk) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (extremely dizzy), GAIT DISTURBANCE (Can't get up and walk/ can barely walk) and NAUSEA (Nausea). At the time of the report, DIZZINESS (extremely dizzy), GAIT DISTURBANCE (Can't get up and walk/ can barely walk) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
This case was reported by a nurse and described the occurrence of fever in a female infant who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hep B recombinant, and inactivated poliovirus vaccine combined (Pediarix). The nurse stated that many pt's experienced a fever following the receipt of Pediarix, however, only one identifiable pt was reported. On an unspecified date in 2004, the pt received the first dose of Pediarix. At an unspecified time following the first admin of Pediarix, on the same day, the pt experienced a fever. The fever resolved 24 hrs later. On an unspecified date in 2004, the pt received the second dose of Pediarix. At an unspecified time following the second dose administration of Pediarix, on the same day, the pt experienced a fever and screaming. The screaming resolved several hours later and the fever resolved 72 hrs later.
Sinking feeling, hollowness in chest, lightheadedness. No dyspnea, rash, itching, or swelling. Vitals stable (BP 126/89, HR 84, pulse ox 98-100%) Patient reports that she has had very similar symptoms after methlparaben, although those were more severe. She does not feel that she needs additional medical attention, declined ED visit.
Had to go to ER, Benadryl did not help much had to take an Epinephrine injection which resolved the problem. Similar reaction last year after taking a flu, pneumonia and using an albuterol inhaler.
Fever, headache, cough, runny nose, fatigue, nausea. I've noticed since there's been some affect of my sense of smell. I went to the ER because I started throwing up and couldn't stop until I got IV medication. I lost my voice and experienced achiness. I took PAXLOVID after going to the ER. I'm still somewhat fatigued and my voice and smell isn't 100 percent back yet. I have a lingering cough.
Delayed menstruation by 10 days, followed by menstruation lasting 9 days.  Period bleeding was very very heavy with large clots.  heavy flow lasting multiple days.   heavier flow than ever.  late cycle not normal.
Two days after receiving DTaP and IPV in Lt. arm child was noted to have redness, swelling and firmness in Lt. upper arm. Also in the middle of the redness was an area of brownish discoloration.The 3rd day after the imms there were blisters or vesicles noted in the area where the brownish discoloration had been. Augmentin 400 mg bid was prescribed. Child had no problems using his arm at all.
APPROXIMATELY EIGHT HOURS AFTER RECEIVING SHOTS, MOM STATES INFANT HAD UNCONSOLABLE CRYING, FEVER (MOM UNSURE OF EXACT TEMP), AND RASH ON GROIN AREA, ARMS, AND HANDS. RASH LASTED APPROX. ONE DAY, BUT CRYING AND FEVER LASTED FOUR DAYS. TAKEN TO ER ON DAY THREE AND THEN FOLLOWED UP WITH PCP NEXT DAY.
sore left arm, neck pain, headache, pain on surface of breasts, chills, sweats
Additional information received from healthcare professional indicated no receipt of vaccines within four weeks of Prevnar and the pt recovery status. Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a physician regarding a 9 month old male pt who experienced fever and acute transient ataxia. At 9 months of age, the pt received the third dose on 24Aug04. The reporter indicated that the pt does not have any relevant medical history. The child is a well baby, no birth defects. Indication for Prevnar was immunization. Product was administered on 24Aug04. Dose regimen was 1 dose. Concomitant therapy included Children's Motrin (ibuprofen). Concomitant vaccines were not administered. On 24Aug04, a 9 month old male pt developed a fever and acute transient ataxia. Several hours post immunization, the child's parents informed the physician that the child developed a fever and acute transient ataxia. The physician stated that the child's fever continued until the next morning. She indicated that she did not prescribed any medications for the ataxia or fever since the child's parents premedicated him with Children's Motrin prior to the third dose of Prevnar, as they had done with previous Prevnar vaccinations. The pt recovered.
The patient documented the incorrect DOB Their actual DOB is listed. The patient was 17 years old at the time of inoculation.
Nurse stated that the patient involved has not reported adverse reaction related to the improperly stored and administered vaccine.; Nurse calling to report adverse event for improperly stored and administered VARIVAX.  Nurse reporting temperature excursion in which VARIVAX was left at room temperature for 24 hours on 8/10/2023 and vaccine was administered on 8/11/2023.  Nurse sta; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 11-AUG-2023, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliter (ml) of a two-dose series (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number U025204, expiration date reported and validated as 13-AUG-2023) as prophylaxis (product storage error). The nurse stated that the patient involved had not reported adverse reaction related to the improperly stored and administered vaccine.  The vaccine was left at room temperature for 24 hours on 10-AUG-2023.
This spontaneous report was received from a doctor of pharmacy via company representative refers to unknown number of patients of under 50 years of age and unknown gender. On an unknown date the patients were vaccinated with a dose of ZOSTAVAX (lot #, expiration date and route not reported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
more likely a viral infection; discomfort in left eye; in bed for around four to ten days; fever of 103.8; body aches all over but more on left side of body; severe headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VIRAL INFECTION (more likely a viral infection), OCULAR DISCOMFORT (discomfort in left eye), BEDRIDDEN (in bed for around four to ten days), PYREXIA (fever of 103.8) and MYALGIA (body aches all over but more on left side of body) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VIRAL INFECTION (more likely a viral infection), OCULAR DISCOMFORT (discomfort in left eye), BEDRIDDEN (in bed for around four to ten days), PYREXIA (fever of 103.8), MYALGIA (body aches all over but more on left side of body) and HEADACHE (severe headache). The patient was treated with Bed rest for Ocular discomfort; Bed rest for Bedridden; Bed rest for Pyrexia; Bed rest for Myalgia and Bed rest for Headache. On 03-Apr-2021, PYREXIA (fever of 103.8) had resolved. On 10-Apr-2021, BEDRIDDEN (in bed for around four to ten days) had resolved. On 22-Apr-2021, OCULAR DISCOMFORT (discomfort in left eye), MYALGIA (body aches all over but more on left side of body) and HEADACHE (severe headache) had resolved. At the time of the report, VIRAL INFECTION (more likely a viral infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: (High) Developed a fever of 103.8 Fahrenheit and recovered on 03-APR-2021.. On 30-Mar-2021, Influenza virus test: (Negative) In the Emergency Room they tested her for influenza and tested negative. They gave her intravenous fluids and released her home after a few hours.. On 30-Mar-2021, SARS-CoV-2 test: (Negative) In the Emergency Room they tested her for Covid-19 and tested negative. They gave her intravenous fluids and released her home after a few hours..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  Treatment details included Tylenol Advil Intravenous Fluids at the Emergency Room  Doctors believed that patient has more likely a viral infection (non-respiratory) than a delayed response to the vaccine for which he tested negative.  Patient was concerned for her second dose scheduled on 13-MAY-2021 as it has been 50 days since her first dose.  Patient went to ER on 30-MAR-2021 and was discharged the same day.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: This follow-up was received on 12-MAY-2021 which updated events, event onset date, event stop date, dose 1 details, lab test, treatment details and patient demographics.
Pt vasovagaled s/p received her covid vaccination. Hx of similar in the past
Client received Janssen vaccine on 08/06/2021. Citywide immunization record shows that the client received Dose 1 Pfizer on 03/22/2021 and Dose 2 Pfizer on 04/12/2021.  Client denied receiving Pfizer doses, stating that he was not in the country. Client was observed for 15 minutes and denies any discomfort. Client left observation in stable condition.
9 by 10 centimeter area erythema, warm, no induration medial to injection Dtap/Hib
mom reports 18MAR96 red face;19MAR96 face cont red & swollen & a rash body wide;these s/sx cont 21MAR96;MD felt was an allerg rxn not caused by the vax
The evening of the day he received both vaccines, he had a near syncopal episode that self resolved gradually. The next morning (12 June 2019), he woke up shivering and feeling very cold but no fever. He also complained of generalized joint pain and a headache.
PT HAD PAIN STARTING THE EVENING OF INJECTION. HER ARM PIT SWELLED UP AND SHARP PAIN ON SHOULDER, ARM PIT AND RADIATING TO HAND.