chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received SHINGRIX. Concurrent medical conditions included shingles (10 years ago) and seasonal allergy. Concomitant products included atenolol, NASACORT, Probiotic, vitamin D and ELIQUIS. On 19th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 19th mMy 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, general body pain, difficulty sleeping, nasal stuffiness, runny nose, nausea, headache and nightmare. On 20th May 2018, the patient experienced feelings of weakness, shaky feelings, influenza-like symptoms and fever. The patient was treated with TYLENOL. On 19th May 2018, the outcome of the injection site pain was recovered/resolved. On 20th May 2018, the outcome of the nightmare was recovered/resolved. On 21st May 2018, the outcome of the general body pain, difficulty sleeping, nasal stuffiness, runny nose, nausea, feelings of weakness, shaky feelings, influenza-like symptoms, fever and headache were recovered/resolved. It was unknown if the reporter considered the injection site pain, general body pain, difficulty sleeping, nasal stuffiness, runny nose, nausea, feelings of weakness, shaky feelings, influenza-like symptoms, headache and nightmare to be related to SHINGRIX. The reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient herself. The patient experienced pain at injection site during the injection. By the evening of the day of vaccination, at around 9 pm, the patient experienced headache, body ache, difficulty sleeping, had a nightmare, had runny and stuffy nose and felt nauseated. One day after vaccination, the patient experienced feelings of weakness, shaky feelings, influenza-like symptoms and fever. The patient reported that this contented through Sunday, 20th May 2018 and she also felt weak and shaky and could not shower or attend church. The patient had a fever of 101 degree F and she took TYLENOL to treat this. The patient had flu like symptoms that lasted all day Sunday and that she went to bed Sunday night at 8:30 pm. When she awoke Monday, 21st May 2018 in the morning, the symptoms had resolved, she felt fine and was able to go to work. The patient was unable to provided full demographics for pharmacy or for her physician. The contact details of the physician was provided.
I received my J&J vaccine on 03-13-2021. On 03-16-2021 I woke up and the left side of my shoulder, both knees, both legs and both feet are inflamed.  I also have cramps to both of my shoulders. On Saturday 03-20-2021 when I woke up my right eye was also inflamed but only lasted one day. I have spasms to my calves with leg cramps. I can not sleep at night due to the inflammation.  I went to see my PCP this morning who prescribed a leg cream for the cramps, but I do not know the name. My blood pressure today in the morning was 154/96.  My doctor said it was a reaction to the vaccine.
Member developed dizziness and metallic taste in mouth about 5-10 minutes after having the vaccine
Headache was worst symptom, also body aches, slight chills, "felt hungover".
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 18th July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm and experienced upper arm pain at site of injection that had not resolved and had actually gotten worse with time.
Sunday: morning (12 hrs later)- nausea; afternoon- fever and body aches and joint aches; evening- continuation but with chills and diarrhea Monday: nausea, fatigue, body and joint aches, evening had chills and fever Tuesday- fatigue, body and joint aches Wednesday- sore at injection site and slight pain under armpit.  Armpit issue resolved by Friday and did not worsen.
she knows 3 other people with the same symptoms/body pain; shoulders are really painful; she can hardly lift her arms up; legs are like she lost mobility; inflammation; This is a spontaneous report from a contactable consumer or other non-healthcare professional reporting same events under the same suspect product for 4 patients. This is one of 4 reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter stated that she knew 3 other people (patient) with the same symptoms, body pain, shoulders are really painful, she can hardly lift her arms up, legs are like she lost mobility and inflammation on an unspecified date. She would like to know is there a way if Pfizer knows of this side effect is there something that can help. The outcome of the events was unknown.  Follow-up attempts have been completed. Batch/lot number is not available for [BNT162B2]. No further Information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101182532 same reporter/drug/event, different patient
No Additional AE; HCP called to inform patient received expired dose of GARDASIL 9. HCP refused to provide patients first name. MIR on 02386787. No Additional AE/PQC.; This spontaneous report was received from an other health professional and refers to a patient of unknown gender and age. The patient's medical history, concurrent conditions, concomitant therapies, previous drug reactions/allergies were not reported.  On 09-MAY-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 mL, once (X1), administered intramuscularly (lot# T030749, expiration date and internal validation established as 16-MAR-2023) (strength was not provided) for prophylaxis (expired product administered). No additional adverse event (AE) or product quality complaints (PQCs) were reported.
2 YO was given kinrix; Kinrix was given instead of DTap; Kinrix was given instead of DTap/ received kinrix as 4th dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included DTap-IPV (had received 3 doses of DTap-IPV on an unknown date).   On 9th January 2023, the patient received the 4th dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 9th January 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 9-Jan-2023 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received a dose Kinrix as 4th dose instead of DTap vaccine at an inappropriate age, which led to wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Hot Arms & legs; Chills; Fever 99.8 F; Tired; This spontaneous case was reported by a consumer and describes the occurrence of TEMPERATURE DIFFERENCE OF EXTREMITIES (Hot Arms & legs), CHILLS (Chills), PYREXIA (Fever 99.8 F) and FATIGUE (Tired) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0139904 and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced TEMPERATURE DIFFERENCE OF EXTREMITIES (Hot Arms & legs), CHILLS (Chills), PYREXIA (Fever 99.8 F) and FATIGUE (Tired). On 04-Nov-2021, TEMPERATURE DIFFERENCE OF EXTREMITIES (Hot Arms & legs), CHILLS (Chills) and PYREXIA (Fever 99.8 F) had resolved. On 06-Nov-2021, FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Nov-2021, Body temperature: 99.8 (High) 99.8 F.         No concomitant medications information was not reported No treatment medications were provided    This case was linked to MOD-2021-403266 (Patient Link).
contracted Covid; contracted Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series of Vaccination completed (Manufacturer unknown)), for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "contracted Covid". The patient underwent the following laboratory tests and procedures: Body temperature: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical information: Subject:  Thanks and gratitude for your efforts to keep us healthy. I'm 76 Covid vaccination and booster contracted Covid was symptomatic cough low temp exhaustion horrid taste in my mouth. I'm on day 5 still positive symptomatic but the Paxlovid helped me so much I wish to thank you all of you for your continued efforts to help humanity.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine leaked from syringe while in contact with patient , contacted Pharmacist and CDC and Glaxosmith who advised to repeat dose at next visit no harm to patient
Initially had a red circle at the injection site for a couple days and it went away, then on 1/11 the red circle has returned bigger, raised, and itchy
24 hrs after injection c/o weakness and tingling right side of face.  Tongue numb.  Difficult to use a straw.  L eye lid with lid lag.
Patient was having dizzy spells after getting vaccine, I offer to call an ambulance for the patient, she refused, We followed the patient in observation for 30minutes patient felt fine and left home, dizzy spells.
Patient with a history of significant allergic reactions to medications. Patient-reported facial tingling and slight itching after vaccination. After oral hydration and serial monitoring in the monitoring area, the patient's symptoms resolved without further intervention. She was discharged home with her husband as a driver.
Patient received the pediatric Bivalent Pfizer vaccine as their first dose rather than the monovalent vaccine for their first dose. The patient was monitored after vaccination and the situation was explained to their legal guardian. The patient did not have any adverse events.
Itchy rash; rash on the increase of arm, chest, belly, belly button, over her shoulders, and down the underarm areas.; Fever; Hot and cold flashes; Hot and cold flushes; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot and cold flashes), FEELING COLD (Hot and cold flushes), RASH PRURITIC (Itchy rash), RASH (rash on the increase of arm, chest, belly, belly button, over her shoulders, and down the underarm areas.) and PYREXIA (Fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol. Concomitant products included CALCIUM and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.   On 05-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced HOT FLUSH (Hot and cold flashes), FEELING COLD (Hot and cold flushes) and PYREXIA (Fever). On 06-Jun-2021, the patient experienced RASH PRURITIC (Itchy rash) and RASH (rash on the increase of arm, chest, belly, belly button, over her shoulders, and down the underarm areas.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash and Itchy rash, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, HOT FLUSH (Hot and cold flashes), FEELING COLD (Hot and cold flushes), RASH PRURITIC (Itchy rash), RASH (rash on the increase of arm, chest, belly, belly button, over her shoulders, and down the underarm areas.) and PYREXIA (Fever) outcome was unknown.
20 seconds p/vax c/o warmth head & neck were fiery red;then c/o chest pressure, BP 108/64 AP 108, lungs clear;c/o mid epigastric pain, c/o  neck pain;c/o sharp pain across rt eye;
I got my first dose of Pfizer september 16, 2021 and after a week I noticed everytime i wash my hands or shower my hands turned purple in the palm area and when i warmed it up its gonna go back to normal but i noticed also that my finger area my veins are purple and its very clear even though my hands are warm already and dry. My hands aren?t like this i know it wasnt like this before. . Supposed to be my 2nd dose was october 7, 2021 but the doctor on that facility didn?t recommend to get my 2nd shot because of my reaction on the first dose.
Information has been received from a claims examiner for a pharmacy regarding a female who was vaccinated with ZOSTAVAX (lot number 672608/1715AA, expiration date 02-FEB-2013). The patient's medical history and concomitant medications were not provided. It was reported that the patient developed a localized site reaction after the vaccine was administered. The outcome of the event was not provided. A lot check has been requested. Additional information has been requested.
Severe dyspnea/headache went to local clinic and was prescribed Prednisone / Z PACK. S/S started 3-4 days after MMR #1 & resolved 3 weeks later.
Dose 1: 29Jan2021; Dose 2: 07Feb2021; she forgot to take the several medicines; stomach problems; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), on 07Feb2021 as dose 2, single (Lot number: EN6201) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "She takes her blood pressure" (unspecified if ongoing), notes: She takes her blood pressure; "She was on a few medications over the 10 years for pain" (unspecified if ongoing), notes: She was on a few medications over the 10 years for pain.; "Pain in her nerves, muscles, and tendons" (unspecified if ongoing), notes: Pain in her nerves, muscles, and tendons.; "She did start with the pain in her foot" (unspecified if ongoing), notes: She did start with the pain in her foot. Concomitant medication(s) included: LISINOPRIL taken for blood pressure abnormal; NUCYNTA taken for pain; SAVELLA taken for pain; ORPHENADRINE taken for pain; AMITRIPTYLINE taken for pain; TYLENOL taken for pain; CODEINE taken for pain; HYDROCHLOROTHIAZIDE. Past drug history included: Levaquin, reaction(s): "nerve pain, muscle and joint pain", notes: I had a reaction to Levaquin 11 years ago and had nerve pain , muscle and joint pain that was horrible at times; Levaquin, reaction(s): "nerve pain, muscle and joint pain", notes: I had a reaction to Levaquin 11 years ago and had nerve pain , muscle and joint pain that was horrible at times; Levaquin, reaction(s): "nerve pain, muscle and joint pain", notes: I had a reaction to Levaquin 11 years ago and had nerve pain , muscle and joint pain that was horrible at times; Levaquin, reaction(s): "nerve pain, muscle and joint pain", notes: I had a reaction to Levaquin 11 years ago and had nerve pain , muscle and joint pain that was horrible at times. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN5318, 72115121), administration date: 29Jan2021, when the patient was 77-year-old, for COVID-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Dose 1: 29Jan2021; Dose 2: 07Feb2021"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "she forgot to take the several medicines"; GASTRIC DISORDER (non-serious), outcome "unknown", described as "stomach problems".  Additional information: It was reported that 11 years ago she had a reaction due to Levaquin that affected her nervous system, her joints and muscles. So she started to take Nucynta, Savella, Ephedrine and Amitriptyline in order to control her pain for almost 10 years. She received her second shot and she realized she forgot to take all her medicines for her pain but she was having no pain at all and sudden she felt well. Now she has been a year without pain. It was also reported that patient was not having other conditions and did not underwent investigation.
Patient was returning to unit. When patient reached unit doors, patient collapsed. Health Care called, 3 nurses and Mini Ambulance deployed. Upon the Staff's arrival CPR was in progress, AED in place, Narcan administered. Ambulance call, transported to Facility.  Patient pronounced 0724 hours
Significant bruising 3 cm x 3cm on left arm at injection site.  Discomfort over site of injection.  Took three weeks to  resolve.
Heart palpitations/atrial fibrulation - up to several events each day over the course of about one month.  Prescribed event monitor with anticoagulation meds; followed by transthoracic echocardiogram.  Symptoms eventually subsided and have not recurred.
Noticed rash aprox 8 days after having vaccines aprox 11 days after having vaccines went to the ER for poss seizure, still with rash 12 days after vaccine.
This spontaneous report as received from a medical assistant refers to an infant male patient of unknown age. On an unknown date between 13-MAY-2013 and 14-JUN-2013 the patient was vaccinated with RECOMBIVAX HB (2.5/0.5 units not provided), (0.5 ml intramuscularly, dose number unknown) (lot # H020604 exp date 10-FEB-2015. RECOMBIVAX HB that had a temperature excursion. No adverse effects were reported. This case is related with the following cases on same reporter link:  1307USA007921, 1309USA012210, 1309USA012211, 1309USA012212, 1309USA012214, 1309USA012215, 1309USA012216, 1309USA012217, 1309USA012218, 1309USA012219, 1309USA012220, 1309USA012221, 1309USA012222, 1309USA012223, 1309USA012224, 1309USA012225, 1309USA012226, 1309USA012227, 1309USA012228, 1309USA012229, 1309USA012230, 1309USA012231, 1309USA012232. Additional information is not expected.
Redness and edema from upper thigh to knee, warmth at touch two hours post vaccination until now.
swollen bottom lip; diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 15:15 (Batch/Lot number: unknown) at the age of 8 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: HPV VACCINE taken for immunisation, administration date 22Nov2021; FLU taken for immunisation, administration date 22Nov2021; MENINGOCOCCAL VACCINE taken for immunisation, administration date 22Nov2021; TDAP taken for immunisation, administration date 22Nov2021. The following information was reported: LIP SWELLING (non-serious) with onset 29Nov2021 15:15, outcome "recovered", described as "swollen bottom lip"; DIARRHOEA (non-serious) with onset 29Nov2021 15:15, outcome "recovered", described as "diarrhea". Therapeutic measures were not taken as a result of lip swelling, diarrhoea.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (06Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Localized skin reaction. Red raised irregular border 10cm x 8cm. Fading center/clearing.
Covid 19 I tested positive on Monday, July 18, 2022 I experienced a cough and sore throat and the next day it was gone. I wasn't taking any medications for Covid.
Sweating; slight fever; Body aches; began to feel unwell; Chills; I developed a cough for 3 days.; This is a spontaneous report from a contactable consumer, the patient. A 40-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: EN6205) via unspecified route in the left arm, as a single dose on 09Mar2021 at 11:45 for COVID-19 immunization (at the age of 40-years). The most recent COVID-19 vaccine was administered in the public health clinic/veterans administration facility. The patient's medical history included allergic to sulfa and hydrocodone. Concomitant therapy included levothyroxine (MANUFACTURER UNKNOWN), multivitamins, vitamin D3 (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN) and fluticasone (FLONASE) taken within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. On 09Mar2021 at 01:30 PM, the patient developed cough for 3 days. On 13Mar2021 (reported as "4 days after the vaccination"), the patient felt unwell with body aches, chills, sweating and slight fever for 2 days. No treatment was provided for these events. On 16Mar2021, the patient underwent nasal swab test whose result was pending. The clinical outcome of the events cough, felt unwell with body aches, chills, sweating and slight fever was reported as recovering at the time of reporting. No follow-up attempts are needed. No further information is expected.
PATIENT REPORTS HEAT RASH THAT APPEARED ON 6/6/21.  IT IS ON RIB CAGE, LOWER BACK, THIGHS, KNEES AND FEET
Pt states that day after vaccine administration she was hypotensive, dizzy, and had body aches. Called rescue, but did not go to hospital. DBP in 40s.