chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe allergic reaction; problem in her ears; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe allergic reaction) and EAR DISCOMFORT (problem in her ears) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (severe allergic reaction) and EAR DISCOMFORT (problem in her ears). At the time of the report, VACCINATION COMPLICATION (severe allergic reaction) and EAR DISCOMFORT (problem in her ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Arm is so sore, I can hardly move it; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 (lot number: EM9809) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included blood pressure, ongoing diabetes (probably 10 years or more). Concomitant medication included metformin for diabetes, unspecified medicine at one every day for blood pressure. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) on 22Mar2021  for COVID-19 Immunization. The patient stated, "I was calling because I had my second shot on Monday and my arm, yesterday and today my arm is so sore, I can hardly move it. I have been massaging and I took Tylenol (treatment) but I was wondering should I put a heat pad on it, do I need call my doctor, it is just unusual sore, it's not just a little sore in my arm, I can even hardly use it and I just want to make sure it's going to get better or not. Now, I do know when he put my shot he did it all the way up at the top of my arm, I never had a shot on my arm almost at my shoulder." The patient stated, there is no Laboratory test, she haven't had any kind of treatment or anything lately." She added, "I was wondering to put a heating pad on my arm for the pain that is what I was trying to find out." The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Pt presents to ED from assisted living facility with reported abdominal pain for 2 days and a brown emesis on 4/13. COVID positive 4/13. Placed on nasal o2 at 6l due to vomiting. Pt placed on cardiac monitor, with audible crackles noted.  Pt very tachypneic increasingly tachycardic, SPO2 66% RA with good pleth on monitor. Pt placed on O2 via NRB at 15lpm 4/13. Patient admitted to inpatient hospice services for terminal wean from 15l/NRB and management of respiratory distress.  Morphine drip initiated at 1mg/hr and titrated as appropriate per order.  Decreased O2 2L per hour as tolerated by pt on 4/14. Discharged 4/14.
Pt did not have an adverse event, but there was a temperature excursion of the J &  J vaccine vial. Vaccine was taken out of fridge at 12:03pm, then 1 dose drawn up at around 12:11pm. I then accidentally left the vial out at room temperature for around 35 minutes. At this point I then put the vial back in the fridge. I asked a couple other pharmacists if okay to use and they said yes, so I drew up more doses around 3:30pm (this is an estimate). I administered this particular dose shortly after drawing up. All doses were administered within the 6 hour timeframe. Per conversation w/ manufacturer the vial was out at room temperature longer than what is suggested (i.e. probably around 5 minutes longer than it should have been out of fridge), so the representative at the mfr is sending this to the safety team to find out if re-vaccination may be necessary.
1740 fainted after giving multiple shots (HPV, MCV4, Hep A & Tdap; becomes pale & non responsive noted with minor shakes lasted few seconds recovered right away.  Seen by Dr., monitored closely by Dr., observed for another 10 min, went home in alert, stable condition.
Administered a Moderna 2nd  dose on 3/7/22 around 12:30a past the Beyond Use Date of 3/3/2022 and manufactured expiration date of 4/24/2022.  Learned of error today when examining number of doses remaining.
This spontaneous report as received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates since 03-JUL-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot# M040143, expiration date 27-MAR-2018 and lot# reported as N001490, expiration date 12-JUL-2018 (dose, route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 15 degrees Fahrenheit and 46 degrees Fahrenheit (also reported as 32.5 degrees Fahrenheit) for 30 minutes. Data logger was not involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-00507513-1708USA001605: US-00507513-1708USA001606.
Severe headache. Full head headache, not a simple sinus headache. I felt like I was hungover. Lasted for 2 days. Tylenol, Advil both helped. Pushed fluids to make sure I was not dehydrated. Had some coffee to make sure it wasn't caffeine withdrawal. Headache became less severe over time. By the third day it was pretty much gone.  Possibly unrelated, starting 04/11/2021 through 04/15/2021 I had severe insomnia. I could not sleep longer than 1-2 hours. Very active mentally while trying to fall asleep. My brain was constantly churning over thoughts, emotions, work, not work, etc. I struggled to just calm my head and go to sleep.  The night of 04/15/2021 I slept 3.5 hours. I was very physically active on 04/16/2021 and slept 10 hours that night (last night). Active today, but back to having trouble going to sleep.
Nausea, light headed, blurred vision and LLQ/RLQ/RUQ pain.
Soreness; Swelling; Fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain, swelling and fatigue. On an unknown date, the outcome of the pain, swelling and fatigue were unknown.   It was unknown if the reporter considered the pain, swelling and fatigue to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not applicable for this report. An unspecified number of patients received Shingrix and experienced soreness, swelling and fatigue. The reporter mentioned that just normal side effects found in product insert. The reporter could not have thought specific patient to report on, just patients in general that have received the vaccine. No patient identifiers, lot numbers, or expiry dates to provide.
I had full body hives. They were red, raised, itchy, and they come and go. When I went to the doctor, and they said they didn't know what cause them. They also started me on a couple medication and referred me to a dermatologist. I am still having problems with the hives.
Sore throat on Sunday, 1/9/22 evening at 1:00AM Started fever on Sunday, 1/9/22 morning at 99 degrees. Low grade fever until Tuesday, 1/11/22 evening. Body rash on the back started evening on Wednesday 1/12. No fever on 1/12/22 Saw doctor and was negative strep throat.  Slight red in the ear but not major.  COVID test negative as of 1/12/22
Pt recvd vax 18AUG92 & became pale & sweaty; Pt recovered on the same day; No further details were provided;
No additional adverse effects were reported in the patient.; a patient received a dose of VARIVAX following a temperature excursion.; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 10-JUL-2020, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 1 dosage form (strength, dose, vaccination scheme, route of vaccination and anatomical site of site vaccination were not reported, lot number S022755, which has been verified to be valid, expiration date reported and validate as 21-JUL-2021) as prophylaxis, following a temperature excursion (product storage error). As concomitant therapy sterile diluent (MERCK STERILE DILUENT) was used to reconstitute the vaccines at a dose of 0.5 milliliter (ml). The administered dose of the vaccine experienced a temperature and time frame in the range of 6 Fahrenheit (F) to 14 (F) (-14 Celcius (C) to -10 (C)) (9.3 F) for 50 minutes, as record by data logger. There was no previous temperature excursion. No additional adverse effects were reported.
Information was received on 14-JUL-2017 from a pharmacist who reported that a 60 year old female patient was administered reconstituted ZOSTAVAX (lot# M038863, expiration 12-DEC-2017) to prevent shingles with diluent (unknown lot#/expiration) on an unspecified date and experienced "pain and redness the size of a 50 cent piece at the injection site" (onset not reported). Concomitant medication included methotrexate. Outcome of events was not reported. No treatment provided. No additional information. Additional information has been requested.
Lymph node swelling, severe left sided groin pain and abdominal pain, ultimatelydiagnosed with shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or around 23-OCT-2013 , the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In approximately October 2013 (reported as "Shortly after receiving zoster vaccine live(ZOSTAVAX)"),  the pt suffered lymph node swelling, severe left sided groin pain and abdominal pain where pt was ultimately diagnosed with shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experiencesd mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment oflife, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   Shingles was considered to be disability.
Shingles outbreak -2 weeks after vaccine. I do not have any underlying conditions.; This is a spontaneous report received from a non-contactable consumer or other non hcp. A 30-years-old female patient received bnt162b2 (COVID-19 VACCINE ,Batch/Lot Number: EWO158), via an unspecified route of administration on an unspecified date as Dose number unknown, single for covid-19 immunization .The patient medical history and concomitant medications were not reported.The patient experienced shingles outbreak 2 weeks after vaccine. Patient doesn't have any underlying conditions.Therapeutic measures were taken as a result of shingles outbreak -2 weeks after vaccine.The outcome of the events was recovering.The treatment received for shingles was Antiviral (Valtrex).The adverse event was non serious not requiring emergency room or hospitalization.Prior and since the vaccination, the patient was not tested or diagnosed for COVID-19. Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.  No follow-up attempts are possible. No further information is expected.
Patient reported severe nausea/vomiting, large rash around injection site and significant pain in affected arm that radiated to entire body.
My daughter had a seizure, during sleep.  She?s in good health, 21 years old with no family history of anyone ever having a seizure. Does the vaccine cross the blood brain barrier??
leukocytoclastic vasculitis; Information has been received regarding a case in litigation from a lawyer referring to a currently 66 year old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided.  On 06-SEP-2012 the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(lot#, expiration date, concentration, dose and route were unknown) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On unknown dates, patients suffered the following injuries and was diagnosed on the following as a result of the zoster vaccine live(ZOSTAVAX) vaccine: sores on legs spreading to arms and trunk, joint swelling and warmth involving wrists, elbows, knees, hips, etc; the patient was diagnosed with leukocytoclastic vasculitis. The outcome of leukocytoclastic vasculitis was unknown. The reporter considered leukocytoclastic vasculitis to be related to zoster vaccine live(ZOSTAVAX).  Upon internal review, leukocytoclastic vasculitis was determined to be medically significant.
I received the smallpox vaccine on 3/19/03.  Headache begun within few hours and persisted since then.  Blood pressure measured on 3/20/03 was 175/82.  Hypertension has continued since then with peak on 3/22/03: 198/84.  Symptoms include headache, flushing, facial numbness and mild confusion.  No previous history of hypertension.  Last measured BP in October, 2003 was 142/80.  Pertinent medical history includes paroxysmal atrial tachycardia of over 20 years, well controlled with 60 mg/day of nadolol.  Starting on 3/21/03, dose of nadolol has been increased to 80 mg/day, and hydrochloratiazide, 25mg/day has been added without significant improvement.  Burst of hypertension with systolic variations from 195-200 to 128-160 have continued.  Work up begun for pheochromocytoma/carcinoid. Could there been any relationship, other than temporary with the onset of severe/symptomatic hypertension and day of smallpox vaccination?
Patient got the first SHINGRIX vaccine and reports swelling on the left side of the face 24 hours after injection (also on the left side). Patient took BENADRYL and iced that side of her face to help with the swelling. Reports swelling has gone down 48 hours post injection but it is still there. Also took ADVIL 48 hours post injection (uses for arthritis as needed). Does not reports a rash, difficulty breathing, swelling of the tongue or throat. Her sleep has been disrupted as she was anxious about something happening to her at night. Did not go to urgent care or ER.
Patient complained of swelling, tenderness, and red streaks of/from injection site (LD).  Told patient to take Benadryl.  Spoke to Patient on 11/05/03 and she said she was feeling better.
Since second dose on 30Mar, my hair is falling out by handfuls#  Extreme amounts of hair loss.  Never happened before vaccine. I am very afraid it is all fallingOut, every bit of my long beautiful; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 30Mar2021 (at the age of 63 years old) as dose 2, single for covid-19 immunisation. Medical history included asthma, hypertension,immune thrombocytopenia, rubber sensitivity and dermatitis contact from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took first dose of bnt162b2 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN-6203), via an unspecified route of administration administered in Arm Left on 09Mar2021 at dose 1, single for covid-19 immunisation. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had allergies Latex and adhesive. On 08Apr2021, the patient experienced since second dose he had hair is falling out by handfuls extreme amounts of hair loss never happened before vaccine. The patient was very afraid it is all fallingout, every bit of my long beautiful. The outcome of the event was not recovered.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Little fever; fever was too high for even the thermometer to pick up; fever was 101 it was lower than the night before but still pretty high; Arm was sore but not terrible; arm had a [massive hard] painful [swelling] for days; Arm had a massive [hard painful] swelling for days; Arm had a massive [hard painful] swelling for days; Chronic fatigue; wiped out for a couple of days; wiped out for a month; Cold; Knocked my immune system off; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001049 (Novavax).  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Little fever; fever was too high for even the thermometer to pick up; fever was 101 it was lower than the night before but still pretty high"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm was sore but not terrible; arm had a [massive hard] painful [swelling] for days"; PERIPHERAL SWELLING (non-serious), INDURATION (non-serious), outcome "unknown" and all described as "Arm had a massive [hard painful] swelling for days"; FATIGUE (non-serious), outcome "unknown", described as "Chronic fatigue; wiped out for a couple of days; wiped out for a month"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Knocked my immune system off". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300272287 same patient/event, different vaccine dose;
Rash at injection site & fever that occurred shortly after getting injections on 7-13-11.
Hardness at the injection site; Itchiness at the injection site; 2 inch ring around the injection site, red pinkish; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness at the injection site), INJECTION SITE MASS (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (2 inch ring around the injection site, red pinkish) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchiness at the injection site), INJECTION SITE MASS (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (2 inch ring around the injection site, red pinkish). At the time of the report, PRURITUS (Itchiness at the injection site), INJECTION SITE MASS (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (2 inch ring around the injection site, red pinkish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: NNI FU  - No new information was provided
Mother gave Tylenol, fast heartburn problems breathing 1:00 am 10/24 101 Fever was bathed by mother. 10/24 was taken to MD given a suppository and sponge bath to reduce fever of 102.8. 10/24 temp down to 99.2.
Erythema of immunization area with (Right thigh) warmth and mild soreness.
1 of 8 pt (4-6 yr old range) seen /win the past wk /w severe local reactions, Pt has 3 X 4 inch area of redness, tenderness & warmth, also had low fever.
Information has been received from a physician concerning two patients who on unspecified dates received both doses of VARIVAX (Merck) and they were both exposed to an outbreak situation and both developed a mild case of varicella. There was no concomitant medication and no pertinent medical history. The patients saw physician for medical attention. Follow up information has been received from the physician's office, concerning a female patient who received the first dose of VARIVAX (Merck) on 03-FEB-2005, and received the second dose on 23-MAY-2008. The reporter indicated that the lot numbers were unknown because the vaccines were given in another center. This is one of two reports from the same source. Additional information has been requested.
PATIENT'S DAUGHTER CALLED TO REPORT REACTION. PATIENT TOLD HER THAT HER ARM WAS EXTREMELY SORE AND HAD A KNOT THE DAY OF INJECTION. STAYED SORE SEVERAL DAYS AND SHE THOUGHT THINGS WERE IMPROVING UNTIL 11/16/16 WHEN SHE STARTED TO BURN AND ITCH AT INJECTION SITE. NOTICED HIVES ON ARM AND AREA FELT FEVERED. USED ALCOHOL TO COOL OFF BURNING BUT IT CONTINUED TO HURT.
Stiff neck and headache on left side; 1 PM crummy stomach; 1:30 PM nausea (took Librex 2 PM); took naprosyn 5:10 PM; palms both hands and arches both feet itched and burned with tingle 7:45 PM; took diphenhydramine 8:15 PM; finally better 10:00 PM.
The night of the vaccination, I had what seemed like food poisoning.  This included abdominal pain and diarrhea.  This quickly subsided.  As of today (2/10/15) I still have injection site pain and swelling of about an inch in diameter.