chrisvoncsefalvay/vaers-outcomes huggingface dataset:
liver enzymes were high; patient only had arm pain; headache; After 2 hours of not feeling well; treated for a migraine; had a hard time swallowing,; had chest pain/felt like she was having a heart attack; her blood pressure was high.; also has tingling in her feet; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC ENZYME INCREASED (liver enzymes were high), VACCINATION SITE PAIN (patient only had arm pain), HEADACHE (headache), MALAISE (After 2 hours of not feeling well) and MIGRAINE (treated for a migraine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PROPRANOLOL, FAMOTIDINE (PEPCID AC) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEPATIC ENZYME INCREASED (liver enzymes were high), VACCINATION SITE PAIN (patient only had arm pain), HEADACHE (headache), MALAISE (After 2 hours of not feeling well), MIGRAINE (treated for a migraine), DYSPHAGIA (had a hard time swallowing,), CHEST PAIN (had chest pain/felt like she was having a heart attack), HYPERTENSION (her blood pressure was high.) and PARAESTHESIA (also has tingling in her feet). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) at a dose of 1 dosage form and LOSARTAN at a dose of 1 dosage form. At the time of the report, HEPATIC ENZYME INCREASED (liver enzymes were high), VACCINATION SITE PAIN (patient only had arm pain), HEADACHE (headache), MALAISE (After 2 hours of not feeling well), MIGRAINE (treated for a migraine), DYSPHAGIA (had a hard time swallowing,), CHEST PAIN (had chest pain/felt like she was having a heart attack), HYPERTENSION (her blood pressure was high.) and PARAESTHESIA (also has tingling in her feet) 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.   This case was linked to MOD-2021-103805 (Patient Link).
Information has been received from a 71 year old retired physician with no known allergies and hypercholesterolaemia who on 7/11/06 was vaccinated in the left arm with a dose of varicella zoster virus vaccine live. Concomitant therapy included ezetimibe. A couple weeks after vaccination on 7/27/06, the pt experienced tachycardia that was persisted. He was seen by a two cardiologists and had an echocardiogram done which did not show anything. Two EKGs were done and his HR was 110-120. He also reported that he was having a little shortness of breath occasionally,but didn't think, it was related to vaccination. He did not have any other cardiovascular problems. The physician reported his sustained tachycardia to be potentially life threatening and disabling because he wasn't sure if his tachycardia was self limiting and temporary or would cause additional problems. He reported that he was nervous when his HR was high for 2-3 weeks. His cardiologist recommended unspecified medication, however the physician refused to take any medication. As of 8/10/06 the physician reported that his heartrate was gradually slowing down, it was 90-100 which was better than before but still not back to normal. Four months prior to vaccination the pt scheduled knee surgery for 8/22/06. He explained that he would proceed with the surgery as long as his heart rate was back to normal. Additional information has been requested.
Patient recieved his vaccines at approx. 4:15 PM. After leaving the clinic he developed hives and difficulty breathing at approx. 4:50 PM. They returned immediately to the clinic where he was noted to have generalized urticaria, wheezing and respiratory distress. Color appeared somewhat dusky. He was immediately given .2ml Epinephrine SQ and 25mg benadryl IM with rapid improvement in symptoms. Patient was then transferred to the emergency room for further observation.
The patient reports developing chills, sweating and vomiting with a fever of 103 F.  He self admitted to ER and received ketorolac and APAP which resolved the symptoms.
This spontaneous case, initially received on 12-Oct-2016, was reported by a health professional and concerns a 42-year-old male patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 08-OCT-2016 to 08-OCT-2016. Dose regimen: 0.5 ml single dose, Route of administration: Intramuscular. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On 10-Oct-2016 48 hours after AFLURIA vaccination, the patient experienced thyroid discomfort (outcome: not reported). Reporter comments: The healthcare professional considered the event non-serious. Additional information was received on 25-Jan-2017: Patient details added (weight and height). On 08-Oct-2016, the patient received AFLURIA (batch number: 13149221A). On 10-Oct-2016, the patient experienced right thyroid pain and odynophagia which improved. The outcome was reported as recovered on 28-Oct-2016. Reporter's comments: The reporter assessed the events as non-serious and considered the causality as certain/highly probable.
people in your employee test developed shingles after having the vaccine; people in your employee test developed shingles after having the vaccine; Nerve pain; This case was reported by a consumer and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2019, the patient received the 1st dose of Shingrix. On 9th December 2019, the patient received the 2nd dose of Shingrix. In March 2020, less than a year after receiving Shingrix and between 2 and 4 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and nerve pain. On an unknown date, the outcome of the vaccination failure, shingles and nerve pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and nerve pain to be related to Shingrix and Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient received both doses of Shingrix and experienced right-side nerve pain along ribs. After X-rays ruled out lesions, the patient's physician tentatively diagnosed shingles, despite vaccine history. The patient did not have rash or blisters. The pain had now persisted for about 62 days though it seems to be lessening in terms of number of episodes, duration of episodes, and severity. The patient just wanted you to know because the patient read that a very small number of people in our employee test developed shingles after having the vaccine, so it could happen. The reporter consented for follow up. This case was linked with US2020AMR068654, same reporter.
Information has been received from a physician concerning an 18 year old female with AMOXIL allergy who on 15-JAN-2007 was vaccinated with the first dose of Gardasil (lot #655619/1427F), IM, 0.5 ml. Concomitant therapy included hormonal contraceptives (unspecified). On 15-JAN-2007, the patient experienced prolonged left arm pain and limitation of movement secondary to arm pain following the first dose of Gardasil. No redness or swelling was noted. A shoulder x-ray was negative. The patient was treated with an unspecified NSAID's (non-steroidal, anti-inflammatory drug) and was referred to a neurologist. At the time of the report, the patient's prolonged left arm pain persisted and was considered to be disabling. Additional information has been requested.
Vascuularitis in both feet, worse in left.  Steroid and antibiotic were prescribed 11/22/21
Whole body chills around 3:15ish in the morning, hot flashes/low grade fever around 5:30, headache and sore arm since I've gotten up, whole body chills throughout the day.
Swelling in legs and feet that started 30 minutes after receiving vaccination and still present 48 hours later. She took a diuretic, which improved the swelling temporarily but it did return.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medications was not provided. On 02-MAR-2016 the patient was vaccinated with an expired dose of ROTATEQ (lot # K004795, expiration date 11-FEB-2016, oral, dose and dose # unknown). No adverse effects reported. Additional information has been requested.
CHILLS, FEVER  100.2, BODY ACHES, H/A and nausea
Pt. calls into work on 12/28/2020 crying and reports that she is not able to move or turn in bed without having sever discomfort in her neck; therefore unable to work her scheduled shift. Pt. reports with movement of her arms esp. her left arm that she gets "shooting pain" with radiation to the nap of her neck. Pt. denies any fevers at this time. Pt. reports that she had medicated with Tylenol Arthritis without relief. Pt. reports noticing muscle aches and discomfort on 12/26 but on 12/28/2020 is severe in nature. Pt. made an appointment with her PCP on 12/28/2020 at 1400. Pt. was instructed to take Ibuprofen 200 mg tid for a total of 600 mg as needed, cont. to use ice at home and was given Diazepam as a muscle relaxant. On 12/29/20 pt. was able to return to work and reported feeling better.  Pt. returned to the clinic on 12/30/2020 again with severe discomfort in the shoulders, neck and upper body. Pt. was seen by PA-C and was administered a shot of Toradil IM, placed on Prednisone 40 mg  for 5 days, lab was obtained and was instructed to cont. with the ice and Ibuprofen.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The nurse reported that one dose of (Oka/Merck) VARIVAX 1350U, 0.5ml, subcutaneous (lot # and expiration date were not provided) that was exposed to -12C for 2 hours, was administered, on 14-JUL-2014, to an unspecified patient. No adverse effect was reported. This is one of several cases from the same source. Additional information has been requested.
shingles my eye Dec. 2019; I got shingles left side of my scalp, face, eye; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In December 2019, unknown after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the ophthalmic herpes zoster was recovered/resolved and the outcome of the shingles was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported that, he/she got the single Shingle vaccine when Medicare started paying for it, the patient got shingles on left side of his/her scalp, face and eye and also in his/her eye. The patient said that, he/she would get the second one this month (September 2021). For the tolerance 2nd outbreak, refer case US2021AMR196898, reported by the same reporter. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR196898:same reporter
Patient was given0.5 ml instead of 0.25ml booster 3rd dosage, patient was called on 1/18/2022 and denies any problems since vaccination. A letter was sent to patient informing of dosage given
Pain of extremities; Painful joints; Swelling of limbs; Rib pain; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain of extremities), ARTHRALGIA (Painful joints), PERIPHERAL SWELLING (Swelling of limbs), MUSCULOSKELETAL CHEST PAIN (Rib pain) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain of extremities), ARTHRALGIA (Painful joints), PERIPHERAL SWELLING (Swelling of limbs), MUSCULOSKELETAL CHEST PAIN (Rib pain), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Pain of extremities) was resolving, ARTHRALGIA (Painful joints), HEADACHE (Headache) and CHILLS (Chills) had resolved, PERIPHERAL SWELLING (Swelling of limbs) had not resolved and MUSCULOSKELETAL CHEST PAIN (Rib pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicine was reported. No medical history was reported. On unknown dates, the patient experienced soreness in feet and hands sometimes in knees and hips, middle toe was swollen, rib cage pain, headache and chills. It was unknown if patient was enrolled in a covid-19 vaccine trial. For Humira, the reporter causality for the event soreness in feet and hands sometimes in knees and hips unknown onset and soreness in feet and hands sometimes in knees and hips unknown onset, middle toe was swollen, rib cage pain, headache and chills was not provided.  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. No treatment medicine was reported.   Reporter did not allow further contact
i had severe gastrointestinal paying; intestinal pain; bad skin rash on my chest and then maybe a week later on my face; This is a spontaneous report received from a non-contactable consumer (Patient). A 55-year-old female patient received second dose of BNT162 (PFIZER-BIONTECH COVD-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 16Apr2021 (at the age of 55-year-old) as single dose for covid-19 immunisation. The patient medical history was not reported and there were no concomitant medications. Patient historic vaccine included first dose of BNT162 (PFIZER-BIONTECH COVD-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation.On 21May2021, the patient had severe gastrointestinal paying, intestinal pain and bad skin rash on her chest and then maybe a week later on her face. Patient reported that, after the second vaccination she had severe gastrointestinal pain that she couldn't attribute to anything else her husband and she had the same vaccine at the same time he also had that gastrointestinal pain but then she would say several weeks after that vaccination she got a really bad skin rash on her chest and then may be a week later on her face that the dermatologist really couldn't distrubute to anything and she thought perhaps it might have something to do with the Pfizer vaccination so she just wanted to report it um she have gotten several different ointments that have finally worked on the rash and the gastrointestinal pain had subsided. Therapeutic measures were taken as a result of adverse events. The events were recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2nd dose not yet received; got covid at the time of the 2nd dose, 3 weeks after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got covid at the time of the 2nd dose, 3 weeks after the 1st dose) and PRODUCT DOSE OMISSION ISSUE (2nd dose not yet received) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced COVID-19 (got covid at the time of the 2nd dose, 3 weeks after the 1st dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose not yet received). At the time of the report, COVID-19 (got covid at the time of the 2nd dose, 3 weeks after the 1st dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (2nd dose not yet received) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that he got Covid at the time of the 2nd dose, 3 weeks after the 1st dose and stated that he needs to get 2nd dose for his employment.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Company Comment: This is a spontaneous case of product dose omission issue for this 48-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 3 weeks after administration of the first dose of the Moderna mRNA-1273 vaccine. No further details were provided. The outcome of the event COVID-19 was unknown at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case of product dose omission issue for this 48-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 3 weeks after administration of the first dose of the Moderna mRNA-1273 vaccine. No further details were provided. The outcome of the event COVID-19 was unknown at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Hives all over body - 24 hours - BENADRYL 50mg tablet - three times a day until rash is gone.
Client reported mild itching in throat and tingling in lower lip. Epinephrine was available for use, but symptoms did not progress and completely resolved without treatment at 40 minutes after vaccination.
Lump in the area they received the vaccine; swollen arm; the patients complain of hot to the touch in the area they received the vaccine; painful in the area they received the vaccine; red in the area they received the vaccine; is the patient pregnant: yes; This spontaneous report was received from a physician's officer manager and refers to three female patients of unknown age. The patient's medical history, concomitant medications, concurrent conditions and drug allergies were not reported.   On unknown date in April 2019, the patients were vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R033079 with expiration date on 06-JUN-2020 for prophylaxis (strength, dose #, anatomical site and route of administration were not provided).   On unknown date in April 2019, the patients called the doctor's office complaining of swollen arm (peripheral swelling), red (injection site erythema), hot to the touch (injection site warmth), painful (injection site pain) and lump (injection site mass) in the area they received the vaccine. The office manger stated that the physician had requested a lot check.  It was reported that the patients were pregnant (exposure during pregnancy). Neither the patients' date of last menstrual period nor the due date were specified at the moment of this report.  No information regarding the pregnancy (outcome pending) and fetal outcome was provided. The outcome of peripheral swelling, injection site erythema, injection site warmth, injection site pain and injection site mass were not reported.   The relatedness between the adverse events and therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided by the reported.
This spontaneous report was received from a medical assistant concerning an unspecified number of patients (demographics unknown). On unspecified dates since 29-JUN-2015, the patiens were vaccinated with doses of improperly stored PEDVAXHIB (dose, route and lot# not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Once I received the dose it was the last day of my period. The next day on 11/20/2021, I had extreme heavy menstrual bleeding. I could no get out of bed and could not go to work, I had heavy menstrual bleeding for 38 days. On 12/10/2021, I went to see the doctor and was prescribed medroxyprogesterone to elevate menstrual bleeding. After 10 days, the bleeding stopped.
The night of second Covid vaccine I fainted after urinating, fell on my face and tried to stand up 2 times but couldn't, my ears where ringing and I felt like vomiting right before.  About 2 days after the vaccine I'm having panic attacks and bad anxiety that isn't going away and I'm continuing to have done then. I started taking Lexapro and Xanax to help but the anxiety still persist and not getting any relief.
pt recv vax 28OCT96 & 18DEC96 pt devel cough, congestion, elevated temp of 99.8, anorexia;2 days later 20DEC96 pt expired-cause unk;
Moderna 0.25ml booster dose given too soon. Second dose in primary series was given on 10/7/21. No treatment required and no adverse reaction noted.
Verbal order for TDAP was given, then injection was given. Subsequent review of NGen showed TDAP 4 wks prior, so pt had an extra dose.
6/13/2022 woke up feeling bad experiencing a fever peaking at 101, a cough, runny nose, and dizzy. Took at home COVID 19 rapid antigen test, positive. I reached out to tele visit with doctor. Doctor prescribed molnupiravir. 6/16 fever broke and I started to feel better. Symptoms improved gradually to 6/23 when things returned to normal.
Dermatitis has been aggravated by the vaccine. When I come into contact with water I experience intense itching. I have been seeing a Dermatologist and an Allergy Specialist they have not ruled out allergy to water.
Arm started to swell around 3 PM. I had to quit work and go home. I was experiencing some moderate to severe pain in my left arm where the injection occurred.  It is almost 9 PM and the arm still hurts, but not like before. On a scale of 1 to 10 the pain factor was about 5 to 7. I was experiencing some mild shock symptoms (flush face). I couldn't use my left arm for anything, the pain was too great.
Vaccine recipient received vaccine on 1/8/2021. At the end of her 15 minute observation had a vasovagal episode with diaphoresis, lightheadedness and dizziness. She was sent to the ED for further observation and had experienced nausea and vomiting.  She was given Zofran. She was stable and discharged from the ED.
member presented for follow up after recieving his small pox vaccine and anthrax on the 8th. On the 17th he had erythema and itching at the site. On the 18th he returned with somilar sx. He developed an all over rash on the 20th in the evening that was extremely pruitic. He was seen in the med clinic on the 23rd and dx with non-viral pustulosis
High Fever.  Rash on face, neck, chest and back.  Abcess on groin area.  Split personality - between happy and miserable.  Required three visits to doctor and antibiotic treatment.