chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Acute onset of Raynaud's syndrome; This is a spontaneous report received from a contactable physician, the patient. A 73-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in right arm on 16Jan2021 (age at vaccination 73-year-old), as single dose for COVID-19 immunisation. Medical history included parkinson's, congestive heart failure, pacemaker insertion. The patient had no allergies to medications, food, or other products. Concomitant medication included Metoprolol (MANUFACTURER UNKNOWN), Entresto, Flomax, Sinimet, Finasteride (MANUFACTURER UNKNOWN), Amantadine (MANUFACTURER UNKNOWN) for unknown indication and from an unknown date.   The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route in left arm of administration on 26Dec2020 (age at vaccination 73-year-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Feb2021 at 19:00, the patient experienced acute onset of Raynaud's syndrome with severe cold sensitivity in both hands. Therapeutic measures were taken with respect to Raynauds syndrome that included Tadalafil, Topical Nirol paste on an unknown date. The patient reported that he consulted a rheumatologist and evaluation for underlying CTD (Connective Tissue Diseases) was normal. The patient reported that he had no personal or family history of rash, arthritis, etc. and that there were no changes in medications. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of Raynaud's syndrome was not resolved at the time of this report.   Information about lot number cannot be obtained. No further information is expected.
Case number PHEH2016US023391, is an initial spontaneous report from a consumer received on 12 Sep 2016. This report refers to an 85 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with one single dose of expired FLUVIRIN (batch number: 157104) at a dose of 0.5 ml, intramuscularly on 12 Sep 2016. It was stated that, 2015/2016 expired vaccine was administered to 05 patients on 12 Sep 2016. No adverse event was reported following this medication error (expired product administered). The case was assessed as non-serious by the consumer.
The night of the side effects were normal, over all fatigue.  The next day my top, left upper lip started to go numb and swell, because of the timeline of the event and the lack of any other symptom I was not thinking allergic reaction, but took a benedryl just in case.  I feel asleep and woke up a couple hour later and the top upper lip swelling had started to go down, but my bottom lip had swollen and looked like a sausage.  At this point it was pretty late at night and figured the ER had bigger problems to deal with and this was either going to be better by morning or worse and would deal with it then.  When I woke up the next day I had some submental pain, but the swelling in my lip had gone down considerable.  At this point I noticed I had considerable pain in my collar bone, I felt the area, noticed a mass, went to the mirror and saw what looked like a golf ball under my skin at my collar bone.  My lymph nodes were completely swollen.  I went to urgent care who instructed me to follow up with my PCP if it didn't go down in a week, my PCP told me we would follow up with an ultrasound if it didn't go down in a month.  At this point this is getting ridiculous.  I understand that swollen lymph nodes are a side effect, but it should not be for a month.  This is causing me discomfort and gets worse the more I move around and on top of that I have been getting numbness in my left arm and hand which is what side the swollen lymph node is on.
Fever; Chills; Headache; Body aches; Nausea; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 11:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 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: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 11:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 28Apr2021 at 22:00, the patient experienced fever, chills, headache, body aches, nausea and vomiting. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills, headache, body aches, nausea and vomiting were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of RECOMBIVAX HB lot # J013394, K010535, K017721, K021444 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Numbness of arms, legs, fingers and toes. Fatigue sharp stinging pains.
Erythema around the deltoid area with a bullseye appearance with slight tenderness. This occurred  9 days after my initial injection.   Treated with Benadryl 50mg PO and 600mg of ibuprofen
The next day when I woke up after receiving the vaccine, I was feeling very itchy everywhere. I had rash around the injection site and my extremities (both ankles, back, left arm).  I did not take any medications.  The rash went away very quickly within 8 hours but I was still feeling very itchy and wanting to scratch constantly.  After 2 days, I decided to go to the doctor.  I was prescribed 1 week of oral steroids  (Prednisone 20mg) and hydroxyzine 25mg.  The redness went away, but I could still feel the raised bumps.   After 4 days of steroids, I started to feel much better and the itchiness went away.
Information has been received from a physician, who was notified by a patient's mother that her 14 year old daughter, with no previous medical history of seizures reported, who on 11-APR-2008 was vaccinated with the first dose of GARDASIL (Lot # 660387/1967U) and on 11-JUN-2008 was vaccinated with the second dose of GARDASIL (Lot # 659182/1757U).  The patient experienced 2 generalized seizures.  On 30-JUN-2008, the patient experienced the first seizure at home which lasted for 5 minutes.  On 05-JUL-2008, the patient experienced the second seizure with duration for 5 minutes.  On 11-JUL-2008, the patient sought medical attention by a phone call.  The patient has recovered and is being monitored.  Upon internal review, the 2 generalized seizures were considered to be an other important medical events.  Additional information has been requested. 8/4/08-records received for DOS 7/5/08-seen in ED for C/O seizure lasting 2 minutes and postictal, hit face during seizure, nose jaw and neck pain. Genrealized seizure. First seizure 5 days ago.
It started with bad arm pain at the site of injection. I went to bed around 12:30 but I couldn?t fall asleep. By 3am I figured the only reason I wasn?t sleep was from the vaccine. I then started to feel extremely nauseous and had chills. At 3:30 am I took my temperature and it was 100.5. I laid in bed until 5am with no sleep still and took my temperature again and it was 103.5. I went back into my bed and fell asleep around 5:30 am. The next day I felt as though I had been hit by a truck. I felt extremely groggy and achy and my temperature when I woke up was around 100. Overall, I felt awful.
Received vaccine and 48 hrs later, lost feeling in hands then body from a blackout. Had felt exhausted after shot for months. Exhaustion for that year.
14 days after vaccines the patient erupted in a papule rash, mainly on the trunk. Some of the lesions had pinpoint fluid filled vesicles. Rash seemed to spread in waves/caps.
Pt given 1st in series of Hep-B (3 doses) and 20 minutes, post vax, student felt "dizzy" and became lethargic. Complained of abdominal pain and a headache. Went to ER where he was given Benadryl.
Non-infectious intermediate posterior and panuveitis; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (Non-infectious intermediate posterior and panuveitis) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis.    Concurrent medical conditions included Panuveitis. Concomitant products included PREDNISONE for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced UVEITIS (Non-infectious intermediate posterior and panuveitis) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Sore arm). At the time of the report, UVEITIS (Non-infectious intermediate posterior and panuveitis) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No treatment information mentioned.  Patient experienced pan uveitis flare up and sore arm on an unknown date.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 63-year-old female patient with medical history of uveitis, who experienced the unexpected, serious (medically significant) event of uveitis an unknown time after a dose of mRNA-1273. The event was described as a flare up. Uveitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63-year-old female patient with medical history of uveitis, who experienced the unexpected, serious (medically significant) event of uveitis an unknown time after a dose of mRNA-1273. The event was described as a flare up. Uveitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Dizzy; Weak; Fever that reads 102.3F; Feeling very sick; Injection site was hot to touch; Arm pain; A spontaneous report was received from a consumer concerning a 21-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm pain/pain in extremity, injection site was hot to touch/ Vaccination site warmth, feeling very sick/malaise, dizzy/ dizziness, weak/ asthenia, fever that reads 102.3F/ pyrexia.  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 first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 20 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the events arm pain, injection site was hot to touch. On 21 Feb 2021, the patient experienced the events feeling very sick, dizzy, weak, fever that reads 102.3F.  Treatment details included Tylenol 650mg.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable. The outcome of events, arm pain, injection site was hot to touch, feeling very sick, dizzy, weak, was unknown. The outcome of event fever that reads 102, 3F was not resolved.
a 80 y.o. female with a past medical history of CLL, chronic obstructive pulmonary disease on 3 L oxygen at baseline, chemotherapy-induced pancytopenia, transfusion dependent anemia, iron overload, and type 2 diabetes who presented to Hospital on 0724/2021 with increased shortness of breath and productive cough and was admitted for COVID pneumonia.
Onset of severe cough on 6DEC90. MD visit on 17DEC. Days in bed x 2. Dx'd w/PNE tx'd Cephalexin & Keflex. Recovered as of 31DEC90.
Enlarged node on left axilla with redness to anterior and posterior back; no other reported injury. Treated with local heat and antibiotics with resolution.
Patient came into the pharmacy and requested a shingles shot, Patient instead received a pfizer shot this would be shot #4 for the patient after patient had already previously completed covid-19 series + booster; Patient received moderna booster on 10/30/2021 patient received other doses at outside location i do not have access to that information; Patient has had no reaction as of 8 hours after IMZ; patient is following up with pharmacy daily
Rash on arm; This is a spontaneous report received from a contactable pharmacist. A 37-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208, Expiration date: 30Jun2021), via an unspecified route on 15Mar2021 (at the age of 37-years) as dose 1, single in the right arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021, the patient experienced rash on arm. Reporter stated that the patient came in for the second dose of the Covid-19 vaccine and that the patient still had a red rash on her arm. Reporter reported that because the rash was still present on the patient's arm, the second dose of the Covid-19 vaccine was not administered and that he did not see the patient's rash but that he was told that the rash was still present. Reporter reported that he did not know if the rash had improved, persisted, or worsened. It was unknown that patient visited to Emergency Room or Physician Office. Reporter stated that the pharmacy on duty on 12Apr2021 instructed the patient to go see her primary care doctor and ask about the rash and see what the physician though. Reporter reported that he didn't think that the patient followed up with her physician but just called to complain. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
5-6 min. after administration of vaccines pt had syncopal episode, was "out" for less than 30 seconds. Given juice and observed for 15-25 minutes before allowing pt to leave office.
Patient was given Pfizer vaccine under direction from physician.  After receiving the Pfizer shot, he disclosed that he actually received the Johnson and Johnson vaccine back in April and that he was very afraid of the variant.  His physician told him that he should wait about a month in between getting a Johnson and Johnson and a Pfizer vaccine.  He decided to wait about 3 months just in case.  He never mentioned anything about receiving a previous COVID vaccine prior to immunization.  He only disclosed that fact after the immunization.
My arm began feeling sore a day after I got the vaccine. The pain got progressively worse. Eventually, I was unable to lift my arm without feeling excruciating pain. It nearly brought me to tears. I began having muscle spasms and my arm would exhibit involuntary movements. I sometimes get a shooting pain down my arm, and it falls asleep/goes numb if I don?t move it for an extended period of time. The issue is affecting my ability to do work effectively. It has been over a month, and I have not gone back for the second shot out of fear of losing my arm mobility. I?m able to workout as I did before. However, the arm where I received the shot becomes severely sore afterwards. My arm is always hurting whether I am typing, sitting down, or not even using it.
rash on site of injection, itchy on left side of my body, slight headache, swelling on injection site, feeling warm on left side. has been going on for 3 days now.
Information has been received from a nurse concerning a 25 year old female who on 08-SEP-2008 was vaccinated with her first dose of GARDASIL (LOT#: 0573X) 0.5mL intramuscularly. Subsequently the patient experienced a severe pain and discomfort in the whole arm that the injection was given in. No treatment requirement. The patient's injection site severe pain and discomfort in the whole arm persisted. The patient sought medical attention in the office on 26-SEP-2008 with continued pain. Additional information has been requested.
Headache, ErythemaMultiform, chills, tingling throughout entire body, flushing cheeks, Narrative:
Pt reported adverse reaction during visit w/ PCP. Pt got first dose of COVID vaccine. Right after getting vaccine, felt very lightheaded like he was going to pass out. Got red, swollen, tender rash around vaccination site immediately (within minutes) afterwards which resolved on its own after one day. No rash elsewhere. Lightheaded symptoms resolved within an hour. Took no meds for symptoms.
sore arm , dry cough, hard to breathe, can't sleep head ache and high blood pressure
Joint pain--started (Feb. 6) about 3 days after 2nd dose.   Tingling,  numb  and painful right hand.  Swelling in right hand--started March 9th.
my platelet level is low; my nose bled a little bit; I felt cold/feel chilly; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 59, no units specified) received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, Batch/Lot number was not reported), via an unspecified route of administration on 21Mar2021, as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 21Mar2021, around 1:15 to 1:30, patient received the vaccine, and the patient experienced nose bled a little bit about 30 minutes. She felt cold/feel chilly, where actually she was hot natured. No fever and don't have any diagnosed blood disorder, but her platelet level was low and was referred to a hematologist. the outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
immediate right upper arm pain,  subsequent swelling of right upper arm radiating to elbow, and persistent pain, throbbing with movement, interfering with sleep more than 1 month later
Progressing as expected towards goals - continuing present plan. Primary Problem: acute respiratory failure, COVID 19, poor appetite. Key findings related to primary problem: alert oriented x 4, coarse lung sounds with expiratory wheezes, dyspnea on speech. Not able to use incentive spirometer-- given Lasix. Incontinent of urine with post void residual more than 300 ml, straight catheter done. No complained of pain. Was hungry at first but lost appetite due to dyspnea on speech and with minimal activity. Encouraged to shift weight to prevent pressure ulcer-- verbalized understanding.
Vaccine 11/17/10 site, red hard, hot 12 cm x 10 cm on day following vaccine 2 day after vaccine red, hard, hot to touch from shoulder to elbow wrapping around to ac. Swelling noted & 2 days after vac. severe headache 10/10 lasting 1 day - slight HA for 1 week, treatment KELFEX BID & BENADRYL. Seen at clinic 11/20/2010.
received a dose of Infanrix that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old male patient who received DTPa (Infanrix) (batch number D2KX9, expiry date 23rd November 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th December 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 6th December 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter reported that a patient received a dose of Infanrix that had expired ,which led to expired vaccine used. The reporter consented to follow up.
Patient unresponsive immediately following vaccine administration for about 20 seconds. Patient unresponsive, sweating, and eye roving.  Patient masked removed and alcohol swabbed waved by nose. Patient response and alert. Patient reports history of anxiety and that he did not eat today. B/P pressure 105/64 and heart rate 67. EMS called and patient declined transport to hospital. Patient walked out of vaccine clinic independently with mother.
first 48 hours tired, burning eyes and mildly sore arm 2 weeks later woke up with at least 3in red inflamed mark at injection site. Very hot, itchy and hurt to touch anywhere around it. entire arm from shoulder to hand is a bit tingly but functional. Call my family doctor that suggested i get it checked out. I went to clinic and they gave me a steroid shot, started me on a steroid dose pack and benadryl. I am to contact them 1.28.21 if not completely cleared up. Then they plan on starting me on antibiotics incase of infection.
Patient states that Pharmacist administered the injection much too high on the shoulder and it caused excruciating pain. Arm became inflamed and was immobile. Has been slowly but steadily improving over the last few days but patient still experiencing great deal of discomfort leading to her call to the pharmacy.
Information has been received from a nurse practitioner (N.P.) concerning an 8-year-old male who on 27-Oct-1997 was vaccinated with a dose of varicella virus vaccine live.  On 13-Aug-2005 the patient experienced breakthrough chickenpox, less than 50 lesions.  Unspecified medical attention was sought.  It was reported that the patient recovered from the breakthrough chickenpox.  No product quality complaint was involved.    The nurse practitioner also reported that the patient's brother also experienced breakthrough chickenpox after being vaccinated with varicella virus vaccine live.  Additional information has been requested.