chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches in arm, back and pelvic area. Fatigue and body weakness after first vaccine for two days. Diarrhea, stomach discomfort, mild fever and body aches after second vaccine. Month following adverse reaction to vaccine, new allergies to food and products, GERD, diarrhea, mild fever, fatigue, dehydration and body ache at vaccine sites on arms. Diarrhea was continuous during the months of April, May and June as a result to certain food. Specific food was eliminated from diet. Such as carrots, broccoli and egg. Diet consisted of fruit smoothies, turkey/ham with crackers and steak tacos. In continuation, body aches/pains and shortness of breath developed as a result to certain food. New diet restrictions were placed in accordance to food allergy test that showed new food allergies. Constipation was treated after using bismuth. Treatment for GERD, body aches/pains, mild fever, allergies, dehydration, UTI: pantoprazole, Tylenol, allergy liquid medication, antibiotic, IV and cranberry D-mannose.
Stevens johnson syndrome/Small blisters first appeared in the nose and around the eyes a couple days; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 28Jan2021 19:00 (Batch/Lot Number: el3247) as a single dose, and her second dose via an unspecified route of administration in left arm on 17Feb2021 11:30 (Batch/Lot Number: en7201) as a single dose for COVID-19 immunization. Medical history included allergies to sulfa and mycin drugs. Concomitant medications included Tamsulosin, atorvastatin, prasugrel, and acetylsalicylic acid (BABY ASPIRIN). The patient was not diagnosed with COVID-19 prior to vaccination. On 02Feb2021, the patient experienced Stevens Johnson Syndrome - small blisters first appeared in the nose and around the eyes a couple days after shot #1. It exploded with blisters all over face, neck and body a couple of days after the second shot. Patient had large blisters and open sores today and still getting new blisters 6 weeks after shot #2. Patient initially assumed that this was shingles in spite of the fact that he had the new shingles shot. He went to the doctor this morning and he diagnosed it as Stevens Johnson Syndrome. Biopsy was taken and sent to a lab. There was no other change in medication history, food, or exposure to potential allergens. Therapeutic measure included gabapentin to lessen pain. Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of events was not recovered. The patient had not been tested for COVID-19 since the vaccination.
Onset of severe arthritis pain in left hip & knee, two weeks after 2nd Pfizer vaccine.  Difficulty walking at times.  (No prior exhibit of this arthritis.)
I thought my first symptom was on June 3rd. I dragged out a test kit from home and it was positive. I started messaging my doctor's office on June 6th. I had a virtual appointment and was prescribed Paxlovid. I took first dose on that Tuesday, the 7th of June. I had runny nose, sore throat. Sore throat was gone by day 6.
The PM of shot pt devel an elevated temp 106 & vomitting; went to ER; 25FEB93 admitted to hosp by MD w/bronchitis;
6days p/vax pt vomited x2, then devel fever 103f. held neck, under jaw bones, with both hands. sl red areas, no appetite. rash started 6/26/99.
Individual recieved incorrect dosage.  Diluent inserted into vaccine vial was not the full 1.8ml
Information has been received from a healthcare worker referring to an unspecified number of children of unknown age and gender. On unknown dates, the children were vaccinated with improperly stored doses of VAQTA (lot number, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
4-5 days after vaccine developed Vertigo; Diagnosed with BPPV.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Sep2021 11:30 (Lot number: EW0187) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Neck stiffness" (unspecified if ongoing); "Dyspepsia" (unspecified if ongoing). Concomitant medication(s) included: DOXYCYCLINE; TRAZODONE; PEPCID. Past drug history included: Lisinopril, reaction(s): "known allergies: Lisinopril"; Steroids, reaction(s): "known allergies: Steroids". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6206, Location of injection: Arm Left), administration date: 09Mar2021, when the patient was 63 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 30Mar2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: VERTIGO (non-serious) with onset 28Sep2021 08:00, outcome "recovered with sequelae", described as "4-5 days after vaccine developed Vertigo"; VERTIGO POSITIONAL (non-serious) with onset 28Sep2021 08:00, outcome "recovered with sequelae", described as "Diagnosed with BPPV.". The events "4-5 days after vaccine developed vertigo" and "diagnosed with bppv." were evaluated at the physician office visit. Therapeutic measures were taken as a result of vertigo, vertigo positional.  The patient was given Vestibular Therapy as a treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Trazodone 50 mg, Pepcid 30mg, Doxycycline medications within 2 weeks of vaccination. The patient did not have Covid-19 prior vaccination and did not tested for Covid-19 post vaccination. Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/ Administration facility.  No follow-up attempts are possible. No further information is expected.
Generalized urticaria, diffuse erythematous, blue bruise like marks on legs.
Immediately following vaccination with Hep A #1 on 04/11/2022, pt reported that her left arm became "numb" and stated that she was unable to move this extremity.  Pt asked husband to massage arm while RN obtained an ice pack from vaccine room.  Upon coming back to room, pt able to move L arm in a circle.  Pt reported that pain began resolving with movement and application of ice.  Pt declined opportunity to speak with RN's supervisor.  Pt stated that shoulder joint hurt, reporting it "felt like my arm fell out of my socket" while arm was dangling for vaccine administration.  RN instructed pt to follow up with provider or urgent care if pain worsens or does not resolve; pt verbalized understanding.  RN contacted pt on 04/12/2022 at 11:15 to follow up on pt's report of arm numbness and decreased ROM following vaccination on 4/11/22.   During phone call, pt reported that she had improved ROM and less pain in L arm on 04/12/2022.  Pt stated that she has bad joints, which she believes caused pain after vaccination after arm was hanging at her side for vaccination.  Pt reported that she does not believe the vaccine administration itself caused pain.   RN counseled pt to follow up with PCP or urgent care if pain does not resolve and/or if ROM affected; pt verbalized understanding, denied questions or concerns at that time.
injection site arm is Red; injection site is Sore; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 6 days after receiving Shingrix, the patient experienced injection site erythema and injection site pain. The patient was treated with immunosuppressants nos (Immunosuppressant Drug (Nos)). On an unknown date, the outcome of the injection site erythema and injection site pain were recovering/resolving.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on an unknown arm. After receiving Shingrix, the patient's injection site arm was red and sore. The patient planned to show his physician. The reporter did not consent to follow up. All information was not available.
I have a large red area on my arm at the injection site. It is raised and warm and it itches.
Pt recv vax on 1/12/99; on same day pt exp sore arm at vax site
Child started to exhibit motor tics one week after vaccine including shoulder shrugging, eye blinking, air swallowing, facial grimace, and involuntarily raising arms. Exhibited increased anxiety and had sleep issues. Treating with supplements.
Fast Heart Beat; This is a spontaneous report from a contactable consumer (patient). A patient of an unknown age and gender received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number/ NDC/ UPC number/ Expiry Date not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient had some fast heartbeat. Patient reported that might have received this vaccine for 2 weeks and 2 days. Patient stated "I recorded for if you say I note you like give and pay attention but I start to measure the oxygen level and the heart beat, I am "90" but they "85" I don't know is this normal or not but I have around "80" score than to the "90" (not clarified numbers)." Patient was supposed to have second dose the 01Mar2021 and wanted to know if can go ahead and take the second dose. Patient wanted to know for how long this side effects can stay, the duration of side effect. The outcome of the adverse event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
who received her 1st shot of our vaccine last 19Feb but was tested COVID-19 27Feb; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection), via an unspecified route of administration on 19Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received her 1st shot of our vaccine BNT162B2 on 19Feb2021 and was tested COVID-19 on 27Feb2021. The patient was scheduled for shot of our vaccine BNT162B2 on 12Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
continued severe pain in hips, back, below shoulder blade right side, legs.  NO RELIEF FROM PAIN  CONSTANT
Dizziness, nausea, headache, fatigue, muscle soreness, pain around injection site when moving arm
Noticed two small rashes like insect bites or possible allergic reaction marks that some times happen when I switch clothes detergents.
Extremely sore injection site, chills, general aches, sore throat and swollen glands, headache, chest discomfort, slight cough ...2 days.
immun was given on 16MAR93; 17MAR94 mom was @ clinic; pt stated had a rash noted on upper extremities red spot areas; 18MAR94 mom called & stated pvt MD had stated pt had allerg react from the shots & was put on DPH;
What is happening: I am experiencing skin itching all over my body everyday almost since 2 Dec, 2021. Red spots with pimple type look that are very itchy randomly appear all over my body and after a while disappear and appear somewhere else. Possible link: I had my booster shot of Moderna on 18 November and just around two weeks from that I started experiencing this. Wondering if there is a possible connection.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I have under my care a 53 year old airplane navigator who was vaccinated for anthrax in late 1990. In January 1991, he developed a chronic recurring movement disorder first manifested by abdominal tightening for 5-10 seconds. In July-August 1991, he developed right hand tremor and a left foot drag. The tremor which has frequency of 4-5 cycles per second, involves his entire arm at rest and recurs for about an hour most days. MRI of the head shows no visible brain abnormalities and EEG indicates that these are not seizures. No treatment has successfully abated the symptoms.
Stomach problems; Fever; Soreness around the vaccination site; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach problems), PYREXIA (Fever), VACCINATION SITE PAIN (Soreness around the vaccination site) and NAUSEA (Nausea) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included METOPROLOL, ATORVASTATIN, LOSARTAN POTASSIUM, TRAZODONE and BUPROPION for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach problems), PYREXIA (Fever), VACCINATION SITE PAIN (Soreness around the vaccination site) and NAUSEA (Nausea). At the time of the report, ABDOMINAL DISCOMFORT (Stomach problems), PYREXIA (Fever), VACCINATION SITE PAIN (Soreness around the vaccination site) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.; Sender's Comments:  MOD-2021-100622:Wife's Case
This is a spontaneous report obtained from a contactable nurse. This nurse reported similar events for 2 patients. This is the 2nd of 2 reports. A 66-year-old male patient started to receive PREVNAR 13 (Lot # M35761, Expiry date: 30May2016) at 0.5 ml, single in left deltoid on 23Sep2016 10:17 for pneumonia immunisation    Medical history included ongoing pancreatitis chronic, ongoing pain, ongoing chronic obstructive pulmonary disease, ongoing intervertebral disc degeneration, ongoing sciatica, ongoing seizure, ongoing lung adenocarcinoma, ongoing osteoarthritis, ongoing prostatic specific antigen increased. Concomitant medication included ipratropium bromide (ATROVENT) 17 ug, as needed (4 times a day) ongoing for COPD, pancreatin (CREON) 36000 units 4 time as a day by mouth for Chronic pancreatitis, glyceryl trinitrate (NITROSTAT) 0.4mg sublingual as needed for angina, morphine sulfate (MS CONTIN) one tablet twice daily as needed by mouth for chronic pain.   The patient experienced abdominal pain, night sweats, diarrhea, fever the evening of the 23Sep2016 after receiving the PREVNAR 13 injection. The outcome of the events was completely recovered on 26Sep2016: all of the patients symptoms were gone within 3 days after receiving the vaccine. There were no relevant tests. The nurse assessed there was a reasonable possibility these events were related to this suspect product.
Patient visited ED on 17 April due to "25-year-old female presents to the emergency department with a gradual onset headache started before she was going to bed, and then while in bed she started to have fever, chills, and body aches, followed by chest pressure, some shortness of breath, and tingling in her bilateral hands.  She had just received her second COVID-19 mRNA vaccine yesterday." Patient's diagnosis was "Adverse reaction to vaccine".
Client arrived on 5/27/21 to the Health Center to get his second dose of Moderna. Client reports that after his first dose on 4/29/21 of Moderna lot #017C21A he experienced a rash on his arm and back two days later and it resolved on its own after 5 days.  Client approved by PHN to administer 2nd dose with a 30 minute wait and no reaction occurred.
Rashes all over my neck, chest, stomach and back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes all over my neck, chest, stomach and back) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced RASH (Rashes all over my neck, chest, stomach and back). At the time of the report, RASH (Rashes all over my neck, chest, stomach and back) outcome was unknown. Not Provided          No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Developed a splitting headache, back of head, right side, minutes after vaccination. Also, arm was very sore 1 hour later, sore spot was over 3" wide at largest point, resolved overnight
Approx 15 minutes after immunizations, pt had 1 minute episode of pallor and "not breathing" requiring stimulation. No resuscitation performed. Event witnessed by additional adult.
11:30 pm started swelling in arm, pain, fever, itching, Tree prescription.
Tender area, Round & swollen around injection site. Clothing bothered it and it begun to itch lasted for 3-4 days. I went back to pharmacy and RPh stated it was normal.
Information has been received from a health professional concerning a 5 year old female pt with no known drug allergies who on 01/10/1997 was vaccinated with varicella vaccine. There was no concomitant medications. In December 2000, the pt developed a "mild to moderate case of chicken pox." The reporter considered vaccine failure questionable. The reporter was inquiring about other cases where children acquired the disease after immunization. It was reported that the pt sought unspecified medical attention. Additional info has been requested.
Very horrible headache, like I have never felt before, low grade fever, shortness of breathe, fatigue, body aches
vaccination site bump/huge like a baseball/visible; warm and hot; painful when bump tried to move; vaccination site swollen; minor fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (vaccination site bump/huge like a baseball/visible), VACCINATION SITE WARMTH (warm and hot), VACCINATION SITE PAIN (painful when bump tried to move), VACCINATION SITE SWELLING (vaccination site swollen) and PYREXIA (minor fever) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No medical history information was reported.     On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE SWELLING (vaccination site swollen) and PYREXIA (minor fever). On an unknown date, the patient experienced VACCINATION SITE MASS (vaccination site bump/huge like a baseball/visible), VACCINATION SITE WARMTH (warm and hot) and VACCINATION SITE PAIN (painful when bump tried to move). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (vaccination site bump/huge like a baseball/visible), VACCINATION SITE WARMTH (warm and hot), VACCINATION SITE PAIN (painful when bump tried to move), VACCINATION SITE SWELLING (vaccination site swollen) and PYREXIA (minor fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was reported to take birth control as concomitant medication.
covid s/s including cough, headache, congestion, runny nose, chills, night sweats, fatigue Treatment: tessalon perles, OTC zinc, OTC vitamin c, Augmentin, OTC probiotics Day 1-3: scratchy throat Starting Day 3: headache, ear ache, congestion, cough Day 4: cough, night sweats, chills, fatigue Day 5 to present (Day 23): productive cough transitioned to dry cough
This spontaneous report was received from a 22-year-old female patient who was reporting on herself. The patient's drug reactions/allergies included penicillin. Concomitant therapies included birth control pills (hormonal contraceptives (unspecified)). The patient's concurrent conditions was not reported. On an unknown date in late 2011, the patient was vaccinated with GARDASIL 9 0.5 ml, suspension for intramuscular injection at 0, 2 months and 6 months schedule via intramuscular route (strength, lot # and expiry date was unknown) for prophylaxis. The patient reported that she had received her 3rd dose of GARDASIL 9 on 09-MAR-2012 and was not aware that she had become pregnant on 10-FEB-2012. On 19-MAR-2012, the pregnancy test was performed. Patient did not seek for medical attention. No adverse reaction was reported. No product quality complaints (PQC) was involved.
Received flu shot on 12/1/14, after an hour of injection she became hot, sweating with pulse at 130, patient did not receive vaccine at our office. Patient reported through online portal.
Per provider, patient had a type 4 hypersensitivity reaction, local Arthus reaction. Per provider, this was not a cellulitis.
Takes injection every week now rather than every two weeks; Vaccine caused sore arm; Fatigue on the booster; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Takes injection every week now rather than every two weeks), VACCINATION SITE PAIN (Vaccine caused sore arm) and FATIGUE (Fatigue on the booster) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.  No Medical History information was reported.  On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Takes injection every week now rather than every two weeks), VACCINATION SITE PAIN (Vaccine caused sore arm) and FATIGUE (Fatigue on the booster). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Takes injection every week now rather than every two weeks) was resolving and VACCINATION SITE PAIN (Vaccine caused sore arm) and FATIGUE (Fatigue on the booster) had resolved.    No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt was given a Tdap and a PPD she has denied any history of issues with vaccines the immunization was given per protocol. the Pt walked to the front desk where she got dizzy she was evaluated by her PCP given smelling salts and her BP was taken after 10 min she was feeling better and left the office.