chrisvoncsefalvay/vaers-outcomes huggingface dataset:
His wife tested positive; His wife tested positive; This is a spontaneous report from a Pfizer-sponsored program with Regulatory Authority Support. A contactable consumer reported for a 71-year-old female patient (wife) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9262, Expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 04Feb2021 (at the age of 70 years old) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6200, Expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 25Feb2021 as dose 2, single COVID-19 immunization. Medical history included urinary tract infection and had treatment for UTI. Caller's wife stated that she had treatment with a Z-Pak. She was prescribed, an antibiotic, and she had treatment for UTI, so that was a different type of antibiotic. She says that the packages for those antibiotics were discarded when they were done with them, she doesn't remember the dosages and doesn't have NDC/LOT/EXP to provide for his Z-pak or her unspecified antibiotic. Caller's wife's outcome of having COVID queried, but not provided. The patient's concomitant therapy was not reported. The reporter stated that his wife did get both doses of the Pfizer COVID-19 vaccine, and she also popped positive for a COVID test on 26Aug2021. He says the good thing was that they were in a group at a family reunion of 25 so maybe 30 people get together for a week in Aug, and of course all of them were vaccinated so they thought they were safe, then he found out he wasn't, so they immediately left the group and nobody else had positive tests, just him and his wife. She says that they had pretty sloppy handwriting, and no NDC/EXP were provided on the handwritten vaccine card. She says she tested positive for COVID on 26Aug2021, then clarifies her first positive was 29Aug2021, using the home test Ellume, which they are having problems with that test it has been on the news. She says she tested negative on 27Aug2021, so she doesn't know. The reporter assessed as non-serious. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 27Aug2021 More information available: No, sars-cov-2 test: positive on 29Aug2021. The outcome of the events was unknown. Follow up attempts are completed. No further information was expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202101332905 same reporter/drug/event, different patients.
Narrative: COVID infection following COVID vaccine series 05/07 COVID vaccine dose #1 05/26 COVID vaccine dose #2 10/18 c/o COUGH, HEADACHE, SORE THROAT, daughter tested positive for COVID 10/19 c/o 1 day of productive clear mucousy cough, Fatigue, Headache, Loss of taste or smell, Myalgias, SOB, sore throat 10/20 c/o Chills, Cough, Fatigue, Headache, Muscle pain Myalgias, Rhinorrhea, Shortness of Breath, admitted thru ED to hospital, given dexamethasone 10/21 Tx w/ O2 NC, REMDESIVIR INJ, dexamethasone 6mg po qday, albuterol/ipratropium nebs q4h prn 10/23 Discharged from hospital with home O2 10/24 remains asymptomatic.
Patient received a Janssen shot after already receiving a Janssen shot about 6 months earlier.
2ml of normal saline was used to reconsitute the vaccine instead of 1.8ml. No adverse effects reported.
Patient was given flu shot. He was talking fine as his mom and sister received theirs. Then he stated he felt dizzy and then fainted. His blood was taken and given water and woke up right away after falling to ground. He was able to speak to mom asking for watering but stayed lying down for about 10 minutes until color came back to his face and BP went up. He was able to leave clinic on his own and speak.
Pt presents to EMS after feeling dizzy and nauseous after receiving second dose of Moderna. Pt is pale and diaphoretic, she was put in wheelchair and wheeled into hallway for further assessment.  PMHx of stomach ulcer and anxiety Allergy to vaccine binder Vitals assessed BP-138/75 SPO2-99% HR-91 RR-14 Airway is patent, respirations are normal and non-labored, pt denies chest pain or shortness of breath PT states she usually feels like this after donating blood. She also states she did not have anything to eat today. She was given a box of apple juice. After 5 minutes vitals were reassessed.  BP-138/70 SPO2-100% HR-90 RR-14 Skin color has improved, pt states she is feeling much better now, diaphoresis, dizziness and nausea has subsided. Pt stood up without complications. Her observation time was up so she was taken to the exit.
severe vomiting; low grade fever; was unable to eat or drink anything; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2022 13:30 (Batch/Lot number: unknown) at the age of 5 years as dose 2 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown.), administration date: 07Jan2022, when the patient was 5 years old, for Covid-19 immunization. The following information was reported: VOMITING (medically significant) with onset 29Jan2022 10:30, outcome "recovering", described as "severe vomiting"; PYREXIA (non-serious) with onset 29Jan2022 10:30, outcome "recovering", described as "low grade fever"; DYSPHAGIA (non-serious) with onset 29Jan2022 10:30, outcome "recovering", described as "was unable to eat or drink anything". Therapeutic measures were not taken as a result of vomiting, pyrexia, dysphagia. Patient did not have COVID prior vaccination and didn't test COVID post vaccination. No known allergies were reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.
ACCORDING TO PTE EXPRESS PATIENT PRESENTD "FEVER, DECREASE OF APPETITE, DIARRHEA, VOMITING, PAIN IN THE CHEST AND LUNGS, WEAKNESS COUGH, LOSS OF SECRETIONS DUE TO EXISTING TRACHEA."
Patient slouched and slowly rolled from a sitting position in the chair to the floor.  (Vasovagal syncope)  She laid on her stomach for a few seconds before starting to speak and a minute or two before getting back in the chair.  After sitting for about 20 or 30 minutes with her mother and myself, she was able to walk.  She did have an emotionally response after coming to.
I had covid in January 2021 with long-term symptoms that did not resolve until May 2021.  These symptoms have begun again since receiving the first shot and have lasted for the past three plus weeks.  Studies need to be done on the potential resurgence of long-term covid symptoms after vaccination.
Sore arm at the injection; Body aches (widespread); Low-grade fever (100.3); Headache; This is a spontaneous report from a contactable consumer or other non Health care professional (Patient). A 39-year-old non pregnant old female patient received bnt162b2 (BNT162B2 Formulation; solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 21Apr2021 at 14:00 as DOSE NUMBER UNKNOWN, SINGLE (at the age of 39-year-old) for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered. The patient was not pregnant at the time of vaccination. Medical history included prolonged complex migraine, fibromyalgia, generalized anxiety and Allergies to medications, food, or other products (Allergies to medications, food, or other products: Doxycycline, Celebrex)-all from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications (other medications the patient received within 2 weeks of vaccination) included sertraline hcl, bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE), nortriptyline and nabumetone; all taken for an unspecified indication, start and stop date were not reported. The patient previously took celebrex and doxycycline and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Apr2021 at 20:00, the patient experienced sore arm at the injection site, body aches (widespread), low-grade fever (100.3) and headache. All side effects gone 30 hrs post vaccination. Since the vaccination, the patient had not tested for covid-19. No treatment received for the events. The outcome of event reported as recovered on unknown date of Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
BECAME DISORIENTED, DIDNT RECOGNIZE STREETS IN HER NEIGHBORHOOD, HALLUCINATIONS (SHE SAW OLD FRIENDS IN THE LIVING ROOM WHO WERE TALKING).  SHE DID NOT KNOW HER OWN HOUSE, WONDERED WHERE SHE WAS.  ABOUT 6 HOURS AFTER THE VACCINE SHE STARTED TO BECOME MORE LUCID, REALIZED THAT SHE WAS NOT ACTING NORMALLY.  ALL SYMPTOMS RESOLVED AND SHE WAS BACK TO NORMAL 3 DAYS LATER.
On June 4th and later, on June 27th 2021 (5 monthes after vaccine) I got severe syncope symptoms without no advanced reasons or warnings. On the 27th, I lost conscious for few minutes whilst sitting in a cafe outside early evening, which followed with non stop vomitings when I woke. I was taken by ambulance to emergency room at  Medical Center, and was released after full scale check ups. The following day, for a whole week I had a severe diarrhea, weakness and more vomiting. Still felt quite weak for more than a month. Still feel far more tired than I used to be.
Teammate was given a Booster dose of the Monovalent vaccine as his booster dose when the Bivalent Booster should have been administered.
RED,SWOLLEN LEFT DELTOID REGION, WARM AND SLIGHTLY TENDER.  EXTENDS TO AXILLA, CANNOT RULE OUT SECONDARY CELLULITIS. PT GIVEN BENADRYL AND TREATED WITH KEFLEX.
Muscle pain; fever (up to 102 F); Pain and swelling in left axillary lymph node; Pain and swelling in left axillary lymph node; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6199 and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 30Mar2021 at 13:45 (at the age of 46-year-old) as DOSE 2, SINGLE for covid-19 immunization.  Medical history included hypothyroidism, hay fever, migraine and penicillin allergy. The patient's concomitant medications included unspecified medication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3248 and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 09Mar2021 at 13:45 (at the age of 46-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The patient received other medications (unspecified) within 2 weeks of vaccination.  The Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  The patient experienced Muscle pain, Pain and swelling in left axillary lymph node, fever (up to 102 F) on 30Mar2021 at 18:00. No treatment was received for the events. The outcome of the events was recovering at time of report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a health professional concerning a white patient with a history of Eczema who on 07/11/2002 was vaccinated with a first dose of varicella virus vaccine live, in the left thigh.  Concomitant therapy on 07/11/2002 included a first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, in the right thigh.  On 05/13/2004 the patient developed symptoms.  On 05/20/2004 the patient presented to the doctor's office with scattered papules, one vesicle on back, check and neck present at one week.  The patient was diagnosed with varicella.  Subsequently, the patient recovered from varicella.  No further information is expected.
Headaches; feeling little more tired; rashes all over body(elbows, hands,feet and a little bit onchest)/ rashes turned from red to purple; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (rashes all over body(elbows, hands,feet and a little bit onchest)/ rashes turned from red to purple), HEADACHE (Headaches) and FATIGUE (feeling little more tired) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced RASH ERYTHEMATOUS (rashes all over body(elbows, hands,feet and a little bit onchest)/ rashes turned from red to purple). On an unknown date, the patient experienced HEADACHE (Headaches) and FATIGUE (feeling little more tired). At the time of the report, RASH ERYTHEMATOUS (rashes all over body(elbows, hands,feet and a little bit onchest)/ rashes turned from red to purple) had resolved and HEADACHE (Headaches) and FATIGUE (feeling little more tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Breakthrough case admission after 3 vaccines Moderna 3/8/21 lot# 037K20A;  Moderna 4/9/21 lot# 027L20A ; Moderna 12/2/21 lot# 034F21A
Pfizer COVID-19 vaccine EUA on 05/05/2021 and tested positive via nasal swab PCR on 05/29/2021.
This non-serious spontaneous case, initially received on 27-Mar-2018, was reported by other healthcare professional (nurse) and concerns a 07-year-old, male child. On an unspecified date, refrigerator was out of range for about 45 minutes and reached a maximum temperature of 48.6F. On an unspecified date, vaccine also underwent second temperature excursion (explicitly coded as incorrect product storage). On 22-Mary-2018, the patient was administered with FLUCELVAX QIV (does: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195235, expiry date: 31-May-2018), which underwent temperature excursions twice (explicitly coded as drug administration error). No adverse effects were noted after the vaccination. This report was linked to case 201801297. Non-significant case correction received with IRD 27-Mar-2018: Repetition of narrative was corrected. Follow up report received on 24-Apr-2018: The dose (0.5ml), route of administration (intramuscular), anatomical location (deltoid) of suspect vaccine was added. The narrative was amended accordingly.
On 7/27/01 pt noted to have a temperature of 101.9F which lasted for 48 hours. Pt was cranky and developed a knot on the thigh that took a week to go away.
no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 28-JUL-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038700 (expiration date: 01-DEC-2021) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010128:Original Case : 2008USA010000 US-009507513-2008USA010124:Original Case : 2008USA010000 US-009507513-2008USA010125:Original Case : 2008USA010000 US-009507513-2008USA010126:Original Case : 2008USA010000 US-009507513-2008USA010127:Original Case : 2008USA010000 US-009507513-2008USA010122:Original Case : 2008USA010000 US-009507513-2008USA010121:Original Case : 2008USA010000 US-009507513-2008USA010123:Original Case : 2008USA010000 US-009507513-2008USA010134: US-009507513-2008USA010135: US-009507513-2008USA010137: US-009507513-2008USA010136:
Severe arm pain/low swelling in arm area. Nausea. Pain near liver area. General fatigue. Mental cloudiness. Random bouts of tinnitus in both ears, switching off, never both ears at once. The arm pain and swelling in shot area lasted about two days,  but the nausea, ;over pain, and fatigue continued for the better part of 4 days after the shot. The tinnitus only happened a couple times about 1-3 hours after the vaccination then ceased. I did not get this verified by a doctor, but I suspect my liver pain was related to an inflammation in the liver associated with the vaccine, as in the past, pain around my liver area has been associated with inflammation of my liver during minor flare ups.
Since receiving the vaccine, I have developed tightness in my chest and shortness of breath.  At times, it has been severe.  Feeling like I might pass out, I went to Immediate Care on 04/12.  They didn?t identify a cause.  On 04/15, I went to my Doctor, who noted wheezing in my upper lungs.  An inhaler and pantoprazole were prescribed.  At times, it feels like I am having something similar to an asthma attack.  The inhaler has helped.  Prior to the vaccine, I didn?t have any history of breathing problems, nor does it run in my family.
This case was reported by a pharmacist and described the occurrence of injection site pruritus in a 72-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medications included Carvedilol, Ramipril and VYTORIN. On 3 March 2014 at 13:40 the subject received a dose of BOOSTRIX (.5 unknown, unknown). Less than one week after vaccination with BOOSTRIX, the subject experienced injection site pruritus and knot at injection site. The pharmacist reported that the subject received vaccine on 03 March 2014 and for the past week he has experienced a knot and itching at the site. No treatment has been applied or taken. The subject contacted the pharmacy on 10 March 2014 at 22:00 with this report. At the time of reporting the events were unresolved. Follow-up information was received on 07 April 2014 via pharmacist who reported no action was taken with BOOSTRIX. No other information was provided. At the time of the report the outcome of the events was not specified.
Received a dose of shingrix after they've completing the series; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional asked was there any implications if the patient accidentally received a dose of Shingrix after they had completed the series, which extra dose administered. The reporter did not consent to follow-up.
Inadvertently given Janssen at 2nd dose visit - was supposed to get Pfizer.
patient came in this afternoon 6 days after receiving her vaccine and mentioned her arm was itchy and she had a red ring around the injection site. The ring was about 2 to 3 inches extended on either side of injection site
Chills, shivering, fever (100.8 at highest), malaise, loss of appetite, debilitating fatigue, severe headache.  Total duration 48 hours. Redness, swelling, tenderness at injection site continuing beyond 48 hours.
On 7/24/02, in the evening around 20:00, redness noted. No fever. On 7/25/02, right arm continued with redness and swelling at the injection site. Tylenol given for discomfort.
TD booster given 10/09/06. On 10/11/06 she reported red area to the side and below the injection site, was evaluated at urgent care center. Received Rocephin injection and Septra PO. On 10/16 there was no inflammation, no palpable knot, still a little sore.
PATIENT CALLED TO REPORT REACTION TO SHINGLES VACCINE. THE DAY AFTER RECEIVING, SHE HAD BODY ACHES, FELT COLD. ON SUNDAY SHE DEVELOPED A LUMP UNDER HER BREAST THE SIZE OF A BASEBALL. SHE SLEPT ALL WEEKEND. TODAY SHE HAS A 6-8 INCH RED SPOT AT THE INJECTION SITE THAT ITCHES. SHE DID COME BY LATER THAT DAY TO SHOW IT TO ME. SHE HAS BEEN USING BENADRYL CREAM FOR THE ITCH. SHE'S BEEN TAKING ALEVE AND USING COOL COMPRESS. SHE HAD CONSULTED THE NURSE PRACTITIONER AT HER WORK FOR GUIDANCE.
Starting 06/28/2022, I developed a very sore throat and my nose was stuffy. I had a fever that went as high as 101.3. I tested positive that day with an at home test. On 06/30/2022, I called the nurses line who connected me with the ER doctor who got me Paxlovid. I just finished the last dose yesterday. My nose is still a little stuffy and my throat is still a little sore but that is it. I finally got my taste back because the medicine made my mouth taste metallic.
fatigued; Feverish; Headache; stuffy head/Head Congestion; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 97x9j, expiry date 30th April 2023) for prophylaxis.   On 3rd December 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 5th December 2021, 2 days after receiving Shingrix, the patient experienced fatigue, fever, headache and head discomfort. On an unknown date, the outcome of the fatigue, fever, headache and head discomfort were recovered/resolved.   It was unknown if the reporter considered the fatigue, fever, headache and head discomfort to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received her 1st dose of Shingrix on Friday, in her left deltoid. She reported on Sunday she felt fatigued, and feverish. She also stated she had a headache and stuffy head (congestion). These symptoms lasted for 4 days and they were now resolved. The reporter consented to follow up. The reporter would not provide her mailing address for documentation of the call. She gave consent to contact her, but not her health care professional.
Rt. deltoid presents with redness & edema 2" x 3"; pt reports "much better" at 5pm next day.