chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse regarding an unspecified patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored PNEUMOVAX 23, lot # L035687, expiration date- 16-FEB-2017 and lot # L040181, expiration date- 18-AUG-2017 (incorrect product storage). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. Temperature was -3 degree Celsius, Time frame was 6 hours and it was back in range. There were no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a pharmacist concerning an 80 year old female who on 13-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck). Subsequently the patient experienced a 3-inch diameter red, raised rash at the injection site. The patient also developed itchiness at the injection site and tiredness. Medical attention was sought. The patient was treated with hydrocortisone cream which reduced the size of her rash and was relieving the itchiness. The patient's tiredness persisted. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is one of several reports from the same source.
Syncope. BPs 119/49 (pulse 58), 99/47 (pulse 59). O2 sats 99%.
Chills, fever, body ache continuing for 24+ hours. Mild pain and swelling at injection site
11 hours after the shot I woke up with chills, fever, aching, headache, dizziness, elevated heart rate 113 beats per minute( i take Atenolo so my heart rate rarelly gets above 70 bpm).
Information has been received from a male patient with no drug allergies and hypertension who on 02-SEP-2011 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck). Concomitant therapy included lisinopril-HCTZ (manufacturer unknown). On an unspecified date in 2011, the patient experienced back pain not too long after vaccination. On 03-OCT-2011, the doctors ordered a magnetic resonance imaging (MRI) and determined he had some enlarged lymph nodes in the right axilla, mediastinum and right supra clavicular that required further investigation. He subsequently had a computed axial tomography (CT) scan with contrast and was diagnosed with moderate lymphadenopathy and they were going to do an axial node biopsy to see what the possible cause of the lymphadenopathy was. He was wondering if they might be caused by the ZOSTAVAX (Merck) considering that on the listed side effect was swollen glands. At the time of the report, the patient's outcome was unknown. Follow up information has been received from the 69 year old male with hypertension who on 02-SEP-2011 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included lisinopril-HCTZ (manufacturer unknown). The patient reported that he had a chest computed axial tomography (CT) scan on 12-OCT-2011. It showed "moderate lymphadenopathy in the mediastinum, mostly posterior and paratracheal regions and also in the right axilla and right supraclavicular region. Query: lymphoma or other lymphoproliferative disorder. "The 3 cm right axilla lymph node was relatively high in the axilla. Recommend correlation with physical exam of the neck regarding any possible cervical lymphadenopathy which might be more amenable to a lymph node biopsy." "Clear lungs was the impression." He would be seeing a specialist today and cancer was suspected. The patient reported that he had a magnetic resonance imaging (MRI) of his back on 03-OCT-2011 because he was experiencing back pain; however, his back pain resolved that same day. The results of the MRI showed prominent soft tissue structures on his vertebrae and it was presumed it was swollen lymph nodes. On 14-OCT-2011 (reported as today), the consumer would be seeing a surgeon (unspecified name). Upon internal review, cancer was determined to be an other important medical event. Additional information has been requested.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve pain and burning sensation. On an unknown date, the outcome of the vaccination failure, shingles, nerve pain and burning sensation were unknown. It was unknown if the reporter considered the vaccination failure, shingles, nerve pain and burning sensation to be related to Shingles vaccine. Additional details were provided as follows: This case was reported for reporter's husband. The age at vaccination was not reported. The reported stated the patient got Shingles shot and at the time of reporting he has shingles. The reporter stated burning the nerve pain were horrible. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Tinnitus in left ear began on 4/25/21, 11 days after 2nd Pfizer dose. Treated with sound enrichment and meditation app Oto. Unchanged after almost 6 months. Chronic headaches and dizziness began 5/27/21. Treated with anti-migraine diet, not effective after almost 6 months. Vertigo (BPPV) on 6/29/21. Treated with Brandt-Daroff exercises, Epley maneuver, and physical therapy. Vertigo resolved but chronic dizziness remains.
AT  1;38P, PATIENT DESCRIBED EXPERIENCING DIZZINESS, SHE CLOSED HER EYES FOR APPROX. 10 SECONDS. WAS ASKED IF SHE WAS FEELING OKAY AGAIN, THAT WE NEEDED TO HEAR HER SAY SOMETHING TO MAKE SURE SHE HAD NOT FAINTED, BUT SHE REMAINED UPRIGHT AND STABLE IN CHAIR SHE WAS SEATED IN. AT 1:41P, PATIENT WAS TALKING & RESPONSIVE, MORE ALERT, BUT SHE SAID SHE WAS FEELING WARM. AT 1:44P, PATIENT WAS MOVED TO WHEELCHAIR, SHE WAS ABLE TO MAINTAIN STABILITY DURING HER STANDING & SITTING BACK DOWN TO SIT IN THE WHEELCHAIR. SHE WAS THEN MOVED TO OPEN HALLWAY FOR COOLER AIR FLOW & MINIMIZE FEELING OF ANXIETY IN SMALL ROOM. AT 1:47P, PATIENT FEELING OKAY NOW, JUST HAD "WATERY EYES PROBABLY FROM ALLERGIES." SHE WAS ABLE TO CONVERSE NORMALLY. AT 1:53P, PATIENT DESCRIBED FEELING OKAY STILL, JUST TIRED.  AT 2:00P, PATIENT'S BLOOD PRESSURE WAS RECORDED AT 109/89, AND SHE FELT COMFORTABLE TO LEAVE WITH HER CAREGIVER.
Patient developed a rash extending around her abdomen and back within 4 hours of vaccine administration, on 8/27/20.  On 8/31/20, Patient developed high fevers, reaching 103.6 degrees on 9/1/20.
On the 3rd day after the vaccine injection mi bottom lip swell up and I began to experience numbness and pins and needle feeling in my feet and hands. Then on the 10th day both of my lips (top and bottom) swell up significantly and my whole face was swollen for 24 hours. Feeling of numbness in feet and hands continued for 3 weeks and I went to ER.
Rec'd a series of 3 vax according to 0, 1, 6 mo schedule given 7SEP90, 5OCT90, 6MAR91 about 6 1/2 hrs p/3rd dose pt ex. anaphyl rxn (SOB, wheezing); became semi-conscious; admitted to ER - headache;In ER diffuse wheezes, resp rate-28,
Left face numbness, weakness, tired. Evaluated by EMS; Refusal to transport.
Immediate itchiness and pain. On Saturday morning, November 26, my bicep was red, swollen and itchy. On Sunday, November 27, my arm was red, swollen, itchy and hot to the touch.
Pfizer-BioNTech COVID-19 Vaccine EUA  hives and rash in my armpits, up my neck, down my chest, and in the groin area
itching of her back and palms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching of her back and palms) 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-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PRURITUS (itching of her back and palms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (itching of her back and palms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not provided.
24 hours - headache, joint pain (every joint), unable to focus, arm pain, low-grade fever 3 weeks - fatigue. Whereas I typically stay awake and do work until 11 pm, I became very tired around 6:30 pm and needed to go to bed      since I was unable to function by 7 pm for 3 weeks.  After 3 weeks I was gradually able to stay up later. I delayed my 2nd dose since I was still experiencing fatigue at 4 weeks.  Covid19(Moderna) shot #2 taken Feb 24 at noon- experienced headache and fever within an hour of taking shot. Felt terrible and went to bed at 7 pm after taking 2 ibuprofen. My husband woke me up around 11 pm. He said I was burning hot and my body was shaking. He gave me a glass of water and 2 more ibuprofen. I barely remember. When I woke the next morning, I felt weak but no fever or headache. No more symptoms.
initially had really sore arm and a knot at the site of injection and very tired. approximately 3 days later started sneezing and itchy, watery eyes. about 5 days after injection started having severe vertigo when rolling over in bed. while I have had vertigo before, it has never been this bad.
increased pain and weakness in grip when reaching arm above shoulder level; increased pain and weakness in grip when reaching arm above shoulder level; injection site pain; Initial information was received on 10-Dec-2019 regarding an unsolicited valid non-serious case from a physician.  This case involves a 32 year old female patient who experienced increased pain and weakness in grip when reaching arm above shoulder level (muscular weakness) (Pain in extremity), and injection site pain (vaccination site pain), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatments, vaccinations and family history were not provided.   On 20-Nov-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ279AC, expiration date: 30-Jun-2020) via an intramuscular route in the left deltoid.  On an unknown date, the patient developed non-serious increased pain and weakness in grip when reaching arm above shoulder level (muscular weakness) (Pain in extremity) and injection site pain (vaccination site pain) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory details were not reported.  Final diagnosis was vaccination site pain, muscular weakness and Pain in extremity.   The patient was treated with ibuprofen.  The event outcome was unknown for vaccination site pain, muscular weakness and mobility decreased.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M034692, expiration date 24-JAN-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -14 through -10 degrees Celsius for 20 minutes and 15 through 46 degrees Fahrenheit for 20 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA013984.
Fever, chills, body ache, headache, sore arm that lasted 1.5 days
While napping an hour after shot I was awoke by what I can only explain as a feeling of being shocked or electrocuted by something for a few seconds, this happens three times. Heart palpitations, chest pains, blurred vision, foggy brain.
For around 3 months post 2nd dose of the Moderna vaccine, I continuously experienced a frightening discomfort in my chest that I had never felt prior to. I felt it in my chest where my heart would be. It would happen fast, felt as if someone walked through me. Almost as if my heart skipped a beat. At the time, I voiced concern to my doctor as well as my family. No-one seemed to take me seriously which made me feel even more frightened and concerned.
Cough, watery eyes, stuffy nose, aches, fatigue. Several hours after shot lasting through next day.
Pharmacist administered four vaccines to different patients in quick succession (one shingles, one flu, two covid); I was the 4th.  He administered it very high in my arm, above the normal deltoid site of my previous three shots.  Immediately upon administration a thick stream of blood began flowing down my arm, pooling next to me on the chair (I have never had that happen).  The pharmacist lacked towels or cleaning products to clean the blood.  I stood up, saw flashes, became dizzy, and could not walk.  I sat down and began sweating profusely for approximately half an hour.  During this episode, the pharmacist erroneously gave my vaccine card (with my sensitive health information) to a different patient, who left the pharmacy with my card.  After receiving rubbing alcohol and water, I was okay within about 45 minutes.  Pharmacist told me I had a vein pierced upon administration,  likely passed out from the blood, and acknowledged giving my vaccine card to the wrong patient with profanity.  Three days later, my arm is still very bruised and sore.  I have had some lymph node swelling, which is decreasing today.
COVID-19 symptoms started 06/03/2022; tested positive 06/05/2022. I had nasal congestion, low grade fever, chills. malaise, flu-like symptoms, bronchial congestion, cough, and a bit of a headache on one day. I would say the flu-like symptoms lasted a couple of days. I had light cold symptoms on Friday and flu-like symptoms on Saturday, and by Sunday I had chest cold symptoms. I don't remember having a sore throat particularly, and mostly had nasal congestion and phlegmy cough congestion. I did have telehealth appointment and doctor stated because I was taking beta blockers and XARELTO, I wasn't clear to take PAXLOVID and to ride out the symptoms. My symptoms lingered a couple of weeks like a bad cold would, but not worse than a bad cold. I had tiredness especially the days of the flu-like symptoms.
Cognitive in nature.  Mimics CVA.  The Day of Aphasia, slurred Speech and simply don't know the name of things I usually know.  Hard to remember medical terms that I use on a daily bases.  I'm still having Cognitive problems.  Made an Appt with a neurologists.  It appears that I should Have just stated from the beginning that I had a stroke and Doctors would have taken me seriously.   But since I stated I believe it is a possible side affect, I'm treated like nothing has happened.  So I have an Appointment some time in Jan 2022 with the neurologists.  As of yesterday I tested Positive for Covid 10/25/2021.  To day I went to get a PCR test done by my provider.
Swelling in his arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in his arm) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in his arm). At the time of the report, PERIPHERAL SWELLING (Swelling in his arm) had resolved.            Concomitant medications were not provided. The patient began experiencing swelling in his arm two days after the vaccination that has now lasted 3 weeks. He consulted with doctors, but the swelling still persists. No treatment details reported.
dose 1 on April 5, 2019, dose 2 on May 8, 2019, and dose 3 on October 7, 2019 / had a recent physical with blood work / does not have enough titer to protect against Hepatitis B; This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a 54-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) for prophylaxis and HBV (Engerix B adult) for prophylaxis.   On 7th October 2019, the patient received the 3rd dose of Engerix B adult. On 8th May 2019, the patient received the 2nd dose of Engerix B adult. On 5th April 2019, the patient received the 1st dose of Engerix B adult. On 27th February 2021, 509 days after receiving Engerix B adult, 661 days after receiving Engerix B adult and 694 days after receiving Engerix B adult, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were reported as follows: The case was reported by patient herself. The patient reported that she received a full series of Engerix-B adult, formulation not known, and was informed that she has no protection for hepatitis B. The patient had a recent physical with blood work, and the physician checked for hepatitis protection. The patient was informed that she did not have enough titer to protect against Hepatitis B. The reporter did not consent to follow up. The patient was seeking reimbursement and informed of GSK (GlaxoSmithKline) policy.
an expired Menactra vaccine was administered, no AE; Initial information received on 10-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 20-year-old female patient who received an expired 0.5 mL dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6151AA and expiry date: 16-Mar-2020) via an intramuscular route in the left deltoid for prophylactic vaccination on an unknown date (reported as March) and patient was not pregnant.  The patient's past vaccination included Menactra in 2011 and in 2013. The patient's medical history, past medical treatment, concomitant therapy and family history were not provided.   It was an actual medication error case due to expired vaccine used.  At the time of this report, no adverse event was reported.  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.
It took two jabs for autoimmunity to set into me. They stole my quality of life; This spontaneous case was reported by a consumer and describes the occurrence of QUALITY OF LIFE DECREASED (It took two jabs for autoimmunity to set into me. They stole my quality of life) 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 QUALITY OF LIFE DECREASED (It took two jabs for autoimmunity to set into me. They stole my quality of life). At the time of the report, QUALITY OF LIFE DECREASED (It took two jabs for autoimmunity to set into me. They stole my quality of life) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Reporter did not allow further contact
Dcfore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Dcfore arm) and HEADACHE (Headache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Dcfore arm) and HEADACHE (Headache). At the time of the report, MYALGIA (Dcfore arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Arm was hot, red and hard where shot was given, also redness on back, also itching. Redness still on arm only.
This case was reported by a consumer via call center representative and described the occurrence of red rash in a female patient who received SHINGRIX for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st October 2018, 5 days after receiving SHINGRIX, the patient experienced red rash, itchy rash and blistery rash. On an unknown date, the outcome of the red rash, itchy rash and blistery rash were not recovered/not resolved. It was unknown if the reporter considered the red rash, itchy rash and blistery rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Around 21st October 2018, the patient experienced a rash that was red and itchy on top of her left ankle. The patient was starting to have blisters on the rash as well.
experienced general soreness; Has a fever; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown, Dose 01), for COVID-19 Immunization; Bnt162b2 (Dose 02), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "experienced general soreness"; PYREXIA (non-serious) with onset Dec2021, outcome "not recovered", described as "Has a fever".  Additional information: Product clarified to the Pfizer COVID vaccine, booster dose. Patient stated that she didn't have time for an experience report regarding her side effects, but she should just follow up with her primary care provider, is that right and How long did the report take. Unfortunately, she had a work call coming up and she was unable to complete. Reported side effects after their booster shot. She said she experienced general soreness & fever after the dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.