chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had the vaccine, shingles/suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the vaccine years ago but the patient was recovering from shingles of 4 weeks right now from the day of reporting. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Pt received his vaccine at 10:35 am and stated that at 11:46 he felt weak and light headed. Pt was clammy and pale his BP was 98/62. Pt states that he did not eat or drink anything prior to his vaccine today.  2 Orange juices given to the pt. Pt states at 10:50 that the orange juice made his head clearer and he no longer felt weak or shaky. Pt no longer looked pale or clammy.
Had dizziness, strong spinning feeling in head, Chills while wrapped in blankets. Chills led into the evening of the 5th. Less prominent dizziness next day and chills had diminished mostly. Called in sick to work on the 6th due to dizziness.
This spontaneous report as received from a pharmacist via Company Representative refers to a patient of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On approx 09-DEC-2014 (also reported as date unspecified four months ago), the patient was vaccinated with ZOSTAVAX subcutaneous (strength, dose, frequency, lot number, expiration and date were not reported). On an unknown date the patient experienced redness at the site of administration. Patient sought medical attention from pharmacist by coming to the pharmacy. The patient recovered from the redness at the site of administration on an unspecified date. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Pt. developed a 4" x 4 1/2" annular raised, hot, hard rash around immunization site (left thigh). Also fever 99 degrees F.
Evening of 11/9/2015, nausea, vomiting, muscle and joint aching. No N/V now but still with muscle and joint aching 11/12/2015. Area of (L) deltoid is pink in color, painful, swelling 11/12/15 still having muscle and joint aches and pains and swelling at site.
Case number PHEH2016US026380, is an initial spontaneous report received from a consumer on 10 Oct 2016. This report refers to an adult female patient. Medical history was and concomitant medication was not reported. The patient was vaccinated with one single dose of Influenza virus vaccine unknown Inn on an unknown date two years ago. The patient received unidentified preservative free influenza vaccine both seasons. The patient experienced had soreness at site, then limited movement of the arm two years ago. last year had swelling and soreness at site which turned to bruising. Final outcome of the event was complete recovery. Seriousness of the event was reported as non serious by consumer. Causality was not reported.
Grandmother states that the child was crying after the vaccination and a few minutes later there appeared a few red lines on his forehead. After he quit crying (approx 30 min) the lines disappeared. She states that every time he gets upset and cries the lines reappear on his forehead.
Started experiencing increasing ringing in right ear 2 months after receiving 2nd dose.   Ringing take form of buzzing, swishing and roaring.  I happens daily but more prominent at night in right ear.  Usually last for several hours non stop.
Upper Ext DVT right subclavian- right forearm pain and swelling for 2 days
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were unspecified. On 28-JUL-2014 the patient was vaccinated with VARIVAX (strength, route, dose, dose number, lot number and expiration date were not reported) instead of ZOSTAVAX. No adverse symptoms reported. None concomitant therapies were reported. The outcome of the event was unknown. Additional information has been requested.
Pulmonary embolism; This is a spontaneous report received from a Pfizer sponsored program, received by a contactable consumer (patient's relative).  A 91-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route, in Feb2021 at single dose for COVID-19 immunization, administered at facility. Relevant medical history included COVID positive from an unknown date and resolved in Jan2021 (COVID test negative one moth before receiving vaccine). No relevant concomitant medications were provided. Patient's relative stated that she died 10 days after receiving the COVID vaccine. The cause of death was not known but caller stated it could be due to pulmonary embolism. The facility did not wait for 3 months before giving the vaccine. Caller stated it should be prominent that patient should wait for 3 months after being tested positive for COVID and receiving the vaccine. It was unknown if an autopsy was performed.  Information about Lot/Batch number has been requested.; Reported Cause(s) of Death: pulmonary embolism
approx 19 hours after rec'ing the MMR shot our son began to run a low grade fever 99.7, vomiting, irritable mood. We informed the doctor's office and as they claimed it is "something viral." This has happened on previous vaccines before with the same response. We never realized we could report adverse reactions ourselves.
July 26, 2007. 2 days post Merck Zostavax. pt had viral stomatitis. Self limited, responded to Valtrex. Probably not related to vaccine.
Soreness in the arm at site; swelling of the arm; warm to the touch at site; body ache; chills.
This case was reported by a lawyer and described the occurrence of mercury poisoning in a male subject aged between 0 and 9 years old who was vaccinated with Engerix B. A physician or other health care professional has not verified this report. The subject was also vaccinated with Hib, Dtpa, OPV, MMR vaccine. The subject was vaccinated with Engerix B vaccine on 16 September 1992, 16 October 1992, and 09 April 1993. At an unspecified time after vaccination, the subject experienced mercury poisoning. According to the legal complaint, the subject suffered and in the future will continue to suffer from the toxic neurological effects of mercury poisoning. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the events were unresolved.
Body ache, low grade fever 99.7, slight congestion, shivering, extreme tiredness
rash under lt breast approx 5PM 10/29/99 using cortisone cream on rash;11/1/99 generalized rash on back, arms, thighs, & palms of hands;pt to see pvt MD 11/1/99;
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The reporter stated that on 25-JUN-2014 the patient was vaccinated with expired PROQUAD (merck) (lot # H021358, expiration date: 29-MAY-2014, dose, units, anatomical location, route of administration were not reported). No adverse effect has been observed. This is one of several reports from the same reporter. Additional information has been requested.
45 minutes after vaccines given, broke out in a rash all over body. Hospitalized for observation.
Loss of taste; Loss of smell; Chills; Headaches; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills) and HEADACHE (Headaches) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills) and HEADACHE (Headaches). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown and AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills) and HEADACHE (Headaches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, SARS-CoV-2 test: positive (Positive) Tested positive for the virus with a mild case.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.   Reporter did not allow further contact
Was 6 weeks pregnant at time of the shot (4/10); missed miscarriage diagnosed on 5/10. 10 weeks. Embryo had stopped developing. 8 to 8.5 weeks (a few days after the prior ultrasound on 4/23 which still indicated normal development of the pregnancy), ca. two weeks after the vaccine. Not sure if the pregnancy loss is related to the vaccine, but reporting after being advised to do so by a representative of the v-safe program.
Vaccine leaked out from syringe at time of administration. Proportion leaked out estimated as more than half. Another dose was prepared and given in the opposite (right) arm.
POTS syndrome; gastrointestinal disease; This is a spontaneous report received from non-contactable reporter(s) (Nurse).  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (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 (Dose 1, Single; manufacturer unknown, batch/lot number: unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Single; manufacturer unknown, batch/lot number: unknown), for Covid-19 immunization. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "recovering", described as "POTS syndrome"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "gastrointestinal disease". The events "pots syndrome" and "gastrointestinal disease" required physician office visit. It was unknown if therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome.  Additional information: Nurse reported that family member had received COVID vaccine and was diagnosed with POTS syndrome and gastrointestinal disease.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 8th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th October 2018, 1 days after receiving SHINGRIX, the patient experienced injection site warmth, injection site pain, general body pain, injection site rash, itchy rash and injection site swelling. On an unknown date, the outcome of the injection site warmth, injection site rash and itchy rash were not recovered/not resolved and the outcome of the injection site pain and general body pain were recovered/resolved and the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site warmth, injection site pain, general body pain, injection site rash, itchy rash and injection site swelling to be related to SHINGRIX. Additional information was reported as follows: On Monday night, the patient was vaccinated with SHINGRIX in left arm. The patient never got sick and she had an allergic reaction to SHINGRIX at the injection site. The patient claimed that she experienced hotness, swelling and a rash that had spread into her inner biceps at the time of reporting. The rash was also itchy and it hurt. The patient experienced the adverse events on the following day after vaccination. The patient also reported soreness around the injection site. The patient had denied permission to contact her physician.
Received Tdap, MENACTRA, & HPV on 12/8/11. Stayed the required 15 min and did well. D/C home. Mother brought pt. back to clinic on 12/12/11, stating that pt. got dizzy in hospital parking garage & fell causing abrasion to (L) knee. Then pt. vomited 2-3 times a day x 3 days. Now mom brings pt. in to be check for first time on 12/12/11. Pt. has had her period for past 2 days.
Just reporting a few side effects from the FLUZONE HIGH DOSE Vaccine: A few hours after the injection, I started with really bad chills, then developed a fever. Lasted 3 days. Nothing life threatening, but worth reporting.
Information was received from a female consumer. On 24-OCT-2013 the patient was vaccinated with ZOSTAVAX in her right arm. The patient stated that after she was given the ZOSTAVAX vaccine, she has been experiencing "three red bumps in her upper left joint." The patient felt it may be shingles. The patient reported she had shingles previously in OCT2012. No further information was reported. Additional information is not expected.
Covid-19 positive test; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid-19 positive test) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 TEST POSITIVE (Covid-19 positive test). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid-19 positive test) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medications were not provided. Treatment information was not provided.
Broke out into a full body itchy rash several hours after receiving vaccine. Went to emergency room for visual examination. Was determined to be a mild allergic reaction, and benadryl was administered. Was evaluated at primary care doctor after rash did not go away after 2 days. No additional treatment was administered. Rash went away after 4 days. Also, 12 hours after receiving the vaccine I had severe fatigue, chills, nausea/vomiting, and headache. Was treated at home with advil and promethazine. These symptoms went away around 36 hours after vaccine was administered.
Pt recv vax on 1/9/99; on 1/11/99 pt exp diffuse aching, fever, chills, sweats, sore/red vax site, nausea & vomiting, frontal headaches & left lower costal margin pain;tx= Cefazulin, Vancogan, Gentagan, Clindamycin
Pt recv vax on 1/14/99; on same day pt exp red/ hot/ swollen area
rash, started 23rd on stomach then rash spread to neck, chest, on the 27th;now rash is everywhere 30NOV;tx w/DPH PRN, TAC ointment;
patient was admitted on 04/19/2005 for vesicular rash typical of chickenpox.  He spent 6-7 hours with his grandson who received varicella vaccine at the doctor's office, the day the child was vaccinated is 04/08/2005. 12/31/09 Patient has been seen for his Egular appt by his MD.
Pt recvd 3 doses of Hep B vax, the 1st two doses were Heptavax given 02DEC89 & 02JAN90 & the 3rd w/Engerix-B 15JUN90 & it was determined that pt did not have titers; A booster dose of Engerix-B was administered 16JUL91;
I had side effects with Pfizer where I had over 103 temperature then when I took the first booster it had to be Pfizer because they weren't allowing you to switch and I got sick again. On 4/22/2022 for the second booster I did Moderna and now I have over 100 temperature so I really am tired of taking these boosters if someone could call me back. I wish to stop taking any Covid vaccinations from here on out.
Pounding heart and shortness of breath; particularly at night. I?ve been woken from sleep with the sensation of a pounding heart.
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2012, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) at a community health center. On an unknown date, the patient was treated by a healthcare provider at a hospital emergency room for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
pt recv vax & devel a rash, fever & diarrhea;No further details were provided;
Off/on joint pain; Dose 1 on 10-May-2021 and dose 2 on 3-Aug-2021; Upper respiratory/sinus (non-covid) Cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Upper respiratory/sinus (non-covid) Cold), ARTHRALGIA (Off/on joint pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 10-May-2021 and dose 2 on 3-Aug-2021) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 033821A) for COVID-19 vaccination.     No medical history information was not provided.  The patient's past medical history included COVID-19 (confirmed with PCR (polymerase chain reaction)) on 08-Jun-2020. Concurrent medical conditions included Hypertension and GERD. Concomitant products included LANSOPRAZOLE and FAMOTIDINE (PEPCID AC) for GERD, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for Hypertension.   On 10-May-2021 at 3:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NASOPHARYNGITIS (Upper respiratory/sinus (non-covid) Cold). On an unknown date, the patient experienced ARTHRALGIA (Off/on joint pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 10-May-2021 and dose 2 on 3-Aug-2021). At the time of the report, NASOPHARYNGITIS (Upper respiratory/sinus (non-covid) Cold) and ARTHRALGIA (Off/on joint pain) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 10-May-2021 and dose 2 on 3-Aug-2021) had resolved. Not Provided          No treatment medications were provided   This case was linked to MOD-2021-275378 (Patient Link).
weakness; cough; fatigue; a temperature/fever; chills; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), ASTHENIA (weakness), COUGH (cough), FATIGUE (fatigue) and PYREXIA (a temperature/fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced ASTHENIA (weakness), COUGH (cough), FATIGUE (fatigue), PYREXIA (a temperature/fever) and CHILLS (chills). The patient was treated with VITAMINS NOS at a dose of UNK dosage form and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, COVID-19 (COVID-19), ASTHENIA (weakness), COUGH (cough), FATIGUE (fatigue), PYREXIA (a temperature/fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Oxygen saturation: 91/93 (Low) oxygen lower than normal (91/93). On 11-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Additional treatment medication included unspecified cough medicine.
pt recv vax & subsequently devel chills & fever that day;by the following day the above rxn had resolved
SORE ARM AT INJECTION SITE RESOLVED IN 2DAYS. FATIGUE AND TIREDNESS WEEK 2-4 THEN RESOLVED Narrative:
Bloody stool and subsequent PCR on stool positive for Rotavirus A (stool collected on 10/1/20)
she had shingles; she started getting rashes on her back; excruciating pain in her back; This is a spontaneous report from a contactable consumer.   A 72-years-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for Injection, Lot number: Unknown, Expiration date: Unknown), at a single dose via unspecified route of administration on 17Apr2021 for COVID-19 immunization. Patient was expected to get the next dose on 08May2021. Medical history and concomitant medications were Unknown. On 19Apr2021 the patient experienced excruciating pain in her back and it lasted for the whole week after two days of vaccination. she visited her doctor, who gave her Celebrex, she started getting rashes on her back on the same day. She was told she had shingles and now she took an antiviral drug. Caller was not transferred due to long wait. She confirmed it was OK to contact her in the evening preferably. Response on the Shingles not found. Spoke per CONS documents below and Referred to her HCP. Outcome of events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Within a few minutes of the injection into my left arm, my left arm felt tingly/numb. It hasn?t resolved since (today is day 8 post injection). It always seems better by the evening but during the day it feels like a soft current flowing through the arm into the hand or as if you had blood flow cut off. It?s not intolerable but I?m aware of my left arm, like something is off. No idea how it could have come on so fast but it did. I am a neurologist and do not believe that any nerve was accidentally injected or damaged in my arm by the needle. Also, on 3/26 and 3/27, I began to experience tingling in both feet & ankles. This has been coming and going. The left arm tingling was present this morning but was better today though not resolved.