chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed a peri-anal abscess; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old male patient received first dose of BNT162B2 (Lot Number: EN6299), via an unspecified route of administration, administered in the left arm, on 03Mar2021 08:45 as a single dose for COVID-19 immunisation. Medical history included Crohn's Disease and Ileostomy. Concomitant medications included vedolizumab (ENTYVIO); esomeprazole sodium (NEXIUM); loperamide hydrochloride (LOMOTIL); simeticone (GAS-X); calcium carbonate (TUMS), all taken for an unspecified indication, start and stop date were not reported. The patient previously took prochlorperazine maleate (COMPAZINE) and dilaudid and both experienced known allergies. It was reported that the patient has Crohn's Disease but had been in remission for several years. Ten days after his first vaccine on 13Mar2021 08:00, he developed a peri-anal abscess that required treatment via antibiotics. It resolved quickly. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 16Apr2021. The outcome of the event was recovered on an unknown date.
Chills, headache, low grade fever, fatigue and muscle weakness  and sore arm. Taking Tylenol.  Symptoms lasted around  42 hours .
I have stuffy nose and nothing else; she is having cold symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  AA 35 year-old female patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASAL CONGESTION (non-serious) with onset Apr2021, outcome "unknown", described as "I have stuffy nose and nothing else"; NASOPHARYNGITIS (non-serious) with onset Apr2021, outcome "unknown", described as "she is having cold symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
already did that, still flu though; Initial information received on 21-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who experienced already did that, still flu though after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine (unknown formulation) (lot number, expiry date, strength, frequency was unknown) via unknown route in unknown administration site  for prophylactic vaccination.  On an unknown date the patient had a non-serious event already did that, still flu though (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Dose 1 4/14/2021 Pfizer EW0169 pt has covid 19
Diarrhea; Belching/burping; Significant abdominal pain; Nausea; Vomiting; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (reported for himself). A 27-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL0140; expiry date: not known), via an unspecified route of administration in the left arm on 08Jan2021 07:20 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. No prior vaccinations within 4 weeks. The patient experienced significant abdominal pain, nausea and vomiting last night at 14Jan2021 20:00. Significant abdominal pain was the first symptom he had. Significant abdominal pain and nausea went away and came back in waves. He had not vomited since midnight. The patient experienced diarrhea which started 07:00 this morning (15Jan2021). Now (15Jan2021), he was burping, it was like weird belching. He wanted to know if these were normal side effects from the vaccine. He was looking at the list and saw nausea as a listed potential side effect, but he did not see diarrhea, vomiting. Therefore, he was calling to see if it is plausible these events were related to the COVID vaccine. The patient di not require emergency room or physician office visit. The outcome of the event vomiting was recovered on 15Jan2021; outcome of the events nausea, diarrhea, and significant abdominal pain was not recovered; and outcome of event belching/burping was unknown.
Pain and rigidity at joints of both hands, shoulders with corresponding inflammation. Pain and stiffness in back and neck.
This spontaneous report as received from a registered nurse refers to an unspecified patient of unknown age and gender. No information on patient's medical history or concurrent conditions was provided. On 29-JUL-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) injection, lot # L009210, expiration date 17-SEP-2016 (route of administration and dose were not reported). No information on patient's concomitant medication was provided. No adverse effects were reported. Additional information has been requested.
In the afternoon I started coughing. Cough got worse the next day and I got tested the next day. Rapid COVID-19 test positive. I saw the Cruise ship doctor and they treated symptomatically and provided a Z-PAK. Symptoms got a little more intense, 5/1 I got a fever, and then everything got slowly better. Just a sniffle, a cough, and fatigue linger at time of reporting.
Hives started 30 minutes later, lasted 2 weeks. Took prednisone and benadryl to control them. She also had subjective SOB and dysphagia.
The patient received her vaccination and approximately 2-3 minutes afterwards she fainted.  She came to right away and within 10 minutes was back to feeling normal.  The patient has a history of fainting almost every time she gets a shot or has anything  dealing  with needles (i.e ear piercing).
This spontaneous report was received from a consumer and refers to her daughter, a "toddler" female of unknown age. The patient's medical history and concurrent conditions were not reported.  On an unknown date, the patient was vaccinated with a dose of hepatitis B vaccine (manufacturer unknown), (dose, route, anatomical location, lot number and expiration date were not reported). On an unknown date at the 4th and 6th month vaccines, the patient was vaccinated with a dose of hepatitis B vaccine (manufacturer unknown), (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. On an unknown date, the patient kept staring in one direction and the mother thought she was having a seizure, also the patient became more anxious, nervous, experienced personality changes and croup on an unspecified date. At the time of the report, the outcome of kept staring in one direction and the mother thought she was having a seizure was reported as recovered on an unspecified date described as her daughter was healthy. Upon internal review, thought she was having a seizure was determined to be medically significant. The relatedness between the events and therapy with hepatitis B vaccine (manufacturer unknown) was not reported. This is one of three reports from the same patient (case #1511USA002447 and 1511USA004138). Additional information is not expected because no contact details were available.
Symptoms started about 16-17 hours after shot, very much like the second dose. Extreme fatigue, EXTREME body pains and aches, chills, slight sore throat. On my second dose symptoms lasted 12 hours, on my 5th dose it lasted a full 24 hours, I had to sleep most of the time because I was so fatigued and my skin and body hurt to touch and movement.
Clinical Summary A 63 y.o. female with a history of COPD, CAD, DM1, HTN, depression, neuropathy, hyperlipidemia, morbid obesity who presented to ED on 12/29/2022 with shortness of breath and congestion and found covid positive and hypoxic. She was transferred 12/30/2022 for further evaluation and management. She was stabilized and ready for discharge on 1/2/2023   1. COVID 19 Pneumonia: 3-4 days of symptoms prior to admission. Tested positive 12/29/22. Required 2L O2 at OLH, due to above. Weaned O2 1/1/23.  Initiated on Dexamethasone (stop state on 1/7/2023) and remdesivir (Completed therapy on 1/2/2023). Improved.  2. DM1: home regimen adjusted while hyperglycemic due to steroids. Endocrine followed, recommended to increase basal and SSI insulin with on steroids.  3. Untreated OSA: needs repeat sleep study and new mask.
Nerve block; This is a spontaneous report from a contactable consumer (patient) reporting herself.  A 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was on the line asking what the rationale was to have to wait for 2 weeks after receiving the Pfizer-BioNTech Covid19 vaccine before getting a diagnostic nerve block. Patient was 90 years old aunt was turned away when she went for her nerve block. Patient was responded; no information about avoiding procedures before or after vaccination listed in the fact sheet. Referred caller back to HCP performing the nerve block for more information. (LAB; Revised: Jan2021). The patient experienced nerve block on an unknown date. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
had both doses of the Pfizer COVID-19 vaccine in March.; Eosinophil is 670 which is 3x more; This is a spontaneous report from a contactable consumer (patient). A male patient of unknown age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown), via an unspecified route of administration on 09Mar2021 as 2nd dose, single for COVID-19 immunization. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he had both doses of the Pfizer COVID-19 vaccine in March. He said that he has testing himself for several years and his eosinophil level was always around 200 and after the vaccine, his eosinophil is 670 which is 3x more. Caller wanted to know whether the vaccine was causing this problem or there had been reports of this experience with the vaccine. The patient was suggested to consult with her physician as there was no information regarding elevated eosinophil count after being vaccinated. The outcome of the events was unknown  Follow up(16Jun2021): Follow up information was received from the same contactable consumer included: non- significant information.  Information on the lot/batch number has been requested.
There's a metallic taste in my mouth plus dryness in the mouth also that's causing bad breath which is lasting for about a week now.
Temperature Excursion; Initial Report Received on 11-Jan-2023  A registered nurse in the reported that a patient (Patient 2) (gender, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On an unknown date, the patient received a dose of HEPLISAV-B (Lot # 937233, expiration date 11 Mar 2023 or Lot # 938794, expiration 09-Oct-2023). The NDC #s, injection site, and route of administration were unknown. The two HEPLISAV-B lot #s affected by the temperature excursion occurred between 22-Aug to 15-Nov (year not reported). For 97% of the time, the temperature was between 8°C - 12.31°C.   No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
fever; chills; myalgia; headache; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th January 2020, the patient received Shingrix (intramuscular). On 13th January 2020, 1 days after receiving Shingrix, the patient experienced fever, chills, myalgia, headache and influenza-like symptoms. On an unknown date, the outcome of the fever, chills, myalgia, headache and influenza-like symptoms were unknown.   It was unknown if the reporter considered the fever, chills, myalgia, headache and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The day before report the patient received Shingrix and reports fever, chills, myalgia and headache, flu like symptoms.   Reporter did not consent to follow-up.
Same day reaction was extremely sore arm. That cleared up. On 3/10/21, I started getting a shingles rash on the right side of my mid-back. Due to extreme internal itching, as well as itching on my back, I did not receive the second dose of the vaccine when s scheduled on 3/15/21.  Doctor confirmed shingles on 3/16/21, but did not think it was because of  the vaccine.  I received the second dose on 4/12/21, 7 weeks after the first one. No reactions after that one except sore arm and fatigue.
States he woke up this morning and his left arm was itching, a couple hours later he looked at it saw small blisters and mild redness.
Information has been received from a physician concerning a 3 month old female with no medical history who on 10/5/06 was vaccainted PO with the first dose of Rotavirus vaccine. There was no concomitant therapy. The physician reported that on 10/6/06, the pt experienced severe diarrhea (about 20 episodes) and vomiting. The pt was subsequently seen by the physician. No lab/diag test were performed. On 10/9/06, the pts severe diarrhea and vomiting fully resolved. The physician considered the diarrhea and vomiting to be other important medical events as the pt was seen a few days after vaccination (OMIC). Additional information has been requested.
This spontaneous report as received from a physician via a company representative refers to a 9-year-old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unspecified date in February 2019 (reported as last week), the patient was vaccinated with GARDASIL 9 injection (dose, route of administration, vaccination site, lot # and expiration date were not provided) for prophylaxis. On an unspecified date in February 2019 (also rpeorted as the following day after vaccination), the patient had difficulty walking. The patient sought medical attention and was seen by the physician. She advised the farther to take the child to the emergency room. The physician reported that there was no follow-up from the father. The outcome of the event was unknown at the time of the report. The causality assessment between the event and the suspect vaccine was not provided.
Second dose more than 35 days apart from the first dose; sore arm after second dose; Numbness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after second dose), HYPOAESTHESIA (Numbness in the arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose more than 35 days apart from the first dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 27B21A0 and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Heart transplant.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jun-2021, the patient experienced PAIN IN EXTREMITY (sore arm after second dose) and HYPOAESTHESIA (Numbness in the arm). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose more than 35 days apart from the first dose). The patient was treated with PARACETAMOL (TYLENOL) for Pain in extremity, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm after second dose) and HYPOAESTHESIA (Numbness in the arm) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose more than 35 days apart from the first dose) had resolved.            Concomitant medications include steroid shots every 6 months.    This case was linked to MOD-2021-230107 (Patient Link).
2MAR95 father states pt c/o swollen lips in AM p/receiving vax, denied other sx-swelling became progressively worse c/o drooling saliva; seen by MD 27FEB was given Cortisone inj & DPH;
OVERHEATED; HARD TIME STAYING AWAKE; TIREDNESS; PAIN IN RIGHT EYE; TINGLING OVER RIGHT EYE; SEVERE HEADACHE (BACK OF HEAD, OVER WHOLE HEAD)/ FELT LIKE HEAD GOING TO EXPLODE/ HEADACHE VERY SLIGHT, FEELS LIKE LITTLE PRESSURE; FELT NAUSEOUS; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included slight sleep apnea/ problems with sleep, pollen allergy, and dust allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced severe headache (back of head, over whole head) / felt like head going to explode/ headache very slight, feels like little pressure. On 10-APR-2021, the subject experienced felt nauseous. On 12-APR-2021, the subject experienced pain in right eye. On 12-APR-2021, the subject experienced tingling over right eye. On 21-APR-2021, the subject experienced hard time staying awake. On 21-APR-2021, the subject experienced tiredness. On an unspecified date, the subject experienced overheated. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) negative. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from overheated, and felt nauseous on 11-APR-2021, had not recovered from hard time staying awake, tiredness, pain in right eye, and tingling over right eye, and the outcome of severe headache (back of head, over whole head)/ felt like head going to explode/ headache very slight, feels like little pressure was not reported. This report was non-serious.
Patient reports swelling and pain at injection site and in axillary. Patient is treating with anti-histamines.
Extreme heaviness in arm that was injected. Also experienced numbness and tingling throughout entire arm and hand. Other hand and feet were also tingly. Blurry vision occurred and extreme diarrhea
Information has been received from a physician concerning an 8-year-old patient with no history of cold sores or exposure and no history of exposure to chicken pox who on 13-AUG-2001 was vaccinated with their first dose of Varivax (Oka/Merck).  On an unspecified date the patient developed right eye subepithelial keratitis "2.5 weeks later".  No cultures or immunology were performed.  The patient was initially seen on the 21-Jul-2005 and again on 26-SEP-2007 and is being treated with push fluids every other day (qod) long-term.  At the time of the report the patient's status was not recovered.  The event of the right eye subepithelial keratitis was considered an other medically important event (OME).  This is one of several reports received from the same source.  Additional information has been requested.
This spontaneous report as received from a other health professional refers to multiple patients of unknown age and gender. On unknown dates, those patients were vaccinated with improperly stored PNEUMOVAX 23 lot # N000508 for prophylaxis. No adverse effect were reported. Additional information has been requested. Sender's Comments: US-009507513-1708USA005938: US-009507513-1708USA005937: US-009507513-1708USA005935: US-009507513-1708USA004523.
1 DOSE OF ADULT  (12+)  PFIZER COVID-19 VACCINE GIVEN TO CHILD 11 YEARS 5 MONTHS AND 29 DAYS OLD
Roughly two weeks after injection, I started noticing inflammation in my neck and throat as well as a post-nasal drip.  I had difficulty swallowing and felt pressure on my windpipe.  This has diminished a bit, but has now become shortness of breath and pressure on my chest.
Site: Pain at Injection Site-Medium, Systemic: Patient states on survey that after needle inserted, her arm by reflex had a reaction like something recocheted inside her arm. Since the injection, pt states her whole left side has been hurting, including her back. She thinks needle may have hit a nerve-Medium, Additional Details: Patient states on survey that after needle inserted, her arm by reflex had a reaction like something recocheted inside her arm. Since the injection, pt states her whole left side has been hurting, including her back. She thinks needle may have hit a nerve. Patient states immunizer asked if she was ok and advised ice packs after apologizing. As the pharmacist at the store, I tried to reach out Monday, 5/17/21, but reached patient's voicemail. I was not able to talk to patient after reading survey
Patient experienced abdominal distention about a week after receiving the COVID vaccine, with progressive jaundice, feeling unwell and eventually went to the hospital, found to be in cardiogenic shock with bi-ventricular failure, acute liver failure and acute kidney failure. Currently still hospitalized for workup of his cardiomyopathy.
Flu like symptoms nausea, soreness in muscles and joints w/ associated weakness in muscles. Fever running 101 degrees throughout night headache and pain behind eyes.
About 2 hours after vaccine my shoulder began to hurt.  Not at the site specifically, but the entire shoulder hurt like it had been pulled from the socket - I cannot raise my arm parallel with my body and could not put behind my back to undo my bra.  VERY painful.  It feels like someone hit me with a baseball bat on my shoulder.  I took tylenol last night and iced, but it didn't seem to help.  I just took 3 advil and the pulsating pain has subsided but I cannot raise my arm and the pain is still present.