chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Issues with my eyesight; My left knee now has issues; I am just worried; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for COVID-19 immunization. On an unspecified date, patient experienced issues with my eyesight, my left knee now has issues, I am just worried. Patient wanted to know what to do or should I expect in future. The clinical outcome of events was unknown.  Information about batch/lot number has been requested.
On 4/17/21 (date of vaccination) I began feeling very tired around 8:30 PM, started getting chills around 9:00 PM, and went to bed around 9:30 PM. On 4/18/21, I woke up around 6:30 AM with severe chills, temperature of 107 (infrared thermometer that is accurate), a severe headache, pain/aching in all joints and throughout my entire body. I used a cold rag to cool down, drank plenty of fluids and got my temperature down to 103 quickly. After taking Tylenol, my temperature came down to my typical 97.4. Throughout the day on Sunday, my headache would not subside (I have had a headache since, and still do), my temperature would climb a few hours after taking Tylenol, and I was awake for roughly 4 hours, total. My joints are still achy, and I now have a post-nasal drip and slight cough. My temperature returned to normal, without medication, by Monday afternoon (4/19/21).
Idiopathic thrombocytopenia purpura with platelet count = 6,000 on 7 Mar 08.  Dropped to 4,500 on 8 Mar 08.  Received platelet transfusion and 2 doses of IVIG.  Subsequently resolved and remaining WNL since.
Information has been received from a father of a 15 year old female who in approximately March 2001 was vaccinated with hep A vaccine. Concomitant therapy included minocycline (dose, duration, and indication not reported). On approximately 01/23/2002, the pt had a severe allergic reaction. The pt developed hives and swelling around her wrists, elbows and feet. The pt was treated with unspecified steroids. The swelling around her wrists and elbows was reduced, but her feet were swollen making it difficult to walk. The pt's father stated that the consulting allergist suggested that the pt's allergic reaction was due to minocycline. He stated that the doctors said "this was a persisting condition." He also stated that his daughter's doctors do not believe his daughter's experience was related to therapy with hep A vaccine. No further info is available.
fifty cents size red area @ inject site noted 16NOV91; Seen by ER MD place on oral ATB;
Acute renal failure; Dehydration; Urinary tract infection; A spontaneous report was received from a nurse concerning a 90-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed acute renal failure/acute kidney injury, urinary tract infection, dehydration and vaccine administered intramuscularly in the right thigh.  Medical history or concomitant medications were not reported.   On 24 Feb 2021, the patient received his first planned dose of mRNA-1273 (batch number: 029K20A) intramuscularly in the right thigh for prophylaxis of COVID-19 infection.   On 08 Mar 2021, he went for cystoscopy and bioscopy with unknown results. On 09 Mar 21, he was sent to the ER for acute renal failure, dehydration and Urinary tract infection (UTI). He was admitted to the hospital.  The events acute renal failure and urinary tract infection were considered to be medically significant.  The action taken with mRNA-1273 in response to the acute renal failure, dehydration and Urinary tract infection was unknown.  The outcome of the events acute renal failure, dehydration and Urinary tract infection was not provided.  The outcome of the event, vaccine administered intramuscularly in the right thigh, was considered resolved on 24 Feb 2021.    The reporter did not provide any causal relationship between mRNA-1273 and the events acute renal failure, dehydration and Urinary tract infection.; Reporter'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.
Client fainted app 5 minutes after receiving vaccine and hit his head on the floor. Client rested approximately 45 minutes but still felt weak. EMS called. On checking vital signs while standing client had seizure at approximately 10:30. Transported to hospital at 10:45 am.
some fatigue; throat is very sore and very dry; throat is very sore and very dry; it is difficult to swallow; his throat does still feel "a bit swollen."; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer Sponsored Program. This male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 29Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported receiving his first dose of BNT162B2 on 29Mar2021 and that his second dose had been schedule for 12Apr2021 which was 14 days and inquired if this was okay as he knew the recommended interval was 21 days. He reported that after his first dose, he did not experience any side effects initially, just "some fatigue." However, he stated that this morning (as of 05Apr2021) his throat was very sore and very dry and reported that it was difficult to swallow. He stated that it had been a couple of hours and he felt a bit better but reports that his throat still felt "a bit swollen." The patient inquired if the side effects he was experiencing with his throat were common with the vaccine of if he could just be getting a cold. He stated that he did read that "there is an issue with lymph nodes" and thinks that the throat is a common area where lymph nodes are. The clinical outcomes of fatigue, throat is very sore and very dry, it is difficult to swallow, and throat does still feel a little bit swollen were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Three to four minutes after vaccination, patient alerted me that she was not feeling well.  Symptoms included rapid heartbeat and "full body sweat."  Patient became unresponsive with eyes open, at which point I retrieved an EpiPen and instructed my technician to call 911.  Patient became responsive within 20 seconds.  Patient remained seated over course of following hour, at which point she reported feeling like her normal self.
Pt did not have any adverse events, however, he did receive 2 sets of the covid vaccine for a total of 4 doses.
the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 25-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Information has been received from a pharmacist referring to a 1 day old male patient. Information about concurrent conditions and medical history was not provided. On 10-JUL-2015 the patient was vaccinated with RECOMBIVAX HB (lot # L007558, expire date 10-NOV-2016, 0.5 ml, intramuscular in the right lower extremity) which was improperly stored. No adverse effects reported at this time. The outcome of the events was not reported. Additional information is not expected because physician gave no consent to be contacted.
Small lump in hip at injection site that itches and is red and painful. Lump not going away and is the same reaction as the last two doses of the same type of vaccination. All three have been reported.  Patient's doctor says it could be ARTHUS reaction and that I should report and find out what else it could be.
sl tongue swelling, difficulty swallowing wrist & ankle pain, t100.4 about 3 hrs p/vax; later temp 103.3; tx APAP; pt cried excessively p/shot;
her blood pressure was bottoming out; feeling like her heart was skipping; This is a spontaneous report from a contactable consumer or other non-HCP via Medical Information Team. A 55-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 20Jul2021 as dose 2, single (at the age of 55-years-old) for COVID-19 immunization. Patient medical history included heart disease and 5 heart attacks. The concomitant medications were not reported. Patient was a 55-year-old female. She received the second dose yesterday (20Jul2021) and after an hour she began feeling like her heart was skipping and her blood pressure was bottoming out. She was highly disappointed in the situation. She had really bad heart disease.  She has had 5 heart attacks.  She was in the hospital in January for her heart. She thought she had made an appointment to see her doctor yesterday however it was for a drive through site. She had to fill out paperwork while moving and by the time she was able to see the side effects she had already gotten the vaccine and she got an outdated fact sheet. Yesterday allowed them knowing more information and that she had a bad heart no one said anything.  She was terrified to get the vaccine but it was better than taking the chance of dying. There was too much they did not know about this shot. She would not let her husband and son get it. She would tell everyone not to get it. We were going to take up for Pfizer because we work for them. The outcome of the events was unknown.
Saturday left deltoid was tender, red and raised. Sunday was worst day being bright red and tender. Monday skin was fading into light pink with a bluish hue.
Difficulty concentrating, maintaining train of thought. Somewhat better now but still struggling with it almost two months after. Tiredness and exhaustion. Still struggling with it.
Pyrexia, Listless This case was reported by a nurse and described the occurrence of fever in a female subject (age not specified) who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  There were no concurrent medications.  On on unspecified date, the subject received the1st dose of Engerix-B. At an unspecified time before 25 July 2006, one day after the vaccination with the first dose of Engerix-B, the subject experienced fever (103 degrees Fahrenheit) and became listless.  Further information was not provided.
HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23; Vaccine was administered to patient after temperature excursion occurred; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 05D22A) for COVID-19 prophylaxis.     The patient's past medical history included Cognitive impairment (mild cognitive impairment).    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that no confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 30-May-2023. Up to 14 vaccination were administered within that time line. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730480 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730480:Same reporter
Mild rash on wrists and elbows that started 30 minutes after vaccination. Kept evolving overnight until waking up with generalized pruriginous rash (arms, hands, thorax, abdomen, neck and feet).
This spontaneous case, initially received from other non-health professional (consumer) on 15-Oct-2018, concerns an elderly female patient, older than 65-year-old. The patient's historical drug included flu vaccine for an unknown indication. The patient's current conditions included a rare spine disease, metastasized paraganglioma. The patient did not receive any concomitant medications. On 12-Oct-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, anatomical site: left arm, route of administration, batch number and expiry date: not reported]. It was reported that the patient wanted a regular influenza vaccine with 4 strains, and she was given FLUAD instead by the pharmacist (coded as wrong vaccine administered). On the same day, almost immediately after vaccination, the patient developed a hard, 3-inch knot in her left arm, where the vaccine was administered. The patient walked home afterwards, and immediately noticed that she was incredibly weak" in her legs as she walked home, something she had never experienced before. When the patient got home, she laid down and she stated that she felt worse and continued to experience weakness, but also dizziness, a headache, and nausea. At the time of this report, the patient was recovering from the event immediate post injection reaction and injection site induration. The outcome of the other events (dizziness, feeling abnormal, muscular weakness, nausea and headache) were not reported. The reporter assessed the case as non-serious.
I can't raise my arm to a horizontal position; Pain is starting to go to my back; Pain is starting to go to my head; Instead of going into the side of my arm, they put it almost vertically down into the joint; joint  is hurting like crazy; A spontaneous report was received from a consumer concerning a patient, of unknown gender and age, who was administered Covid-19 vaccine as follows: instead of going into the side of his arm, they put it almost vertically down into joint/ MedDRA PT: product administered at inappropriate site and experienced it is hurting like crazy/ MedDRA PT: vaccination site joint pain, can't raise my arm to a horizontal position/ MedDRA PT: vaccination site joint movement impairment, pain is starting to go to my back/ MedDRA PT: back pain, and pain is starting to go to my head/ MedDRA PT: headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 032L20A) for prophylaxis of Covid-19 infection.   The patient reported that instead of going into the side of their arm, they put it almost vertically down into joint and it is hurting like crazy. Two days later, it is getting worse, and the patient can't raise their arm to a horizontal position. The patient also stated that pain is starting to go to their back and their head.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events of it is hurting like crazy, can't raise my arm to a horizontal position, pain is starting to go to my back, and pain is starting to go to my head, was considered as unknown. The event, vaccine instead of going into the side of his arm, they put it almost vertically down into joint, was considered recovered.; Reporter's Comments: The events of vaccination site joint pain, vaccination site joint movement impairment, backpain and headache developed after first dose of mRNA-1372. 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 is in follow-up to report(s) previously submitted on 5/28/2004. Initial and follow-up information has been received from a RN concerning a 15 month old male pt with no medical history reported and with no illness at the time of vaccination who on 03/10/04 at 9:30 am  was vaccinated SC in the left thigh with a first dose  0.5mL dose of MMRII (Lot # 646072/0806N). The patient was also vaccinated with a fourth dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (Infanrix), which was administered intramuscularly in the right thigh, at 9:30 am on 10-Mar-2004. On 16-Mar-2004, the patient developed a fever (body temperature measurements not provided). On 18-Mar-2004, the patient developed a "rash (measles-like)" (initially reported as a red rash from head to toe). Subsequently, the patient recovered (date not provided). Unspecified medical attention was sought. No further information is available.
Information has been received from a health professional concerning a patient who on 11-OCT-2007, was inadvertently vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). Initially it was reported that this was a case of product confusion, but the health care provider on telephone follow up reported that it was just human error and did not have anything to do with an actual product confusion. No adverse experiences were related to this event. No further information was available. Additional information has been requested.
Patient stated she developed extremely swelling in the arm that she received the flu shot. Upon inspection, the arm looked completely normal, no swelling after 1 week.  We recorded the flu administered on the Right arm and pneumo on the Left, but patient insisted that we got it wrong. She said she remembered flu was administered on the right, and pneumo on the left.
pt had a local react of itching, swelling, & redness approx 3" circular @ inj site; started on the eve of 10APR; redness dec to 5cm on 13APR; pt also c/o nausea; 14APR redness, swelling & itching subsided;
Sore arm; fatigue; night sweats; This is a spontaneous report from a contactable Other Health Professional (patient). A 39-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 22Dec2020 07:15 at a single dose for COVID-19 immunization at the hospital. Medical history included anxiety from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medications included ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE), escitalopram oxalate (LEXAPRO), birth control and unspecified MVI. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm, fatigue and night sweats on 22Dec2020 with outcome of recovering. No treatment was given for the events. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on batch/lot number was requested.