chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant, concerning 10 to 15 patients of an unknown age and gender. The patients' medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included properly store sterile diluent (manufacturer unknown). On an unspecified day in August 2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 with lot number N010109 and expiration date on 20-NOV-2018. The storage temperature was 47 to 77 degrees Fahrenheit (°F) for a time frame of 30 minutes. There was also a previous temperature excursion of 47 to 77 degrees Fahrenheit (°F) for 15 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same source. Sender's Comments: US-009507513-1708USA012976: US-009507513-1708USA012974: US-009507513-1708USA011949: US-009507513-1708USA012972: US-009507513-1708USA012973.
Only after I inquired several days later, the patient reported she felt like her throat was swelling inside and developed a cough around 6pm- she did not call anyone but states she took some Benadryl and went to bed- resolved in morning when awoke.  No localized reaction reported. I explained the seriousness of anaphylaxis and advised her to consider this an allergy from here on.
p/vax started hurting & swelling around 3:30-4PM cont to get worse;swelling from shoulder to elbow;prompt care next AM;given steroids & ATB;
I experienced chills, fever, headache, body aches, feeling very tired, racing heartbeat, and difficulty breathing.  I called the on-call nurse line and was advised to go to the emergency room due to my fast heartbeat.
Complaints of itchy arms and resident contributes it to the vaccination.  Benadryl and prednisone.
36 week pregnant, Edd 29 April, hard red tender lump at injection site, impacting range of motion with no pain, warm to touch, quarter sized.
Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; This is a spontaneous report from a contactable other HCP. A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 08Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included postural orthostatic tachycardia syndrome. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of bnt162b2 (anatomical Location: Arm Left) on 18Dec2020 09:30 and experienced headache, arm pain. Concomitant medication included spironolactone and metoprolol. The patient experienced events after the second dose: fever, chills, muscle and joint pain, headache, fatigue on 08Jan2021 21:00. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering.  Information about lot/batch number has been requested.
Swollen hands; dizzy; This is a spontaneous report from a contactable nurse. A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), intramuscularly in the left arm, on 17Dec2020 at 14:00 (at the age of 38-years-old) at a single dose for COVID-19 immunization. Medical history included non-ongoing COVID-19 (previous well recovered from COVID-19 months earlier) from 2020 to an unspecified date. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. It was unknown whether the patient received other vaccines within four weeks prior to vaccination or other medications within two weeks of vaccination. The patient experienced swollen hands and dizzy on 17Dec2020 at 15:00. The events resulted in emergency room/department or urgent care visit. Therapeutic measures were taken as a result of the events, which included cetirizine hydrochloride (MANUFACTURER UNKNOWN) and monitoring. The clinical outcome of swollen hands and dizzy was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
"worst singles of his life!" shingles rashes & blisters all over body, leg swelling, body ache, was bed ridden all of the above are still going on since shot on 6/15/19
Between the last V-Safe check and the most recent one, I experienced a mild sudden high frequency sensorineural hearing loss and tinnitus in my right ear.  I am an audiologist at a Hospital and a colleague tested my hearing. A colleague who works at my hospital and at a Medical Center prescribed a burst and taper of prednisone and an MRI to confirm absence of an acoustic neuroma (MRI was clear). After about 3 weeks the hearing returned to baseline. Tinnitus persisted for a couple more weeks, but has largely resolved as well. The MD indicated this was likely an idiopathic sensorineural hearing loss, but I thought I should report it since this has never happened to me before.
Patient was given the Pfizer COVID-19 vaccine 8 days after the extended expiration date.  The patient did well during the waiting period after the vaccine. PRIVATE was called and message was left on the patient's phone to return call to our facility.  We plan to re-vaccinate per guidance from the PRIVATE Center.
Vaccination site swelling; vaccination site erythema; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (vaccination site erythema ) and VACCINATION SITE PAIN (Vaccination site pain ) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included TELMISARTAN for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (vaccination site erythema ) and VACCINATION SITE PAIN (Vaccination site pain ). At the time of the report, VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (vaccination site erythema ) and VACCINATION SITE PAIN (Vaccination site pain ) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. No concomitant medication were provided.
Rashes, extreme fog brain, irregular heart beat, extreme fatigue and muscle atrophy. All lasting 12 months. Over-the-phone doctor visits: 03/19/2021: Rash cream.
3/18/23 -  I had an ulcer in my stomach.  I had to have surgery on 3/20/23. I had x-ray, blood tests, MRI and they were all normal.  I had a patch placed.  I was placed on several medications, Omeprazole, Tamulosin and Eliquis.
At 2:30pm on 3/19 had coughing attack lasting several minutes with wheezing but resolved completely.  7pm on 3/19 coughing with wheezing more severe than earlier.  There was nausea and I felt feverish.  I almost called emergency services but it resolved itself in about 10 minutes.  Slept off and on next 12 hours.
Patient called and complained of vomiting for about 4 hrs. straight and was weak the next day. (Evening after shots).
This spontaneous report was received from a nurse practitioner and refers to a 2 year old patient of unknown gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, at one year of age, the patient was vaccinated with VARIVAX (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. On an unknown date, an unspecified amount of time after the dose was administered, the patient developed shingles. The outcome of the event was not reported. The relatedness between the event and VARIVAX was not reported. Additional information has been requested.
some cough and phlegm frequent sneezing body aches, particularly arms and shoulders minor scratchy throat
Case number PHHY2014US093799 is an initial literature report received on 26 Jul 2014. The author discussed about lichenoid drug reaction following influenza vaccination in an HIV (human immunodeficiency virus) positive patient. This report refers to a 46-year-old female patient. Her medical history included treatment for HIV disease. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. One day after vaccination she developed a diffuse, pruritic rash. Physical exam and histopathology were consistent with a lichenoid drug eruption. The author concluded that the patient's underlying HIV disease, known to be a risk factor for both cutaneous drug reactions and more severe manifestations of lichen planus and likely predisposed her to this generalized hypersensitivity phenomenon. The final outcome and seriousness of the events were not reported. It was reported this was only the fifth reported case of lichenoid drug reaction and only the second generalized case, following influenza vaccination.
chest tightness; shortness of breath; rapid heartbeat; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Jan2022 18:30 (Lot number: 33025BD) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Colitis ulcerative" (unspecified if ongoing), notes: other medical history: Ulcerative Colitis, known allergies: Note that I am aware of; "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: LIALDA; VYVANSE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FH8020, Location of injection: Arm Right, Vaccine Administration Time: 05:30 PM), administration date: 02Nov2021, when the patient was 39 years old, for COVID-19 Immunization, reaction(s): "numbness and tingling in both arms n hands, entire arms fall asleep", "numbness and tingling in both arms n hands, entire arms fall asleep". The following information was reported: CHEST DISCOMFORT (non-serious) with onset 10Jan2022, outcome "not recovered", described as "chest tightness"; DYSPNOEA (non-serious) with onset 10Jan2022, outcome "not recovered", described as "shortness of breath"; HEART RATE INCREASED (non-serious) with onset 10Jan2022, outcome "not recovered", described as "rapid heartbeat". The events "chest tightness", "shortness of breath" and "rapid heartbeat" were evaluated at the physician office visit and emergency room visit.  Additional information: The patient did not receive any other vaccines within 4 weeks. Other medications in two weeks were Prescribed Lialda & Vyvanse. The patient was waiting to see a doctor today (11Jan2022). Post vaccination, the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Swelling of tongue, throat tightness, metal taste, arm pain, headache, fatigue, muscle weakness
Digestive problems; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 28May2021 (Batch/Lot Number: ER8735) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included gastrointestinal disorder from an unknown date and unknown if ongoing (So my experience in the past if I have some kind digestive issue I go on very careful diet for 3-4 days and it gets better). The patient's concomitant medications were not reported. The patient experienced digestive problems on 01Jun2021. patient stated, "So after the first shot, 4 days later I started to have digestive problems. So my experience in the past if I have some kind digestive issue I go on very careful diet for 3-4 days and it gets better, it improves but it didn't improved. When probed if patient took Famotidine and Gaviscon as a treatment of adverse event (digestive problems), patient stated, "Well I tried to take care of it myself but first, I tried Gas-X and then I tried TUMS, I tried Gaviscon and then when I went to the primary care she said try Famotidine which I did and you know, I couldn't take it at all, you know it's the way I can tell, as if I can see the prescription for the medicine (Famotidine) going up through my esophagus cavity and that kind of thing and I could tell it makes it worse, So I just stopped taking it. Yesterday when I went to the primary care physician, she said you know just go through the Gastroenterologist, then I have to wait another 10 days. I called 3 Gastroenterologist they said, they have put me on your waiting list and I haven't got any result from them for a long so, I don't know, I don't know what's next." Therapeutic measures were taken as a result of digestive problems. The outcome of event was not recovered.
Mother called 12/03/2001 states child's arm is red. Nurse states red with scab. Augmentin 400 mg PO BID times 10 days. Nurse states area appeared red with apparent scratched marks on left arm. Spoke with Mom 12/05/2001. Pt is better, but still on meds.
Patients mother noticed slight swelling after administration of flu vaccine.  On 11-3-15 patients right arm was red and swollen from shoulder to elbow. Warm to touch. No pain, no fever, no breathing difficulties.  Moves arm well.
Patient received Covid Vaccine Moderna at 1145, multiple syncopal episodes at pharmacy, sent to ER. Outcome Death
RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 52 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 31-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-OCT-2021, the patient experienced received 2.5ml of the janssen covid-19 vaccine. On 31-OCT-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219386, 20211219686 and 20211219807.
Medical staff was called for patient distress. Upon getting to the car that the pt was in, he reported trouble focusing, left sided chest pain, and sweating.    Gen: Awake, Alert, Moderate Distress, diaphoretic Cardio: RRR w/o m/g/r Resp: LCAT in all fields, mildly increased work of breathing Skin: no rashes noted, no edema noted of the face or angioedema noted of the lips Psych: anxious Neuro: able to answer questions appropriately, able to follow instructions, CN 2-12 grossly intact   Pt instructed that his symptoms were not necessarily consistent with anaphylaxis but with diaphoresis and left sided CP I recommended that he be evaluated in the Emergency Department. Pt agreed to this. Transport to ED via EMS was offered and pt declined as he had a driver. Informed pt that I could not make him go via EMS but I did recommend it. Pt expressed understanding but thought that he would be fine with it being as close as it is and him being the passenger, so he again declined transport via EMS. They were instructed to proceed directly to the ED for further Eval.
I felt like my throat was closing off within 30 minutes of the vaccine. I felt like the top of my tongue, root of my mouth, and back of throat was burning off. Lost all sense of taste and still have not regained taste, still get a burning sensation in my tongue. Was diagnosed with COVID tongue. Felt flu-ish for a couple.
tested positive for Covid-19/runny nose and sore throat began; tested positive for Covid-19/runny nose and sore throat began; This is a spontaneous report from a contactable pharmacist (patient). A non-pregnant 40-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, intramuscularly, administered in arm left on 05Mar2021 10:00 (Lot Number: EN6205) at the age of 40 years old, as dose 1, single dose, and second dose, intramuscularly, administered in arm left on 26Mar2021 10:00 (Lot Number: ER8727) at the age of 40 years old, as dose 2, single dose for covid-19 immunisation. Medical history included known allergies: Penicillin, Sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. There was no other vaccine in four weeks. Other medications in two weeks includes multivitamin. On 13Oct2021, runny nose and sore throat began. On 14Oct2021, tested positive for Covid-19 (Nasal Swab). Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Vaccination failure and COVID-19  cannot be completely excluded.
Headache, watery bowel movements (3), twitch (raises shoulders and lowers shoulders real fast in a jerking motion) never seen in this child before.
nausea and feeling unwell; nausea and feeling unwell; Headache; Chills; husband bought her juice on 19 Mar 2021/States that it may have been too much and may have caused diarrhea; husband bought her juice on 19 Mar 2021/States that it may have been too much and may have caused diarrhea; Tiredness; muscles in back feel tight and sore; muscles in back feel tight and sore; really sick; Fever; Weakness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration on 14Mar2021 14:00 (at the age of 70-year-old) as dose 1, single for covid-19 immunisation. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing Caller states that she is pretty healthy and controls with a good diet and eats just right. Is not on any medications for this. States that she is fairly active, coagulopathy from an unknown date and unknown if ongoing States that her and all of her sisters have this clotting disorder. Concomitant medications included aspirin [acetylsalicylic acid] taken for coagulopathy from 2011 and ongoing; diphenhydramine taken for hypersensitivity, start and stop date were not reported; melatonin taken for insomnia, start and stop date were not reported. The patient previously took flu vaccine vii for immunisation, statins for blood cholesterol increased and experienced myalgia. On 17Mar2021, patient experienced tiredness. On 19Mar2021, patient experienced husband bought her juice on 19 mar 2021/states that it may have been too much and may have caused diarrhea. On 20Mar2021, patient experienced nausea and feeling unwell, chills, headache. On an unspecified date in Mar2021, patient experienced muscles in back feel tight and sore. On an unspecified date in 2021, patient experienced fever, weakness, sick. Therapeutic measures were taken as a result of headache included tylenol. The outcome of the events nausea and feeling unwell, chills was recovered on 22Mar2021. The outcome of the event weakness was recovering and the outcome of tiredness, husband bought her juice on 19 mar 2021/states that it may have been too much and may have caused diarrhea, fever, headache, sick, muscles in back feel tight and sore was unknown.   No follow-up attempts are needed. No further information is expected.
25 minutes post injection hypotension, tachycardia (116), lowered body temp.(96.8), dizziness, dry mouth, numbness and tingling in hands. Arrived at Hospital ER 2 hours post injection. Symptoms subsided about 2.5 hours post injection. Similar but milder symptoms on the morning of 03/31 with diarrhea.
Information has been received from a physician concerning a 7 year old patient, with no pertinent medical history, or pre existing allergies, who on 24-JUL-2000 was vaccinated subcutaneously into the right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (lot # 634478/0091K). Suspect therapy, that same day, included a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot # 635283/0406K), administered subcutaneously into the left thigh. There was no known illness at the time of vaccination. On 01-APR-2007, the patient developed itchy spots on the body and arms. Some spots on body and arms had watery centers. One was present on the outer eyelid, but there was no swelling of the eyes. On 03 APR 2007, the patient recovered. No relevant diagnostic tests were performed. Additional information is not expected.
Fatigue, weakness, flu-like symptoms onset on 2/6/14-No treatment except advised to rest-called back 2/10/15. Same symptoms-CBC ordered-CBC normal-called again 2/16/15-continued symptoms-advised to see PCP.
Vaccine sight became increasingly bruised, inflamed and itchy. Although the injection site was sore for day 1-3, there was no redness or increased swelling. After resuming a regular workout schedule, on 1/16 I noticed the area was red, sore, itchy and grew to about 6 inches long on my left deltoid appearing in a triangular shape. On 1/17 and 1/18 the site continued to itch, cause redness and is still sore. On 1/19, today, the redness, swelling and itch has decreased but is still evident.
I felt like I had tunnel vision, dizzy, wasn't functioning very well. I had fatigue as well.  I went to the ED for observation.
have a 3" raised hot circle at the injection site; have a 3" raised hot circle at the injection site; Running a low grade fever; irritable; bad headache; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-val conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration o 20Jan2020 at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient received the Prevnar 13 pneumonia shot on Monday (20Jan2020) and on is Wednesday (22Jan2020), the patient had a 3" raised hot circle at the injection site, and it was hard. The patient was running a low grade fever, irritable and bad headache for two days on an unspecified date in Jan2020. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Pt told me when she picked up her Rx's today that she got from Dr. for #30 prednisone 10 mg tab & # 20 doxycycline 100 mg tab that her Dr. told her not to get the High Dose Flu shot again with her COPD.
expressive aphasia for one day. In emergency department, noted to be hypertensive to ~200/100 with HR to 100s.