chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching with no rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching with no rash all over the body) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was reported.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching with no rash all over the body). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching with no rash all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No new information was provided in the follow up   This case was linked to MOD-2021-062228 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: No specific follow-up information recorded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062228:
got the flue; Initial information received on 26-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer..  This case involves an unknown  age and gender patient who developed flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On 26-Oct-2022, the patient received a  dose of influenza vaccine produced by unknown manufacturer (with unknown formulation, frequency, strength, dose, route, lot number, expiry date and administration site) for influenza and prophylactic vaccination(immunization).  On 07-Nov-2022 the patient developed flu (influenza) (Latency:12 days) following the administration of influenza vaccine .  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
severe dizziness; Nausea; vomiting (dry heaving); extreme fatigue/feeling of being washed out; sore throat; low grade temperature; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), TEMPERATURE REGULATION DISORDER (low grade temperature), DIZZINESS (severe dizziness), NAUSEA (Nausea) and VOMITING (vomiting (dry heaving)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20/2019(?)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBUPROFEN for an unknown indication.    Concurrent medical conditions included Sore throat on 11-Jan-2021 and Temperature body decrease on 11-Jan-2021.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient started IBUPROFEN (unknown route) at an unspecified dose. On 11-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and TEMPERATURE REGULATION DISORDER (low grade temperature). On 17-Jan-2021, the patient experienced DIZZINESS (severe dizziness), NAUSEA (Nausea), VOMITING (vomiting (dry heaving)) and FATIGUE (extreme fatigue/feeling of being washed out). The patient was treated with PARACETAMOL (TYLENOL) on 18-Jan-2021 at an unspecified dose and frequency; IBUPROFEN (MOTRIN CHILDREN) on 18-Jan-2021 at an unspecified dose and frequency and Lozenges at an unspecified dose and frequency. On 11-Jan-2021, OROPHARYNGEAL PAIN (sore throat) and TEMPERATURE REGULATION DISORDER (low grade temperature) had resolved. On 18-Jan-2021, NAUSEA (Nausea) and VOMITING (vomiting (dry heaving)) had resolved. At the time of the report, DIZZINESS (severe dizziness) and FATIGUE (extreme fatigue/feeling of being washed out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded, however the events may have an alternative cause. Further information have been requested.
Patient was walking around and fell, maybe passed out. Walked the patient over to a seat and he passed out again. I then called for an ambulance and monitored the patient until the ambulance arrived. Patient was sweating profusely so I had the patient lay down on the ground on his side until ambulance arrived. Patient did not want to go with the ambulance as he felt like he didn't need it. He was back to normal and left the facility.
ended up in the hospital for days, never had it before and ended up with the flu every year after for 3 years; Initial information received on 06-Dec-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional via social media.  This case involves a 22-year-old patient of unknown gender who ended up in the hospital for days, never had it before and ended up with the flu every year after for 3 years (influenza), while patient received Influenza Vaccine.  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after administration of suspect vaccine, the patient ended up in the hospital for days (seriousness criteria), never had it before and ended up with the flu every year after for 3 years (influenza).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.; Sender's Comments: Sanofi company comment dated 09-Dec-2020: This case concerns a male patient who presented with flu after vaccination with Influenza Vaccine from unknown manufacturer. The time to onset was unknown. However, patient's medical condition, concomitant medication, laboratory tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Immediately after receiving vaccine, pt had complete loss of consciousness for approximately 30-45 seconds.  Pt was lowered to the floor and placed in trendelenburg.  BP 132/71, HR 93, 98% on RA.  BP 10 minutes later with pt lying down dropped to 83/49, HR 52 and 99% on RA.  Each time we attempted to have pt sit up, Pt would begin to have tingling in extremities and ringing in ears.  EMS called.  BP eventually raised to 127/66 with pt sitting upright but EMS preferred to transport pt to Hospital. Pt evaluated in ED and notes indicate that EKG was done and revealed normal sinus rhythm. Determined to be vasovagal reaction leading to syncope. Pt discharged to home in stable condition.
One day after second dose, patient developed fatigue, headache and body aches. Two days after 2nd vaccine dose, patient had persistent symptoms, but developed fever to 106 and chest pain.  ER evaluation showed abnormal EKG (ST elevation) and elevated troponin to 1523 ng/L. he was admitted for observation, had a normal ECHO and trended troponins. His troponin peaked at 3452, and continued to decrease. he did not require any intervention.
post-herpetic neuralgia; multiple outbreaks of herpes zoster; This spontaneou report was received from a lawyer regarding a case in litigation and referred to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or around 01-DEC-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dosage schedule, route, lot number and expiration date were not provided). On unspecified dates (reported as subsequently), the patient experienced multiple outbreaks of herpes zoster and postherpetic neuralgia. On unspecified dates, the patient was treated by a healthcare providers for multiple outbreaks of the events. The outcome of multiple outbreaks of herpes zoster and postherpetic neuralgia was not reported. The lawyer considered the events of multiple outbreaks of herpes zoster and postherpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).
The day after the shot I was tired, groggy and achy. I took two naps and some ibuprofen. In the days following, I experienced severe aches and pains in my upper arms and thighs. This continued and got steadily worse for  two weeks. No fever or loss of taste. I called the doctor and was told people have different reactions, maybe I should get tested for  covid. I did not. Pain continued. I had trouble sleeping, despite constant ibuprofen. I could not turn over in bed. End of the third week I went to an accupuncturist/massage therapist, who has helped me before . I 've had two treatments and am feeling incrementally better each day. Thinking back on how I feel today--which is still achy, as you might feel with the flu--I realize I was in serious agony for those weeks before treatment. Just prior to the shot, I had been for a full physical and bloodwork and was judged by my doctor to be one of the healthiest people in her practice. I was perfectly fine before this shot.
Vertigo, ataxia, nystagmus, dysmetria. Physical therapy, daily aspirin.
Patient received shot on 10/2, came in a few weeks later saying her arm hurt and what could be done and I recommended OTC remedies. Patient called again on or around 11/7 and said her arm still hurt and so I recommended she contact her primary care physician.
Bradycardia as low as 36 beats per minute and erratic heartbeat began October 13,2022 and worsened to the point that I went to the ER on October 16, 2022. I was transferred by ambulance for observation and monitoring through October 17, 2022. Bradycardia and erratic heart-rate were confirmed and I was discharged to follow up with cardiologist at a later date.
Pregnant :YES/Patient last menstrual period date: 08Nov2021; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "no" (unspecified if ongoing). Date of last menstrual period: 08Nov2021. The patient is expected to deliver a baby(s) on 15Aug2022. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Vaccine dose number=1,, Vaccine brand=Pfizer / BioNTech,, Vaccine brand unknown=False,, Vaccine administration date=May2021, Vaccine lot unknown=True,, Vaccine lot unknown_reason=Not available/provided to reporter at the time of report completion,, Vaccine dose number unknown=False,), administration date: May2021, when the patient was 35 years old, for COVID-19 Immunization; Bnt162b2 (Vaccine dose number=2,, Vaccine brand=Pfizer / BioNTech,, Vaccine brand unknown=False,, Vaccine administration date=Jun2021, Vaccine lot unknown=True,, Vaccine lot unknown_reason=Not available/provided to reporter at the time of report completion,, Vaccine dose number unknown=False,), administration date: Jun2021, when the patient was 35 years old, for Covid-19 immunization. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 08Nov2021, outcome "unknown", described as "Pregnant :YES/Patient last menstrual period date: 08Nov2021". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. describes headache starting immediately after vaccine.  Describes as pressure 7/10.  After evaluation by EMS, pt. has no change in condition.  Pt. cleared by EMS to return home @ 10:25am.  Pt. denies any other complaints.  Driven by companion home.  Will follow up with PCP prior to 2nd dose.
extreme swelling and heat at injection site lasting more than 28 days, arm pain lasting > 3 months diagnosed as bicep tendonitis
Rash and swelling from shoulder to elbow; Rash and swelling from shoulder to elbow; Continued itching; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced rash, swelling arm and pruritus. On an unknown date, the outcome of the rash, swelling arm and pruritus were recovered/resolved.   It was unknown if the reporter considered the rash, swelling arm and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had rash and swelling from shoulder to elbow for one week and continued itching persisting. The patient showed reaction to pharmacist 3 days after receiving the Shingrix.
Patient reported extreme tenderness the evening after the vaccination. Over Friday, Saturday and Sunday, the patient reports that her arm has swollen significantly and is still very tender. She also reports that the skin of her arm is hot to the touch. The redness and swelling seems to be most prominent around the site of injection, but she states the whole upper arm area is affected.
Information has been received from a 42 year old female registered nurse, concerning "seven other nurses" and "several others" who were vaccinated with Hep B vaccine. Subsequently, post vaccination, the seven nurses were "diagnosed with either lupus, arthritis, chronic fatigue syndrome or fibromyalgia."  In addition, several others have experienced symptoms but not yet been diagnosed."  Additional information has been requested.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient. A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 28Sep2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of suspected Covid-19. The information on the batch/lot on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
she could hardly walk; dry heaving; Her stomach muscles hurt from the dry heaving; dizzy; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (she could hardly walk), RETCHING (dry heaving), ABDOMINAL PAIN UPPER (Her stomach muscles hurt from the dry heaving) and DIZZINESS (dizzy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy and Diabetes.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced GAIT DISTURBANCE (she could hardly walk), RETCHING (dry heaving), ABDOMINAL PAIN UPPER (Her stomach muscles hurt from the dry heaving) and DIZZINESS (dizzy). In March 2021, GAIT DISTURBANCE (she could hardly walk), RETCHING (dry heaving), ABDOMINAL PAIN UPPER (Her stomach muscles hurt from the dry heaving) and DIZZINESS (dizzy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  She stated that this was following her second Moderna vaccine. She was fine the very next day. She did a bunch of stuff. The third day, she woke up and she was so dizzy she could hardly walk. She started dry heaving. She dry heaved for about 40 minutes or so. Then she climbed back into bed and went to sleep. She did not know how long later, but she was fine when she woke up. Her stomach muscles hurt from the dry heaving.  Patient received dose 3 of Moderna vaccine on 03 NOV 2021, batch number: 014F21A. She received Pfizer vaccine on 10 MAY 2022 and Pfizer bivalent vaccine on 14 OCT 2023.  No treatment information was provided.
Patient stated that she had full body aches, serious headache, chills/fever, sweating, no appetite (dropped 4.2 pounds). Side effects started the evening of the shot 5/18/21 and pt states she has gotten better as of 5/20/21. Pt stated she is not 100% but feeling better.
my chest hurt; I started coughing all of a sudden.; My heart started raising.; I had to lay on my stomach to relieve the pressure and pain in my chest.; I was having troubling breathing; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 at 18:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose (lot number: 6207) of the same vaccine on 09Mar2021 at 06:30 am in left arm for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient reported that she had the second dose at 6:30 p.m. By 10:30 a.m. the next day she started coughing all of a sudden. Needed to take an inhaler to some what calm it down. Her heart started raising. That evening she had to lay on her stomach to relieve the pressure and pain in her chest. The following day went to the doctor because her heart was raising so much that she was having troubling breathing and her chest hurt. They did an EKG it was concerning of how fast her heart was beating. That same day the patient was sent to a cardiologist. Her heart was still raising and they did a EKG and the beats were about average. So then she had an Cardio gram and that was normal. The next day the doctor called and gave her the ECO reports and the cardiologist believed it was from the vaccine. The onset date of all adverse events was reported as on 31Mar2021 at 10:30AM. All events were reported as non-serious by reporter. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. The outcome of all the events was unknown.
I have had Tinnitus since the age of 22 in my right ear and was able to live with it. After my first injection the tinnitus in creased in tone. But after the second shot the next day it was far worst. My left ear started ringing. The ringing was so loud it was unbearable. Both ears was ringing a different tone. I could not sleep at night, my anxiety increased and I became more depressed.
I had sciatic nerve pain down my right leg. I received a lumbar epidural steroid injection on 08/18/2022.
Dx'd with viral syndrome April 3rd at a medical center ER. On 4/7/03 at approx 12 p.m. PT's wife noticed red bumps on his left forearm. By 4/8/03 a.m. he noticed another area of red bumps on left forearm antecubital fosa, minimal itching and no ___ spread at time of visit.
Flublok was accidentally administered to a patient 15 years of age, with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a Nurse on 29-Oct-2019.  This case involves a 15 years old patient (unknown gender) for whom it was reported that Flublok (influenza quadrivalent recombinant vaccine [Flublok Qiv] (Batch No:Unknown, Expiration date: Unknown)  was accidentally administered to a patient 15 years of age (Inappropriate age at vaccine administration).  The patient s past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the Inappropriate age at vaccine administration.  At the time of reporting the patient had no adverse event.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
minor flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of flu like symptoms in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced flu like symptoms. On an unknown date, the outcome of the flu like symptoms was recovered/resolved.   The reporter considered the flu like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's sister. After receiving Shingrix, the patient experienced minor flu-like symptoms. No further details were collected. Reporter provided limited information. This case was linked with case US2020223077, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020223077:same reporter
Redness and inflammation that spread down from injection site along the left bicep.  Patient stated it was warm and her body ached. She is taking tylenol and ibuprofen and using a cold compress.