chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a patient received an expired dose of FLUZONE QUADRIVALENT vaccine/ No AE; a pregnant patient received an dose of FLUZONE QUADRIVALENT vaccine/ No AE; Initial information received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from a other health care professional via consumer via phone via regulatory authority number: 00794278.   This case involves a 25 year old female pregnant patient who was exposed to an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] at 32 weeks of pregnancy during third pregnancy trimester (expired product administered and exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e., before pregnancy outcome was known.   The date of last menstrual period was reported as 18-Feb-2021.  The estimated due date is 25-Nov-2021.  It was not reported if patient had previous pregnancy.   The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant Medication: None.  On 30-Sep-2021, the patient received a 0.5 ml first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE prefilled syringe lot number: UT7073NA, expiry date: 30-Jun-2021, frequency: once, strength: standard via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy and also a case of actual medication error due to expired vaccine used (latency: same day).  It was reported "Caller states that a patient received an injection of FLUZONE QIV No Preservative (NP) from a prefilled syringe on 30SEP2021 that had expired on 30JUN2021. Caller asked if this was considered a valid dose or if it would have to be repeated. Caller asked for information on how to proceed."  Product used: used and still using product: no.   Adverse event (AE) symptoms: No AE.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.   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.
Dizzy, jittery, and racy, whole left side tingling under skin and headaches.
Development of bilateral Tinnitus and decreased hearing.  (Ears feel and act as if they have water in them), Hearing decreased approx 50% bilaterally.
PATIENT COMPLAINED OF ITCHY BUMPS/REDNESS AFTER ANTHRAX VACCINATIONS 1-3.  DIAGNOSED WITH ECZEMA (PRESENT ON TRUNK AND NECK) CAUSED BY ANTHRAX IMMUNIZAITONS.  FIRST DOSE ON 17 DEC 07, SECOND DOSE ON 3 JAN 08 AND THIRD DOSE ON 18 FEB 08.
6 MONTHS AFTER SHOT CLAIMS SHE GOT SHINGLES FROM THE SHOT? ALSO COMPLAINED HER ARM HURT FOR MONTHS
Came to the hospital 12/6/21 via EMS after being found minimally responsive. In the emergency room he was found to be dehydrated hypernatremic obtunded right lower lobe infiltrate on chest x-ray sodium was 157 potassium 4.9 chloride 118 BUN 54 creatinine 2.5 CPK 1907 troponin 365 lactate of 2.6. At that point the patient was negative for COVID.  Patient had cardiac arrest 1/11 with restoration of circulation. He has had a prolonged hospital stay and tested positive for COVID 1/24/22. Patient was being evaluated for trach and peg tube prior to COVID diagnosis - trach and peg on 1/28/22.  Patient has not required treatment for COVID.  Patient vaccinated Pfizer 8/6/21 & 8/27/21.  Discharged 2/4/22
1 of 4 pts vaxed from same lot exp and adverse event; pt exp inject site react - 10 cm in diameter (bruising, swelling, warm to touch, outer edges-red); rx warm compresses; also had h/a; 11NOV93 3 wks; later devel severe flu sx-bronchitis;
This spontaneous report as received from a consumer refers to a female patient of unknown age. The patient was vaccinated with dose 1 GARDASIL on 21-NOV-2008. Batch number, route of administration and anatomical location were not reported. No other co-suspects were reported. No concomitant medications were reported. On unknown dates, the patient received dose 2 and 3 of GARDASIL on 21-NOV-2008. Batch number, route of administration and anatomical location were not reported. There was a time lapse of two years between the second and third dose. No adverse event or treatment information was reported. Additional information has been requested.
rash but not near the injection site; Initial information was received on 02-Oct-2020 regarding an unsolicited valid non-serious case from the pharmacist via phone.  This case involves an unknown demographic patient who experienced rash but not near the injection site (rash), while the patient received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   On 30-Sep-2020, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (batch number and other dosing details were not reported) for prophylactic vaccination.  On 01-Oct-2020, the patient developed non-serious rash but not near the injection site (rash), 1 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information available on the batch number for this case.
Itchy rash with a few blisters all over body, but mostly on trunk front/back and left side of neck and under arms where shot was given; blisters were few and on my legs; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 16:00 (Lot Number: ER8732) as SINGLE DOSE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Medical history included renal cancer, allergies to Pennicillin, sulfa drugs, codeine. Concomitant medications included zinc; cyanocobalamin (B12-VITAMIIN); ascorbic acid (VITAMIIN C); olopatadine hydrochloride (PATADAY); fluticasone propionate (ALLER FLO), all taken for an unspecified indication, start and stop date were not reported. The patient experienced Itchy rash with a few blisters all over body, but mostly on trunk front/back and left side of neck and under arms where shot was given. The blisters were few and on legs. An itchy bump appeared under left arm after 4 days and a few days later the rash was very itchy and appeared every where else. The events onset date was reported as 06Apr2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. Patient I was told to take allegra, use calamine lotion. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Instantly within seconds of shot became drastically flushed in face and neck with some hive/blotching. Lasted for about 45 mins-1hr. O2 was fine, no breathing issues.
He received anthrax immunization 2002-2004 and his chronic joint/muscle pain throughout his body, heartburn and diarrhea. Symptoms: Rash, oth nonspecific skin eruption, Generalized Pain, Dizziness and giddiness, Malaise and fatigue, Disturbance of skin sensation.
This spontaneous report as received from a registered nurse refers to a 16 year old male patient. The patient's concurrent conditions and medical history were not reported. The patient received a mixed regimen of GARDASIL and GARDASIL 9. He received his first two doses of GARDASIL on 09-MAY-2014 and on 18-JUL-2014 (dose, route, lot# and expiration date were not reported) and dose #3 with GARDASIL 9 (dose, route, lot# and expiration date were not reported) on 27-MAY-2015. No adverse experiences reported. This is one of two reports received from the same source. Additional information has been requested.
Days after 2nd dose noticed odd grainy rash around eyes. Kind of like liquid sand. Just around eyes near nose. Also noticed Rosacea suddenly got worse around same time (which never happened before). Rash (not sure what else to call it) lasted about 3 weeks, almost disappeared, then returned in early June. Saw doctor for unrelated illness on 6/24/21, and she noticed eyes. Said it was infection, possibly complication of Rosacea, and prescribed Doxycycline Hydrate 100mg 2x/day for 10 days. Mostly improved after treatment. Returned shortly after. Saw different doctor on 7/14/21. He prescribed same but added 100mg 1x/day for 20 days. Two days after seeing him (did not start 2nd round of Doxy until 7/17/21) rash got much. worse on 7/16/21, spreading throughout face and into eyes. As I type this on 7/22/21, there is no improvement. As my only income is SS Disability, I do not have funds to see a Dermatologist or Optometrist, even though my vision is in danger. Obviously, I don't know if this was caused by the vaccine. All I know is that it started around the time of the 2nd dose on 5/14/21. I have taken 1 Pneumonia vaccine and flu vaccine for many years and never had a reaction, but I understand the MRNA technology is different. Now my big concern (in addition to this condition) is if I can get a booster when available or any other vaccine. I was intending on getting the Shingles vaccine, but now I am afraid to get anything. All that said, I am thankful for the vaccines and would rather be dealing with this than Covid.
Swelling of throat to uncomfortable point, but did not close.  Hard to swallow.   This occured within an hour of injection
Patient came back to the vaccine room on 15MAR21 to report swollen lymph nodes in his neck that started on 12MAR21 @ 2000.
I tested positive in May 26. I got it from my husband. I had sore throat, nasal, congestion and body aches. I had alternating body temperature. I went from fever to chills. I was prescribed Paxlovid and took it for 5 days and I got better quickly. I tested negative a few days later. I got a few symptoms again in June, and I was sick again for two weeks. It was the same symptoms just more severe. It lasted two weeks. When I took the Paxlovid on June 1 and was negative. I believe the rebound happened after the Paxlovid.   Delivery of child 01/22- at 6 lbs and 3 oz
The first COVID-19 case my daughter tested positive on 4/6 so I tested and was negative. Then the Saturday I was positive. I had fever, chills, body aches, low appetite, coughing. Theses lasted for 2-3 days. The second was 11/22 and I had coughing from dry to congested cough. It kept me up at night. First dry then productive. No fever. Weak with body aches, sore throat, tired. I still have some symptoms today, the cough has decreased a bit. The cough was producing a thick colored phlegm so I was put on a Z-PAK. The cough has lessened but I still have fatigue.
low-level headache (was able to go to work, but a bit miserable), tired/run down-lasted several hours (no more than 10) arm pain (at injection site)-it is a bit warm to the touch and a small bruise- still occuring (approximately 12 hours after it started this morning)
After vaccine administration.... c/o tongue tingling on left side, c/o tingling left temple....  Employee states having symptoms similar to shellfish allergy reaction....
Pt c/o numbness and tingling of mouth and face, headache, loss of memory x 2-3 days. Pt did not seek treatment
No additional adverse event reported; HBP reported an adverse event. Caller stated VARIVAX was administered after a temperature excursion. No additional AE or PQC reported. No additional information provided.   ?    Names of vaccines involved (including lot/exp): VARIVAX Lot U039726, E; This spontaneous report has been received from an office manager, regarding an identified patient of unknown gender and age. Information regarding the patient's historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided.   On unspecified dates, the varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # U039726 experienced a temperature excursion of -13.5 Celsius degrees (C) for a timeframe of 1 hour 0 minutes and 0 seconds; no previous excursions of temperature for this lot number. If a digital data logger was involved was not reported (product storage error) (product storage error).   Consequently, on 02-JUN-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous Injection, (lot number U039726 confirmed to be a valid lot with expiration date reported and stablished as 15-DEC-2023) administered as prophylaxis (strength, dose, vaccination scheme, route of administration and anatomical location were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).
Client stated 10 min after leaving our office, about 20" after receiving the vaccination, she experienced dizziness and racing heart rate. Client stated 3-4 days later she went into see a Family Nurse Practioner as she had a walnut sized swelling under her arm along with a swollen arm. Client said the FNP thought it could have been a reaction to the vaccine or could have been an allergic reaction. Client stated a week after she felt achy and tired. Client stated about 2 weeks later the lump was still present. Client stated 1 month ago she saw her regular MD who also felt possible reaction to the shot or could have been an allergy and requested the client find out from PH if thimerisol or latex connected with the shot. Client then called us, which she stated was about 3 months from when she received the shot. Client stated the walnut sized lump had gone away but now she has a cold and states the 'lymph node' has reappeared.
Patient received vaccine at 9:05am and felt flushed at 9:10am - patient did not feel dizzy.  She was given two ice packs and felt fine at 9:20am and left after observation time with husband
1 week after immunization, patient had paralysis in both legs for 2 days. She also had rashes on both arms and legs and was vomiting.
Lt arm swelled and was warm. Lt side of neck ached as well as widespread muscle/joint pain for one week.
My periods are always regular, in terms of length, and in terms of amount of blood. I generally would have about 2 - 4 hours of heavy blood per period (total period lasting 4 days). After the first  dose (and before the 2nd dose), the 3rd and 4th day of my period were extremely bloody (menhorragia) for the full two days. I was soaking through super tampons or super Thinx underwear in an hour. The clots were larger and more plentiful than usual, and the blood had a different quality -the blood itself was very thin and watery, with the clots being thick and gelatinous. My period is always over by Day 5, but this cycle, I bled for an extra day.
Runny nose; headache; I lost my smell; not feeling good; throat hurt; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as dose 2, single (at the age of 65-years-old) for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 22Jan2021 (Batch/Lot number EL9262, Expiration date: May2021) as dose 1, single for Covid-19 immunisation and had a light headache, face was swollen, throat was swollen little bit. On an unknown date, the patient had a light headache, runny nose and her throat hurt for one day. She stayed not feeling good for five days since 14Feb2021). She also lost her (sense of) smell to the day of the report and still had no sense of smell. The patient underwent lab tests and procedures which included COVID test: negative on 19Feb2021. The events not feeling good resolved on 19Feb2021, the event throat hurt resolved on an unspecified date in 2021, the event "I lost my smell" had not resolved, while the outcome of the rest of the events was unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Swelling and tenderness under left eye where I previously had cosmetic fillers. I had fillers under both eyes but only the left side is swollen.
red, hot, swollen felt ill all weekend with lightheadness- seen in clinic cool moist compress, Tylenol Q 6hrs  f/u PCP in 3-5 days if persists or ER if worsens.
PATIENT GIVEN RABIES VACCINE* AT APPROXIMATELY 1PM ON 2/6/05 IN THE OUTPATIENT DEPARTMENT.  HE STARTED WITH VOMITING AND DIARRHEA AROUND 12AM ON 2/7/05.  THE VOMITING WAS ON & OFF FOR 12-18 HOURS.  THE DIARRHEA LASTED FOR 3 DAYS.  ON 2/13/05, HE WOKE UP AND VOMITED ONCE DURING THE NIGHT.  HE HAS BEEN COMPLAINING OF STOMACH PAIN FOR 3-4 DAYS.  ON 2/16/05, HE STARTED WITH DIARRHEA AGAIN. ON 2/17/05, VOMITED ONCE AT ABOUT 4AM AND WHEN WOKE UP AROUND 7AM, WAS COVERED IN HIVES.  HE WAS SEEN ON 2/17/05 AND TOLD TO GIVE BENEDRYL.  *UNABLE TO FIND DOCUMENTATION OF VACCINE LOT #.  ACCORDING TO HOSPITAL PHARMACY WOULD PROBABLY BE THE SAME AS WHAT THEY STILL HAVE IN STOCK.  THE VACCINE IS RABAVERT LOT #336011.
pain in arm, kind of at the site of injection; specifically when I lift my arm a little bit up, I get pain in that area; pain in arm, kind of at the site of injection; specifically when I lift my arm a little bit up, I get pain in that area; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced: "pain in arm, kind of at the site of injection; specifically when I lift my arm a little bit up, I get pain in that area" (non-serious). The clinical course was reported as follows: The patient reported that they received the first dose of the "vaccine of Pfizer" (name not clarified) on 23Dec2020. The patient reported that they were still experiencing "pain in my arm, kind of at the site of the injection but specifically when I lift my arm a little bit up, I get pain in that area and that has been like since I got the shot." The patient wanted to know if they should be concerned about getting the second vaccine. The clinical outcome of the events was unknown.
This spontaneous report as received from a female consumer refers to her 23 year old daughter with allergy to amoxicillin. On 04-APR-2014, the patient was vaccinated with the first dose of GARDASIL. On 05-JUN-3024 the patient was vaccinated with the second dose of GARDASIL (lot # J013277, expiration date:06-AUG-2014, strength unknown, 1 single shot, intramuscular). Concomitant therapies included ZYPREXA and CELEXA (dosage/frequency/manufacturer unknown). In approximately 19-JUN-2014, reported as "2-3 weeks after", the patient discovered lumps in her breasts. The patient sought unspecified medical attentions, two ultrasounds and a biopsy were performed and they were awaiting the results. No adverse effects were reported with the 1st shot of GARDASIL. The outcome of the event was unknown. Additional information has been requested.
Skin rash all over body starting that night of receiving the vaccine, itchy, tolerable with BENADRYL. No anaphylactic symptoms. Presents to clinic for care on 8/28/17 with the rash. Photos taken. Advised to continue BENADRYL and monitor.
Patient and family had a strong opposition and anxiety disorder towards Pfizer; parent of patient requested that Moderna was given to daughter
pt recv vax 25OCT96 & 25OCT96 pt devel swelling, redness, & heat in arm;28OCT96 pt recovered from the swelling, redness & heat in arm;
Patient with local erythema and warmth and circular patch overlying both injection sites. Currently on CEFZIL to treat ear infection. Treated with MOTRIN and antihistamine.
Patient was noticeably more fussy the afternoon of his appointment.  That day he slept longer intervals than ever before but was extremely fussy when awake.  This continued until 5:30 on 6/27 when he had an approximately 3.5hr stretch of inconsolable crying and screaming and poor appetite.  That night he slept through the night (12:00AM to 9:00AM) despite being breastfed and usually waking up twice in that time span.
I felt sore muscles, fatigue, and slight chills, elevated heart rate (up to 110s) and a restless sleep.  Symptoms resolves by the middle of the next day (about 24 hours after the injection.
Body aches, chills, nausea, malaise, used Tylenol, lasted 48 hours
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Rebound Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient got a TriPedia DTaP shot. A few hours later he started looking droopy and needed to sleep. So he napped and when he woke up he had a fever that lasted for 4 days. During this time he cried a lot would not eat and would not sleep more than 2 hours. The fever ended after 4 days and now he just cries all the time, he wants to be picked up and when you pick him up then he arches his back and cries and wants to get down. He's inconsolable.
Acute intense R shoulder pain the day of immunization. Unable to move R arm without significant pain. Spread to L shoulder by next day. Unable to sleep on either side. Mostly resolved by appt on 9/7/18.
Sudden death. Found face down on bedroom floor in early hours of morning two days after 2nd booster (4th shot).
05/29/2022 I had fatigue, sneezed a lot and watery eyes. It felt like allergies, and I do not have allergies.  I was super tired. The next day I began coughing, had body aches, fatigue, runny nose, had shortness of breath and postnasal drip.   I was no longer sneezing. I took an at home COVID test on 5/30/2022 around 1:30PM ET and it was positive.  I had a tele health with my doctor and he prescribed me an inhaler which I never used. I did take Pepcid which I had seen would help with COVID.  It took about a week to feel better but am still a little fatigued and a mild cough.
Information has been received from a pharmacist concerning a now 74 year old female patient with sensitive to sulfites who had a localized reaction after vaccination with PNEUMOVAX 23. It's unknown if the patient had sought any medical attention. The patient subsequently experienced injection site bleeding, injection site swelling, rash and local reaction while on therapy with ZOSTAVAX (Merck) (MSD, WAES0907USA00753).  Additional information has been requested.