chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse referring to a 2 month old patient of unknown gender. It was reported that the baby was healthy and had no prior re-flux or vomiting issues. The patient did not have any pertinent medical history or drug reactions or allergies. In 2016, on an unspecified date, the patient was vaccinated with the first dose of ROTATEQ (orally, Lot # M022373, expiration date: 20-FEB-2018; dose not reported) for prophylaxis. The patient did not have concomitant medications. On 12-DEC-2016, reported as within the last week, the patient experienced projectile vomiting after took the complete dose of ROTATEQ. The baby did not receive another dose of ROTATEQ. There was no any treatment given for this adverse event. No laboratory test were performed. A product quality complaint was filed. At the time of the reporting, the outcome of vomiting projectile was reported as recovered/resolved in December 2016. The causality between this event and the therapy with ROTATEQ was unknown. This is one of the 4 cases reported by the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA010135: US-009507513-1612USA010099: US-009507513-1701USA004119:
No adverse events, but patient is employee of the hospital and received a high dose flu shot in error two weeks after receiving a regular dose flu shot. Patient/employee reported that the first shot had been a COVID vaccine, but she was mistaken. Vaccine consent and record shows that she received a regular dose flu shot (Fluzone by Sanofi, lot UT8076LA) on 9/27/23. Employee was monitored for an hour and checked up on through her work day. No issues reported.
This case was reported by a consumer and described the occurrence of pain in arm in a 62-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (light case of shingles 10 years before the date of reporting). Previously administered products included Flu shot with an associated reaction of pain in extremity and Tetanus shot with an associated reaction of pain in extremity (the patient was hardly sore after receiving Tetanus and Flu shots the present year). On 29th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. But, it could be 61 or 62 years old. The patient was in good health condition with no serious underlying health problems. The patient received SHINGRIX on an unknown arm. The patient's arm was so sore that she could not sleep and could not find any pain reliever that helped much at all and asked to suggest one. The patient asked how long would this pain last, do any physicians or pharmacies give the shot in the rear, would her 2nd dose be as painful and should she decide to not get the 2nd dose and does her 1st dose give any immunity. The patient was not sure if she can go through this pain again. Since she wasn't prepared for how sore her arm would be after a shingles a shot, she did not know what pain relieve would work or what to try. She thought that, people should be warned just how painful it could be. Her pain was terrible for 3 days. Luckily she did not had to go to work. So, she waited a couple of days for a reply and no suggestions from GlaxoSmithKline experts on what to do were received. She would not recommend the shingles shot to anyone as she did not want them to hate her. This case has been linked to case US2018GSK060750, reported for the same patient.
This spontaneous report was received from a nurse refers to 3 unspecified patients of unknown age. The nurse reported that 3 unspecified patients were administered GARDASIL (strength, dosage, route and indication unknown) which were stored improperly on an unknown date. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Light-headed, dizziness, felt faint, tired, hard to breathe and swallow. Took Benadryl right away. Had same reaction with Tdap back in April 2010. Was asked to send blood sample, sent sample, never heard back after blood was mailed.
mild pain; fatigue, like "she had had the flu shoot"; swelling of her arm, a small hardness; A spontaneous report was received from a Consumer concerning a 82-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events mild pain and swelling of her arm and a small hardness(Peripheral swelling ) and fatigue,  like she had had the flu shoot (Influenza).  The patient's medical history was not provided. Concomitant medications reported were Blood pressure medication and Thyroid medication for unknown indication, Iron for her anemia.  On 23 Jan 2021, approximately one day prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) unknown route, in the right arm for prophylaxis of COVID-19 infection.  On 23 Jan 2021, the patient experienced mild pain and swelling of her arm and a small hardness and Fatigue like she had had the flu shoot. The patient did not receive any treatment medication and drank water and went to sleep and she was better.  Action taken with mRNA-1273 in response to the events was not reported.  Outcome of the events mild pain and swelling of her arm  and a small hardness and fatigue like she had had the flu shoot" was resolved on 23-JAN-2021.; Reporter'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.
Less than 24 hrs from getting the shot I got my period, I don?t get my period on this birth control, this was very abnormal, heavy bleeding and painful cramps, which I?ve never had in my entire life. Still have this 2 weeks later along with shortness of breath.
got sick; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer/non-health professional.  This case involves patient (unknown demography) who got sick, while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got sick (within a week) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
pt recv vax SEP96 & devel flu sx, loss of taste x/events to the present, loss of smell & sinus drainage in DEC96 & cont w/these events to present;pt states these events have affected daily living;pt to MD & given ATB;
several episodes of shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of Shingrix, the patient experienced several episodes of Shingles. The reporter consented to follow up.
8/15/2018: Needle felt like a hot iron going in the skin. Zoster burn non-stop. Local area pain, swelling, feverish, red, hot to the touch. Swelling the size of 1.5 inches in diameter. Used ice, BENADRYL and TYLENOL 8/16-18/2018. Low grade fever 100degrees, body aches, glands swollen on entire left side of body (neck, armpit, groin), nausea & headache. 8/19-31/2018. Swelling increased in size to 3.5 inches in diameter, painful to touch, fiery, light headache, use ice & TYLENOL. 8/28/2018- 9/11/2018 painful watery blister in left ear after the 11th went away and started peeling, used ice, BENADRYL, rubbing alcohol, and hydrogen peroxide and TYLENOL. 9/1/2018-9/14/2018 injection site turned black and started peeling circle 3.5 inches in diameter.
shingles; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 02Feb2021 (batch/lot number and expiration date not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 17Feb2021 (also reported as 18Feb2021; pending clarification), the patient developed shingles with blisters. His 2nd dose was supposed to be on 23Feb2021 and was moved to 10Mar2021. Now that all the blisters have dried up, he asked if he can go ahead with his 2nd dose tomorrow (10Mar2021). The patient recovered from the event on an unspecified date.   Information on the lot/batch number has been requested.
pt reported 2 days p/vax had rash, hives & numbness of both jaws & chin;reported to MD-who said to observe;
PATIENT'S PRIMARY CARE PHYSICIAN CALLED TO LET US KNOW THE PATIENT HAD A STROKE 1 MONTH AFTER GIVEN THE 2ND DOSE OF PFIZER VACCINE.
This spontaneous report as received from a registered nurse refers to a 61 year old female patient with not known drug allergies and hypothyroidism. Past drug history was unknown. On 17-MAR-2013, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous injection in the left arm (lot # reported as 80211712, Exp. on 06-MAR/2014). Concomitant therapies included vitamins (unspecified) and AMBIEN. On the evening of 17-MAR-2013, the patient experienced redness at the injection site. On 19-MAR-2013, the patient experienced further redness and swelling at the injection site. She had was described as a vesicular rash which looks lie classic shingles just at the injection site. The patient relevant labs data was unknown. As of 19-MAR-2013, the patient no longer takes the ZOSTAVAX and continued to experience the redness, swelling and vesicular rash to the injection site. The outcome of redness at the injection site, swelling at the injection site and rash vesicular to the injection site was reported as not recovered. The causality for the event was unknown. Additional information is not expected.
Tired/Fatigued; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration on 21Jan2021 as single for covid-19 immunisation. The patient medical history was not reported. The patient received concomitant medications. The patient experienced tired fatigued for 2 weeks on an unspecified date. She has already had both doses of the vaccine, her second dose was 11Feb2021 and her first dose was 21Jan2021. She went to a facility in her neighborhood. She just had bloodwork done last Thursday the 18Feb202, her primary doctor checks it every 3 months since she was on medications, they have to check her blood work to check her liver enzymes to see if they are elevated or not since she takes statins. She spoke to her doctor yesterday, she asked for an antibody test to be drawn. She knows that when they get the vaccine, both times with Pfizer, they have to get Pfizer the first time and Pfizer the second time, same with the Moderna. The caller's antibodies were showing negative, which the doctor has seen other patients who are elderly who have had negative antibodies too. When she had the blood work done it would have already been 3-4 weeks from the first dose. The caller's doctor was not sure why that was, he seems to think that after the first dose there should be some sign but however he was saying, an article said it may take older people a little longer before there was an immunity against the virus from the vaccine. She doesn't know if it should be from the time you take the second shot or the time of the first shot? She wanted to know did she get the shot right? Did they give her water? What's going on? She was a nervous wreck because she knows she can't go get it again. She wanted to know how can they say its 95% effective? Did the people in the trials get a blood test for antibodies? How many were her age that were in the trials? The patient underwent lab tests and procedures which included antibody test: negative on 18Feb2021, planning on repeating the antibody test again in April, blood test: unknown result on 18Feb2021. The outcome of event was recovered on an unspecified date.  Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL9262 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL9262, fill lot EL9253, and the formulated drug product lot EL9244. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow up attempts are possible. No further information is expected.
Low fever, 100.7 degrees & shivers almost 23 hrs after the shot was given.  On and off for about 8 hrs
Dizziness Vitals - oxygen 99 heartrate 73 BP 110/62
Sharp pain  in the left side of their chest, and hasn't gone away; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Sharp pain  in the left side of their chest, and hasn't gone away) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 CHEST PAIN (Sharp pain  in the left side of their chest, and hasn't gone away). At the time of the report, CHEST PAIN (Sharp pain  in the left side of their chest, and hasn't gone away) was resolving.            Concomitant medications were not reported. Treatment details were not provided.  It was reported that the patient felt slightly better at the time of report.
LOSS OF APPETITE; HEADACHE; NAUSEA; TIRED; COULDN'T SEE WELL; LEG MUSCLE CRAMPING; DECREASED BLOOD PRESSURE; FELT LIKE PASSING OUT; BAD FEELING; TROUBLE IN SPEAKING; LEG PAIN; CHILLS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included disabled with weak /bad left leg, and migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A (maybe 201AZ1A), and batch number: 201A21A (MAYBE 201AZ1A) expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced couldn't see well. On 28-APR-2021, the subject experienced leg muscle cramping. On 28-APR-2021, the subject experienced decreased blood pressure. On 28-APR-2021, the subject experienced felt like passing out. On 28-APR-2021, the subject experienced bad feeling. On 28-APR-2021, the subject experienced trouble in speaking. On 28-APR-2021, the subject experienced leg pain. On 28-APR-2021, the subject experienced chills. On 28-APR-2021, the subject experienced nausea. On 28-APR-2021, the subject experienced tired. On 29-APR-2021, the subject experienced loss of appetite. On 29-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't see well, leg muscle cramping, felt like passing out, bad feeling, leg pain, chills, and nausea on 28-APR-2021, and the outcome of headache, loss of appetite, decreased blood pressure, trouble in speaking and tired was not reported. This report was non-serious.
Patient received the first dose / in 2018 and has not received dose two; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Palpitation; Pinch near heart; Sore throat; phlegm; Stomach warmth; Body aches; Could not get up from bed; Increases in temperature; Headaches; Shivers; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation), CHEST PAIN (Pinch near heart), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (phlegm) and FEELING HOT (Stomach warmth) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Hospitalized twice due to COVID 19) in July 2020, Breathing difficult and Heart disease, unspecified (Long QC prolongation).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PALPITATIONS (Palpitation), CHEST PAIN (Pinch near heart), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (phlegm), FEELING HOT (Stomach warmth), PAIN (Body aches), GAIT DISTURBANCE (Could not get up from bed), BODY TEMPERATURE INCREASED (Increases in temperature), HEADACHE (Headaches) and CHILLS (Shivers). At the time of the report, PALPITATIONS (Palpitation), CHEST PAIN (Pinch near heart), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (phlegm), FEELING HOT (Stomach warmth), PAIN (Body aches), GAIT DISTURBANCE (Could not get up from bed), BODY TEMPERATURE INCREASED (Increases in temperature), HEADACHE (Headaches) and CHILLS (Shivers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case concerns a 52-year-old female with a nonserious unexpected event of pain, chest pain, palpitations, productive cough, oropharyngeal pain, feeling hot, gait disturbance, and expected body temperature increased, chills, headache. Event onset the same day as first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 52-year-old female with a nonserious unexpected event of pain, chest pain, palpitations, productive cough, oropharyngeal pain, feeling hot, gait disturbance, and expected body temperature increased, chills, headache. Event onset the same day as first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Severe uterine cramps; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 09Apr2021 at 13:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa. The patient previously received loperamide hydrochloride (IMODIUM AD) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included ethinylestradiol;norgestimate (SPRINTEC 28 DAY) and omeprazole (MANUFACTURER UNKNOWN); both for unspecified indication from unknown date and unknown if ongoing. On 13Apr2021 at 19:00, 4 days after vaccination, the patient experienced severe uterine cramps, the patient wasn't due for period until two weeks after 23Apr2021. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe uterine cramps was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Nausea and dizziness 5 minutes after injection. Vomiting 20 minutes after injection. Throat felt scratchy and c/o chest felt "heavy" 25 minutes after injection. Gave Epinephrine 0.3mg IM x1 and placed on oxygen 2L/min via mask. EMS contacted. She declined EMS transport to hospital. EMS gave Zofran ODT (dose unknown). Nausea improved. Breathing improved, but still c/o feeling like she has to take shorter, more frequent breaths. Dizziness also improved. Oxygen removed and observed about 2 hours after incident. Patient requested to go home with family. Gave ER precautions and advised emergent evaluation/management.
Pt has numerous red, itchy spots all over her body. She also, however, started taking tramadol around the same time as the vaccination, but she states she had taken tramadol before. She has also had the flu shot in years past. She has taken BENADRYL and used hydrocortisone as of 11/15/16, and had not contacted her doctor.
After getting a Pneumovax 0.5 ML shot from Pharmacy I noticed swelling, redness, itching and muscle pain in the area of the injection. No other symptoms have been observed.
Patient was getting first dose of covid vaccine and started to feel clammy and tachycardic, he was taken to med obs feeling dizzy and hot. bp was 130/79, HR was 91, 97% on room air, 10 minutes after taht patient bp was 123/69 HR 88 and oxygen was 96 on room air. He was given snacks and a drink, at 1307 bp was 107/71 HR 93 and  he had no complaints of dizziness. Patient was taken to the exit via a wheelchair.
A female reported that she received an injection of TD Toxoids Adsorbed, Purogenated in 1994, when she was 27 years of age. At the time of vaccination, she was pregnant; trimester of pregnancy at vaccination was not provided. The reporter, subsequently, delivered a normal child. Since that time, she has been unable to conceive.
Patient was given a TB skin test when she was actually suppose to get a Tdap vaccine. Patient did not have any reactions to the TB skin test. Patient was notified of the mistake and given the Tdap vaccine.