chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller is a consumer who received her second dose of Pfizer-Biontech Covid19 vaccine, yesterday and woke up with a high fever between 101.5 degree F-102 degree F; She is feeling pretty miserable; she was freezing; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9267; expiration date: unknown) via an unspecified route of administration in left arm on 24Feb2021 at 15:45 (at the age of 65-year-old) as single dose for COVID-19 immunization. Medical history of the patient included Hypothyroidism, Cholesterol, Palpitations. Concomitant medication included Rosuvastatin Calcium taken for cholesterol, Metoprolol Succinate taken for palpitations, levothyroxine sodium (SYNTHROID) taken for Hypothyroidism, Women's Multivitamin, Biotin, ergocalciferol (VITAMIN D), Omega 3 all started on an unspecified date. Prior Vaccinations (within 4 weeks) first dose of COVID19 Vaccine was none. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9263; expiration date: unknown) via an unspecified route of administration in left arm on 03Feb2021 (at the 65-year-old) as single dose for COVID-19 immunization. On 25Feb2021, at around 03:00 the patient woke up with a high fever between 101.5 degree F-102 degree F, she was feeling pretty miserable. She didn't take her temperature at that time, but she was freezing. Patient asked if she can take Tylenol. Outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.
One day after vaccine, patient observed a rash to upper torso lt upper extremities bilat. took a BENADRYL - self administered. Doing fine 2 days after vaccine.
Pt recvd vax 16FEB94 & devel sz p/vax; pt noted having shaking of extremities several times during the noc along w/high fever; noted 1st onset AM of 17FEB94;
The patient received the vaccine on 1/30/2018. She now has a rash about 2 inches x 21/2 inches around the injection site. The rash is tender to the touch. She will seek medical attention if it worsens.
first vaccine had been expired when it was given; Initial information received on 12-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA106093.  This case involves a 20 years old female patient who received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] and reported that first vaccine had been expired when it was given.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 01-Apr-2019, the patient received a dose of suspect 0.5 ml RABIES (HDC) VACCINE (lot number: N1B902M and expiry date: 18-Mar-2019) via unknown route in the right deltoid.  It was a case of actual medication error due to expired vaccine used.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Patient notified this nurse on 04/04/2022 that she experienced joint pain, light-headedness, feeling cold, insomnia, fatigue, and agitation for approximately 8-10 hours the evening that she received her Shingrix vaccine. She reported symptoms to her Primary Care Provider, as well.
The syringe leaked per patient. And he believed that he didn't receive the full dose. I reached out to the manufacturer and got an expert clinical advise and they said that CDC recommend to redo the vaccine per this incident/scenario. I called the patient and told him they are offering him the shot for free. He said he will come and get the dose.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. In July 2014 the patients were vaccianted with an improperly stored GARDASIL 120 Y (dose, route, lot number and expiration date not reported). No adverse effects reported. This is one of several reports received form the same reporter. Additional information has been requested.
Information has been received from a healthcare worker referring to an unspecified patients of unknown age and gender. On unspecified dates from 15-JUN-2015 through 13-AUG-2015, the patients were received improperly stored doses of PROQUAD (Merck), lot # L004005, expiration date 05-AUG-2016 (strength, dose and route were not reported). No adverse effects reported. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient did not complain of any adverse reactions. She had come in 5-12-23 requesting her 2nd dose. When rerifying her information, she should have not received the 1st dose. Patient is under 50 y.o. and states that she had no health conditions other than history of shingles.
The patient was given an expired vaccine well past the 30 days recommendation. No s/s of and adverse  event at this time
7 Days after getting my 1st dose, I had "COVID Arm"  Red, swollen and hot at the injection site. It was gone within 2 days. I didn't take any treatments.  I did have a similar reaction with a Tetanus Shot at the injection site years ago, but it went away. I thought it was just a normal reaction.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The unspecified patients were administered PEDVAXHIB (lot# L012837, expiration date 11-MAR-2018)(dose and frequency not reported), which were exposed to temperatures outside of the recommended range since 05-NOV-2015. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In 2008 (exact dates of each vaccination not reported), the patient received 3 doses of GARDASIL (route and site of administration, lot # and expiry date were not reported). On an unknown date, after receiving all 3 doses of GARDASIL, the patient experienced myasthenia gravis and premature ovarian failure. The outcome of the events was unknown. The relatedness between myasthenia gravis and premature ovarian failure and GARDASIL was not provided. Upon internal review, the event of myasthenia gravis was considered medically significant. Additional information has been requested.
This spontaneous report was received from a registered nurse regarding a 6 months old patient of unknown gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 15-FEB-2018, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # N013393 and expiration date: 11-DEC-2018), (strength and dose were not reported) orally for prophylaxis. It was reported that the vaccine was stored between 0 degrees Celsius to 1 degrees Celsius (0.4 C) for 30 minutes. Previous cold temperature excursion (09-FEB-2018) was from 0 degrees Celsius to 1 degrees Celsius (0.9 C) for 40 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the multiple reports received from the same reporter. Sender's Comments: US-009507513-1809USA008677: US-009507513-1809USA008678: US-009507513-1809USA008679: US-009507513-1803USA009994.
Numbness in left arm, hand, left side of face. Dizzy, light headed. At 12:23am: woke up achy, fever, ringing in ears. Achy flu like symptoms including severe stomach cramps the next day.
Mom states that she noted pt had started limping & walking w/stick in yard; started on 8APR92 & check pts leg noticed red splotch approx 1 in from area that shot was recvd; area hot, measures 6.8 cm red, sl raised & sl red & tender to touch
Patient informed the pharmacy 12/14/20 (over one year later then the time of vaccination) that he has been dealing with pain and limited movement in his left arm since he as received the vaccine in December 2019. He said he did physical therapy and received treatment from doctor and the condition improved as of 12/14/20 but not totally recovered.
Patient had a fall with Loss of Consciousness.  Head CT showed bilateral subarrachnoid hemorrhage.  Transferred to neuro critical care.  Repeat stability head scans showed worsening bleed.  Patient intubated on day 2 for airway protection. EEG negative for seizures. Elevated temps with no known source of infection yet.  Duplex upper and lower extremities (negative).  Patient unable to communicate, follow commands or move upper extremities or lower extremities purposefully.
The pt developed chills, loss of appetite, "did not feel like himself." Contacted office on 05/28/2002 at 8:40am and the pt stated that he's feeling better and eating well.
The day after the vaccination, the patient developed a rash on his neck and left shoulder. He also developed a rash on his left leg.
Severe leg cramping; So bad could not walk; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Apr2021 at 13:45 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received rosuvastatin calcium (CRESTOR) for unknown indication on an unknown date and experienced drug allergy. On 16Apr2021 at 17:00, the patient experienced severe leg cramping, so bad could not walk. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included unspecified medication for muscle spasms. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe leg cramping, so bad could not walk was resolved on an unknown date in Apr2021.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
I had a high fever 12 hours after the vaccine, that only lasted for a day arm ached a couple of days, very fatigued for a week after the vaccine.
06/09/2016 Mild rash to both upper extremities and required evaluation at local ER. Instructed to administer oral Benadryl with cold/warm compresses to sites. Received varicella to L arm and MMR to R arm.
urticaria 11 days after booster; persistent dermatographia since booster (for 2 months now)
lightheaded; tingling in her fingers; feverish but my temperature was ok; night sweats; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had COVID vaccine and experienced a couple of side effects two days after getting the vaccine which lasted 3 days. On an unspecified date, she was lightheaded and had this random tingling in her fingers. She also felt feverish but her temperature was ok but she was also feeling like she was having night sweats. She got a first dose of the vaccine at 2pm on Wednesday, then she woke up on Friday morning and felt, everything was like subtle, and did not feel like she had to stay at home. She could go to work, was just how she felt. Sometimes it felt like it was just in her head but then by 5 or 6 days later, that Monday or Tuesday morning she woke up and everything was gone and back to normal. Outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.
can't get rid of this deep cough; wheezing; can't taste; can't taste or smell anything; sinus cold; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (can't get rid of this deep cough), WHEEZING (wheezing), AGEUSIA (can't taste), ANOSMIA (can't taste or smell anything) and NASOPHARYNGITIS (sinus cold) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (can't get rid of this deep cough), WHEEZING (wheezing), AGEUSIA (can't taste), ANOSMIA (can't taste or smell anything) and NASOPHARYNGITIS (sinus cold). At the time of the report, COUGH (can't get rid of this deep cough), WHEEZING (wheezing), AGEUSIA (can't taste), ANOSMIA (can't taste or smell anything) and NASOPHARYNGITIS (sinus cold) outcome was unknown.            No concomitant medication information was reported.  Treatment medication was not provided.
didn't feel well; slight fever; possibly fatigue; This is a spontaneous report received from a contactable consumer (reporting for his wife). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient didn't feel well after the first dose. She had a slight fever and possibly fatigue. The outcome of the events was unknown.    Information on the lot number has been requested.
PATIENT DEVELOPED DIARRHEA THE FOLLOWING NIGHT AFTER RECEIVING FLU SHOT
Breakthrough case admission after three vaccines Janssen 3/12/21  Lot#1802068;  Janssen 12/17/21 Lot# 211D21A;  Moderna 8/18/22 Lot# 052B22A
About 14 hours after receiving shot, began to feel achy, light headed, chills and joint pain.  No fever detected.
pt recv vax 11SEP95 & 8FEB97 pt devel approx 30 pox over entire body;
Patient was given Pfizer vaccine and she started wheezing and shortness of breath about 10 minutes after she received the vaccine. She used inhaler, but still reported SOB, and palpitation. Immediately she was transferred to the ED accompanied with RN.
PATIENT CALLED ME TODAY , 9/4/2020 SAYING THAT HE WAS TIRED YESTERDAY AFTER HE WENT HOME AFTER GETTING THE FKU SHOT HOWEVER HE DID NOT HAVE FEVER  ALOS HE WAS SO EXHAUSTED , TODAY HE IS NORMAL NO SYMPTOMS AS YESTERDAY
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 51.3 F for 30,75 hours and in 59.4 F for 4,5 hours) doses of VAQTA (lot # M027879, expiration date 24-JAN-2018; dose and route of administration were not reported). No adverse effect and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Additional information has been requested.
redness and induration and cellulitis of the upper arm  treated with cephalexin for 7 days
This retrospective pregnancy case was reported by a consumer (mother of subject) and described the occurrence of stroke in a female foetus subject who was exposed to ENGERIX B (GlaxoSmithKline), FLUARIX during pregnancy. A physician or other health care professional has not verified this report. Parent medical history involved the mother considered to be a high risk pregnancy "as she has no thyroid." The subject's mother received the 3rd dose of hepatitis B vaccine recombinant; GlaxoSmithKline; unknown; unknown given "after the baby's delivery" in 2012. The subject's mother did not report if she was breast feeding the subject. On October 2011 at 13:00 and September 2011 at 13:00 the mother of unknown age received 2nd dose and 1st dose of ENGERIX B (transplacentary, unknown details). In September 2011 the subject's mother received unspecified dose of Influenza vaccine (transplacentary, unknown details). The subject was exposed to ENGERIX B and influenza vaccine unspecified "between 16 and 25 weeks gestation" during the 2nd trimester. The date of delivery was reported and weighed 3.8 kilograms. The method of delivery, gestational age at delivery were not reported. On 24 March 2012, 11 days after birth, the subject experienced seizures and was admitted to the hospital for 4 days. After discharge, the subject's mother noticed the subject was not using the left side of her body" (left or right sided weakness etiology unknown) and "held her hand tightly with the thumb inside her hand which she referred to as cortical thumb" (cortical thumbing). It was unclear as to the onset of the left or right sided weakness etiology unknown as the mother also reported that the subject "was not moving left side of her body" as "ongoing since birth". At 7 months of age, the subject was evaluated by neurology. The subject had 2 MRIs (nuclear magnetic resonance imaging). The mother was told that the subject "had a stroke in utero some time before 26 weeks gestation." The mother was also told that the subject "had brain damage as the right side of the baby's brain was half the size of the left side (congenital brain anomaly NOS)." The subject's mother considered this to be a congenital anomaly "as that is what the doctor said." The subject's mother reported that the subject was "now walking but walks with a limp and leads with the right side of her body and holds the left hand like a claw (claw hand)." At the time of reporting, the subject was receiving physical therapy. At the time of reporting, the subject had not had any seizures since discharge from the hospital and the subject did not take any medication. At the time of reporting the outcome of the events were unspecified.
Hospitalized with vomiting, fever, chest pain, fatigue, coughing x 1 week, dx COVID pneumonia.
Patient was given 0.3 ml undiluted covid-19 vaccine. Patient declined to wait 15 minutes for possible side effects.
40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) 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 EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored).    Concomitant and treatment medications were not provided. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021 and best used date was reported as 30-Jul-2021. The patient did not report any side effects. This case belongs to patient no 20 reported in source document.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master Case ID
Severe headaches; This is a spontaneous report from a contactable Nurse. A 38-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 38 years), dose 2 intramuscular, administered in Arm Left on 12Feb2021 16:00 PM as dose 2, single for COVID-19 immunisation administered in hospital. Medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 38 years), dose 1 intramuscular, administered in Arm Left on 22Jan2021 16:00 PM as dose 1, single for COVID-19 immunisation. The patient did not receive any other medications within 2 weeks of vaccination. The nurse reported, the patient experienced severe headaches on 16Feb2021. The reporter assessed the event as non-serious. Covid was not tested prior to or post vaccination. The outcome of event was not recovered.   No follow-up attempts are possible. No further information is expected.
30may90 pt vax 3rd hepta B. 02jun90 pt ex n/ and stiff neck. pt devel fever, gen body aches and vomiting. 04jun90 pt devel severe diarrhea. treated w/asa.
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Patient's medical history and concurrent conditions were not reported. On 15-MAY-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot number K010441 (dose and route were not reported) and a dose of improperly stored MMR II lot number reported as 002528 (dose and route were not reported). No adverse effects were reported. This is the one of the several reports from the same reporter source. Lot number 002528 is an invalid lot number for stored MMR II. Additional information has been requested.
20-25 minutes  after the receiving the vaccine patient started having lip tingling and tongue itching.  Then  approximately 5 minutes last she had itching around nasal area and cheekbone.