chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
The patient arrived at this clinic on May 22, 2021 for his second vaccine and was given the Moderna vaccine and it wasn't until after the shot was given and information to be entered on his vaccine card that it was noted that he received the Pfizer vaccine on or approximately April 9, 2021 at Redmond Regional Medical Center, Rome, GA.  Provider was notified of incident and he was brought into an exam room where he was reassured that the two vaccines were similar the possibility of an adverse event was low.  The patient had no physical complaints at that time and was discharged from clinic
Hospitalization for Nausea/vomiting, incidental COVID-19 on dates 9/8/22-9/10/22.  Treated with no medications for COVID-19.
Patient representative called pharmacy 4/12/21 stating husband, fainted while at dinner about 5 hours after receiving vaccination on 4/11/21. 911 was called and patient was cleared by EMS at home.
Systemic papular rash over upper torso.  Diurnal fevers since injection.  Given antihistamine.
can barely lift her arm; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (can barely lift her arm), HEADACHE (headache) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LIMB DISCOMFORT (can barely lift her arm), HEADACHE (headache) and PYREXIA (fever). At the time of the report, LIMB DISCOMFORT (can barely lift her arm), HEADACHE (headache) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Fever and "stiffness" occurring after nap 2 days after vaccines...possible febrile seizure per ER and admitted for further testing. Head MRI and spinal tap pending.
didn´t receive 2nd dose, 1st dose given on 2020; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-Jun-2022. Reporter's Comments: The patient did not receive the 2nd dose of Shingrix and 1st dose was given in 2020. Consented to follow up was granted. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule.
8 minutes after vaccination patient reported tongue tingling and swelling.  Epinephrine was administered and patient began to feel a little better but 5 minutes after epinephrine patient reported feeling like her throat was beginning to swell. Patient went to hospital via ambulance, was reported by daughter that patient was released from hospital after a couple of hours and was doing well.
rash, reddened area @ inj site 10cm x 6cm  reddened area 3-3 1/2inches from inj site  5cm x 7cm;red areas raised along anterior margin;
Severe hives all over my body  They appear daily throughout the entire day They are large itchy lumps that come and go with allergy meds allergist suggested for me
Patient felt light-headed for approximately 20 minutes after ZOSTAVAX. Laid flat, water, chocolate.
Red, swelling, itchy rash at injection site nine days after injection. The rash spread rapidly but was gone within 48 hours
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4509739-00 (Company). A 52-year-old female patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Batch/Lot number: unknown), on 13May2021 as dose 2, single (Batch/Lot number: unknown) and on 23Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) till Jul2022, subcutaneous for psoriatic arthropathy, psoriasis. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "Moderate to severe chronic plaque psoriasis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was dosage permanently withdrawn in Jul2022. Additional information: Reported causality for adalimumab by reporter: Not related. Reported causality for BNT162B2 by reporter: Possible. The reporter considered "covid-19" related to BNT162b2. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of VARIVAX (dose, route of administration, lot# and expiration date were not reported), which underwent supported temperature excursions. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was given her first dose of the pfizer vaccine at around 915 am she had mentioned that she had an allergy to penicillin but it wasn't an anaphylactic reaction. After the shot she went and sat in the chairs out front and shortly after someone called out that she needed help nurse ran to her side and she was unresponsive with shallow breathing and sweating and we called 911. As nurse was checking on her nurse 2 grabbed the epipen and administered right away. She came to after the epipen and we were able to talk to her a bit she mentioned that she has fainted a few times. We noticed that she had urinated at some point not sure if it was before or after epipen. The 911 operator suggested that we get her on the floor and have her lay down so we got her on the ground and laid her down as we were doing this she was going in and out of responsiveness. We attempted to take her blood pressure but the machine errored out a couple times. As we were trying to get the blood pressure the ambulance showed up and they took over care. She was transported to Clinic ER. She called later in the afternoon to let us know that she was doing okay and that she appreciated what we had done for her.
Pt recvd vax & exp muscle pains following vax w/Hep B vax & was not sure if sx had started a/began the vax series; No further details were provided;
I experienced severe joint pain after the vaccine that gradually got worse. The pain felt like all my joints were squeezing. It is a hard feeling to describe but it was very painful. I continued to maintain my activity by found my yoga and Pilates etc. but I felt myself not being able to move as well as I used to. With the second dose, it came and went a lot more than with the first dose. The first dose lasted a few days, but the 2nd dose was recurring. I contacted a rheumatologist, and I was told the doctor would not be able to see me until 3 weeks. I then went to a pain management doctor who was unable to treat me. He said this was out of his expertise. I was able to be seen by the doctor I initially went to. He told me my knee would need to be drained. The knee was drained, and blood was drawn to check for infection, gout, etc. I was told to take Tylenol after the knee was drained. The results for the blood work would be in in a week. I was told to see him in a week. I had seen an orthopedic doctor in July and was told after an X-ray, that I have arthritis in my knee. I was offered a cortisone shot but since I have followed natural medication for 25 years, I refused. I kept putting ice and taking Advil. I went back to see doctor who told me I did not have any disease or infections. My knee had to be drained again. I was currently walking with a cane. After the knee is drained, I do feel relief. The doctor then suggested the cortisone shot. At this point I was desperate for relief, so I took it. I was told to come back in a month. We would discuss prescription drugs he said but I was afraid of the side effects especially after being on natural medicines for so long. I had eczema in the past and also feared this condition being flared up. Since I had so much inflammation throughout my body, I experienced pain in my left shoulder as well. I am unsure if this is related to the vaccine. I was told I could undergo a noninvasive method of pain relief or surgery. I opted for the surgery and had that done yesterday. My knee does not pain as much.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 73-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 11:00 as dose 5 (booster), single (Lot number: GJ3275), in right arm and on 28Apr2023 at 11:00 as dose 6 (booster), single (Lot number: GJ3270) at the age of 73 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 21Dec2020 at 17:00 as dose 1, single (Lot number: EJ1685), in left arm, on 11Jan2021 at 16:00 as dose 2, single (Lot number: EL3302), in left arm, on 01Oct2021 at 17:00 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 20Jun2022 at 10:00 as dose 4 (booster), single (Lot number: FP3175), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Afib S/P Successful Ablation", start date: 20Jan2015 (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Midazolam, reaction(s): "drug allergy"; Valproic acid, reaction(s): "drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive; (Sep2023) Negative; (19Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, patient took Paxlovid from 12Sep2023.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 administration.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On Monday, 24-MAR-2014, the patient was inadvertently administered ROTATEQ (oral, expiration date 18-MAR-2014, dose, frequency and Lot# not reported). No adverse effects were reported. Additional information has been requested.
Fever, chills, nausea and severe migraine headache. I get headaches, but not like this. All of my joints and muscles hurt. So, I called my doctor and she told me it would last 48 hours and to call back if I wasn't better by Monday.  She advised me to drink lots of fluids and that I could take Advil, but I didn't take any. I started feeling better Sunday evening and I went to work on Monday. I didn't feel great, but I was a lot better.
Information has been received from a physician concerning a 25 year old female with no drug allergies who on 27-Dec-2006 was vaccinated with the first dose of Gardasil (yeast). Concomitant therapy included ZITHROMAX. Subsequently, on an unspecified date, the patient experienced nausea and dizziness. The patient did not seek medical attention. No diagnostic studies were performed. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested. 5/14/10 Follow up: Subsequently, on 02-JAN-2007, the patient experienced headache, nausea and dizziness. The patient repsonded to Phenergan and Transderm scop. No diagnostic studies were performed. On 04-JAN-2007, the patient recovered from headache, nausea and dizziness. No product quality complaint was involved. No additional information is expected.
Right arm hot to touch, red, swollen (15x11cm). Benadryl and Tylenol.
Pt came in 11/10 and explained that 1 hr after receiving the flu shot on 11/8 she began to feel very sick. On that evening, she presented with a fever, dizziness, and chest pain. She said that these adverse reactions were present throughout the night. The next day, the chest pain were no longer present. She said that she began to have a sore throat and a fever on 11/9 with dizziness still present. She claimed that she may have been dehydrated and has been trying to actively rehydrate. Today 11/10, patient is claiming to be still dizzy, and has a sore throat. I informed the pt that the flu shot that she had received is an inactivated vaccine and should not get sick from it. I asked the patient if she had seen a doctor for her condition. She said no. I suggested to the patient to consult with a physician regarding her condition and to call the pharmacy tomorrow to update us on how she is doing. She took a business card and went home.
she developed symptoms of malignant hypertension; She feared she was having a stroke; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An adult (also reported as in her 40s) 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: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: MALIGNANT HYPERTENSION (medically significant), outcome "unknown", described as "she developed symptoms of malignant hypertension"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "She feared she was having a stroke". The events "she developed symptoms of malignant hypertension" and "she feared she was having a stroke" required emergency room visit. Therapeutic measures were taken as a result of malignant hypertension, cerebrovascular accident; patient had to be on a blood pressure medication.  Clinical course: It was reported that patient feels that the malignant hypertension started after the booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Acute right lower lobe subsegmental pulmonary embolism. Patient presented with right-sided, intercostal chest pain and shortness of breath. CT angiogram revealed a PE with small infarct, no heart strain. Patient started on pain medication and anticoagulation. Anticipate full recover and discharge the day after hospital admission. This is hospital day 1.
Patient received Covid19(Pfizer) vaccine on 02/26/2021 at 3.55pm and on 02/27/2021 in the morning he had swelling in his left leg ( patient had knee replacement in same leg 9 months ago). He waited 2 days and still no improvement. He went to Beaumont urgent care on 03/03/2021 and he was referred to emergency room at hospital. He was admitted due to blood clot in left leg and lungs, where he had leg surgery. He was prescribed Eliquis 5 mg twice a day.
I understand you need reports on mild side effects as well as serious ones. Mine were uncomfortable, but not alarming. I only had pain in my arm after the first shot, April 2. This report focuses on the second shot, April 30.  Pain in shoulder began about 4 hours after shot. Migraine started about 4 hours and 45 minutes after my shot and lasted nearly three days. Such a long migraine is unusual for me.  However, I avoided taking pain killers as I had heard that could limit immune response to the vaccine, so that could be the reason it lasted so long. Also had some chills and aches and pains.   I am delighted to be vaccinated.  I am reporting here, rather than on your consumer focused reporting site, because it only permits reporting side effects I am experiencing today. It is now three days after the shot, I have no more symptoms.  They ended at about 2 days and 20 hours after the vaccine.
Side effect with vision; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Side effect with vision) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (Side effect with vision). At the time of the report, VISUAL IMPAIRMENT (Side effect with vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details was not provided by the reporter. Treatment information was not provided. For mRNA-1273 (COVID-19 Vaccine Moderna), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Around 13:30, the pt complained of "throat felt tight, closing; breathing difficult". She was taken to ER and given "5 shots and O2" and sent home after 1 hour.
Facial tingling, itching and redness; Facial tingling, itching and redness; Facial tingling, itching and redness; This is a spontaneous report from a contactable nurse (patient). A 64-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), intramuscular in the right arm on 08Jan2021 10:00 at a single dose for COVID-19 immunization. The patient's medical history included mild adrenal insufficiency. Concomitant medication included hydrocortisone to 06Jan2021. The patient previously took lidocaine and experienced allergies to lidocaine and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced facial tingling, itching and redness on 08Jan2021 10:45. Therapeutic measures were taken as a result of facial tingling, itching and redness and included treatment with self administered chlorpheniramine 12 mg. Outcome of the events was recovered on Jan2021. The events were considered non-serious by the reporter.  Information on the lot/batch number has been requested.
Severe diarrhea, vomiting, headache, fever, chills, and fatigue. Had diarrhea and vomiting for hours. During my last trip to the bathroom, I became dizzy, disoriented, and was unable to see. Then I passed out. When I came to, I was on the floor and had a lump on my head. Doctor diagnosed me with a concussion.
Patient reports feeling lightheaded, flushing, and feeling nauseous. Patient is currently on cancer medication and cleared by EMS.
Aching and throbbing throughout left arm one half hour after DT given.  Pain worse with movement.  Continued pain. Diagnosed with subacromial and subdeltoid bursititis.  Injection likely superior to ideal site.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 16:45 as dose 5 (booster), single (Lot number: GH90702) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: BISOPROLOL [BISOPROLOL FUMARATE], start date: Jan1994; CALCIUM CITRATE WITH VITAMIN D3, start date: Jan1989; CHLORTHALIDONE, start date: Jan2004; ESTRADIOL [ESTRADIOL BENZOATE] vaginal, start date: Jan2004; LEVOTHYROXINE [LEVOTHYROXINE SODIUM], start date: Jan1994; LISINOPRIL [LISINOPRIL DIHYDRATE], start date: Jan2004; MULTIVITAMIN [VITAMINS NOS]; OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]; VITAMIN B [VITAMIN B NOS], start date: Jan1989; VITAMIN C [CALCIUM ASCORBATE], start date: Jan1989. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19; treatment with Paxlovid.