chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant, concerning an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored dose of ROTATEQ lot # M045545 and lot number M041770 for prophylaxis. No adverse effects reported.
This case was reported by a pharmacist via call center representative and described the occurrence of hives in a male patient who received SHINGIRX for prophylaxis. On 13th February 2019, the patient received the 1st dose of SHINGIRX. On 13th February 2019, several hours after receiving SHINGIRX, the patient experienced hives. On 14th February 2019, the outcome of the hives was recovered/resolved. It was unknown if the reporter considered the hives to be related to SHINGIRX. Additional details were provided as follows: The age at vaccination was not reported. The patient date of birth, batch number and expiration date were not reported. Around 3:00 to 4:00 pm (exact time was not reported), the patient received SHINGIRX. The patient contacted Pharmacist around 08:00 to 8:30 pm (exact time was not reported), to advise that he had broken out in hives on his back. The pharmacist followed up with the patient on the next day and patient reported the hives had completely resolved. This case had been linked with case US2019GSK036497, reported by same reporter.
presented to the ED on 9/8/21 and admitted with SOB and diarrhea. The pt was sent 9/8/2021. The patients daughter stated that the patient received both doses of the covid vaccine.    In the ED, the pt test positive for COVID-19. She was hypertensive and sat at 81% on 4LNC. She had a leukocytosis and was hyponatremic. ABG suggestive of primary respiratory alkalosis with secondary metabolic acidosis. The patients BNP was 390, CRP 9.7, ferritin 356, D-dimer 2.95. CXR showed evidence of HF with cardiomegaly with moderate R and small L pleural effusions and likely pulmonary edema. CTA demonstrated no presence of PE, only changes of CHF and moderate b/l pleural effusions and consolidation likely representing atelectasis.    Pt was admitted for management of COVID 19 pnuemonia and CHF exacerbation, and hyponatremia. She was started on Remdesivir 200mg x1 followed by 100mg daily, Decadron 6mg daily, Rocephin 1g IV daily, Azithromycin 500mg x1 followed by 250mg daily, Lopressor 25mg BID. She received 1 dose of Lasix 40mg. She was started on 4L oxygen. She tested negative for legionella and strep. Over the 6 day course of her hospitalization the pt?s oxygen levels improved and was gradually weaned off oxygen. Her COVID labs were monitored daily. Her hyponatremia resolved with improved oral intake. She was evaluated by PT/OT. She was discharged back to Residence.  Pt is to continue home medications and starting decadron for 4 more days, Mucinex 600mg,  Albuterol inhaler, Miconazole Nitrate Powder as described above.
My right arm was aching 3 days after shot and when I looked in the mirror at the injection sight which was done on my tattoo, my tattoo has literally dissolved and appears distorted now. I called Rite Aid and informed them of the reaction and they suggested I report this action.
Patient said arm was very sore, could not move or lift, was red at injeciton site and down below elbow.
104 temp, chills, dizziness, painful electric shock sensation, hurt to breathe , cough, stuffy nose, diarrhea, fatigue, hurt everywhere, extremely painful headache, sweats lasted 3 days
Continuous nausea; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 30Mar2021 at 09:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and COVID-19 on unknown date. The patient did not have any allergies to food, medications, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN, strength 25 mcg) and hydrochlorothiazide (MANUFACTURER UNKNOWN, strength 25 mg) all from an unknown dates taken for unknown indications. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 09Mar2021 at 09:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 23:00 the patient experienced continuous nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported adverse event. The clinical outcome of the event continuous nausea was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
body aches; fatigue; headache; This is a spontaneous report from a contactable nurse reporting for herself.  A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration at left arm on 08Jan2021 14:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included Seasonal allergies. Concomitant medications included omeprazole and Multivitamin. The patient historic vaccine included the first dose of BNT162B2 received on 18Dec2020 07:30 AM at Left arm for covid-19 immunization, 1st dose symptoms started about 4hrs after: Nausea, body aches, fatigue, severe headache-all lasting 3-4 days. The patient experienced on and off headaches, body aches, fatigue all starting around 18-20 hours post second injection on 09Jan2021 and lasting less than 48 hours. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date in Jan2021.
Rash on my right knee first doses. Now with booster, I have rash and my skin is dark on both my inner thighs.
Signifigant redness, swelling,and discomfort  to most of right upper arm injection site.
1:02pm: tingling and numbness in my left hand (middle and ring finder), weakness in hand and arm 1:07pm: tingling and numbness  my right hand (middle and ring finder), weakness in hand and arm 1:17pm: dry mouth, heart racing, swelling in throat & tongue, slightly dizzy 1:22pm: flushed face and neck Throat and tongue swelling quickly subsided. Heart racing lasted about an hour., 11pm: sore arm at injection site (left arm) Today (4/10/21) : injection site still sore, middle and ring  finger still slightly  numb, dry mouth, overall feeling of tiredness
Kinrix were exposed to 11°C for 35hs non consecutive hours (one dose) and 11°C for 37hs with no prior excursion and the administered to a patient; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 4-year-old patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th April 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-Oct-2022 Reporter's comment: The nurse called on 19th October 2022 and reported that on 2021 their Kinrix were exposed to 11 degree Celsius for 35 hours non consecutive hours (one dose) and 11 degree Celsius for 37 hours with no prior excursion and then administered to a patient.  The health-care professional was not aware of patient´s gender when asked.  The consent to follow-up was granted via email. The vaccine administration facility was the same as primary reporter. Additional supportive information: The patient received Kinrix vaccine which was exposed to 11 degree Celsius for 35 hours non consecutive hours (one dose) and 11 degree Celsius for 37 hours with no prior excursion, which led to incorrect storage of drug. This case is linked to the case US2022150628, US2022150629, US2022150631 and US2022150632 reported by the same reporter.; Sender's Comments:  GSK-US2022150628:Same reporter GSK-US2022150629:Same reporter GSK-US2022150631:Same reporter GSK-US2022150632:Same reporter
dizziness, headache (still have 6 days after second dose (shot on 4 Nov 2021),  Pain in left arm up to when i had second dose (feels like a typhoid shot).  An hour after first dose had cramps/squeezing in my left testicle.  I had chest pain after the second dose (felt like someone was standing on my chest, that happened twice within 4 hours after 2nd dose)  i have not recovered from the headaches (feels like someone is squeezing the top of my head)
Large (4 inches long, 2 inches wide), red, itchy, rash that appeared 8 days after vaccination ("COVID arm"); realize that this is not truly an "adverse" life-threatening event, but think that it is vastly underreported (the symptom reporting app stops on day 7, and this appeared on day 8). Took photo for documentation.
2 inches below injection site and 1 inch over close to inside of arm.  2 inches x 2 inches large raised hot, itchy, sore red welt.  looked faintly bubbly but never got to that stage.  Had it for 4 days, each day getting progressively better.
MENSTRUATION AFTER MENOPAUSE; This spontaneous report received from a consumer concerned multiple female patients of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. No concomitant medications were reported.  On an unspecified date, the patients experienced menstruation after menopause. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of menstruation after menopause was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210619369.; Sender's Comments: V0:20210621127-COVID-19 VACCINE AD26.COV2.S-Menstruation after menopause. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
02Nov2021 her and her husband got the covid vaccine booster; He got a little dizzy; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for old male patient (reporter's husband). A 73-year-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection,Batch/Lot number: not reported), via an unspecified route of administration on 02Nov2021 as DOSE 3 (BOOSTER, SINGLE for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. 02Nov2021, the patient experienced her and her husband got the covid vaccine booster and On an unspecified date in 2021, he got a little dizzy. Caller reporting on her husband. 02Nov2021 her and her husband got the covid vaccine booster at the doctors office.They both waited the 15 minutes. He got a little dizzy but nothing like what happened to her.The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
higher blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for COVID-19 immunisation. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "higher blood pressure".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
18 hours after receiving injection pt developed weakness, nausea, dizziness, and two inches with of bruising/swelling at injection site. Seen in ER. Completely recovered within several days except for bruising, which lasted a week.
Veteran received his 3rd dose on 11/18/21, 2 days later noticed reddened colored spots forming a clustered band-like circle  around each lower leg. No pain, no itch, no swelling. He presented to the VA outpatient clinic 11/23 for evaluation worried that was due to his recent moderna shot.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 59 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 01-MAR-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Temperature was 102F the evening of IZ, had high-pitched cry, difficult to console, poor feeding, not smiling or maintaining eye contact, seemed to be "spaced out" per dad. Seen in our office at 10:00 on 2/13/01 and temperature was 98.7 (R) and essentially normal exam.
Patient had local reaction red and white bumps 2 min after administration - given P.O. BENADRYL.
15 minutes after adminstration, pt was unresponsive to initial situation and had cyanotic to face. Had spontaneous recovery without need for intervention. Seen by ED facility with normal vital signs and normal physical exam find
Patient presented to the Emergency Room approximately 27 hours post vaccination with injection site cellulitis.   Symptoms included reddness, heat and edema.  Warm compresses were recommended.
To Whom it May Concern: I am writing to notify you of my experience concerning the Zostavax vaccine.  During a routine physical, I was offered the vaccine because I am over 60.  Because I have been plagued with herpes since childhood, I felt it would be a good idea to receive it, which I did on December 28th.  On January 12th, I had been feeling very tired and began having pain in my ribcage and lower back.  On January 16th I broke out in shingles.  I went in to my doctor and was given a prescription for acyclovir.  I also received the actual information sheet from the pharmaceutical company which stated that a recipient should not be around newborns, pregnant women or immunocompromised persons.  I am an RN in an Intensive Care Nursery and had been working post-vaccine.  This cause quite a bit of distress in the ICN and also the Infectious Disease Department...and, of course, to me.  I also spent my holidays with a person who has leukemia, my grandchildren, one of whom was too young to have received the chickenpox vaccine.  On January 18th one of my grandsons had chickenpox although no other students in his school had them.  I, of course, was not able to return to work until the 6 weeks period ended.  I strongly feel the information regarding avoiding newborns, pregnant women and immunocompromised people should be included on the office handout from CDC.  My doctor is going to give prospective recipients both sheets in the future.  I requested that she also notify you of my situation just to further legitimize these facts.
Patient was vaccinated at 1:05 with Hep B, at 1:06 with MCV4, at 1:07 pm with varicella. At 1:08, Patient stated, "I feel dizzy". Patient became sweaty. Applied cold pack to the back of patients neck. BP 100/61, O2 sat. 99% RA, P 68, Resp. 20, At 1:15 patient was alert and oriented x3, stopped sweating and stated, "I feel better". BP 110/78, P 64, O2sat 99%, Resp. 20, At 1:35, patient had no symptoms of distress or dizziness. Patient smiling and stated,  "I feel fine". BP 114/78, P 72, Resp. 20, Temp. 97.7, O2 sat 99%. Alert and oriented x 3. Discharged with father and instructed to call EMS or ER if symptoms return. Patient verbalized understanding.
Received TDAP 6/12/2008 to left deltoid. No other vaccinations given. Last TD 9/9/2005. Complained of sore arm last night that awakened her from sleep, site itches, and over last few hours 6/13 increased warmth, itching and numbness radiating down top of left arm over top of elbow (AC) with radiation to thumb and axilla. No chest pain, fever, SOB, or rash. Seen by immunization tech with site warm to touch with "red streak" - referred for evaluation. Concerned about possible worsening reactions following history similar site soreness with passing out and upcoming weekend. Pt is right handed. Denies any new foods, detergents, deodorants, soaps, lotions, cloths, not outside in grass, etc. No dogs/cats/animal contact. PMH: seasonal allergies, allergy sulfa, flu, hep B, egg astro-rama (surfactant), and thimerasol. Medical problems: migraines, sleep disorders, dry eyes, skin warts, et al. ~Past vaccine reactions: last flu shot in 1993: heavy arm, lymphadenopathy to axillary and clavicular nodes x 1 week. Flu like s/s for 1-2 weeks. Had Hep B series, after third shot July 1993 had following reaction: difficulty breathing, stopped per family, passes out , uncons few moments but unsure while family seeking help, woke up feeling bad. Did have lymph node swelling near shot, redness and sore at site. No rash, fever remembered. Did have body aches with chest sore as it hurt to breathe. Unsure of duration of reaction, no medical f/u sought.~ S/s resolved by day 2 with MOTRIN and warm compress.
Initial and follow-up information has been received from a health professional concerning a 16 year old female with Crohn's disease who on 15-MAY-2007 was vaccinated in the right deltoid with Gardasil (lot # 657622/0388U).  Concomitant therapy included PENTASA.  The nurse reported that following vaccination, the patient developed a large, red, swollen, warm and painful area one inch below the injection site.  The area was about 10 centimeters wide.  The patient was given BENADRYL.  The area had improved slightly since BENADRYL was started.  At the time of the report, the patient had not recovered.  The nurse also reported the experience of other patients with Gardasil (WAES #0705USA03739).  Additional information has been requested.
Infant developed urticarial rash, mainly on face and trunk, a few hours after receiving vaccine on 1/28/06.  Seen by MD 1/30/06. Given PO Benadryl.  Infant well on 1/31/06.
Nausea intermittently / Intermittent nausea; Chills; This case was reported by a physician via call center representative and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2019, the patient received Shingrix. On 2nd October 2019, 1 days after receiving Shingrix, the patient experienced nausea and chills. On an unknown date, the outcome of the nausea was not recovered/not resolved and the outcome of the chills was recovering/resolving.   It was unknown if the reporter considered the nausea and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. It was 3rd day after the vaccine and the patient was still having chills and nausea intermittently. Overall the patient was feeling much better than the evening of 2nd October 2019, but still had intermittent nausea. This information was received via chat and the reporter was unresponsive to questions for adverse events.
I was completely covered in hives all over my body as well as welts, i also was so nauseous that i wasn't able to eat and was throwing up and it consisted for 4 days start sept 1st and ending the 5th.
shingles; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of an unknown age. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. In 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route, vaccination site, lot # and expiry date were not specified) for the long-term prevention of shingles and zoster-related conditions, as prescribed and/or administered by a pharmacist. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt has and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The causality was related.