chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cold; 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 74 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold".  Additional information: Patient called to cancel her appointment because she had a cold. Patient stated that she had her first dose of  PFIZER-BIONTECH COVID-19 VACCINE few weeks ago ( patient did not remember the date) was scheduled to get second dose tomorrow but needed to cancel it because she had a cold.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
experiencing joint and muscle pain; experiencing joint and muscle pain; This is a spontaneous report from a contactable consumer (patient). A 76-year-old patient of an unspecified gender received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 01Mar2021 at 12:45 (lot number was not reported) as dose 1, single for COVID-19 immunization.  Medical history included Guillain Barre and allergies to sulfa on unknown dates. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient did not receive other vaccines in four weeks and other medication in two weeks. About four to five days after the vaccine, on 05Mar2021 (as reported), the patient started experiencing joint and muscle pain. These have not improved and have actually gotten worse. Pain killers do not help. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-DEC-2015 at 04:12, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 5.2 and 4.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency and Health Clinic (HC) that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of HA / HC. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
1st dose given by another provider.  Second dose given 20 days after first and a different brand.
Patient reported skin burning and nausea/vomitting for 3 to 4 days
Initial soreness led to pain traveling to left shoulder, lower back, right side buttocks and down right leg; seen at ER and diagnosed w/ muscle spasm; currently experiencing pain in left shoulder when driving, turning, or talking on phone and in right leg.
Redness/swelling distal (R) arm. Hypersensitivity to vaccine
Papular rash on arms, legs and torso. No fever, no blisters and mouth clear. No localized pain and no swelling, no bruising, no blisters. Acting alert and good P.O.
Fever of 101 degrees for three hours on Sunday, Feb. 22. Monday, woke up with vertigo, and it has continued for two weeks so far.  Treating with antihistamine. Not helping.
Less energy, headache, joint ache, chills, over-heating, unable to sleep, shivering, injection-site pain.   Took extra strength tylenol at 2:00am, 9:00am and 4:00 pm. Eating food and drinking water helped slightly, but full night sleep the following night helped most. Was recovered by Sunday morning and shot received on Friday afternoon.
sore arm; tired; She has been fully vaccinated and boosted/ she was diagnosed with the COVID Omicron variant in Jan2022; She has been fully vaccinated and boosted/ she was diagnosed with the COVID Omicron variant in Jan2022; she's had ongoing inflammation of her hips and shoulders; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 81 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jan2022, outcome "unknown" and all described as "She has been fully vaccinated and boosted/ she was diagnosed with the COVID Omicron variant in Jan2022"; INFLAMMATION (non-serious) with onset Jan2022, outcome "not recovered", described as "she's had ongoing inflammation of her hips and shoulders"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "tired". The events "she has been fully vaccinated and boosted/ she was diagnosed with the covid omicron variant in jan2022" and "she's had ongoing inflammation of her hips and shoulders" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) provided the inflammation markers; (14Feb2022) inflammation marker is even more elevated; sars-cov-2 test: (Jan2022) positive. Therapeutic measures were taken as a result of covid-19, inflammation.  Clinical course: Investigations: states they did quite a bit of bloodwork which provided the inflammation markers and did more blood work this past Monday and the inflammation marker is even more elevated from the last blood work and they decided to put her back on Prednisone and mild pain medication. States that they put her on the medication on Wednesday and she is feeling relief with the prednisone he would think is what is giving the relief. Caller states if it's not authorized his question is it legal for her to get the 2nd booster shot or anything to stop her from getting the 2nd booster and could her doctor order a 2nd booster and she could get it.  The lot number for bnt162b2 was not provided and will be requested during follow up.
low grade fever, sore throat, congestion, body aches, joint pain, sweats, dizziness, headache
Had a high fever of 104 and irritability after shots on 6/27/06. Mother did not tell MD until 8/28/06.
It was reported that a 18-year-old female patient receive rabies and hepatitis-b (unspecified) vaccinations on 13-Sep-2000.  Reportedly on 14-Sep-2000, the patient experienced malaise, nausea, feeling feverish, joint stiffness, A fine rash was noted on examination of the patient on both her forearms and under both breasts. Patient was treated symptomatically with Atarax and Ibuprofen.  From additional information received on 08-Dec-2000, "Reviewed, no added info at this time".
cough and shortness of breath. Pt notes his wife and daughter are recently covid-19 +. He tested negative ~10 days ago but developed symptoms ~2 days ago. He notes cough, shortness of breath, myalgias. ? Fever. No vomiting. No alleviating or aggravating factors.
Pain in left testicle for 4 days, Exam inconclusive,  concurrently - 30 days+ hematospermia  Ultrasound recommended and identified hydroceles. Pain decreased after 7 days, Noadditional treatment recommended beyond pain management as needed.
Patient complained of feeling light headed and dizzy at 10:05 am. I turned the fan on and took vitals which were stable. Stayed with patient until she was feeling completely fine, total time 45 min.
My ears have been stopped up on a continuous basis since the vaccine. I can't sneeze. I had a headache from 07/25/2021 through 08/01/2021 across my right eye.
Hospitalized 5/30/22-6/15/22 weakness, fall, elevated troponin, PNA, respiratory failure, UTI, cough, hypoxia, SOB, blood in stool,
Tightness in chest, hard to breath, raising heartbeat, off and on fevers. Extremely fatigued
Hives on wrist, arms, back, stomach, breast, and thighs; Rash; This is a spontaneous report from a contactable other health care professional. A 27-year-old non pregnant female received first dose of BNT162B2 (Pfizer BioNTech Covid 19 Vaccine) (Batch No: EN6199) via an unspecified route of administration, in left arm on 04Mar2021 (at the age of 27-year-old)  for COVID-19 immunisation. The patient medical history included hypertension, left ventricular hypertrophy and hypermobility. The patient was allergic to Ciprofloxacin, Sulfa, Ace Inhibitors, Minocycline, Nabumetone and Cefaclor. The patient had not received any other vaccine within 4 weeks of COVID-19 Vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for COVID-19 since the vaccination. Concomitant medications included Bystolic (MANUFACTURER UNKNOWN) and Xyzal (MANUFACTURER UNKNOWN) for an unknown indication. On 11Mar2021, the patient experienced rash and hives on wrist, arms, back, stomach, breast, and thighs. Therapeutic measures included Dexamethasone injection and oral Prednisone which included Doctor visit and emergency room visit. The clinical outcome of the events was not resolved at the time of report. No follow-up attempts are needed. No further information is expected
After the vaccine, pt experienced facial flush. Pt was given Benadryl 50 mg at 1:05 pm on 1/6/21
c/o back, neck, & h/a pain;chest pressure from aches; nausea;no vomiting;no fever;no rash;sx subsided on 3APR96;
Initial unsolicited report received from a nurse on 01 June 2016. This case involves 4-year-old male patient who was vaccinated with a dose of DTAP (batch number was reported as unknown, route and site of administration not reported) on an unspecified date. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced seizure and unable to relate any information on the seizure including if he was febrile at the time. It was told by pediatrician never to take pertussis vaccine again. The patient required ER/doctor visit. Laboratory data was reported as none. The patient's corrective treatment was not reported. On an unspecified date, the patient was recovered from event. Upon internal review the case was considered as serious because of important medical event seizure. List of documents held by sender: none. Sender's Comments: This is a poorly documented case. Time to onset is unknown. Additional information on the patient's medical history and immunization history, vaccination details, complementary investigation results ruling out a concurrent infection and exploration of alternate etiologies is needed to further assess this case. Based on the available information, the role of the vaccine cannot be evaluated.
Patient described red rash going up left arm and part of neck appearing about 2 weeks after vaccine. Recommended he take BENADRYL for the reaction and patient said he would try that.
his face started swelling around the jaw area towards the ear and jaw area; it's hard to eat and chew; it's hard to eat and chew; Along with lower back pain; This is a spontaneous report from a contactable consumer (reported for husband). A 55-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: Not provided) via an unknown route of administration on an unknown date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient received first dose of the Pfizer vaccine about 48 hours ago but last night her face started swelling around the jaw area towards the ear and jaw area, that was hard to eat and chew; along with lower back pain on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a physician referring to a 15-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 29-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot# N014945, expiration date 31-AUG-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 24-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012768.
Approx 30-45 after immunization c/o left arm numbness, SOB, tingling around mouth, pt states difficulty in speech , states it is hard to talk, states " it feels like there is oatmeal in my mouth), denies numbness or tingling to throat. Speech is slow but clear.
This spontaneous report as received from a physician via Company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose not reported). At month 3 the patient was vaccinated with the second dose of GARDASIL (dose not reported) and at month 5 with third dose. The patient's outcome was not reported. Additional information is not expected.
Patient Received his vaccination first and was fine While waiting for Mom and Sister to get their vaccination he was standing behind me and then fell forward on my arm and then fell to the gRound. Patient's father who is a physician and was waiting in the waiting area outside the immunization Room Came in and Revived the patient. The patient was Somewhat disoriented and very pale. I then went out and got the child a bottle of water while his dad held him and made Sure he was Responsive, coherent and ok. Patient was a little emotional and complained that his head hurt. They Sat outside the immunizing Room for about 10-15 minutes and then left. I called Mom later on in the afternoon to check on the patient. Mom said he had a Slight headache but otherwise was feeling ok, doing much better and playing outside.
stomachache, vomited, diarhea; t100, arm swelled to size of baseball bat; no other in family had severe local reaction; seen by MD 2NOV92;
On day 7 after the shot, I began 4-5 days of "Covid arm".......  My right arm at the injection site had about a 3 inch rash - itched and burned a lot for the first 2 days.  I treated with hydrocortisone cream.    NOT a big problem, but thought I should report it in case you're keeping track.         Just had my second shot yesterday 2/26/21 in the same arm.
Initial unsolicited report received from a consumer on 21-AUG-2017. This case involves a 75-year-old female patient who was vaccinated with an intramuscular second dose of (IMOVAX) in right deltoid and patient also received an intramuscular second dose of RABAVERT (manufacturer: GSK) in the left deltoid (for both the vaccines: batch number, expiry date, dose were not reported) on 03-AUG-2017. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Concomitant medications were not reported. On 03-AUG-2017, same day following the vaccination, the patient had headache which comes and goes like a shooting pain, muscle weakness, atrophy in muscles of arms and legs, losing weight, she is hungry but cannot eat, low BP, neck and shoulder stiffness, eye pain, brain feels foggy, weakness in legs, difficulty in swallowing and is uncertain if her throat is swollen, pain in her ribs. It was an actual medication error due to extra dose administered. No lab test was performed. Corrective treatment was not reported. The patient did not recovered from the events at the time of reporting (Patient states her symptoms are ongoing and not subsiding). List of documents held by sender: none. "This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error."
Low grade fever; Arm soreness with some numbness around the injection site; Arm soreness with some numbness around the injection site; Nausea; Elevated heart rate; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 03Feb2021 (at the age of 40-year-old), as unknown, single, in left arm, for COVID-19 immunization at Workplace Clinic. The patient's medical history included glaucoma, bipolar disorder, corticosteroids allergy, and COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Feb2021, patient experienced arm soreness with some numbness around the injection site, nausea, and elevated heart rate. Patient received Ibuprofen as a treatment medication. The patient had COVID prior vaccination and was not tested COVID post vaccination. The patient underwent lab test and procedure which included heart rate: elevated, on an unspecified date in Feb2021. The clinical outcome of all the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt exp an episode of symmetrical myoclonic jerking on 7DEC91 & again on 8DEC91; no LOC or post ictal state, no fever; returned completely to nl;
Swollen (L) arm 7 3/4" w/ pain. Unswollen (R) arm 6 3/4. No fever. After cold compresses/swollen has gone down.
She got her vaccine, and she remembers very clearly that she had mentioned to her husband that whoever was administering the vaccine had given it high up on the arm and did not cover it with a band-aide. For the next couple of days had the usual sore arm. Eventually about 1 to 1/2 weeks after she was taking some anti-inflammatory medication for 3-4 weeks. Once that wore off 2 days later she had severe pain in her left shoulder, and it was out of the ordinary, no trauma to that shoulder, nothing to have caused that pain. She went to take a shower and got dressed and noticed that she had a sore arm within 5-10 minutes had full blown sharp pain. She went to the closest ER and asked her about the vaccine and did not look into that, and took an x-ray and gave her pain medication. She took that and it did not help her much and then saw her physician. When they saw how much pain that she was in and could not move her arm at all and were suspicious for an inflammatory process. She had an MRI that showed a good to moderate amount of fluid in her left arm bursa and that this should be looked into. Her blood work came back as showing that she had some sort of infection going on. She was told to go to an ER immediately so that they could tap the fluid and see what was going on. She went to another ER and then they started investigated and she had a lot of infected shoulder bursa that was isolated to that area and said that it had to be inoculated. Eventually she had to have surgery to get the shoulder bursa cleaned out and found that it was a common bacteria on the skin, and administered by inoculation. She mentioned to her orthopedic that she had the vaccine and no band-aide and that he agreed it was due to that. She was on anti-inflammatories that masked the pain so that's why it took so long to find it. She now has a frozen shoulder, and has a PICC line inserted so she can get antibiotics 3 times a day for a full month and is finishing that course today. The surgery was 4/6/21 and started that a day or two before the surgery.
Breakthrough case admission after 3 vaccines Moderna 1/5/21ot# 037K20A;  Moderna 2/2/21 Lot# 032H20A;  Moderna 11/11/21 Lot# 034F21A
This man developed a rash consistent with Shingles in the right 5th cervical distribution that extended down the right arm beginning 7 to 8 days following a ZOSTAVAX vaccine at a local pharmacy. He was prescribed VALTREX for the rash and LYRICA for moderate symptoms of post herpetic neuralgia.
On Sunday, 1/17/21, patient was nauseous and vomiting and could not keep anything down at one point vomit was dark in appearance.  Patient receives home dialysis when nurse came to home on Monday, 1/18,  saw condition of patient and sent them to the hospital.  At the hospital it was noted she had redness throughout body, no hives or blisters.  Patient was lethargic, received antiemetic and medication for rash, does not know what medications were.  On Tuesday, 1/19,  she received 2 liter transfusion, discharged on Thursday, 1/21.  Today, Thursday 1/28 patient still feels lethargic and states rash is peeling.
patient immediately felt light headed and weak as soon as the shot was being injected into his deltoid.  After 2 minutes the patient still felt weak and the staff proceeded to lay him onto the floor.  At this time, the patient passed out for about 5-7 seconds and he was conscious for the rest of the time.  Blood pressure was 100/49 at the time when he fainted.  By the time the EMT came, his BP was 112/69.
pt recvd vax;w/in hrs exp paresthesias in both hands & a spacey feeling; lasted several hrs;
feeling like a bad cold, tired. went to ER because Dizziness and nausea - scared to drive next day to work. was given Meclizine for dizzy. 2nd shot not much better - felt like a weird few seconds of complete shut off.  Any help with this bill will be appreciated
Break through case not all items are known.  came into the  ED with a headache, neck stiffness, cough, anorexia and fatigue. He was given sodium choloride 0.9% bolus 500 ml @ 100ml\hr 1 dose. Time July 4th 2021 @13:29 Discharged home told to contact PCP if he has issues. Discharge 07/04/2021 15:55