chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial case received on 13 January 2011 from a health care professional, who is also the patient. A 55-year-old female patient received an intramuscular right deltoid injection of IPOL (lot number A0491-4) and an intramuscular right deltoid injection of TYPHIM VI (lot number A0823, not a valid sanofi pasteur lot number) on 22 August 2008. In September 2009 (patient unable to provide exact dates due to memory problems) she was diagnosed with a brain tumor, and underwent brain surgery. Per the patient, she continues to have memory problems and has not returned to work.
Pt experiences 1/2-1 inch swelling at the site (from elbow to half way to shoulder) redness & itching x 5-7 days.
Patient felt faint and heart started racing after receiving first dose of Moderna vaccine.  Patient's sister states she has history of anxiety.
Patient received 1dose of the JJ vaccine approximately 3 minutes later patient complained of being dizzy......patient lost consciousness for about 20 seconds came to then began to sweat. Ambulance was called and arrived within 4 minutes. Patient was evaluated then transported to local hospital to be checked out.
Her whole arm(on which vaccine was administered) was inflammed and swollen and she developed a rash within 1-2 days. She also had a mild temperature the day after vaccination and reported that she did not feel better. However the temperature subsided in a day. The rash was bothering her and so she decided to visit a walk-in clinic and she was daignosed with cellulitis. She was given antibiotic (IV) in the clinic and was prescribed a course of oral antibiotic also.
Severe headache, weakness while standing, low grade fever, nausea, and heavy sweats and chills.  Treatment: Rest  Outcomes: Still weak from the adverse event. Left work early on 04-13-2021 due to some motion sensory illness (nausea like symptoms with an elevated temperature).
This spontaneous report as received from a nurse professional via a company representative, refers to a 16 year old male patient. The patient's concurrent condition included allergy to penicillin (unspecified). The patient's medical history was not reported. There was no concomitant therapies. On 22-AUG-2014 the patient was vaccinated intramuscularly (IM) with the first dose of GARDASIL (batch #, lot#, an expiration date and dose were not reported). Subsequently, the patient received the second dose of GARDASIL (batch #, lot#, an expiration date and dose were not reported) on an unspecified date. The patients received the third dose of GARDASIL (batch#, lot#, an expiration date and dose were not reported) on 20-AUG-2015, 12 months after the initial dose, which was past the recommended guidelines in the product information (PI) sheet. Immediately, after receiving the GARDASIL shot, the patient's eyes rolled back and foam started to generate out of the corner of the patient's mouth. The patient sought medical attention. The nurse practitioner advised the patient to lay down for an unspecified amount of time. On the same day, the patient recovered from the events before leaving the nurse practitioner's office. There was no treatment given to the patient and no lab diagnostics studies performed for the events. The relatedness between the events and the GARDASIL was not reported. Additional information has been requested.
1st does none, 2nd dose been 6 hours, today 4/6/21-none yet.
24 hours post injection chills, sweats, nausea, vomiting, hydrated given IV ZOFRAN in the ED and discharged
Vomiting, fever (101.5), and rapid heart rate (180 bpm).
Sore arm after injection; This is a spontaneous report from a non-contactable consumer or other non health care professional. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number: not reported, expiry date: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm after injection on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left arm pain at site of injection; Pain was majorly at movement; This is a spontaneous report from a non-contactable physician. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 04Mar2021 at 13:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, dyslipidemia, cancer and inverse psoriasis on topical treatment. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included enalapril (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN), both taken for unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 11Feb2021 at 13:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 04Mar2021, on the day of injection around 18:00 to 19:00, the patient had left arm pain at site of injection and had lasted less than 24 hours and experienced pain majorly at movement. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left arm pain at site of injection and pain majorly at movement were resolved on an unknown date on Mar2021.  No follow-up attempts are possible. No further information is expected.
Intermittent excessive crying & reported fever 2nd day p/vax apparently resolved by 3rd day;
Myalgia, Started with chills, then myalgias and left arm pain; SOB started 4/11/2021 with mild dyspnea on exertion and mild nose bleed (resolved). Narrative: Symptoms improving
c/o chills, nausea, hypertensive (170/100), flushing of face, redness and blotching of chest and neck
Heart palpitations started 4/11/21 and have continued consistently to this reporting date.
Patient called pharmacy at 3:30 pm on June 20th stating the vaccine she recieved on June 15th had some adverse reactions she wanted to talk to the pharmacist about. Pt reports experiencing shooting nerve pain running to throughout her body, and the pt reports she was unable to sleep on either side of her body that night. Pt also reports she experienced joint pain as well and states that the joint pain and nerve pain lasted for about 2 days. The pt also reported pain at the injection site that lasted 5 days from (06-15 to 06-20). Pt states that she did not take any medication at this time for the shooting nerve or joint pain and just tried to "exercise it out".
patient received IPOL from a punctured vial after it was exposed to a temperature excursion with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient received IPV (VERO) [IPOL] from a punctured vial after it was exposed to a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Sep-2022, the patient received 0.5 ml dose of suspect IPV (VERO), suspension for injection from a punctured vial (lot V1B901M; Expiration Date :22-Jun-2024) via unknown route in unknown administration site for immunization after it was exposed to a temperature excursion with no reported adverse event (poor quality product administered) (latency; same day).  This situation occurred due to fridge malfunction Max/Low Temperature reached 16.6C, 8.9C, +9.6C, +8.6C, +12.8C for 1st excursion 6 HOURS and 17 MINUTES 2nd excursion 23 MINUTES 3rd excursion 15 MINUTES 4th excursion 8 MINUTES 5th excursion 6HOURS and 16 MINUTES. Human error was not involved.  Action taken: not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient was given Moderna vaccine and she was under the age of 18 at the time.  Vaccine was approved by Father to give and documented in the chart. There was no Adverse event from the vaccine.
Where I was given the injection, I have a large red  swollen bump. It's been 48 hours and it seems to be getting larger. It's looks similar to a spider bite.
Pt screened for hx conuvls, allergy to egg or meds; in good hlth; recvd MMR approx 5 mins later pt fainted; quickly regained consciousness; alert oriented x 3; vx pulse, resp 16, BP 110/60;
Her response to the pneumococcal polysaccharide vaccine was inadequate; This literature marketed report was received from the authors in a published literature article titled as stated below, concerning an adult female patient. Our patient first came to medical attention in childhood where she was noted to suffer from numerous episodes of otitis media, bacterial pharyngitis, and bacterial pneumonia. She developed bouts of oral thrush even aside from antibiotic use. At age 24 years she developed her first of two lifetime cases of optic neuritis. She was also diagnosed with hyperparathyroidism in setting of osteoporosis and numerous fractures. She had three children, with one diagnosed with type 1 diabetes and rheumatoid arthritis. Her infections persisted and she was referred to an immunologist at 57 years of age, who noted a mildly low immunoglobulin g (IgG) of 612 mg/dL and immunoglobulin A (IgA) of 75 mg/dL.   On an unknown date, her response to the pneumococcal polysaccharide vaccine (manufacturer unknown) (exact dose, route of administration, lot number and expiration date were not provided) was inadequate and she would be diagnosed with common variable immune deficiency (CVID).  The outcome of the event was unknown. The author considered the event to be related to the adverse event.  Literature report: Recurrent Infections and Profound Autoimmune Disease in a Patient with a Heterozygous TNFSF12 Variant.  A copy of the published article is attached as further documentation of the patient's experience.
This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 14-JAN-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Patient seen in the ED on 6/16 for weakness and overall failure to thrive. A COVID PCR test was ordered on 6/16 which was positive. Patient was admitted from 6/16-6/29  for general weakness and inability to care for himself.  This meets criteria for vaccine breakthrough case review.
Left lower thigh purple - erythema 5x5", heat, 2x3" induration 4d after Varivax. Tired, napping. No fever, no adenopathy, no rash elsewhere
Patient states she had swelling of her tongue and throat that started approximately 2-4 hours after she received the injection. She states she took a Benadryl and the next day took an antihistamine and was better. Reaction was not severe enough to cause SOB or any visit to a medical facility.
Day of injection, rash developed on legs and elbows, no fever, very itchy.
Pt given TDAP, Heat 8-2-12 for wound check. (L) arm appears red. N.P. Rx KEFLEX. Dx with cellulitis.
Within two weeks after vaccine I?ve had horrible joint and tendon pain. I?ve been an active, extremely healthy individual my entire life and it?s preventing me from doing my daily running, cycling, and working out routines that I?ve done throughout my life.
Child noted red painful swollen area on right posterior upper arm where Varivax was given. Today (1-22-15) the swollen area is larger, approx. 3" diameter and feels hard.  Still red and painful.
the patient's diagnosis is Polymyalgia rheumatica; This is a spontaneous report from a contactable consumer. An adult male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 for COVID-19 Immunization. The patient had inflammation after receiving Pfizer COVID vaccine and is being treated by a rheumatologist. The reporter said the patient's diagnosis is Polymyalgia rheumatica. The outcome of the event was not recovered. Therapeutic measures were taken as a result of event.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Pt recvd a series of 3 doses of Engerix-B 28MAR91, 25APR91, & 25SEP91 & 30OCT91 titers were checked & a low response was detected; initially pt believed titer was 11 but p/reviewing records learned titer was 12.6;
Expired vaccine used; Patient got 0.5 ml of booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and ACCIDENTAL OVERDOSE (Patient got 0.5 ml of booster dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and ACCIDENTAL OVERDOSE (Patient got 0.5 ml of booster dose). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and ACCIDENTAL OVERDOSE (Patient got 0.5 ml of booster dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received contains no new information.
Asthma attack; This is a spontaneous report from a contactable consumer(patient).   A 57-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on 02May2021 (At the age 57-year-old) as dose 1, single for COVID-19 immunization. Medical history included neuropathy peripheral (Neuropathy), nerve injury. The patient's concomitant medications were not reported. The patient experienced asthma attack on an unspecified date. The patient stated, she have several underline autoimmune conditions (history) and her Neurologist said that she personally needed to get the Covid Shot. The patient first dose shot administered on May 2nd and she had adverse effect which she did not report. Patient took the prednisolone shot for the asthma attack, patient waited 3 hours in the rain and did not get the appointment at 11:30, so she cancelled, and she tried to reschedule. she went for an appointment on 23Sep, and she was told by someone that she have to receive his second dose shot and she received that, within 20 minutes and she had breathing difficulty and she couldn't breath, so she used albuterol inhaler (treatment) and went to the Pharmacist about what was going on, breaking up hives on his body, so Pharmacist told to go home and take Benadryl. She have Neuropathy, nerve damage (history). his fingertips were annoying, she was having electrical impulse in feet. she also had severe Migraine, so this Sunday this was the first time she was not able to walk. she didn't have fever but she had just cold, she didn't have the neurological symptoms, so she just did see his Neurologist she take Gabapentin 1800 mg now Doctor increased it to 2400 mg a day and she have to receive Sumatriptan injection for Migraine (treatment) so that's the one until today so far and however she still have the neurological issue of the fingertips pain, numbness and the electrical impulse. Therapeutic measures were taken as a result of asthma attack. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Mild sleepiness; mild dizziness; mild fatigue; mild soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient, received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, in arm Left on 13Feb2021 09:00 (Batch/Lot number: Em 9809 (ks)) as SINGLE DOSE, for covid-19 immunisation. The patient did not have any allergies to medications, food or other products. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has been tested for COVID-19, post vaccination. Medical history included pcos (polycystic ovarian syndrome) and hbp (hypertension) from an unknown date and unknown if ongoing. Concomitant medications included metformin and atenolol taken for an unspecified indication, start and stop date were not reported. The patient experienced mild sleepiness, mild dizziness, mild fatigue and mild soreness at injection site on 13Feb2021 14:00. The patient underwent lab tests and procedures which included COVID-19 test negative on 23Nov2020. On an unspecified date of Feb2021, the outcome of the events was recovered.   Information about lot/batch number has been requested.
Swelling at injection site. erythamatous loacalized reaction, arm warm to touch, severe tenderness.  Appeared as extreme localized reaction to injection.
kidney damage; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 74-years-old via an unspecified route of administration on 10Mar2021 10:00 (Batch/Lot Number: EN6208) as 2nd dose, single dose for covid-19 immunisation. Medical history included severe acid reflux from an unknown date and unknown if ongoing (treated with omeprazole for 8 days). The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 (lot number: EL9265) and experienced kidney damage, fever/temperature started out at 99.9 and went up to 101, had joint pain and a headache, chills, light ache, weird feeling, getting sick and little bit of jaw chopping due to chills.The patient previously took omeprazole for severe acid reflux. The patient experienced kidney damage on an unspecified date. She says the kidney damage is ongoing because her GFRs were down and she doesn't know why they dropped all of the sudden. She says they dropped all the way to 21 and 24, her creatinine was up 2 and a quarter, she never had a problem, and currently as of today the kidney doctor can finally say it was the vaccine. She says her creatinine was up, in her past numbers stuff is dropping off but creatinine was up at 2.25. She says her BUN was 23, 24. She says those GFRs the higher GFR, the 29 one, was at 24 on 16Feb2021. When asked if she means GFR EST she says whatever one was 29. She says one of her GFRs was 24, and the GFR EST was 12. She says 15 is kidney failure so she was just above kidney failure. She says it is slowly coming back. She says the GFR one increased 2 points, the other 1 points. She says the other thing that is going on could be related to the kidney is that her CO2 numbers went from normal to increasing. She says today it is 34, a little above. She says she had 3 metabolic panels after that. She says she hasn't had a test; then last metabolic panel was 24Apr2021 and the numbers for her CO2 all along has been 31 or 32, now all of the sudden for 2 months in a row is is 33, now 34. She says something is going on. She says she had a urine test today but has trouble locating it on her report.  The patient underwent lab tests and procedures which included blood creatinine: 1.93 on 26Feb2021; 1.34 on 24May2021, carbon dioxide: 34 on 24May2021; 31 or 32 on 24Apr2021, GFR EST: 29 on 26Feb2021; 45 on 24May2021, GFR EST-other: 25 on 26Feb2021; 39 on 24May2021, GFR: 12 on 16Feb2021, BUN: 23, 24 on an unspecified date. The patient was recovering from the event.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021147970 same patient, vaccine, similar event, first dose
patient described "flu" like symptoms of achy all over and a low grade fever that started the evening after immunization and has continued the day after.
At 11:05 am this client received two vaccines one was MCV given in Left deltoid, HPV 9 given in right deltoid, client stood up walked towards her mother and fell forward hitting her head on chairs then mother held her and LVN helped mother roll onto her back, she responded immediately and asked mother "what happened?" RN came into the room and helped with elevating her feet, applying cool pack to injuries which swelling showed up on bridge of nose and forehead. Blood pressure was 107/82, pulse 100 at 11:15 RN checked pupils and they were equal/reactive. Mother gave client two puffs of her personal inhaler at 11:20 am at 11:24 am pulse was 96, Res-20. Advised to seek medical attention at this time for injury to nose. Client received Coke to drink, has a c/o nausea no vomiting at this time. At 11:33 is sitting up talking with mother, cool rag to neck drinking a Coke. At 11:40 am client was able to ambulate to vehicle with assist from Mom and RN, kept cool packs to apply as needed. A copy of nursing note involving incident sent with mother. Mother did state during the episode that "she has never passed out before."
pt recv vax 8APR97 & 10APR97 pt exp hives & itching everywhere on body, x/face;
I am reporting on the FLUZONE HIGH-DOSE 2017-18 0.5ml syr, qty. 0.5. I have the following allergies: iodides, DEMEROL 100mg tablets, bees. Several hours after my annual flu shot, I got all the symptoms of flu. It started with a sore throat, then aches, loss of appetite, weakness, and soreness at the injection site. This has happened for the last two years. My doctor said that I am receiving a higher dose of the flu virus since I turned 65. I am reporting these symptoms because the drug information leaflet says that I should not expect flu symptoms. The symptoms subsided after about 30 hours and with treating the symptoms.