chrisvoncsefalvay/vaers-outcomes huggingface dataset:
States within 24 hours of getting vaccine she began having headaches and feeling weak.  The headaches would wake her up at night.  Then her Right ear began burning and moving down into her face.  Within 4 days of injection her right eye began tearing and running down her face, and she was unable to keep food in the right side of her mouth.  Right side of mouth also drooping. Saw doctor on 11-2-09 and was diagnosed with Bells Palsey and put on steriods.  States doctor told her it was from the H1N1 vaccine and symptoms should be reported to vaccine provider.
Severe chills, overall muscle pain, nausea, vomiting.   That lasted about 24 hours.  Arm pain and swelling for about 2 weeks.  Lack of energy and weakness for one week.   GI pain for 1 week.  Treated with anti-emetics, rest, liquid diet, bland diet.
After second injection (2/10/2021) flu like systems. Joint pain, weakness in legs very very sick feeling. This occurred on 2/11/21. Started to feel better the following day. 2/12/2021
Breakthrough case admission after 5 vaccines Moderna 2/16/21 lot# 038K20A;  Moderna 3/16/21 lot# 030A21A;  Moderna 11/1/21 lot# 088D21A;  Moderna 5/1/22 lot# 057M21A;  Moderna 10/20/22 lot# 049D22A
pt recvd vax;devel sz a few hrs p/ vax; T 100.1 ; seen in er;possible fever w/ sz;
C/O high fever per mom of 105.0 at home. Mom took child to ER on 10/14/15 when the fever occurred. Mom didn't follow-up with our office till today on the child's one year old health check appt.
24 hours after shot in arm, I started feeling sick, feverish and tired. i went to bed sat afternoon and slept on and off for a solid week. ipassed this virus to my husband the following day. same for him, in bed for a solid week. muscle,joint aches, headaches, tired.
Swollen arm and tightness near injection site. Reported within 12 hours following administration on 10/19/2018. Symptoms persisted through 10/20.
Rapid heartbeat (pulse) between 100 and 120 bpm for 9 days then pulse returned to normal on day 10 after the vaccine.
Vaccination that had expired.; This case was reported by a other health professional via interactive digital media and described the occurrence of expired vaccine used in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter gave a Pediarix Vaccination that had expired. The reporter enquired what was the procedure to fix this error.
Information has been received from a 63 year old female consumer who about three years ago in approximately 2007 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number unknown). The consumer stated that on 19-JUL-2010 she developed shingles after receiving ZOSTAVAX (Merck). At the time of the report, the patient had not recovered from shingles. It was unknown if the patient sought medical attention. Additional information is not expected.
Fainted, unresponsive, dizzy, nausea, vomiting, low blood pressure and pulse, pale
Fatigue, chest pain (heart attack like symptoms) lasted until 1st week of Jan. 2013. All tests were negative - no other known cause. Dyspnea, SOB, was told ? pleurisy ? pericarditis, but all tests normal. No temp. I am the patient completing this form. I have had problems, twice, in the past with flu shots - severe vomiting, fever, fatigue. I was given a waiver from my physician to not have it, but our hospital said it was mandatory and even with the waiver, we would be required to wear a mask 8 hours a day until March 1st. I thought I would try and get again. I was assured by occupational health that it was a 'dead virus' and I would not have any problems. The day after receiving it, I was extremely tired, that continued for a few weeks, then I started to notice S.O.B. this occurred gradually. By the night of Nov. 11th I couldn't even lie down to breathe, I had to sleep sitting up. Upon going to work Nov. 12, the pain & SOB became so severe that the other employees rushed me to the ER. I was admitted on the cardio unit and released 2 days later. Pain remained severe off & on for several weeks. All tests were negative including CT, chest, blood, stress, EKG. No real diagnosis was ever made. Until I had that shot I had never missed a sick day from work in almost 5 years.
arm hurt slightly; worse after the 3rd dose; it was like someone hit him in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt slightly), CONDITION AGGRAVATED (worse after the 3rd dose) and FEELING ABNORMAL (it was like someone hit him in the arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088B, 001A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt slightly). an unknown date, the patient experienced CONDITION AGGRAVATED (worse after the 3rd dose) and FEELING ABNORMAL (it was like someone hit him in the arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm hurt slightly) had resolved and CONDITION AGGRAVATED (worse after the 3rd dose) and FEELING ABNORMAL (it was like someone hit him in the arm) outcome was unknown.            Concomitant product use was not provided by the reporter.    This case was linked to MOD-2021-361686 (Patient Link).
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not provided. On 14-DEC-2016, the patient was vaccinated with one improperly stored dose of VAQTA injection, lot # M022924, expiration date 24-JAN-2018 (exact dose and route of administration were not reported). There was no adverse effect reported. Product quality complaint (PQC) was not involved. Administered dose of vaccine experienced the temperature excursion of more than 46 degrees Fahrenheit but less than 77 degrees Fahrenheit for 6 hours and 15 minutes. Data logger was involved. There were no previous temperature excursions reported. Additional information has been requested.
patch of red purple breakout in my left shoulder and another on my breast and by day end it turned dark; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 83 year-old patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (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: SKIN DISORDER (non-serious) with onset 19Feb2021, outcome "unknown", described as "patch of red purple breakout in my left shoulder and another on my breast and by day end it turned dark". The event "patch of red purple breakout in my left shoulder and another on my breast and by day end it turned dark" was evaluated at the physician office visit. Therapeutic measures were taken as a result of skin disorder.  Additional Information: The patient reported that some hydrocortisone cream was used and an appointment was made with a dermatologist and was given 3 bottles of rx's and 2 made the patient so nauseated so it was thrown away. When the patient saw the primary doctor, he said to just use cream.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had severe chest pain and pressure for hrs.  that evening - I got the shot in the afternoon Oct 23/08
Received vaccine 10/4/07. Mother reported to father that child had "temp of 102.5 and was almost seizing." Followed up 10/8/07. No further fever, s/sx detected.
2/13-rec'd vaccine in left deltoid; 2/16-pain in left side of neck, developed blistery lines there which then crusted over; 2/17-felt ball-like area at injection site which also developed blistery bumps and felt hot; no documented fever; 2/21-redness and itchiness left neck, shoulder and arm; blistery bumps over deltoid.
My daughter had a fever of 102 and a rash on her chest and legs for 3 days. Treated with Tylenol and Advil.
Itching, burning - 8 hr after. BENADRYL 50mg, Hives
pt recv vax 15MAY98; pt had a rash on neck @ time of vax;pt devel sore throat,fever;seen by MD 22MAY98; strep test;dx w/fever, sore throat tx w/ceclor;26MAY98 fever, chills, severe sore throat;T101.5;eye swollen;throat edema;
Initial report received on 19 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3500AA received on 02 December 2009, lot number C3541AA received on 03 February 2010 and lot number C3591AA received on 07 April 2010 and 1 dose of DAPTACEL; lot number C3618AA received on 13 April 2011 (routes and sites of administration not reported). The subject developed a cough in 14 July 2012, approximately 15 months after the last dose. On 21 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 26 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 26 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Information has been received from a registered nurse referring to a 6 year old female patient with sickle cell anaemia. The patient did not have known drug allergies. On 16-MAR-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K020215 with expiration date of 15-MAY-2016, 0.5 ml once, subcutaneous in the right thigh). Concomitant vaccines included a flu shot and a H1N1 shot which were given at different sites. On 19-MAR-2016, the patient was admitted to hospital with a cellulitis at the right thigh and treated with intravenous clindamycin, and was discharged on an unspecified date in March 2016. The patient was sent home from the hospital on oral clindamycin, prescribed for 9 day. On 22-MAR-2016, she came to the office for a follow up visit and the right thigh was completely clear with no evidence of infection at all. The outcome of cellulitis at the right thigh was reported as recovered on that day. The causal relationship between cellulitis at the right thigh and PNEUMOVAX 23 was not provided. The reporter requested for a lot check for PNEUMOVAX 23 (lot # K020215 with expiration date of 15-MAY-2016). Additional information has been requested.
Nausea; Fever; Achy; Achy/ achy from tips to fingers to toes; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 57-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2019, the patient received the 1st dose of Influenza vaccine Quadrivalent 2019-2020 season and the 1st dose of Shingrix. On 31st October 2019, less than a day after receiving Influenza vaccine Quadrivalent 2019-2020 season and Shingrix, the patient experienced general body pain and pain in fingers. On 1st November 2019, the patient experienced nausea and feverish. On 1st November 2019, the outcome of the general body pain, pain in fingers, nausea and feverish were recovered/resolved.   It was unknown if the reporter considered the general body pain, pain in fingers, nausea and feverish to be related to Influenza vaccine Quadrivalent 2019-2020 season and Shingrix.  Additional case details were reported as follows: The reporter was the patient's wife. The patient received Shingrix vaccine in unknown arm and Flu vaccine in the opposite arm. Within the night after vaccination the patient was extremely achy from tips to fingers to toes. The patient woke up the next morning after vaccination feeling nauseous and feverish although he did not want to check his temperature. He went to work for approximately 3 hours. The patient felt better after returning from work where he ate. The patient did not have symptoms afterwards. The reporter consent to follow up. This is 2 of the 2 linked cases reported by the same reporter.
blood pressure of 200/100; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure of 200/100) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 immunization: Moderna Covid-19 vaccine (dose 1), Moderna Covid-19 vaccine (dose 3, booster) and Moderna Covid-19 vaccine (dose 2). Past adverse reactions to the above products included No adverse event with Moderna Covid-19 vaccine, Moderna Covid-19 vaccine and Moderna Covid-19 vaccine.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (blood pressure of 200/100). At the time of the report, HYPERTENSION (blood pressure of 200/100) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 200/100  high.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
5 days after vaccinations given child's speech became slurred, regressed to only "babbling" for 1 week - rash and fever for 2 days.
Pain felt throughout the body. Started around 8pm Friday. At 1:00am on Saturday, the pain was extreme. Took my son to hospital. They gave him intravenous Motrin and an saline solution IV. About 1 hour later, started to feel less pain. Was discharged at 3 am. Next two days, took Advil and Tylenol alternately. By Saturday afternoon, was feeling better but pain persisted in legs. By Monday, pain had lessoned quite a bit. He was able to engage in normal activities.
stomach cramps, severe, watery diarrhea, have had for 3 days so far, still ongoing.  On day 2 went to emergency room, was treated for dehydration.
This case was reported by a consumer and described the occurrence of gout in a 66-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (as a child). Previously administered products included Shingles vaccine (received the old vaccine several years ago without problems). On 20th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced swelling, movements reduced, grip strength decreased, pain upon movement and joint warmth. On 23rd October 2018, the patient experienced gout, degenerative joint disease and wrist pain. The patient was treated with NSAIDS. On an unknown date, the outcome of the gout, degenerative joint disease, wrist pain, swelling, movements reduced, grip strength decreased, pain upon movement and joint warmth were unknown. It was unknown if the reporter considered the gout, degenerative joint disease, wrist pain, swelling, movements reduced, grip strength decreased, pain upon movement and joint warmth to be related to SHINGRIX. Additional details were provided as follows: The patient never had shingles in past. The patient received SHINGRIX on the right deltoid. The patient experienced pain in right wrist. Over the next few days symptoms progressed to a pain level of 8 by 10, swelling, inability to actively move fingers, pain on movement of wrist, pain touching wrist, heat in the joint, and total loss of grip strength. Pain was a constant ache at 3 to 5 by 10 level with sharp pain on movement. White blood cell count result was 6.4, uric acid result was 6.2, and X-ray result was degenerative joint disease. The patient was diagnosed with gout by MD received from physician of gout or pseudo gout. Splinting, NSAIDS and heat have all proved helpful. The patient asked if she should expect the same reaction to the second dose. If so, was it likely to recur in the same joint. The patient also asked would it help to have next dose in left arm her non-dominant arm.
overnight, possibly 12 hours later, felt significant heat in my internal and external body. Did to take my temp, but it was somewhat overwhelming. Oddly, at the same time I needed to put a blanket over my body, even though I felt I was burning up interiorly and exteriorly.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 Lot # M038216, expiration date: 09-MAY-2018  and Lot # M042599 17-JUN-2018 (strength, dose, route were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported. The temperature was between >8C - 25C, for a time frame of 5 hours, 30 minutes. There were no previous temperature excursions. The call was  because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004701: US-009507513-1701USA004702: US-009507513-1701USA004703: US-009507513-1701USA004704.
Tinnitus in left ear; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8731) via an unspecified route of administration in the left arm on 16Apr2021 at 12:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken within two weeks of vaccination were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 12:45, the patient experienced tinnitus in left ear. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event tinnitus in left ear was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
After recieveing Mantoux, patient walked back in to secured area and become light headed and passed out. Due to low BP nurse on duty called ambulance.
This spontaneous report as received from a other health professional refers to a 14 month old patient. On 08-JUL-2014 the patient was vaccinated with MMR II (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. Activity date reported as 14-JUL-2014. This is one of several reports received from the same source. Additional information has been requested.
Administered 2 doses of the Moderna COVID-19 vaccine 5 days past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 2 doses of the Moderna COVID-19 vaccine 5 days past the expiration date) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 2 doses of the Moderna COVID-19 vaccine 5 days past the expiration date). On 27-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administered 2 doses of the Moderna COVID-19 vaccine 5 days past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The patient was administered with Moderna COVID-19 vaccine 5 days past the expiration date and had no other symptoms experienced.Date the vial was initially stored in the refrigerator was on 10 Jan 2022 and there were no temperature excursions.   This case was linked to MOD-2022-462697 (Patient Link).
Itchy red rash left upper arm a few inches distally to vaccine site. Lasted 1 week. Never spread. Resolved on own. No treatment needed
Dizziness; Headache; Tired; Pain at the site of injection; A spontaneous report , was received from a consumer (patient), a 58 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced dizziness, headache, tired (fatigue), and pain at the site of injection (injection site pain).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A), intramuscularly for the prophylaxis of COVID-19 infection.  On 23 Dec 2020, after the first shot, the patient experienced headache, dizziness (like confused), tired and pain in site of injection. No treatment medication information was available.  Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of events, dizziness, headache, tired, and pain at the site of injection was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of headache, dizziness, headache, fatigue, and injection site pain,  a causal relationship cannot be excluded.
Around ten minutes post injection PT experienced tingling throughout body, slight constriction in throat, lungs clear throughout no wheezing,  BP: 138/89, o2 saturation: 98%, HR: 89  PT then developed facial swelling ,  administered benedryl at 1815 PO, constriction continued as well as facial swelling post medication admin.  PT declined Epi-Pen recommendation.  At 1830 an addition PO administered, no change in PT condition. Decision to contact EMS at this point,  Medic responded to the scene where patient was sent to hospital.
Pt nearly fainted - no loss of consciousness, sweating and blood pressure dropped approximately 5-10 minutes after vaccination.