chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High blood pressure; High pulse; felt like something was not right; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of   in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Cholesterol total abnormal NOS. Concomitant products included LISINOPRIL, ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) and EFINACONAZOLE (JUBLIA) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with LISINOPRIL at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Heart rate: over 100 (High) over 100. On 24-Jan-2021, Hypertension: over 200 (High) over 200.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Little diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Little diarrhea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced DIARRHOEA (Little diarrhea). On 20-Jan-2021, DIARRHOEA (Little diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included cholesterol medication, and medication for relaxing (not specified).
He got the first dose on 06Jan then 12Jan he tested positive; He got the first dose on 06Jan then 12Jan he tested positive; This is a spontaneous report from a Pfizer sponsored program, via a contactable consumer (patient). A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCIN, lot number: EK9231), on 06Jan2021 at single dose for covid-19 immunization. Medical history included idiopathic pulmonary fibrosis. Concomitant medication included nintedanib esilate (OFEV). patient got the first dose on 06Jan then 12Jan he tested positive and then he already scheduled for booster shot on 27Jan and he is asking if he can take that also because according to his doctor, other doctor said do not take it, the other doctor says take it. No investigation assessment. outcome of the events was unknown.
severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP)  (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "severe headache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Caller wants to know if she can take Tylenol Medical Information, no: Customer and/or medical inquiry was NOT forwarded.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Stomach ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 7 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "recovered" (2021), described as "Stomach ache".  Additional information: The patient felt better soon after the stomach ache. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headaches; Joint pain; fevers off and on; Feeling yucky; Cough; Swets; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 18Aug2021 at 18:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos, blood pressure high, allergy to sugarcane, very sensitive to soy (allergy). Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atenolol (TENORMIN), amlodipine besilate (NORVASC), progesterone (MANUFACTURER UNKNOWN) and thyroid medication (unspecified); all taken from an unknown dates for unknown indications and unknown if ongoing. The patient previously received cefalexin (KEFLEX) and hydromorphone hydrochloride (DILAUDID) on unknown dates for unknown indications and experienced drug allergy. On 21Aug2021 the patient experienced headaches, joint pain, fevers off and on (reported as an), feeling yucky, cough, sweats. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headaches, joint pain, fevers off and on, feeling yucky, cough and sweats were not resolved at the time of this report.
Injection at 5:30 PM 1/21 ? Minor arm pain about 2 hours (7PM) after the injection ? Pain in the arm increased substantially by around 10 PM ? Major Arm Pain continued morning of 1/22, with minor fatigue.  Through the morning on 1/22 the fatigue increased and I felt colder than usual. By about 1 PM I had started a mild headache as well, which worsened throughout the afternoon. I took ibuprofen and went to sleep around 4PM ( chills, major headache, and fatigue was at its peak) and awoke around 7PM - at this point the headache and chills had subsided and I felt almost back to normal. Mild pain persists at the side of the injection as of this morning 1/23.
13.5 x 11cm swelling/erythema at central blueness and paleness. Picture attached.
1 day p/vax pt devel a raised 2.5mm x 2.75mm area of redness @ the inj site;no further info was available @ the date of this report;this is 1 of 12 pt from this site to have an adverse rxn;
Experienced same typical symptoms such as fatigue and nausea for two days only after getting the vaccine.  But also had an adverse reaction to my left eye for week where it became inflamed and very bloodshot red.  Eye continued to swell and drain fluids and was extremely soar and painful with blurred vision.  Made appointment at my family physicians office on 4/13/2021 where doctor subscribed drops to be administered 3X daily.  This is where I am now.
Case previously recorded as MA2009-3918. Initial case report received from a health care professional via MedCom on 09 NOV 2009. A 2-year-old male patient was accidentally vaccinated with S-OIV FLUVIRIN (batch no. 100923) on an unreported date in 2009. MedCom reference no.:NA09-007863.
Dizziness, Headache, Sedation, Myalgia, Nausea Vomiting, Injection site pain, nasal congestion, Narrative: Received 1st dose 12/31/20 - developed injection site pain 3 hours after dose x several days. Also noted nausea x 2 days, and fatigue x 3 days. Received 2nd dose 1/26/21. Developed shoulder pain (at site of injection) 3 hours after dose. On 1/27/21 noted sinus congestion, headache, dizziness, nausea, myalgias, and fatigue. Slept 16 hours on 1/27/21. Improvement noted on 1/28/21. Missed work x 1 day. History of COVID infection 9/2020.
patient complained of dizzyness, nausea and mild lower abdominal pain without fever for 2 days after vaccination.
I95.9 HYPOTENSION 7/10/2023 UTI (URINARY TRACT INFECTION)
I had two shots in each arm as outlined in Item 17. I had normal soreness in both arms during the 3 days following the vaccines. However, my left shoulder has since had significant pain and limited range of motion. I got the shots on Dec 13, 2018 and a couple of weeks later, while traveling abroad, contacted my Doctor about the pain. I tried heat/ice, ibuprofen, light exercise, but nothing has healed it or brought relief. As I sit here over a month later, the pain is still significant and has an effect on my daily life. I struggle to do basic tasks: get dressed in the morning, drive, grab food from the shelf, carry medium/large boxes, etc.
Patient states that arm/shoulder is still significantly painful following injection over 2 weeks ago. Patient states she cannot comfortably lift her arm
This spontaneous report was received from a nurse referring to an 11 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 20-MAR-2017, the patient was vaccinated with first dose of GARDASIL 9 injection series (dose and route of administration were not reported) (lot # M033583 and expiration date: 14-APR-2019) for preventative of cervical cancer. On 20-MAR-2017, after the injection, patient had a severe injection site reaction. The reporter stated that the patient experienced severely swollen and red. The outcome of events was reported as recovered/resolved (reported as resolved on its own). The causality was not reported. No further clarifying information was provided by the reporter. There was no product quality complaint (PQC) reported.
redness, swelling at injection site and distal;  Patient saw doctor and received prescription for clindamycin.
This case was reported by a dentist via call center representative and described the occurrence of malaise in a unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced malaise, gastrointestinal symptom nos and fever. On an unknown date, the outcome of the malaise, gastrointestinal symptom nos and fever were unknown. It was unknown if the reporter considered the malaise, gastrointestinal symptom nos and fever to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not applicable. The age group was not reported, but was captured as adult as per the vaccine indication. The reporter said he recommended to his patients to get vaccinated with SHINGRIX. The health care professional said a lot of his patients had complained of having malaise, fever and gastrointestinal symptoms after the 1st dose of SHINGRIX. The health care professional was calling to ask if patients would have the same or worse reaction after the 2nd dose to SHINGRIX so he could continue to recommend to his patients to receive the 2nd dose of SHINGRIX.
mom reports extreme irritability, unable to sleep during the noc;no fever, no swelling of thigh;seen by MD 11AUG95;@ inguinal line poison ivy bulbous lesions;11AUG95 blisters on thigh just above vax site
I had a patient come to the pharmacy requesting a flu shot on May 24, 2022.  I advised him that we?re already past the recommended time frame for getting the flu shot and he said he still wanted to get it to be safe.   I administered the flu shot.   Today (May 25, 2022), he called me and asked if we offer any other vaccines.  Facility has a tool to recommended vaccines based on the patient?s demographics.  It also provides a snapshot of their vaccine history based on data. - Upon reviewing this information and data available on the record system, it appears that the patient has received over 30 vaccines in the last 2 weeks, including multiple flu, HepA, HepB, HPV, Meningitis, MMR, Pneumo, and COVID vaccines?   He indicated on his consent for that he has NOT received any vaccines in the past 4 weeks.  - There is no PCP listed on his consent form - I do have his phone number and address
Fever; Could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and INSOMNIA (Could not sleep) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PYREXIA (Fever) and INSOMNIA (Could not sleep). At the time of the report, PYREXIA (Fever) and INSOMNIA (Could not sleep) outcome was unknown.
This case was reported by a physician and described the occurrence of swelling at the injection site in a 42-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included degenerative arthritis and multiple sclerosis. Concurrent medications included Gabapentin, Glucosamine, Baclofen, Arthrotec, COPAXONE and PROVIGIL. On 31 October 2008 the subject received a dose of FLUARIX at 1.0 ml in the left arm. On 1 November 2008, 1 day after vaccination with FLUARIX, the subject developed a swollen red area on her left upper arm about the size of a small lemon. The area was tender to touch and she put ice on it and used NSAIDs. Within two to three weeks it was better, but her left arm did continue to hurt. Three weeks prior to reporting, the pain began to intensify. The subject experienced tremendous aching pain in the lateral part of her upper arm, neck and shoulder, radiating down her arm. She wakes up at night due to the pain. The reporter stated that the subject holds her arm on her upper abdomen because it hurts for her arm to hang down. The subject stopped climbing stairs and cannot pick up her child due to the pain, but she still continues to work. She sought medical attention on the day of reporting and the following was noted: The injection site area was mildly swollen, the subjects reflexes and strength were normal, but when a little pressure was put on the arm, the subject resisted. There was no numbness or tingling. Deep touch was normal and deep tendon reflexes were normal. The reporter suspected that the injection may have been given too deep in the muscle and therefore, performed an ultrasound that was found to be normal. It was specifically noted that the events of swelling, redness, tenderness and pain were worse at the time of reporting and probably related to treatment with FLUARIX. The outcomes and relationships of the other events to FLUARIX were not specifically stated. Follow-up information was received on 23 January 2009: The diagnosis was reported as arm pain at injection site. Onset date of earliest sign or symptoms was 31 October 2008. Outcome of the events was reported as unresolved and worse. The reporter considered the events were possibly related to FLUARIX. Ultrasound of the left upper arm was negative for hematoma. A biopsy was not performed. The subject did not use alcohol or tobacco. The subject has received flu shots "yearly".
Patient received the vaccine a week early. She was to return on 9/29/21 and she was vaccinated today on 9/22/21. No adverse event at this time.
Receiving infusion for Covid virus. Six minutes into the infusion I felt nausea and my blood pressure, heart rate, oxigination levels, and temperature dropped. I broke out into a cold sweat and felt like I was passing out. My skin color turned gray/green. Infusion was stopped immediately and nurses administered hydration to bring stats back up to normal. I was given a flue shot on Monday 09/27/2021. I was diagnosed with Covid on Wednesday 09/29/2021. The infusion was given to me on Friday 10/01/2021. Took about 30 minutes until my stats came back to normal.
Within 5 minutes tongue swelled and throat scratchy.  Given Epipen and transported by ambulance to Hospital.  At hospital given IV prednisone and Pepcid
Patient received Prevnar13 at approximately 12:30pm on 8/27/2020. She claims at around 11pm on 8/27/2020, she began vomiting. She reported the event at 9:26am on 8/28/2020, and at the time of reporting she noted her chest had a burning feeling as if she will vomit again.
autoimmune disease; sore and swollen joints; sore and swollen joints; ANA screen positive; My right wrist is swollen and quasi immobile and my left hand also; My right wrist is swollen; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer.  A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0164), via an unspecified route of administration in left arm on an unspecified date (at the age of 64-years-old) as dose 2, single for COVID-19 immunisation. Patient medical history included thalassaemia minor. The patient had no known allergies. Concomitant medications included Venlafaxine Hydrochloride (EFFEXOR XR) and Trazadone. Other medications the patient received within 2 weeks of vaccination was trazadone and effexor XR. Patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8733), via an unspecified route of administration in left arm on 16Apr2021 at 13:00 as dose 1, single for COVID-19 immunisation. 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 vaccination. On 01Jun2021 at 12:00, almost one month after the second dose, the patient developed autoimmune disease symptoms including sore and swollen joints. Patient received treatment for adverse events. Antinuclear antibody test (ANA) titer positive at 1:640 speckled and ANA screen positive. Erythrocyte Sedimentation Rate (ESR) and rheumatoid factor were normal. She never had such symptoms before. Her right wrist was swollen and quasi-immobile and left hand also. She was referred to a rheumatologist. Outcome of the events was not resolved on an unspecified date.
This spontaneous report as received from a registered nurse refers to an unspecified number of children. The patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (dose, route and lot number not provided) on unknown dates "within the past 13 months". No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Prolonged Fever (over 103), ringing in ears, dizziness, rash over entire body and face. Some soreness in legs but that went away.
slightly numbness of tongue (only front part of the tongue).; This is a spontaneous report from a contactable other health care professional (patient). A 52-year-old female (non-pregnant) received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation; solution for injection; Lot number: EN6202; Batch no: not reported) via Intramuscularly administered in Right arm on 28Feb2021 09:00 AM (at the age of 52-years-old) as dose 1, single for covid-19 immunization at Hospital. Medical history included Grave's disease, hypothyroidism and right shoulder soreness. No known allergies were reported. Concomitant medications included medications within two weeks as Liothyronine sodium; L-thyroxine [LEVOTHYROXINE]; Ubidecarenone (COQ-10); multi-vitamins (gummy chewable); Biotin; Cyanocobalamin (VITAMIN B-12); Hyaluronic acid; Triamcinolone acetonide (NASACORT) all taken for an unspecified indication except Ibuprofen, start and stop date were not reported and Ibuprofen taken for right shoulder soreness (last dose taken on 2/26 evening). No other vaccine received by the patient within four weeks. The patient did not have covid prior vaccination. The patient had not been tested for covid post vaccination. On 28Feb2021 09:30 AM after the vaccination, the patient experienced slightly numbness of tongue (only front part of the tongue). AE dose not resulted in ER or physician office visit. No treatment was received to the event caused. Outcome of the event was not resolved.  No follow-up attempts are possible; Information about batch/ lot number cannot be obtained.
Intense itching left arm injection site after 2nd dose lasted 4-5 days; Joint Pain after 2nd dose lasted 4-5 days; Muscle pain after 2nd dose lasted 4-5 days; Fatigue after 2nd dose lasted 4-5 days; Pain on left arm injection site after 2nd dose lasted 4-5 days; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PRURITUS (Intense itching left arm injection site after 2nd dose lasted 4-5 days), ARTHRALGIA (Joint Pain after 2nd dose lasted 4-5 days), MYALGIA (Muscle pain after 2nd dose lasted 4-5 days), FATIGUE (Fatigue after 2nd dose lasted 4-5 days) and VACCINATION SITE PAIN (Pain on left arm injection site after 2nd dose lasted 4-5 days) in a 70-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (Intense itching left arm injection site after 2nd dose lasted 4-5 days), ARTHRALGIA (Joint Pain after 2nd dose lasted 4-5 days), MYALGIA (Muscle pain after 2nd dose lasted 4-5 days), FATIGUE (Fatigue after 2nd dose lasted 4-5 days) and VACCINATION SITE PAIN (Pain on left arm injection site after 2nd dose lasted 4-5 days). At the time of the report, INJECTION SITE PRURITUS (Intense itching left arm injection site after 2nd dose lasted 4-5 days), ARTHRALGIA (Joint Pain after 2nd dose lasted 4-5 days), MYALGIA (Muscle pain after 2nd dose lasted 4-5 days), FATIGUE (Fatigue after 2nd dose lasted 4-5 days) and VACCINATION SITE PAIN (Pain on left arm injection site after 2nd dose lasted 4-5 days) had resolved.            Concomitant and treatment medication was not reported.   This case was linked to MOD-2022-595957, MOD-2022-595959 (Patient Link).   Reporter did not allow further contact
began w/induration & erythema w/in hrs of receiving vax;area has inc to its measurements of 4.5 x 12 cm w/ 0.5cm (diameter) of induration @ its center;some limping 11OCT95 which has improved today
Day 7 injection site began itching w/mid annoying like a wasp bite.  No medical care required. Site of injection turn red (cell phone, square size.  Annoyance lasted about 3 weeks.  Seemed lesser at top and moved down my arm.
Sore arm at injection site (day of shot and next 2 days) Severe Gout flare up (10 pm day following shot and next few days) recovered - lingering Tiredness
OUT OF RANGE FOR 3 DAYS; This spontaneous report received from a health care professional 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: 206A21A expiry: 07-AUG-2021) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced out of range for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of range for 3 days was not reported. This report was non-serious.