chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired dose of Havrix was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 43-year-old female patient who received HAV (Havrix 1440) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.  On 06-FEB-2023, the patient received the 1st dose of Havrix 1440. On 06-FEB-2023, an unknown time after receiving Havrix 1440, the patient experienced expired vaccine used (Verbatim: Expired dose of Havrix was administered). The outcome of the expired vaccine used 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 Information: GSK Receipt Date: 20-MAR-2023 The reporter was an Office Admin. The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up via postal. The patient received a dose of expired Havrix vaccine, which had led to expired vaccine used.
Arm was just a little sore; Has been tired since then; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was just a little sore) and FATIGUE (Has been tired since then) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, CALCIUM, VITAMIN D NOS, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), OMEPRAZOLE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced FATIGUE (Has been tired since then). On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm was just a little sore). At the time of the report, VACCINATION SITE PAIN (Arm was just a little sore) and FATIGUE (Has been tired since then) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included vitamins. The patient did not receive any treatment medications.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a registered nurse refers to a unknown number of patients of unknown age and gender. On an unknown date in 2013 the patients were vaccinated with GARDASIL. It was reported that unknown number of patients might have received improperly stored GARDASIL doses exposed to 31F from 15-OCT-2013 to 10-DEC-2013. No adverse effect reported. Additional information has been requested.
Two days after 2nd COVID vaccine patient experienced loss of vision in right eye. He also reports having a cough for a week after the shot.  This adverse reaction was uncovered during an unrelated hospitalization while taking patient history. 22 days after the onset of vision loss, he reports that vision has slightly improved but remains hazy and distorted.
12 hrs after vaccination (3:00 a.m. 2/8/12) - chills, fever, entire body pain - joints, back, face, ears, throat "sinus headache over 1/2 face"; knee pain, ankle pain, eye ache, outer ear pain. Continuous until 2/1/12 afternoon. Required 24 tx. TYLENOL & ALEVE rx. 2/9/12 - lethargy, weakness, knees fell wobbly; dizziness, could not attend class x 2 days due to extreme symptoms.
This spontaneous report as received from a nurse refers to a male patient who is currently 4 years old. Information regarding patient's medical history, concurrent conditions, concomitant medications, drug reactions, allergies and past therapies were not reported. On an unspecified dates, the patient was vaccinated with two doses of improperly stored PROQUAD lot # N015623, expiry date: 15-NOV-2018, lot #N024564, expiry date: 06-MAR-2019 for prophylaxis whose dose and route of administration were not reported. It was reported that vaccine was reconstituted with the sterile diluent (MERCK) lot # L030305, Expiry date: 08-APR-2018 also reported as "30-APR-2018" which was stored in proper conditions. The PROQUAD was subjected to a temperature excursion of 6 degree F to 14 degree F (5.9 degree F) for a time frame of 18 minutes which was noted from a data logger. There were no previous temperature excursions. No adverse effect reported. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1804USA002069.
At 1am arm became more sore. At 2am, 14 hours after second shot, I was cold and was shaking. It felt like the origin of the sensation was in my mid spine. Then it would radiate to upper back, torso,  arms and legs.  Shaking/ was incontrollable for 40 to 50 seconds off and on for 2 hours. Then I fell asleep woke up again shaking 3 hours later. Lasted 1 hr. Then stopped.. Currently, 10:45 am. I feel sore but no shaking.
Immediately after injection, felt like a volcano eruption that was forming a large area of hurt.  Cont. through the evening. Nausea: Approximately 4 PM  Nausea set in.  I did "not" vomit.  But it was a strong feeling.  Ate light supper and around 7/8 PM Nausea came around again.  Did not vomit.
Flu-like symptoms; high fever (102 F); headache; chills; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP6955), via an unspecified route of administration in left arm on 27Mar2021 13:15 (at the age of 60-years-old) as dose 2, single for COVID-19 immunization. Medical history included hypertension (moderate hypertension (well controlled)). The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6208), via an unspecified route of administration in left arm on 06Mar2021 01:15 a.m. (at the age of 60-years-old) as dose 1, single for COVID-19 immunization and experienced Fever and Vaccination site pain. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not having any known allergies. The patient experienced flu-like symptoms, high fever (102 F), headache and chills on 28Mar2021 03:00. Since the vaccination, patient has not been tested for COVID-19. The patient received treatment with ibuprofen 400 mg. Outcome of events was resolving.  No follow-up attempts are possible. No further information is expected.
Chills, sweats, eye puffy, headache, sore, fatigue, foggy headed
After administration it was identified that Tdap was given instead of HBV.  No adverse reaction.
Left arm - Pain at site of injection that spread down arm, macular red rash localized to left arm and fever (tmax103).
Eosinophilic pneumonia; eosinophilic 'proctitis'; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received bnt162b2 (BNT162B2), on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient experienced eosinophilic pneumonia. The reporter wanted to know If there is any data regarding like an eosinophilic 'proctitis' or eosinophilic pneumonia following the vaccine. The outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This non-serious medically confirmed report (initial receipt 13-Oct-2014) concerns a female patient who has an allergy to tree nuts and oils. On an unspecified date, the patient received AFLURIA (batch number not reported) for the prevention of influenza. On an unspecified day after receiving AFLURIA vaccine, the patient developed an hives and urticarial reaction (hives) at the injection site. The doctor did not treat the hives and it resolved by itself in 24 hours. Outcome was recovered.
had 2 1/2-3in long x 1 1/2 inch wide red & warm area;lt leg seen by own MD who stated was allergic rxn to serum;told to keep an eye on it & if worse call back;was better 1wk p/vax;
first dose on 8/13/2019, second on 11/11/2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number 45N3Y, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 13th August 2019).   On 11th November 2021, the patient received the 2nd dose of Shingrix. On 11th November 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.  The reported did not had any more information regarding 1 dose lot number. The reporter consented to follow up.
injection site pain; This is spontaneous case report received from a contactable consumer, the patient. A 45-year-old adult non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot/batch number: EL3247) via an unspecified route of administration on 16Mar2021 at 11:30 on left arm for COVID-19 Immunisation. Medical history included seasonal allergy and asthma. The patient did not had any allergies to medications, food or other products. The patient's concomitant medication included Zyrtec (cetrizine) for unknow indication. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Past drug history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot/batch number EL3247) via an unspecified route of administration on 22Feb2021 at 10:45 on left arm for COVID-19 immunisation. On 16Mar2021 at 14:00, she experienced injection (vaccination) site pain. Therapeutic measures were taken for event experienced and included acetaminophen. The clinical outcome of the event injection site pain was recovered.
arm hurts; body ache; heavy headedness; more tired; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 on an unspecified date at single dose for COVID-19 immunization and experienced injection site pain, feeling more tired than usual the day off and after and headache. After receiving the second dose, the patient experienced arm hurts way more than last time, a lot more body ache, heavy headedness and just feeling more tired on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Joint aches (fingers, neck, shoulders) chills, tiredness, headache, pain at the injection site
Severe sore throat inflammation. Severe ear infection with 50% hearing loss. Chest congestion and racking cough. Nausea and vomiting.
Polyuria since vaccination given at DPH on 11/10/09. Seen by MD today 11/13/09
My mother has experienced a severe reaction to her vaccine. Diagnosed with brain encephalopathy probably caused by molecular mimicry in response to the Covid vaccine, she is now being treated as an inpatient at the Clinic.  She was fully independent- living alone, mobile, with excellent cognitive function.  On January 21, 2021 she received her 1st Moderna vaccine. Subsequently family noticed small balance changes, slight fine motor coordination changes (handwriting, etc) and a little forgetfulness not previously seen. Everything was chalked up to her being 89 years old.  She remained independent and relatively fully functional.  Patient is now unable to stand without assistance, leans backward when trying to stand, has developed a spastic tremor bilaterally in her arms, and her cognition is completely altered.  Hallucinations, memory loss, can follow some directions but not all, speech clear but inappropriate.  This declines DAILY. As of March 7th, she could not identify immediate family members in a photo. These changes have all occurred within the past few weeks and appear to have an acute underlying cause not related to age.    Medical staff are looking at an autoimmune encephalitis picture based on the antibodies developed from the vaccine attacking the tissue in the brain and spinal cord that resembles the small piece of the vaccine.    She is currently at the Clinic affiliated hospital. At this time, family is contacting Clinic main campus to request further investigation.   Photographic evidence of rapid decline available, but not able to attach to this form:   Available are three pictures of a log patient keeps with her vitals that she was doing every day.  1. Personal log of vital signs pre Covid vaccine/dose 1 - you can see the handwriting is concise, clear, and orderly.   2. Personal log of vitals after Covid dose 1 on Jan. 21 - slight changes in the handwriting and orderliness but still ok.  3. Personal log of vitals after Covid vaccine dose 2  Feb. 17 - note the illegible handwriting, missing entries, and no spatial awareness of line alignment.  Available are three photos of crossword puzzles she does every day.    1. Puzzle dated Feb.12. Demonstrates her ability to accurately fill most answers with clear writing.   2. Puzzle dated Feb.19 shows an ability to fill in only a couple answers with obvious handwriting changes.   3. Puzzle dated Feb. 21 shows inability to complete, and a strange discrepancy between ability and inability- note 29 across and 18 down.  Patients outcome is undetermined as diagnosis/treatment and prognosis are ongoing.
9 days after the vaccine I still have a very inflamed throat, chronically and visibly inflamed lymph nodes. I have 4 days of anti-inflammatory treatment but no results.
Immediate onset of urticaria at site of both injections. No other symptoms or ash or spread of hives.
Patient reporting chest pain within a few hours after receiving shot and lasting 24 hours after receiving; This is a spontaneous report from a contactable pharmacist. A 22-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via intramuscular route of administration in the right arm on 14Jul2021 at 14:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient had any medical history and known allergies. It was unknown whether the patient was pregnant at the time of this report. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0202) via intramuscular route of administration in the left arm on 22Jun2021 at 22:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. On 14Jul2021 at 18:00, within a few hours after receiving shot, the patient reported chest pain that lasted 24 hours after receiving. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event chest pain was resolved on 15Jul2021.
3 hours after Immunizations-developed high pitched shrill cry lasted 1 hour + (1230pm) temp no higher than 100 degrees. 7 hours after developed rash on abdomen described as hives by parent (430pm). Rash described as macular-papular rash by ER doc. 6-21-10 at 1730.
Shaking; Diarrhea; Exhausted; body sore; Sore arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arms), TREMOR (Shaking), DIARRHOEA (Diarrhea), FATIGUE (Exhausted) and MYALGIA (body sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included BENAZEPRIL and HCTZ for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arms). On 24-Feb-2021, the patient experienced TREMOR (Shaking), DIARRHOEA (Diarrhea), FATIGUE (Exhausted) and MYALGIA (body sore). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arms), TREMOR (Shaking), DIARRHOEA (Diarrhea), FATIGUE (Exhausted) and MYALGIA (body sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
None noted at time injection was given.  Patient received Moderna vaccine for 1st on 01/25/2021 and Pfizer was given for 2nd dose on 02/22/2021.
Having an adverse reaction which deals with his eyes; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER (Having an adverse reaction which deals with his eyes) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE DISORDER (Having an adverse reaction which deals with his eyes). At the time of the report, EYE DISORDER (Having an adverse reaction which deals with his eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
The patient was nervous about getting her COVID-19 vaccination due to autoimmune/Lyme disease health issues. We went over her VAR form, allergies, health conditions, and verified her MD still wanted her to get the covid shot. She came in with her elderly mother. She was given her first dose of Moderna around 7pm. I advised her to stay 15-20 minutes after her vaccination seated to ensure her safety. I noticed she was holding her head in her hand after about 10 minutes. I went out to check on her. She said she felt really tired, weak, had red blotches on her skin, felt heart rate high, back aches or pain. I checked her blood pressure twice and it was 150/101 and 171/101.  I called 911 to have her evaluated. She chose to go to the ER via ambulance due to pre-existing health conditions and felt this would be best. I felt so as well. It did seem the EMT and fire department didn't want to take her. I told them about her autoimmune issues and asked if they felt it was wise for her to go get monitored as I know she was very worried about an inflammatory response due to the Lyme/autoimmune disease health conditions.
This is a spontaneous report from a contactable consumer (patient). A 58-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER2613), dose 1 via an unspecified route of administration, administered in left arm on 16Mar2021 at 09:30 as dose 1, single (at the age of 58-years-old) for COVID-19 immunization. Medical history included salfa allergy. There were no concomitant medications. Prior to the vaccination, within four weeks patient did not receive any other vaccines and not diagnosed with COVID-19. And not received any other medications within 2 weeks of vaccination. On 19Mar2021 at 16:00, The patient experienced fever 102, headache, chills and nausea. The patient underwent lab tests and procedures which included body temperature: 102 (unknown units) on 19Mar2021. Since the vaccination, the patient had not been tested for COVID-19. The reporter classified the events as non-serious and stated the events result doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was resolving. No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a pharmacist and refers to a currently 71 year old female patient with hypertension and none drug reactions or allergies. On 20-FEB-2014, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, (dose, anatomical location, lot number and expiration date were not reported). The patient's concomitant therapies included FLEXERIL and tramadol hydrochloride. On an unknown dates, the patient had experienced three outbreaks of shingles since receiving ZOSTAVAX. The patient sought medical attention by visiting the physician and was currently being treated with valacyclovir for her current shingles outbreak. At the time of reporting, the patient did not recover from shingles outbreak. The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Information has been received from a nurse concerning a "14 or 15" year old female who was vaccinated intramuscularly with a 0.5 mL second dose of Gardasil.  Subsequently the patient experienced nausea, was white in the face, and sick to the stomach.  The patient sought unspecified medical attention.  Subsequently, the patient recovered.  This is one of several reports from the same source.  Additional information has been requested. This is in follow-up report(s) previously submitted on 6/14/2007; 7/6/2007. Information has been received from a nurse concerning a 13 year old female with a history of reactive sympathetic dystrophy, who on 11-DEC-2006 was vaccinated intramuscularly in the left deltoid with a 0.5 mL second dose of GARDASIL (lot# 653937/0637F). Subsequently the patient experienced sick "queasy" to the stomach, dizzy, and weak immediately following the dose. The patient sought unspecified medical attention. Subsequently, the patient recovered on 11-DEC-2006. The patient's experience did not prevent her from receiving the third vaccination. Additional information has been requested.