chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer BioNTech COVID-19 Vaccine EUA Rashes appeared on both legs one day after first dose of vaccine. Rashes are slightly raised and slightly itchy.
Her arm was swollen all the way down to her wrist; part under her arm pit was very sore and swollen; extremely painful and relaxing by her side was uncomfortable; extremely painful and relaxing by her side was uncomfortable; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 52-years-old female patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection; Batch/Lot Number was ER8731; Expiration date: Unknown), via an unspecified route of administration in Arm Right on 14Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant was not reported.   On an unspecified date, The patient stated she is calling regarding the Pfizer COVID19 vaccine and has some questions about that. Got the shot about 3 weeks ago and her arm was swollen. The part under her arm pit was very sore and swollen. It did not turn red. She had swelling in her armpit area, for 3-4 days it was very swollen, her arm was swollen all the way down to her wrist and really painful right underneath her arm, The part under her arm pit was very sore and swollen. It did not turn red. Even to put deodorant on was extremely painful and relaxing her arm by her side was uncomfortable.    The patient would like to know whether she should get the next dose of the Pfizer COVID vaccine after the side effects she had from the 1st dose. She had called the doctor and they said that it happens sometimes. Does not know if she should get the second shot. Confirmed that the shot was the first dose of the COVID vaccine. Is signed up for the second shot 05May2021. She had COVID and does not want to get it again. Do not want to spread to others.  On an unspecified date the patient underwent lab tests and procedures which included antibody test: positive for antibodies, sars-cov-2 test was negative. Had tested negative when she thought she had it and got an antibody test a few weeks later that was positive for antibodies. There is no product complaint to report. Yes, there is a medical information request.  No follow-up attempts are needed. No further information is expected.
There were things that I expected, like the muscle aches, fatigue, fever. But I didn?t know I was going to get such heart palpitations. I got the shot Friday afternoon, I started noticing the palpitations Saturday afternoon, and now Sunday night they?re really bothering me. They?re almost continuous. It feels like I drank a lot of caffeine, but I haven?t.
The pt had a Td in the left arm and HepB #3 in the right arm on 6/29/99. According to the pt, she experienced hives, itching and shortness of breath 5-10 minutes after vaccination receipt (the pt does not recall eating anything "unusual" I that am or initiating the use of any new hygiene/laundry products). The pt was reassured by the corpsman and observed for about 30 minutes. The pt's breathing returned to normal and the hives resolved during this time (no treatment was administered). The pt returned to work and the itching resolved also (the pt does not remember the timeframe). On 6/30/99 the pt reported to medical with complaints of induration, itching and redness at the injection site which was recorded as "site located on the posterior aspect of the tricep." There is no record of the complaints/events of the previous day. The pt was diagnosed with a local reaction and treated with BENDARYL and TYLENOL. The pt was seen on 7/1/99 for increasing pain and numbness to the left arm. A 5cm x 4cm area of erythema and induration was noted at the posterior aspect of the arm. The pt did not have axillary adenopathy but was TTP, motor strength was intact and DTRs were 2/4, decreased sensation was noted. The pt was treated with NAPROSYN 500mg bid and CIPRO 500mg bid for 10d (for possible cellulitis). The pt's symptoms improved but the pt does not recall the details. The medical record indicates that she received Td 2/13/07 without adverse events.
Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 001A21A) for COVID-19 vaccination.     Concomitant products included ESTROGEN NOS;PROGESTERONE and LEVODOPA for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 28-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
i have been having breathing  issues that come and go that i have never had before. chest congestion and pain around my left rib cage with mucus rattleing in my chest.
Chest pain, laryngitis, rash on inner arm (ipsilateral to vaccine administration)
Patient was discharged at 1:25 came back at 1:36 with itchy rash on forearm, given Benadryl 50mg IM. Assessed by doctor working clinic at 2:15, rash was fading and itching resolved. No breathing or airway issues, was discharged.
This spontaneous report was received from a physician assistant refers to a 61 year old male patient with no drug allergies. Current conditions included asthma and hypertension. On 21-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J1007, expiration date April 2014) subcutaneously. Concomitant therapies included amlodipine and benazepril hydrochloride. On 21-OCT-2013 (within 12 hours after vaccination), patient developed significant localized reaction. Patient presented to the urgent care facility on 24-OCT-2013. The physician assistant reported that the patient's arm in which he received ZOSTAVAX was swollen, non-tender with no associated lymphadenitis. She further reported that at the actual injection site, there was roughened non-vesicular, indurated red tissue with dried serous fluid just from the injection site. She reported that around the site, the arm had an angloedematous type of look. Pharmacist reported that the patient stated that the area is mildly pruritic with some pain. Physician assistant had not treated that patient at the time of this report. No laboratory diagnostic studies were performed. The patient sought medical attention for the events. The events were not resolved. Causality was not reported. Additional information has been requested.
ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ACUTE DVT OF RIGHT POPLITEAL VEIN CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Patient during her 20 minute observation period post vaccination reported to begin feeling warm and she was feeling faint. Patient looked uneasy. Patient then ate a snickers bar in her purse and felt better, stating she must have felt uneasy because she had not eaten and was also a bit anxious after getting her shot. Patient walked out of the pharmacy at the end of her observation period saying she felt fine and was going home. Upon calling the patient 12 hours later on her cell to see how she was doing, the patient said she was fine, and no change since she left the pharmacy this morning.
This spontaneous case, was initially received from other health professional (Pharmacist) on 04-Oct-2017, concerning a 43-year-old adult female patient. The patient's historical conditions included hypothyroidism, anxiety, HSV (Herpes simplex virus) 1 and 2, blood clotting disorder-factor 5 leiden and bacterial vaginosis. The patient's concomitant medications included VALTREX, Levothyroxine, Duloxetine, FLAGYL for an unknown indication. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195239, expiry date: May-2018, route of administration, anatomical location: not reported). On the same day after receiving the vaccine, the patient experienced tingling of her lips and then about 2 hours later her tongue started tingling. At the time of this report, the outcome of the event was not recovered. The reporter assessed the report as non-serious. Non-significant case correction received 04-Oct-2017: Batch number (195239) was captured in the case form and narrative was amended accordingly.
Severe pain and heat in deltoid where vaccine administered, which worsened over the course of 10/18/16. 3:00 AM 10/19/16 onset of chills and fever (100.7).  Fever persisted, averaging 101, throughout 10/19/16, and returned to normal on the morning of 10/20/16.  Severe arm pain persisted through 10/20/16.  Pain and heat have moderated, but pain continues upon deltoid contraction or local pressure; heat is constant.
Large red itchy rash on injection site exactly one week after the injection. Also slightly swollen lymph node and dull pain in axilla. Rash seems to be getting worse.
Pt. had diarrhea starting on 11/30/11 to 12/5/11. She had sweating starting 11/30/11 and 12/1/11. Felt so weak. She said she thinks she "passed out" or fainted in her wheelchair. Had constant nasal drip.
FEVER; BACK PAIN; SORE ARM; STOMACH ACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 10:00 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested.   No concomitant medications were reported. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced back pain. On 09-MAR-2021, the subject experienced sore arm. On 09-MAR-2021, the subject experienced stomach ache. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, back pain, sore arm, and stomach ache. This report was non-serious.
Flu like symptoms 1 week post injection followed by residual swollen glands in neck , with chills.  Symptoms continued and worsened to include Dyspnea,  Tachycardia,  palpitations ,  flushing, diaphoresis,  severe head ache and weight loss of 12 pounds in 4 weeks.
Rash on arm (opposite arm of injection) 30 mins after shot that spread to 80% of my body over the next 30 mins or so. Dizziness, headache, nasal congestion, rapid heartbeat. Next morning 10 big bruises all over my body like I had been battered. Rash covering the rest of my body except the skin on my face except for a sliver of rash infront of my ears. Low grade fever and just feeling very unwell.
tested positive again for COVID on 17May; tested positive again for COVID on 17May; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 42 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03May2022, outcome "not recovered" and all described as "tested positive again for COVID on 17May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Positive, notes: I tested positive for COVID on 03May; (06May2022) Negative, notes: negative on 06May; (17May2022) Positive, notes: tested positive again for COVID on 17May. Therapeutic measures were taken as a result of covid-19. Clinical course: Other medication in 2weeks: No. I tested positive for COVID on 03May, negative on 06May, finished Paxlovid on 08May, and tested positive again for COVID on 17May. Additionally, I redeveloped symptoms, namely runny nose and cough. No follow-up attempts are possible. No further information is expected.
Vaccine stored outside of manufacturer guidelines, product stability is unknown. Potential expired product used for immunization. patient stated no adverse events from this vaccine administration were experienced
What happened was the MA drew up Proquad, Proquad diluent, and Varivax (all on one syringe) and it was administered to the patient. A double check was done by another MA but not until they were already drawn up. At that point it was labeled MMRV so she thought it was Proquad. I contacted someone @ 1413. I told her the situation and she said that the patient got an extra dose of varicella. She advised we call the parents and discuss the following: There is an increased risk of febrile seizures with the additional dose of varicella. Watch for fevers and give acetaminophen and/or ibuprofen to reduce fevers as needed.  MA will contact the patients parent and discuss.
flu like symptoms; she had nausea and vomiting; she had nausea and vomiting; tremor; soreness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), NAUSEA (she had nausea and vomiting), VOMITING (she had nausea and vomiting), TREMOR (tremor) and PAIN (soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PREDNISONE for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), NAUSEA (she had nausea and vomiting), VOMITING (she had nausea and vomiting), TREMOR (tremor) and PAIN (soreness). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), NAUSEA (she had nausea and vomiting), TREMOR (tremor) and PAIN (soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was reported.
patient had a locked shoulder..... shot was given too high, patient saw his family doctor for treatment.
Patient received BOOSTRIX vaccine on 4/10/18 in left arm. Patient called today 4/11/18 and stated he had a fever of 101 and chills and TYLENOL and MOTRIN did not bring the fever down. Advised pt to seek medical attention.
Severe shoulder pain radiating down lateral part of arm injection given very high on shoulder.  Continued pain weeks later. Have taken one Medrol dose pack but pain continues.
LOST THE ABILITY TO GRIP ANYTHING WITH LEFT HAND; BACK VERY PAINFUL; OFTEN SLEEPING MUCH MORE THAN I NORMALLY DO; INFLAMMATION; This spontaneous report received from a patient concerned a male of unspecified age. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced lost the ability to grip anything with left hand, back very painful, often sleeping much more than i normally do, and inflammation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lost the ability to grip anything with left hand, back very painful, often sleeping much more than i normally do and inflammation was not reported. This report was non-serious.
101.5F fever for two days, fatigue, headache, subnormal fever on day 3, allergic skin reaction, severe tenderness
vaccine 2 vials were not mixed,pt received only one in error,no adversese effect reported parent notitied to have correct dose administered
Screaming and jerking episodes about 1 to hours after administration of vaccine. (Second vaccine given about 2 weeks after 1st flu vaccine) Follow up 02/07/05: Child did not die, Clinic will fax EEG report.
Severe awful pain at the injection site left arm; out of the hospital due to a concussion; This serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-JUL-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Severe awful pain at the injection site left arm) (serious criteria hospitalization) and concussion (Verbatim: out of the hospital due to a concussion) (serious criteria hospitalization). The outcome of the injection site pain was not resolved and the outcome of the concussion was resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix. The reporter considered the concussion to be unrelated to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix. The company considered the concussion to be unrelated to Shingrix.   Additional Information: GSK receipt date: 13-OCT-2023 The reporter was the patient who stated she received Shingrix first dose and since then she had been suffering a very severe awful pain at the injection site.  According to the reporter the physician did not understand what was going on and se will have an appointment soon for an x-ray.  The customer also stated she was out of the hospital due to a concussion that she was not linking with the vaccine.  The patient reported that she was not going to receive SHINGRIX shot 2.  Consent provided to contact treating physician.
Discharge Provider: DO Primary Care Provider: DO Admission Date: 12/18/2022 Discharge Date: Dec 22, 2022  COVID positive Date: 12/18/2022   PRESENTING PROBLEM: Acute asthma exacerbation [J45.901] Exacerbation of asthma, unspecified asthma severity, unspecified whether persistent [J45.901] COVID-19 [U07.1]   HOSPITAL COURSE: Pt is 77 y/o female w/ past medical history of asthma on chronic steroids, chronic diastolic heart failure, pulmonary htn, htn, permanent afib, cirrhosis, CKD stage 3a  who presented with asthma exacerbation 2/2 COVID 19. She had presented with over a week of symptoms and had completed 5 day course of prednisone. In ED, pt was tachycardic and tachypneic.  CXR showed no acute process. COVID was found to be positive. ProBNP was wnl. CBC and CMP was largely unremarkable.    Following admission pt was started on IV Solu-Medrol and DuoNebs around the clock. She did not receive remdesivir given length of symptoms.  Patient's symptoms slowly improved.  Patient required Robitussin DM around the clock and codeine and guaifenesin cough syrup at night due to severe cough.  She was weaned from IV Solu-Medrol to prednisone 40 mg daily.  Patient intermittently required oxygen and she was seen by Pulmonary Rehab recommended 2 L at rest and 3 L with activity.  Patient was feeling much better and was feeling well enough to discharge home and was up independently in room without difficulty.  PT and OT recommended home with home healthcare.   Patient discharged to complete a prednisone taper of 40 mg x 5 days, 30 mg x 5 days, 20 mg x 5 days, and then resume chronic 15 mg daily.  She was given prescriptions for Mucinex, Robitussin DM, and codeine/guaifenesin cough syrup at night if needed - limited to 3 days.  Maps reviewed.  Start talking form completed.  Risks of opiates reviewed with patient.  She was enrolled into the transition to home program.  Visiting nurses were set up by care management.  Portable oxygen was delivered to room and she will call airway oxygen for home oxygen on discharge.  Discharge instructions reviewed with family as well.  Patient discharged home in stable condition.  Outpatient follow-up with PCP in 1 week.
Impressions Adverse reaction to vaccine, initial encounter   Patient with sensation of generalized body warmth within 15 minutes after receiving first dose of Moderna COVID-19 vaccine No rash noted on exam No associated symptoms including but not limited to itching, chest pain, shortness of breath, difficulty swallowing, or any focal neurologic deficits   We will monitor patient for 1 hour  Patient states that his symptoms continue to improve and that he is feeling well Vital signs have remained stable throughout patient's ED course including oxygen saturation of 100% on room air Patient remains afebrile and nontoxic in appearance   At the time of discharge the patient remained in stable condition.  The patient was counseled to return the emergency department immediately with worsening symptoms.  The patient voiced understanding and agreement with treatment plan.  He is also aware that he may return to the emergency department at anytime for any reason for reevaluation, and should return with worsening or persistent symptoms.
she's getting a false positive HIV test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HIV TEST FALSE POSITIVE (non-serious), outcome "unknown", described as "she's getting a false positive HIV test". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient reported that she took the initial dose of the Pfizer covid-19 vaccine and she guessed that it induces our body to produce the S protein that can build immunity to the vaccine for the second dose. She reported that she is getting a false positive test result for HIV and trying to know if that is related to the covid-19 vaccine. She does not have the second dose yet. She asked whether her body continue to produce the spike protein if she only get one shot of Covid-19 vaccine and no 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
felt like i had the flu; arm got sore; threw up" in middle of night; achy weakness; achy weakness; low grade temp; chills; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received BNT162b2 ((Pfizer-BIONTECH Covid-19 Vaccine) , via an unspecified route of administration on 31Jan2021, as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported.  The patient received 1st dose of vaccine on 31Jan2021 and was "fine for 2 days" then felt the effects in Feb2021: "threw up" in middle of night, achy weakness, chills, low grade temp. He stated, "soreness in arm, Achy and weak this morning when I got up. I am feeling better now." The patient reported that , "'my arm got sore and I felt like I had the flu for about 24 hrs.-took Tylenol" and was asking if he should be concerned the symptoms started more than 36 hours after getting the 1st dose. The outcome of the events was not reported.  Information on lot/batch number has been requested.