chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 79 year old female who on 10/26/05 was vaccinated with a second dose of Pneumococcal 23v polysaccharide vaccine (lot 647661/0055R). She called the following day to complain of pain, redness, and swelling at site of injection. The nurse practitioner advised acetaminophen Tylenol for pain and ice packs. She was advised to call the next day if not better. At the time of the report, she had not called. The pt was considered to be recovering. It was also reported that two other pts had an adverse experience following vaccination with Pneumococcal 23v polysaccharide vaccine WAES0511USA00025 and WAES0511USA00420. Additional information has been requested.
Injection site red, epidemetis, hot to touch and achy from shoulder down to elbow after 24 hrs.
4/10 7:00 Pm fever started.  By 9:30 pm, Fever 104.1 on Tylenol, Vomiting, Dizziness, Shaking, Stomach discomfort.  I was not able to get my temperature down. I had to go to the local emergency room.  I was given IV fluids with anti nausea.  4/11 Fever still 102 in the morning.  Vomiting had stopped after trip to the emergency room.  Still had fever (101) at bedtime. Genrally felt cruddy. Bad headache. 4/12 Low grade fever in the morning and over all malaise. 4/13 Feel better but not great
Pt developed decreased level of consciousness within 5  minutes of IM injection.  Pt had eyes closed, non-verbal and did not follow commands.  Pt was evaluated by MD on site and EMS.
Nausea, slight temperature, 4x5cm red area left upper arm-day after immunizations.  Westcort cream, Phenargan, Benadryl, Tylenol, Lesin;
RED, ITCHY, WARM TO THE TOUCH , SWOLLEN. LASTED A FEW DAYS.
Feels like onset of pneumonia; Congested; Coughing; Chest is heavy; Increased BP 161/97; A spontaneous report was received from a consumer who was a 56-year-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced feels like onset of pneumonia, congested, coughing, chest is heavy and increased BP 161/97.   The patient's medical history included post-traumatic stress disorder, depression and asthma.  Concomitant product use was not provided by the reporter.   On 07-Jan-2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 07-Jan-2021 the patient received the Moderna vaccine. On an unknown date, he reported that he felt as if pneumonia was setting in.  He stated that he was congested, coughing and had chest heaviness.  Additionally, he stated that his blood pressure was elevated to 161/97.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, feels like onset of pneumonia, congested, coughing, chest is heavy and increased BP 161/97, was not provided.   The outcome of the events, feels like onset of pneumonia, congested, coughing, chest is heavy and increased BP 161/97, was unknown.; Reporter's Comments: This spontaneous report refers to a case of a 56-year-old female patient with medical history of post-traumatic stress disorder, depression and asthma, who experienced events of feels like onset of pneumonia, congested, coughing, heavy chest and increased BP 161/97 after the administration of the first and only dose of mRNA-127 (Lot number unknown, Exp date-unknown). Based on temporal the information provided and the absence of any other etiology factors a causal association between the events and vaccine administration cannot be excluded. However, the patient has history of asthma and post-traumatic stress disorder which are confounding factors.
After the second shot I had symptoms of chills,  fever, and fatigue.  Four days later I began experiencing dizziness and spinning.  I visited a doctor and he told me I have vertigo (BPPV). The symptoms match vertigo, but I?ve never experienced it before in my life.  It seems like it?s possible that it is a result of the second shot. I?ve read online there are many other people getting similar symptoms.
This spontaneous report was received from a healthcare worker refers to a multiple unspecified patients of unknown age. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX lot # L017146, 13-MAY-2017, L017142, 30-MAY-2017, L050560, 14-DEC-2017. No adverse effects were reported. Temperature of 2.8 degree centigrade for 6hours 46 minutes and it was administered, previously there was no temperature excursion. This is one of the 3 reports received from the same reporter. Additional information has been requested.
Petechial rash, thrombocytopenia platelet 13,000 at madir. Hospital discharge summary state unsteady on her feet (dizziness), minor head injury with ecchymosis (injury accid, echymosis) and URI (pharngitis.).
Felt fine until 11 hours after 2nd shot, then felt like I was hit by a truck so went to bed. Could not sleep all night because bones started to ache terribly...felt like my bones were going to explode, which seemed like a very unusual reaction. Halfway through the night, got nauseous. Later in the night got stuffed nose and headache. Woke with headache, body aches, fuzzy head and had fever up to 101.5 all day. Took a Tylenol in the morning and drank a cup of coffee and lots of water which made headache disappear. Finally took a Motrin at 6pm and started feeling much better by 9pm. Slept well. By 7am next morning, was 100% fine albeit tired.
This spontaneous report was received from a pharmacist and refers to a 60-year-old female patient. The patient had allergy to penicillin and tramadol and no medical history. On 22-NOV-2017, the patient was vaccinated with a dose of ZOSTAVAX injection, lot # M041511 with expiration date on 08-JAN-2017. The dose of the vaccine was reconstituted with sterile diluent (MERCK) injection (dose, lot number and expiration date were not reported). Concomitant therapies included levothyroxine sodium (manufacturer unknown), lisinopril (manufacturer unknown) and famotidine (manufacturer unknown). On 01-DEC-2017, the patient developed a shingles rash and was diagnosed with a mild case of shingles. The patient sought medical attention at an unspecified primary care office and was prescribed valacyclovir as a treatment. The patient recovered from the event on an unknown date in December 2017. The relatedness between the event and ZOSTAVAX and sterile diluent (MERCK) was not reported.
Insomnia (the evening of the vaccine was completely sleepless,  was unable to fall asleep the following evening until 2 am) Low grade nausea (started about 3:00 pm  day of vaccine and lasted 24 hours) Arm soreness and severe loss of range of motion overhead for 3 days, started about 3:00 the day of vaccine
p/vax rt arm sore right away, hand tingling, ?swollen, sore & numb;?nerve struck;pt states has circulation pain;dx reflux sympathetic dystrophy;
Soreness in arm radiating down past elbow. Fever, headache, nausea, achiness, shortness of breath.
Redness, swelling of arm, warmth in adjacent area. BENADRYL.
Janssen COVID-19 Vaccine EUA Per POD First Aid provider syncope episode, complaint of tingling to lips and difficulty breathing, patient experienced a syncopedic reaction when returning from bathroom, was unconscious for 1 minute, complained of dizziness, odd taste in her mouth and difficulty breathing.  12:15 PM B/P 150/82 Pulse 68 Respirations 16 Pulse ox 98% 12:20 PM B/P 122/72 Pulse 64 Pulse ox 100% Benadryl administered @ 12:20 PM, patient transported to A Medical Center for evaluation.
Shortness of breath, itching all over about 3 hours post vax. About 6 hours later began to wheeze. Received treatment for allergic reaction. Pt sent home on prednisone. Rash started again 4 days later, return to ER for additional treatment and 7 days later much improved.
Positive Rapid COVID-19 Test on the 29th; This is a spontaneous report from a Pfizer-sponsored program. A contactable other healthcare professional (HCP) reporting for herself reported that a 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 22Jan2021 at singe dose for covid-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient experienced Positive Rapid COVID-19 Test on 29Jan2021, and she was due for her second COVID test on 17Feb2021, so she was calling to see if it was still okay for her to get her second dose of the vaccine as scheduled, since she has now had COVID. The patient stated that she did not think there was anything else relevant, other than the fact that she was in contact with people who were potentially COVID positive in the facility where she works. Patient stated that they perform COVID testing at her job, so she was around people who were suspected to have COVID. The outcome of the event was unknown.  Information about Batch/Lot number has been requested.; Sender's Comments: There is no reasonable possibility that the event "positive rapid COVID19 test" within 7 days from the administration of the first dose was related to BNT162b.  This is more likely associated with an earlier acquired infection during these pandemic times.
low energy; It took 3 months to get her voice back; she had breathing problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "low energy"; APHONIA (non-serious), outcome "recovered", described as "It took 3 months to get her voice back"; DYSPNOEA (non-serious), outcome "unknown", described as "she had breathing problems".  Additional information: Caller was asking what was the difference between the bivalent ba1 vs ba4/5. She had a very bad case of corona virus in June, it took 3 months to get her voice back, she had breathing problems and low energy. Caller stated she got covid on the plane when traveling. Caller also stated she had all her prior covid vaccinations from Pfizer and had either 4 or 5 doses (unsure). Caller stated she will be coming back in December and trying to decide which would be best for her to receive.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201296087 same patient; different event;
Case number PHEH2012US016367, is an initial spontaneous report received from a pharmacist on 17 Aug 2012. This report refers to a female patient of unknown age. She was vaccinated with MENVEO (batch number: A11064, Expiry date: Dec 2013) 0.5 ml intramuscularly on an unknown date. The pharmacist reported that the patient experienced syncope episode sometime in 2012 (unspecified date) after receiving MENVEO. Event outcome, seriousness and causality were not reported.
The vaccinated individual was underage at the time of vaccination. She reported no signs and/or symptoms.
The vaccine was not properly diluted prior to injection. There was only 0.8ml of sodium chloride added to the vial instead of 1.8ml.
No adverse reaction was observed in the patient at this time. This report is intended to make a record of the erroneous administration of a dose of the Pfizer/BioNTech COVID19 vaccine as the second dose to someone who had received the Moderna vaccine for the first dose in the series. The patient has been notified and due to the dementia of the patient, the family will be notified.   Staff involved have been reminded of the vital need to verify information thoroughly before medication administration.
Breathing attack, gasping for air and convulsions at midnight. Duration about two minutes. Severe hives beginning January 14 and persisting until February 25. Hives have decreased but itch remains. Hives resulted in a visit to the urgent care, dermatologist, allergist, and two ER visits. One ER visit was the result of restricted breathing in the airway. None of the visits resulted in a diagnosis. Cause of the hives remains uncertain. Medications taken: Dexamethazone, Benadryl, Methylprednisone, Hdrooxyzine, Allegra, Zertec, Claritan, Triamcinolone Cream. All medications had minimal affect.
pt recvd vax & inconsolable crying all day & night; fever 103; x 3 days.
patient experienced vertigo (dizziness) starting about 20 minutes after receiving the vaccine administration. pt reported symptoms 4 hours after administration and was given 25 mg diphenhydramine with recommendation that if it didn't go away, to take another 25 mg. pt was being monitored every 60 minutes for changes.
Initially pain and swelling.  The next day markedly swollen in dependent area and hot and red with pain and some itching.  Since then better, but still at 6 days out it is still indurated, edematous and very itchy.  Not painful and hot and red anymore.
Redness & itchness at injection site. Referred pt to take Benadryl & cortisone cream.
Pt stated he awoke 5/22/18 morning with symptoms of red, itchy hands and feet along with splotchy, irregular rashes on groin, axilla, upper back and shoulders. Pt stated he took fexofenadine to help with itchiness and it seemed to improve. Pt contacted pharmacy on 5/23 to report reaction. Pt stated the rash was much improved but still very itchy.
Strong dyspnea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old adult male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9267 and Expiration date was unknown), via an unspecified route of administration in left arm on 11Feb2021 at 17:00 (at the age of 60-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included none and concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient had no Known Allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. On 11Feb2021 at 23:00, the patient had experienced Strong dyspnoea for 3 days after 1st dose starting first night. Then disappeared. The patient had visited urgent care, Primary doctors, Pulmonologist. Adverse event resulted in doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care. The patient did not receive any treatment for AE and no Hospitalization prolonged. Since the vaccination, the patient has been tested for COVID-19. Covid test type post vaccination was reported as Nasal Swab. On 13Apr2021, the patient underwent Covid 19 rapid diagnostic test and the result of covid test was reported as negative. The patient underwent lab tests and procedures which included blood test: ok, computerised tomogram thorax: negative, electrocardiogram: negative, oxygen saturation: ok, spirometry: normal, x-ray: negative in 2021. Outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
NO DILUENT, RESULTING IN HIGHTER THAN AUTHORIZED DOSE ( 0.3M OF UNDILUTED VACCINE ADMINISTERED)  NO ADVERSE REACTION HAS OCCURRED AS OF 10/27/21 12:00PM
Pfizer bivalent was supposed to be administered but the Pfizer monovalent was administered
This spontaneous report was received from a registered nurse refers to a patient of unknown age and sex who was one of the totally 9 patients. The registered nurse reported that VAQTA, RECOMBIVAX HB and GARDASIL were exposed to 31 F degrees on 01-OCT-2012 and RECOMBIVAX, 5mcg/0.5ml, (Lot Number: 0384AE, exp: 02-NOV-2014 and Lot number: 0293AE, exp: 01-SEP-2014) was then, administered to 9 patients over a period of eight weeks (unspecified date in 2012). This patient was one of 9 patients who was involved in this AE with RECOMBIVAX HB (improperly stored RECOMBIVAX administered). The patient received 5 doses of RECOMBIVAX HB total. This occurred because 2 doses of the RECOMBIVAX HB the patient had received were improperly stored so they were readministered. Dose 1 was administered 23-OCT-2011 (this dose was improperly stored and administered by a different healthcare provider at a different facility, details of the temperature excursion are unspecified). Dose 2 was administered 21-NOV-2011. Dose 3 was administered 09-MAY-2012. Dose 4 was administered 03-DEC-2012 (this dose was improperly stored and administered by nurse). Dose 5 was administered 07-FEB-2013. No other co-suspects were reported. No concomitant medications were reported. No symptoms reported. Patient's outcomes were unknown. This is one of several reports from the same source. The nurse stated that they were in the process of revaccinating approximately 275 patients. She was not aware of any adverse event being reported. Additional information is not available.
Patient became incontinent, urinary and fecal accidents after being fully potty trained, it was like he couldn't feel himself using the bathroom, I started him on a probiotic assuming he was constipated or something, by mid March 2017 his symptoms had subsided, he does still have an occasional urinary accident. He also ran a mild fever, no hives this time.
On 12/6/2021 I felt fatigue with headache in the afternoon. Then on Tuesday 12/7/2021, Wednesday 12/8/2021 and Thursday 12/9/2021 developed a sore throat and still very fatigue (until Saturday 12/11) and chills (until Friday 12/10). Then On Sunday 12/12/2021 had congestion and blowing my nose a lot, which I still have. It's improving though.
Information has been received from the mother of an 11 year old male with severe acid reflux and possibly a hiatal hernia, severe allergies to many different things such as pollen, dust, and various foods, mild asthma, anxiety problems and a history of seizure as an infant after DPT vaccination, who on 07-FEB-2007 was vaccinated with a dose of Gardasil by mistake. Concomitant therapy included ZYRTEC, PAXIL, PRILOSEC and different allergy shots. The report stated that her son was supposed to have received an unspecified hepatitis vaccine. On 12-FEB-2007 the patient was feeling achy, weak, tired and nauseous. She also stated that she was not sure that these symptoms were related to the vaccine. Medical attention was sought. The patient was reported as not recovered at the time of this report. Additional information has been requested.
Information has been received from a health professional concerning a 12 year old male with no known medical history who on 07-SEP-1995 was vaccinated with a 0.5 mL dose of Varivax (lot # 608582/0410B). There was no concomitant medication. On 27-FEB-2006 the patient developed a severe case of chickenpox greater than 200 lesions noted. Unspecified medical attention was sought. On 21-MAR-2006 the patient recovered. There was no product quality complaint involved. The patient's sister (WAES # 0603USA03381) had a similar experience following vaccination with Varivax. Additional information has been requested.
My daughter took Bexsero vaccine at the pediatrician's office on Aug 12, 2019 and went off to college. Next morning she woke up with a fever, chills and a big rash on her arm, looked like a burn and she was c/o of arm pain. Told her to take Benadryl and Tylenol. The next day she was able to move her arm and eventually swelling went down and then her skin started peeling. After the bubbling/redness of the skin there appeared like small tiny veins that were where the blister was and were blue/purplish in color. Those eventually darkened and her skin peeled. She has skin  discoloration over that area now. I need to know what to do about giving her the booster. I have pictures, if that helps, that I mail email somewhere.
This case involves a 17 years old male patient who received a dose of flublok, with no reported adverse event while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient received unknown concomitant medication of Pfizer. On 17-Dec-2021, the patient received 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE, once with lot UJ723AA via intramuscular route in the right deltoid as prophylactic immunization. On 17-DEC-2021 the patient developed a non-serious "17 yo paitent received a dose of flublok, with no reported adverse event" (off label use) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) was not applicable. It was not reported if the patient received a corrective treatment for the event (17 yo paitent received a dose of FLUBLOK, with no reported adverse event). At time of reporting, the outcome was Unknown for the event 17 yo paitent received a dose of flublok, with no reported adverse event.
I started getting a scratchy throat and having a nasal drip kind of thing on Tuesday the 28th. On the 29th my symptoms had gotten worse, so I tested for COVID-19. I had chills, body aches, headache, and a chest cough. I also had a weird sensitivity to light that caused me to have to wear sunglasses. I also lost my sense of smell. When I wore glasses, my headache was not that bad. I contacted my doctor, but I did not take antivirals. I took Advil, Tylenol, Mucinex, and Afrin nasal spray. I started feeling pretty good but on Monday April 3rd, 2023.  I took a walk and all my symptoms returned. I had a tiny bit of fever, fatigue the headache and cough returned. It lasted for 24 hours. I still have hoarseness, fatigue, and I continue to wake up with a headache. I have symptoms but it's not that bad.
injection site pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lymph node excision (right side) and cancer (with cancer pain).   On 17th April 2019, the patient received the 1st dose of Shingrix. On 17th April 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the retired pharmacist, who reported for herself. The patient experienced injection site pain, while it was given. For the tollerence of 2nd dose refere case US2019131719, reported by same reporter.
Post vax, the patient developed a hive type rash, mainly on his arms and a little on his legs. The patient was treated with Benadryl.