chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT became hyporesponsive few minutes after vaccines given. Mom pinched pt didn't respond, MD called pt with normal color, time breathing, heart rate. Resp to water in face with crying but not to name calling and gentle stroking. After slowed respond to water, felt to be ok so sent home. Was at same time as pt nap time but per mom seemed to occur within a few minutes after vaccines given.
A few weeks after my second Pfizer COVID vaccine, I developed chronic hives, mainly on my torso and upper thighs. Mainly, the areas would be red and itchy and usually disappear within a few hours. On occasion, welts would be visible in the red area. Hydrocortisone 1% sometimes caused relief of the itching. I didn't consult a MD for months and just lived with the symptoms. While at my son's dermatology appointment, I asked the MD if he had heard of my symptoms post vaccination.He said he was currently treating 4 patients with my exact symptoms. He recommended Allegra 180mg  1-2 times daily. I started this regime a few weeks ago and it is working. However, if I miss a dose, the rashes immediately return. I am concerned that I will not be able to get the booster shot in October.
Patient became syncopal approximately 10 minutes after receiving vaccine without verbal warning.  Rolled out of chair onto floor.  Did not lose consciousness and was A&O immediately after.  No physical injuries reported.  Patient able to walk out on own within 30 minutes of event.
Presented complaining of worsening shortness of breath, cough and generalized weakness. Dx w/  COVID-19 PNA complicated by acute hypoxemic respiratory failure; tx w/steroids, O2, zinc; weaned off O2 for dc home
LEFT  BREAST OR CHEST PAIN/BURNING; BACK PAIN; BILATERAL LEG PAIN; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient have no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced left breast or chest pain/burning. On 10-APR-2021, the subject experienced back pain. On 10-APR-2021, the subject experienced bilateral leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bilateral leg pain, left breast or chest pain/burning, and back pain. This report was non-serious.; Sender's Comments: V0:As per standard protocol, MAC comment is not required for non-serious cases.
patient developed a warm sensation through arm.  We had the patient stay for monitoring for 30 mins following her injection of the moderna COVID19 vaccine.  Then the patient developed 3-4 Hives.  BEnadryl and Zyrtec was given.
Patient was receiving the booster dose while at work. About 1 hour after vaccine was given, patient started to shake and studder during normal conversation with coworkers. Patient left work and went to  the urgent care. Where they did not perform any tests and sent her home to rest. They told her that this ADR had been reported 51 times and that it would go away in a few days. The next morning (Tuesday 1/25) patient woke up and starting shaking again around 8am, then she started to studder again starting at 11am uncontrollably. The symptoms would only subside during sleep. The next day (Wed 1/26) patient woke up and symptoms persisted and she decided to visit her physician. During her physician visit they performed an EKG and blood work to try and determine what was going on. All test came back normal. The physician determined that she was having bronchial spasms and sent her home with some Hydroxyzine and it should go away in a few days.
2 inch red, painful area on left arm at injection site which developed approximately 3 hours after injection; headache and muscle aches that started approximately 12 hours after injection
Pt. felt dizzy & weak after the vaccine administration within minutes. She was given O2 in office & legs elevated & felt a little clammy & then was fine. D/C in stable condition.
Shingles after series completion of Shingrix/Suspected vaccination failure; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On 8th April 2022, the outcome of the shingles was recovered/resolved. On an unknown date, the outcome of the vaccination failure was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 08-APR-2022 Reporter's Comment: The reporter was reporting that patient getting shingles after series completion of Shingrix.  The reporter consented to follow up from safety team. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
For an entire week I have experienced chest pain and shortness of breath. I have been unable to do anything more than walk at a moderate pace without running out of breath. My heart feels like it is beating out of my chest. The chest pain is constant in thee lower right side of my chest. I am a healthy 21 year old who works out 6 times a week. I have never had any health issues.
Patient's agent claims the patient had a swollen, red arm for 1 week after receiving FluzoneHD.
no adverse event; improperly stored; This spontaneous report as received from a medical assistant referred to a patient of unknown age and gender. The patient concurrent condition, medical history, concomitant therapies and drug reactions/allergies were not reported.     On 10-APR-2019, the patient was vaccinated with one dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R022879, expiration date 02-AUG-2020) (dose, unit and route were not reported) for prophylaxis (product storage error). No adverse effects were reported. Temperature: 35.42F. Time frame: 18 minutes. There was no previous temperature excursion.; Sender's Comments:  US-009507513-1904USA008552: US-009507513-1904USA008553: US-009507513-1904USA008542:
This is a spontaneous report from a contactable consumer (patient). A 31-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 31, via an unspecified route of administration, in left arm, on May 19, 2021, at 14:45, single dose, for COVID-19 immunisation. Medical history not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunisation. On May 21, 2021, at 21:15, patient experienced severe nausea and dizziness. Since the vaccination, patient has not tested for COVID-19. No therapeutic measures taken as a result of the events. The outcome of severe nausea and dizziness: unknown (at the time of report). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Numbness, tingling sensation in left arm. Extreme pins and needles feeling, like loss of circulation in hand and fingertips. Strange sensation constant with spikes throughout. From around 10:30am today  till ongoing.
About 2.5 hours after the initial injection (like 1:30pm), my arm (around the injection site) started to feel sore like after getting a flu shot. It was manageable but noticeable. Around 10:30pm I began to run a fever. When I took my initial temperature (around 11:00pm) it was 100.5. A half hour later I threw up and took my temperature again and it was up to 102.3. I took Children's Chewable motrin (the only thing we had in the house and I don't like taking pills anyway) and went to sleep.  I woke up without a fever, temperature this morning was 98.8. The arm soreness continued into the next day and the soreness spread into my right armpit. The injection site is still extremely sensitive (even to put lotion on) at this time on 2/7/21 @9:30pm. Some chills continued throughout the day but nothing a blanket or a warm shower couldn't fix.
w/in mins of inject, hypotension, bradycardia, h/a, cold extremities, anaphylactic shock;
Developed a full feeling in left ear and tinnitus about 6 days post-vaccination. It felt like I needed to pop my ear, but it wouldn't.
pt awoke 22JUN92 w/paleness of lips, face; has fever of 101 & staring into space; ?lethargy; parent to see MD;
I have had severe nausea since  the day I got my first phizer dose.  I also had severe pain from my uterus contracting for 9 days from august 9th to august 18th.
Currently has urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Currently has urinary tract infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 16-Nov-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 URINARY TRACT INFECTION (Currently has urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Currently has urinary tract infection) had not resolved.            No concomitant medications were reported. Treatment medication include Antibiotics.   This case was linked to MOD-2021-030725 (Patient Link).
Eight days after vaccination. I developed hives around the injection site. Sore  lymph node under right armpit. Tingling and numbness and bilateral legs
4/23/04: Mom called stating redness and swelling at injection site left leg. Welt noted and is very hot to touch. Mom advised to have him seen-she states better today will wait.
pt recvd vax; fever elevated to 103; n; v beginning 3sep94; tx upon hosp; IV fluids antiemetic, anti histamines, steroids; hosp 12sep94;
Chills, stomachache, headache, nausea, no appetite,  extreme fatigue. Next day diarrhea, runny nose, extremely high blood pressure never had numbers so high, along with the first day symptoms..shortness of breath which I did have became worse.
Diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included NISOLDIPINE, OMEPRAZOLE, HYDROCHLOROTHIAZIDE and ALPRAZOLAM for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea). At the time of the report, DIARRHOEA (Diarrhoea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021:
Information has been received from a consumer concerning her 18 year old daughter with no known drug reactions or allergies who in July 2010, was vaccinated with a first dose of GARDASIL (Lot# unknown). Second dose of GARDASIL (Lot# unknown) was given on 01-SEP-2010. Concomitant therapy included unspecified birth control pill. The consumer stated that after the first dose of GARDASIL the patient did not have any adverse effect. The consumer reported that in the evening of 02-SEP-2010, her daughter became very ill with a fever of 103F, viral sores in mouth, sore throat and chills. The consumer stated that her daughter was bleeding in her throat and could not swallow. The patient was taking to the emergency room Monday, on 06-SEP-2010, and a tested for strep throat was done which was negative. The mother said that her daughter had missed college classes, and was taking MOTRIN and TYLENOL, and could not swallow. She also stated that she was planning to contact her daughter's physician. The mother adds that her daughter declines her third dose of GARDASIL. At the time of the report, the patient had not recovered. Patient's fever of 103F, viral sores in mouth, sore throat, chills, bleeding in her throat and cannot swallow were considered to be disabling by the reporter. Additional information has been requested.
Sick after every one received; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 04-Dec-2020. This case involves a patient of unknown demographics reported sick after everyone received (Illness), while the patient received Influenza vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient reported sick after everyone received (Illness) unknown period of time after the administration of influenza vaccine.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
pain on both of his arms in the deltoid muscles; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain on both of his arms in the deltoid muscles) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain on both of his arms in the deltoid muscles). At the time of the report, VACCINATION SITE PAIN (pain on both of his arms in the deltoid muscles) had not resolved.            No concomitant medication was provided. No treatment medication was provided. Patient reported that he had the 2 shots of the Moderna vaccine and wants to find a place where he can have the booster dose done on his thigh or rear.
Itchiness in the palm of my left hand (same side of the vaccine injection). This happened with my 2 last moderna vaccines and now again with the booster. I mentioned this to the pharmacist and she urged me to report this via this site.
Stomach Cramps; headache; Nausea; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 23Feb2021 13:45 (at the age of 51-year-old) (Batch/Lot Number: EL 3247) as DOSE 1, SINGLE for covid-19 immunization. Medical history included cardiovascular disease. Concomitant medications included Lipitor 40 Mg (LIPITOR [ATORVASTATIN CALCIUM]), Clopidogrel-75 mg (CLOPIDOGREL), Advil-400 Mg (ADVIL [IBUPROFEN]), Aspirin-81 Mg (ASPIRIN [ACETYLSALICYLIC ACID]) and Metoprolol-25 Mg (METOPROLOL) where all were taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. Patient did not received any other vaccines within 4 weeks to the COVID vaccine. On 24Feb2021 the patient experienced stomach cramps, headache, nausea and dizziness. Where the patient experienced the mentioned symptoms on the second day, and the symptoms got reduced on the day 3 after vaccination. Where the patient received regular medications post vaccination. Patient did not received treatment for the events. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. Outcome of all the events was recovering.   Follow-up attempts are completed. No further information is expected.
expired vials were used to provide 38 doses; Sore arm; some identified common side effects after the vaccine (ex: sore arm, etc.); This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (some identified common side effects after the vaccine (ex: sore arm, etc.) ), EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) and VACCINATION SITE PAIN (Sore arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) and VACCINATION SITE PAIN (Sore arm). In November 2021, the patient experienced VACCINATION COMPLICATION (some identified common side effects after the vaccine (ex: sore arm, etc.) ). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) and VACCINATION SITE PAIN (Sore arm) had resolved. In November 2021, VACCINATION COMPLICATION (some identified common side effects after the vaccine (ex: sore arm, etc.) ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No vial went any temperature excursions.  Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. Till 19-Nov-2021, there were no adverse reactions to the vaccine.  As of 19 Nov 2021, there were no adverse reactions to the vaccine reported by the list below. We spoke with some that received the vaccine during these dates and some identified common side effects after the vaccine (ex: sore arm, etc.) and only lasted for a few hours but no more than 24 hours for 1st dose, 2nd dose and Booster.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: The additional information included suspect administration date. On 19-Nov-2021: Follow-up information included about patients details On 19-Nov-2021: Significant FU appended (Second reporter Information was updated)
Patient was inadvertently given the Pfizer product instead of the intended bivalent booster.
Initial information received on 11-Oct-2018 regarding an unsolicited valid non serious case received from  other health professional. This case involves 3 patients who were given injections of suspect vaccine was ADACEL that had been frozen later after they gave the injections. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. No other vaccines were given that day at their Well Check Up. On an unknown date, the patients received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U5468A and expiry date: 30-Sep-2018) (dose in series, route and site of administration was not reported). It was a case of actual medication error due to incorrect product storage. It was unknown if the patient had any adverse event. 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. List of documents held by sender: none.
At check out dizzy, seizure like activity per mom. Fainted, fell back on wall and slid to floor.
This spontaneous report was received from a physician regarding a 15 year old female patient with no pertinent medical history, drug reactions or allergies. On 20-APR-2015, the patient was vaccinated with the first dose of GARDASIL (0.5 ml, intramuscular, lot number was not provided). There was no concomitant medication. On 23-APR-2015, the patient developed upper lip swelling and a few hives on the left forearm and wrist. The patient sought medical attention, at office visit. Subsequently, she was prescribed BENADRYL. Laboratories tests were not performed. It was not known if the patient would continue the GARDASIL series. At the time of the report, the patient's outcome was unknown. Additional information is not expected since the physician did not want to be contacted.
Local symptoms: Pain -discomfort, redness, swelling, itching. General symptoms: Chills, headaches, joint pains, muscle pains, nausea.  Narrative:
Patient had the common/expected fatigue/myalgia/low grade fever following the 2nd COVID vaccine.  Then, once this resolved, he developed chest pain and shortness of breath.  He was  admitted to the hospital and found to have pericarditis with elevated troponin and mild/nonspecific EKG changes.  He had echocardiogram, CT angio coronary, and cardiac MRI as part of evaluation.  He was treated supportively with NSAIDs and discharged with only mild residual pain.
Patient's wife said sprycel was discontinued due to development of pulmonary artery hypertension that was due to sprycel or covid 19 vaccine (pfizer - 2nd one given late April or early May 2021). She was not sure. Patient became sick in August, had trouble breathing in September, and on September 16th and November 1st had fluid pulled off of lungs and currently taking furosemide.
Symptoms from improperly administered vaccinations - known as SIRVA, for "shoulder injury related to vaccine administration'' - include chronic pain, limited range of motion, nerve damage, frozen shoulder (the inability to move the shoulder) .  I received a COVID-19 vaccination (2nd dose as part of the Janssen study )..  When the nurse injected the needle into my arm it HURT.  I started to leap off the table but she told be to stop and 2 nurses stepped forward to steady me.  I told her it hurt extremely bad but she didn't withdraw the needle.  Another nurse handed me a tissue to wipe the tears from my eyes.  The injection  hurt, more so than the usual injection. In the days that followed, the pain in my right shoulder worsened. Initially, I dismissed it as typical post-shot soreness. But it didn?t go away.  Months later, it still hurts. The sports medicine doctor says I have excess fluid buildup in the bursa.  He withdrew the fluid.  I'm still going for physical therapy 3 times a week to get back range of motion and strength in my arm.  I?m convinced this occurred because the nurse injected the vaccine too high on my arm. I had no symptoms before the shot, and pain has persisted since.