chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Huge knot underneath my arm that didn't go away for over month. Right near left armpit. The shakiness I felt the very next day, 2nd shot I got very sick. Later in the night I started feeling sensation of hypoglycemic and that lasted for several days and was completely gone within a month. I started getting sinus infections about 2 months after the second dose. I went to urgent care 2-3 times, both doctor and I treated the symptoms with decongestant, allergy pills,  inhaler. They put me on antibiotics and steroid. Amoxicillin, Z-Pack, the steroid I am not sure. Prednisone maybe.
Starting 3 days after the vaccine, I had tightness in my chest. It developed into chest pain and irregular heart beats, to the extent that by day 7 after the vaccine i requested a visit with my primary care doctor, and on day 10 I was seen by my doctor. My ECG was normal, but he also heard an abnormal rhythm when listening with the stethoscope, which prompted  him to order a Holter monitor. At this time, I have an appointment scheduled to receive the monitor on November 17, 2021.
Migraines; Eyesight since migraine gotten blurry; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 adverse event self-reporting method.  A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the arm right on 26Feb2021 at 15:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm right on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included migraine from an unknown date and the patient stated that she had migraines her whole life. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had received unspecified concomitant medications.  The patient experienced migraines and eyesight since migraine gotten blurry from 05Jun2021 at 08:00. Details were as follows: on 05Jun2021 at 08:00, she started with migraines and had continued daily pounding to, at the time of this report (12Jul2021) and her eyesight since migraine gotten blurry. On an unknown date, the patient had an MRI (magnetic resonance imaging), CT (computed tomography) scan (results unspecified). She had been to the neurologist, pain doctor, chiropractor, holistic doctor, eye doctor (because her eyesight since this migraine had gotten blurry) and they could not find anything. The patient explained that no medication would help her with the pain which was odd, as when she normally would get a migraine, something would help. The patient stated, nothing had helped. The only change in her life had been the vaccine. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of these events. Since the vaccination, the patient has not been tested for COVID-19. The clinical outcome of migraines and eyesight since migraine gotten blurry was not recovered.
Swollen & sore lymph tissue in armpit, first red/swollen/painful at injection area, then turned to a bruise. Pain in shoulder.
Info has been received from a 45-year-old female pt, a registered nurse with questionable drug hypersensitivity to sulfa who on 10/09/2002 in the AM was vaccinated by intramuscular injection in the right deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Additional therapy given in the AM on 10/09/2002 included an intramuscular injection in the left deltoid with a dose of influenza virus vaccine. The reporter indicated she has a "flu vaccine every year". Concomitant therapy included "antiinflammatories". On 10/11/2002 the pt developed a reaction over half the arm between the elbow and shoulder, described as "redness 4-5 inches from mid bicep to mid tricep", she could not raise her arm, had joint aches, fever of 100.6, blister type appearance of arm, swelling of arm and severe pain. The pt went to her physician on 10/11/2002 and was treated with prednisone, and cephalexin (KEFLEX) (total daily dosage, and stop date not reported). The reporter indicated she did not have any illness at the time of vaccination, and had not experienced any adverse events following prior vaccinations. The reporter requested a lot check. It was noted the pt recovered on 10/18/2002. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter mentioned 13 other patients who also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES #0210USA01734, 0211USA02240, 0211USA02241, 0211USA02242, 0211USA02243, 0211USA02244, 0211USA02245, 0211USA02246, 0211USA02247, 0211USA02248, 0211USA02249, 0211USA02250 and 0211USA02251).
I developed tinnitus and had to call the employee hotline late in the evening because it was driving me crazy. I could not sleep for weeks until I got used to the sound, but I've never really gotten completely used to it and must avoid certain situations because of the associated labarynthitis.
2 days p/vax pt exp severe pain in lt arm & shoulder;pain persisted for 6wk;p/pain resolved devel paralysis of deltoid, supraspinatus & infraspinatus muscles;pt seen by neuro & orthopedic surgeon;dx Parsonage Turner's synd;atrophy deltoid;
Information has been received from a consumer concerning her approximately 16 month old daughter with no pertinent medical history of drug reactions or allergies who on 13-FEB-1995 was vaccinated with the first 0.5 ml dose of MMR II.  In approximately February 1995, "shortly after receiving the vaccination", the patient developed autism.  The patient's autism improved.  On approximately 1998, "when the patient was 5 years old", the patient was vaccinated with the second dose of MMR II.  On approximately 1998, "after receiving the booster of the vaccine", autism reappeared and had been "downhill ever since".  It was reported that the patient also received OPV-MERIEUX and DPT-HIB conj vaccine (unspecified carrier) on the same day.  The patient also received 5 other vaccines that same day however they were unknown.  Lab tests were done but no results provided.  At the time of this report, the patient's autism persisted.  Unspecified medical attention was sought.  Upon internal review, autisms were considered to be other important medical events.  No further information is available.
Myalgia, Arthralgia, NauseaVomiting, FATIGUE AND MALAISE Narrative:  Day 2-Fatigue-all day day 2 1-6 pm- generalized pain, back & neck pain, Nausea 1pm-3pm   Other Relevant History:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Neither medical history, concurrent conditions nor historical drugs were reported. On 27-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 lot number N013521, expiration date 23-JAN-2019 (dose number and route of administration were not reported) for prophylaxis. The reporter stated that, on an unspecified date in the beginning of 2017 (reported as "earlier this year"), the patient was also administered a dose of PNEUMOVAX 23 (dose number, route of administration, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Injection was on 10/13/09 at PCP office. By 10/16/09 a.m. the progressive weakness made walking difficult. First symptoms were in legs, then arms then swollen hands with generalized pain all over. Returned to PCP 10/19/09 was sent to ER at about 4:22 pm. Was admitted directly to hospital. Discharged on 10/29/09 to hospital rehab 10/29/09 to 11/6/09. Admitted also 11/23 to 25/09.
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 09-FEB-2016 the patient was inadvertently administered improperly stored ZOSTAVAX (lot # L027321 with expiration date: 21-OCT-2016 or lot# L035283 with expiration date: 15-DEC-2016, route and dose were unknown) (incorrect product storage). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Eye was swollen; Eye was swollen and red; This case was reported by a other health professional via call center representative and described the occurrence of eye swelling in a infant male patient who received DTPa-HBV-IPV (Pediarix) (batch number 23YL4, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, less than a day after receiving Pediarix, the patient experienced eye swelling and eye red. On an unknown date, the outcome of the eye swelling and eye red were recovered/resolved.   It was unknown if the reporter considered the eye swelling and eye red to be related to Pediarix.  Additional details were reported as follows: Reporter was medical assistant. The age at vaccination was not reported. Reporter stated that the patient received a dose of Pediarix, and on the same day, the patient developed eye swelling and redness. Reporter stated that the patient's mother reportedly did not had to intervene at all, and the patient's eye was swollen and red for about 4 hours before resolving. The reporter consented to follow-up.
Approximately 15 minutes after receiving injection, patient complained of itching around her mouth. She told nurse that she had a shellfish allergy, although no allergies were listed on her consent form. Diphenhydramine 50mg was administered. Patient waited 10 minutes after receiving diphenhydramine before leaving.
Approximately 10 hours after receiving the vaccine I started to feel extremely dizzy and light headed like I needed water really bad, but 10 fold more intense. I began to sweat profusely from my entire body and I began to get the trembles. I sat down and waited it out. The episode lasted 10-12 minutes. I felt drained physically afterwards, like I had just exercised intensely.
A report was received from a health care professional on 25Oct02 concerning 7 vaccinees who experienced red, burning, hard nodules at the site of the injection, after receiving Fluvirin on 22Oct02. On 22Oct02, seven out of 68 employees who received Fluvirin at a community hospital experienced red, burning, hard nodules at the site of injection within a few hours. The vaccinees were seen in the ER. The vaccine was administered using a TB syringe with a prefixed needle. It was unk if the pt's recovered. The reporter suspects that these adverse effects are probably associated with this particular batch of Fluvirin. The following day, additional employees received Fluvirin from a different batch and no adverse effects were noted.  Update 1 20Feb03: A report was received from a health care professional concerning a vaccinee of unk demography who experienced raised red induration at the injection site 15 min after receiving Fluvirin on an unk date. The vaccinee had recovered at the time of the report. Three other vaccinees had the same reaction to the same batch. There was insufficient information to determine the reporters causality assessment. See Ref: PJP200200541, PJP200300089, PJP200300090.
The client received the first dose of Moderna COVID vaccine (Lot#069H21A, exp: 04/06/2022). LVN checked the client's birthday prior to administering the vaccine. LVN noted the client was 17 years old after administration of the Moderna vaccine. RN The client did not report any symptoms during the 15 minute observation period.
administered an expired act-hib vaccine with no reported adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old female patient to whom administered an expired Hib (PRP/T) Vaccine [ACT-HIB]with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza Vaccine for Prophylactic vaccination.  On 29-Sep-2023, the patient received an expired dose 4 at a dose of 0.5 ml of suspect Hib (PRP/T) Vaccine Powder and solvent for solution for injection (strength: standard, frequency: once, expiry date: 10-Sep-2023, lot UJ797AA) via intramuscular route in the left thigh as immunization (expired product administered) (same day latency)  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the Directive 2001/83/EC and Module VI 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.
Pain radiates from lower back to pelvis and buttocks; Hot and cold sensation in right arm; Hard to sit down; Lower back aches; Needle is pricking me; Whole body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain radiates from lower back to pelvis and buttocks), REVERSED HOT-COLD SENSATION (Hot and cold sensation in right arm), MOBILITY DECREASED (Hard to sit down), BACK PAIN (Lower back aches) and PAIN (Needle is pricking me) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (Pain radiates from lower back to pelvis and buttocks), REVERSED HOT-COLD SENSATION (Hot and cold sensation in right arm), MOBILITY DECREASED (Hard to sit down), BACK PAIN (Lower back aches), PAIN (Needle is pricking me), MYALGIA (Whole body aches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Pain radiates from lower back to pelvis and buttocks), REVERSED HOT-COLD SENSATION (Hot and cold sensation in right arm), MOBILITY DECREASED (Hard to sit down), BACK PAIN (Lower back aches), PAIN (Needle is pricking me), MYALGIA (Whole body aches) and PYREXIA (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.   Concomitant medications include Multivitamin Gummi. Treatment details include herbal tea.   This case was linked to MOD-2021-079137 (Patient Link).
2 days after immunization, ran fever, left upper arm became swollen, red, and warm to touch. Told to give ibuprofen and ice; if not better go to ER. Next day, took to ER and diagnosed with cellulitis. Given Rocephin and PO Keflex. Talk to mother 7/29/02, arm 100% better.
5 Weeks Post Vaccination Vomit 4 days, Diarrhea 6 days, Encephalopathy >24hrs, Seizure, Lost speech, Regressed over a 6 week period. Receives IVIG monthly.
Blotchy red rash starting shortly after vaccine given and worsened over next 2-3 days. Maculopapular rash on face, neck and trunk.  Less on the extremities. Benadryl.
, Additional Details: about 5-10mins after recieving the vaccine pt complained of back pain/dizzy,fainting. sat her down gave water. she was very nervous. no site/neck,shouolder pain but back pain of the same side. she called husband. after staying for 15 mins she felt better to leave but had gone to urgent care.called in pm to follow up around 7pm. she was  better. they did blood work at uc. bp was high and blood work showed a MI from past few months. nothing new. she said she was okay now. no pain or dizzy
large (20 cm) raised, reddened, painful area over left deltoid, hot to touch
It was 3 or 4 days after my 3rd Covid vaccine that I got very sick.  I was very congested, headache, body aches, and cough.  The congestion was very deep in my lungs and I had to fight to get it loose and get the congestion out.  I was exhausted as well.  I did not react to the first two vaccines this way.  I felt it was important to report this.
headache; sore arm; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (headache) and MYALGIA (sore arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Hashimoto's disease and Thyroidectomy. Concurrent medical conditions included Rheumatoid arthritis.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and MYALGIA (sore arm). The patient was treated with HYDROCORTISONE at a dose of UNK dosage form; ADALIMUMAB (HUMIRA) at a dose of UNK dosage form; ETANERCEPT (ENBREL) at a dose of UNK dosage form and HYDROCODONE at a dose of UNK dosage form. At the time of the report, HEADACHE (headache) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Other treatment medication included oral steroids.   This case was linked to MOD-2021-336827, MOD-2021-336828 (Patient Link).; Sender's Comments: This case concerns a 47 year-old female patient with medical history of Hashimoto's disease, who experienced the unexpected serious events of headache and myalgia. The events occurred on an unknown date after the first dose of mRNA 1273 vaccine. The rechallenge is not applicable in this case as no additional dosing will be given. The medical history of Hashimoto's disease, remains a confounder. The benefit-risk relationship of the vaccine in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.
Previously positive for COVID-19 on 9/1/2021. Presented to the ER for acute abdominal pain and vomiting with suspected appendicitis.
This spontaneous report was received from a registered nurse, referring to a unspecified number of patients of unknown ages and genders. The medical history of the patients or concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (which had the lot number of: L019836, expiration date: 24-MAR-2017) (doses, anatomical sites and routes were not reported). Concomitant medication of the patients were not provided. Additionally, no adverse effects were reported and there was not product quality complaint. This is one of several cases from the same reporter. Additional information has been requested.
Headache, Myalgia, Arthralgia, Fever, injection site burning Narrative:  04/12/21: Patient reports experienced "burning on injection" when received J&J vaccine on 04/12/2021. Also reports experienced symptoms of injection site pain/redness/swelling/itching, chills fever, headaches, joint pain, muscle/body aches, and loose stools. Reports consulted with medical professional via text (no in-person/in-clinic visits). Reports no medications were utilized for symptom relief. 04/16/21: Patient reports continued symptoms of injection site pain/redness, chills, fever, headaches, body aches, photosensitivity, and being flushed. Reports use of Tylenol and Motrin for symptom relief.
Information has been received from a physician concerning a 72 year old female patient who on 28-JAN-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 658397/1820U) (route and site not reported). On 27-JUL-2009, the patient developed shingles. The patient had visited the office to seek medical attention. The patient was currently being treated and has not recovered. Follow-up information has been received on 24-AUG-2009. It was reported that there was no way to get a sample from the patient since her lesions have dried up and healed. The patient was still having "terrible neuralgia". Follow-up information has been received from the registered nurse concerning the patient with a history of chickenpox at the age of 10-12 who on 28-JAN-2008 received on 0.5ml dose of ZOSTAVAX (Merck) (lot# 658397/1820U). There was no illness at time of vaccination. It was reported that a rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. On 27-JUL-2009, the patient developed severe rash with multiple lesions from C3-4 distribution to mid spine level, left arm, left fingers and left side.  At the time of the report, the patient's lesions have dried, but the patient was still having severe neuralgia at lesion sites and the level of pain was reported as 10. It was reported that there was no recent exposure to chickenpox or herpes zoster. No direct fluorescent antibody was done, no specimen was collected for PCR and no photo was taken. Shingles and severe neuralgia were considered to be disabling and an other important medical event by the registered nurse. Additional information has been requested.
The patient got paranoid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PARANOIA (non-serious), outcome "unknown", described as "The patient got paranoid".  Additional information:The caller was a consumer asking if a person has received the first dose Pfizer Covid 19 Vaccine is 21 days the maximum number of days that a person is able to take the second dose Pfizer Covid 19 Vaccine for it to be effective? Received their first dose Pfizer Covid 19 Vaccine, went to receive the second dose Pfizer Covid 19 Vaccine and the facility was out of the Pfizer Covid 19 Vaccine: The patient is very concerned about not being able to get the second dose Pfizer Covid 19 Vaccine. The caller stated she is just a friend of the patients. The patient got paranoid and the caller thought she would see if she could ease the patients mind. No other Products. No investigation assessment. The caller did not know the patients date of birth. Stated the patient is in his thirties. The caller did not know the patients weight, maybe 200lbs but the caller was not sure. Height was a little over 6 foot. The patient received First dose in month, July. The patient was supposed to go back like about maybe 2 days ago to receive the second dose Pfizer Covid 19 Vaccine and the patient did go but the facility was out of the Pfizer Covid 19 Vaccine. Lot/NDC/expiration: The caller did not have this information to provide. The caller states she just knows the patient was supposed to go back to get the second dose Pfizer Covid 19 Vaccine on 28JUL2021 and the patient did so but the facility was out of the Pfizer Covid Vaccine. History: No, not to the caller was knowledge.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.