chrisvoncsefalvay/vaers-outcomes huggingface dataset:
given FluLaval after being frozen at -0.45C; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Flu Seasonal QIV  (FluLaval Tetra 2021-2022 season) (batch number AD49D, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2021, the patient received FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse given FluLaval after being frozen at minus 0.45 Celsius for 15 minutes to the patient, which led to incorrect storage of drug. The reporter consented to follow up. This case was 1 of 10 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021230181:same reporter US-GLAXOSMITHKLINE-US2021230173:same reporter US-GLAXOSMITHKLINE-US2021230178:same reporter US-GLAXOSMITHKLINE-US2021230186:same reporter US-GLAXOSMITHKLINE-US2021230191:same reporter US-GLAXOSMITHKLINE-US2021230180:same reporter US-GLAXOSMITHKLINE-US2021230195:same reporter US-GLAXOSMITHKLINE-US2021230177:same reporter US-GLAXOSMITHKLINE-US2021230192:same reporter
On her way home & passed out in her car seat. Patient didn't remember that she had passed out after waking up.  Episode occurred about 20 minutes after receiving the vaccine; no other symptoms noted at the time event occurred.
Shingles; Inappropriate Schedule of Vaccine; Pain / lower abdominal pain; This case was reported by a physician via sales rep and described the occurrence of shingles in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 3rd December 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 5th December 2018, 2 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced lower abdominal pain. On an unknown date, the patient experienced shingles and incomplete course of vaccination. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown and the outcome of the lower abdominal pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles and lower abdominal pain to be related to Shingrix.  Additional case details were reported as follows: The patient was treated with valtrex and still had pain. Less than a year after receiving the Shingrix vaccine, the patient had shingles. The patient never came back for the second dose, which led to incomplete course of vaccination. The reporter consent to follow up.
Moderna COVID-19 Vaccine EUA  Excessive shoulder pain with limits on range of motion. Has diminished in the past 36 hours but pain still persists and range of motion is not back to normal.  Only took Tylenol, aleve, and albuterol.
24hrs after injection, injection site red, swollen and itching. 4-5 inch area on left thigh was warm to touch.
Two inches below area of injection to half circumference or arm to past top of shoulder rash/redness.  When patient came tell us this area was decreasing in size from the start.  I contacted the patient today at 9/13/16 for follow through.  He stated he did not contact his doctor put on hydrocortisone cream and the rash completely went away yesterday evening.
7 days after the injection- my arm started becoming really itchy and swelled up.  There was a hard lump at injection site and it was itchy for a few days.  Again, it did not start until 7 days after my first Moderna shot.
weird headaches; ear, neck, and intestinal stuff going on; ear, neck, and intestinal stuff going on; ear, neck, and intestinal stuff going on; Flu; Bad Shoulder; Bad Back; Arm Pain; minor leg ache; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for a female patient (sister) that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 28Apr2021 (Batch/Lot Number: EW 176) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history is none. The patient historical vaccine included BNT162B2 for Covid-19 Immunization; Lot no: ER8729, 1st dose. There were no concomitant medications. It was reported that said she started having weird headaches and something else. The caller thought to herself wait, we had identical vaccines at same time, same place. Her sister started having weird headaches and something else, too, but the caller cannot think of it. she declined to complete a report on behalf of her sister stating she does not know enough about her sister situation. She does not feel confident going through a report. Her sister told the that her headaches are starting to back off today, too, her sister had some ear, neck, and intestinal stuff going on. It was weird stuff, and the caller wants to leave it at that. It was Flu like, Bad headache, Bad shoulder, Black, arm pain, aches for about 8 days (2 weeks after shot). I did get covid test and it was negative. (I had been totally and completely isolated since onset Mar2020) As of today, I still get some minor leg/back/head aches ocassionally that I would deem unusual for me. (do not regret vaccine at all). The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on an unspecified date. The outcome of events was unknown.  Information on lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021569201 Same reporter/diff patient
HE WOKE UP AT 4:30 CONFUSED, TALKING OUT OF HIS HEAD, THEN WENT BACK TO SLEEP AND WOKE UP AT 0630 WITH HARD SHAKING CHILLS, JOINT PAIN (SHOULDERS AND KNEES), ALTHOUGH HE HAS HAD 2 TOTAL KNEE REPLACEMENTS), HEADACHE, FATIGUE AND MALAISE, AND TEMPERATURE OF 101,5(NOT RESPONSIVE TO EXTRA STRENGTH TYLENOL) 20BENADRYL 25MG EACH , PEPCID 20MG AND GATORAID. .  COULD NOT RAISE EITHER ARMS AND STATED THAT THE "BALL JOINTS" IN SHOULDER WERE VERY PAINFUL. AT 4;20 PM TEMP WENT DOWN TO 101.4, AT 6;30 TEMP 100.3 AND 8:45PM TEMP 99.3. AFTER THIS HIS SYMPTOMS SUBSIDED EXCEPT FOR SORE ARM AND SHOULDERS, SIDE EFFECTS LASTED ABOUT 14 HOURS.  BUT STRANGE THING HAPPENED ON 02/21/21 HIS ENTIRE MIDDLE FINGER ON LEFT HAND TURNED VERY RED, BUT NO SORENESS OR PAIN. , AND NO OTHER FINGERS WERE RED AND RESOLVED ON 2/22/21
1. Chest Pain, PVC's and aFib events.  Saw my cardiologist in 2021 post vax. I had a full workup and the abnormal heart rhythms were noted. The aFib went on for 8 months very frequently and has tapered off but every once in awhile I get an episode. The chest pain was really intense in the first 2 weeks, on and off fo 1-5 minute episodes. Working out and resting. It softened in intensity after a couple of months  2. Menses  Cycle was a MESS. Lots of heavy bleeding for the first cycle after the vaccine, and I bled for 18 solid days. The next few cycles were heavy and long with LOTS of clotting. My cycles finally regulated again after 7 or 8. Since the age of 26, my cycles have been regulated with estrogen and progesterone due to an infertility issue and I take them to protect my bones. (Privacy) has seen me before ad recommended this in my late 20's. So the vaccine altered my cycles while taking my normal medication.  3. I had 3 months of achy sometimes intense breast pain. I followed up wit my OBGYN and they ordered a mammogram, which was normal. I also reported my abnormal bleeding to them in 2021. I regularly get a flu shot. In Oct of 2021 I received my flu vaccine. The breast pain returned on and off for 2 weeks post flue vaccine. In the almost 40 years of taking the flu vax, I have never experienced d this.
Numbness/tingling - seizure. Dizziness - fell. Extreme vomiting. Fever muscle aches - headache.
Patient complained of bilateral arm itchiness. She refused benadryl at the pharmacy for fear of drowsiness while traveling home but purchased some to take home with her
Information has been received from a consumer concerning a female friend who was vaccinated with a dose of Zostavax (Oka/Merck). On an unspecified date the patient had injection site redness, swelling and pain. At the time of the report the patient's status was unknown. It was noted the patient's friend had a similar reaction to Zostavax (Oka/Merck) (WAES # 0712USA01226). This is one of two reports received from the same source. No further information is available.
Information has been received from a physician concerning a female who on unspecified date was vaccinated with a first dose of GARDASIL and had syncope. The physician did not specify if the patient fully fainted. After the second dose of GARDASIL on unspecified date, the patient felt dizzy. The physician reported that the patient then received the third dose of GARDASIL on unspecified date but they had her lay down to receive the vaccine and no experience was reported. The patient sought medical attention to the physician. Additional information has been requested.
About 3-4 days post vaccination the patient noticed a large bilateral red rash, slightly raised on his mid back.  The rash does not burn/tingle, but is very pruritic.  He has used Gold Bond cream for some relief from the itch.  The rash is still present and pruritic as of 11/9/2009.  Since the rash has not improved over 3 weeks time, I suggested he make an appointment with his Primary Care Provider.
I have not had a menstrual cycle or any symptoms thereof in years; last week I started a menstrual cycle, and after 5 days of this, it has occurred to me that this could be a result of the vaccine.
she is a Cancer patient; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer patient of an unspecified age received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER COVID-19 VACCINE) on an unspecified date as dose 1 for covid-19 immunisation. She received the first and second dose of Pfizer Covid-19 vaccine and wanted to get the booster shot. Asked how long it would take for the booster to be effective and was there any statistic showing the effectiveness of the vaccine in immunocompromised persons. The patient states that she is a cancer patient and was not confirmed if it is a pre-existing condition. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Within minutes of injections, pt became acutely droopy, nauseated and vomited profusely. He was flushed and sweating. 3x4 cm. Wheal at site of VARIVAX injec. (L) upper arm. Heart reg. No SOB or wheezing. Called mom at home and pt now has wheal on (R) arm where MMR given. Gelatin stabilizer in common.
Big black bruise; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EN6207; Expiration Date: 21Jul2021), via intramuscular on 25Mar2021 in left arm as dose 2, single for covid-19 immunization. The patient's medical history was not reported, prior vaccinations and concomitant medication were reported as none. Historical vaccine included bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EN6198; Expiration Date: 21Jun2021), via intramuscular on 01Mar2021 in left arm as dose 1, single for covid-19 immunization and the patient experienced lightheaded, high blood pressure, left arm muscle weakness for a month, hands a little numb too. On 25Mar2021, the patient experienced big black bruise. The patient underwent lab tests and procedures which included blood pressure measurement: norm high on 01Mar2021, electrocardiogram: good (normal) on 01Mar2021. The outcome of event was recovered on 01Apr2021 in 1 week.  Follow-up attempts completed. No further information expected.
I had my vaccination on 11/02/2022. In 12/2022 my spouse became ill with respiratory infection. I got sick about 2 weeks later and I was sick for about 3 weeks. This included fatigue, congestions, lots of coughing, lethargic and runny nose. I went to urgent care and was prescribed antibiotics for respiratory infection. I do feel ok on 02/02/2023 but not 100%.
Patient is a 65 y.o. male with hx of HTN, HLD, hypothyroidism, hereditary hemochromatosis, and gout who presents due to headache, nausea, fatigue, myalgias, fevers, dry cough, and loss of taste. Has had some soreness in his chest from coughing. Denies SOA. No diarrhea. Has not had much appetite. Had his COVID-19 booster on 11/30/21, then developed symptoms on 12/1/21 which he initially attributed to the booster. Had a COVID test on 12/2/21 that was positive. Symptoms continued to worsen. In the ER he had O2 sats as low as 92%, was placed on 2 liters. CTA chest showed mild patchy ground glass opacity in the mid and lower lung fields bilaterally. Admitted for further management.  No info in registry about what booster he received.  Initially received Janssen vaccine on 3/24/2021. No Lot number provided.
I contracted COVID-19 04/16/22 with symptoms of sore throat, fever of 104, fatigue, runny nose, congestion, headache, chills, myalgia, mild fever, and I was ill for 7 days. I was prescribed Paxlovid 4/17/22. I had lingering symptoms of runny nose and congestion. I relapsed on 5/4/22 into my previous symptoms with new symptoms of nausea, increased severity in congestion, low grade temp, fatigue and myalgia.
At injection site - soreness and aching Full body within 13 hours - vomiting, diarrhea, body aches, fever, chills, cold sweats, intense stomach cramps lasting 12 hours.  The following day I still had a slight fever, body aches, headache, and chills.
No adverse effects reported; Pharmacist reports that the vaccines were not administered within at least 4 weeks apart, as specified by the Prescribing Information.; Information has been received from a pharmacist referring to a unknown gender patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On 20-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. On 03-SEP-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R020652, expiration date: 18-JUL-2020, dose, frequency and route were not reported) for prophylaxis (inappropriate schedule of product administration). Other suspect product included sterile diluent (manufacturer unknown)(dose, frequency, route, lot # and expiration date were not reported) used for reconstitute with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX). No adverse effects reported. The sterile diluent (manufacturer unknown) used to reconstitute varicella virus vaccine live (oka/merck)(VARIVAX) was stored in the correct temperature storage range. And the varicella virus vaccine live (oka/merck)(VARIVAX) was stored in the correct temperature storage range as well. It was unknown the temperature storage conditions of the sterile diluent(manufacturer unknown) used to reconstitute the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine and the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine.
Approximately 24 hours after administration of vaccine, patient's Right Deltoid began to swell and began running low grade fever.  At 48 hours, patient was running a fever of 102 degrees that lasted for 24 hours. Right Deltoid eventually swelled to golf-ball size with erythematous and warm & tender to touch.  No signs of streaking to suggest lymphangitis. The reaction is believed to be to the Pertussis.  Patient has received DT in the past with no incidents.
4/17: 2nd dose moderna vaccine 4/17 night: chills during the night 4/18 morning and day: very achy (exacerbated previous back pain that I have on and off) and exhaustion, swelling at injection site 4/19 additional swelling and redness at injection site,  hard lump under skin at injection site and circular red patch, a little itchy
Allergic reaction within 4 hours of administration of vaccine. External ears red and swollen, welts, no itching, wheals on buttocks, abdomen and legs.
Large about 2.5 inch erythematous and pruritic localized reaction around injection sight. No notice of bruising. Has lasted 3 days and is now getting better. patient reported being lethargic but no other reaction or side effects were noted by patient.
received a half dose booster vaccine (0.25ml) instead of a full third dose of 0.5ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (received a half dose booster vaccine (0.25ml) instead of a full third dose of 0.5ml) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (received a half dose booster vaccine (0.25ml) instead of a full third dose of 0.5ml). On 23-Nov-2021, ACCIDENTAL UNDERDOSE (received a half dose booster vaccine (0.25ml) instead of a full third dose of 0.5ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have information about the first 2 doses. Patient is on medication that can cause immunocompromise, and got cancer. No concomitant medication was reported. No treatment medication use was reported.
Wheezing, coughing 24 hours after shot given. Took zyrtek. Benadryl, prednisone 10mg, venturing inhalerx4
Patient presented to ED with left facial droop, slurred speech, difficulty swallowing, speaking, tongue swelling, tingling in hands and feet.
ADMINISTRATION OF VACCINE OUTSIDE OF RECOMMENDED STORAGE CONDITIONS FOR POSSIBLY HUNDREDS; This spontaneous report received from a pharmacist concerned multiple patients of unspecified age and sex. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, 043A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-MAY-2021, the patients experienced administration of vaccine outside of recommended storage conditions for possibly hundreds. The patients were vaccinated with punctured vials that had been left at room temperature for over 2 hours. It was reported that, this involves hundreds of patients dating from as early as 15-MAY-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine outside of recommended storage conditions for possibly hundreds was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210653950- Covid-19 vaccine ad26.cov2.s- Administration of vaccine outside of recommended storage conditions for possibly hundreds. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
On 8/8/2021 I got sick with fever, body aches, nausea, vomiting, diarrhea, and chills. I went to the ER because I couldn't breathe and I felt like my throat had closed up. They tested me for covid and it came back positive. I was there for about an hour. They sent me to another ER where I received anti nausea meds so  I would be able to keep down liquids. They also gave me fluids. I was there for about an hour and a half and couldn't get a room so the doctor helped me in the waiting room. I was sick for 7 days and lost 15 pounds. I tried to find out if it was a variant but the ER said they were unable to find out. They assumed I had the delta variant.
The caller's armpit started to hurt really bad and the pain is now radiating down her arm and she can't lift her arm.; The caller's armpit started to hurt really bad and the pain is now radiating down her arm and she can't lift her arm.; Woke up this morning and her armpit/breast area is in agony; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization. The patient experienced the caller's armpit started to hurt really bad and the pain is now radiating down her arm and she can't lift her arm, woke up this morning and her armpit/breast area is in agony on an unspecified date in 2021. The patient is calling about the Pfizer covid 19 vaccine. The patient's armpit started to hurt really bad and the pain is now radiating down her arm and she can't lift her arm. The patient took Tylenol but it is still sore, the Tylenol dulled down the pain a little bit but it is still there. When the patient's arm touches her body it is aggravating. Its a deep tissue pain. The patient wants to know if this could be from the vaccine. The patient received the second dose of the vaccine Tuesday late afternoon, 16Mar2021. Patient received 2nd dose on Tuesday. Woke up this morning and her armpit/breast area is in agony. The patient received treatment medication for the events. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
Rash on arm at injection site. Achy chills very sleepy for 24 hours. Still have red rash but feel great now.
Raised bump at the shot site 8 days after the shot.  Hot to the touch, painful and arm ached.  I took a Benedryl, went to bed and woke up and it still was hot and looked bigger than before.  Decided to go to urgent care.  They told me to put a Steroid cream on it 2x a day for 5 days and take Benedryl at night.  If that doesn't work he wrote me a prescription for an antibiotic JUST IN CASE it spread further up or down my arm.  If that happens he told me to take the first dose and go back to urgent care.
Patient was fully vaccinated, receiving 2nd dose of Moderna on 3/23/21 at clinic.  Patient had received 1st dose of Moderna vaccine on 2/23/21. Patient tested positive for COVID-19 on 7/29/21.