chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 12 hours after vaccination I started feeling headache and body ache. It continued throughout the night. I did not feel feverish but I had chills and extreme fatigue. Just very extreme flu like symptoms.  After those symptoms cleared up I had a red lacey rash across my entire torso front and back. That cleared up after a few days. I didn't have any problems until July when I was exercising I happened to move my head quickly and almost blacked out. I thought it would go away but it continued throughout the night. I went to urgent care the next day. They told they thought I had an inner ear infection in the right ear and they sent me home to wait for it to resolve. It did not so I called my primary physician to be seen as a follow up. She examined me and she stated she didn't see signs of an ear infection. She saw an Nystagmus. She had me to do movement and balance tests. She thought I had Benign paroxysmal positional vertigo, BPPV. She recommended I go to physical therapy. I made the appointment and by the time I went I felt a little bit better but it might have been the, Meclizine medication that as prescribed. I went to the physical therapist and he did some tests and did not see any Nystagmus. He asked me if I saw an ENT. I went to see the ENT and she was very dismissive to my symptoms. She told me that it might be TMJ and that I should see a dentist. During this time the vertigo has not gone away and I didn't have any other neurological issues. The dentist said that I should go to a oral surgeon. The oral surgeon said that I should see a specialist but I couldn't due financial reasons. At this point it had been a couple of months. In September I went to see my primary again because it wasn't going away. She said that I should have an MRI of inner auditory canal. The MRI showed a 1.7 centimeter extra axial mass in the right frontal lobe, above my right eye. I have another MRI with contrast of my brain tomorrow night. They couldn't see if it was malignant so this MRI is to determine that.
This spontaneous report as received from a nurse refers to a 15 year old patient of an unknown gender. On 25-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Client received second dose on 03/08 at 2 pm.  She had pain and a little lump at vaccine injection site on the following day, 03/09.  On 03/10 about 1000, client noticed site to be red, swollen and had a bump.  She report the size is smaller than a tennis ball but larger than a golf ball.  The site is not itchy or having drainage.  Client has called her PCP office, no tests, labs, or treatments ordered.  Client also report when she received her first dose on 02/08/2021, she had no reactions.
My mother, with no health issues and a very active lifestyle, had the Johnson and Johnson vaccine on March 12. Four days later, she had a serious stroke, And is still in the hospital unable to talk or eat.
We all went for testing and also tested positive; We all went for testing and also tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110).  A male patient in his 60's received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "We all went for testing and also tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: tested positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Customer Verbatim: My husband and I are in our 70's and my son and daughter in-law and 18-month granddaughter live with us. She is a teacher and tested positive for Corvid. We all went for testing and also tested positive. We all had received Pfizer inoculations and boosters and although our tests are positive, we are all functioning very well. We are so very thankful to Pfizer.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200676409 Same product/reporter/AEs, different patient
Mother reports "welt" @ injection site in back of Left arm which progressed in size from the evening of 06/10/14 to morning of 06/12/14 at the time mother phoned with reaction.  Size reached 3 inches in diameter, is raised, and is also warm to touch, therefore has an appt. with family doctor to examine.
Described tingling and swelling in all extremities that started the same night that she received the vaccination (1/14/21). Arm red and warm to touch. Symptoms had improved by Monday 1/18/21. She contacted her specialty provider who is aware of the adverse events. Doing well at this time.
Covid monitoring documentation. PT admitted 12/21/21 documented to have positive covid. PT received 1st dose Pfizer 1/14/21 Lot EL3249, and 2nd dose Pfizer 2/4/21 Lot EL9261.
THE VACCINE WAS KEPT IN THE FREEZER AFTER DELIVERY AND THAWED OVERNIGHT AND KEPT IN THE FRIDGE TILL VACCINATION / DRUG STORED IN INAPPROPRIATE TEMPERATURE; This spontaneous report received from a pharmacist concerned a 57-year-old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1821288 and expiry: UNKNOWN) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, the subject experienced the vaccine was kept in the freezer after delivery and thawed overnight and kept in the fridge till vaccination / drug stored in inappropriate temperature. The action taken with covid-19 vaccine was not applicable. The outcome of the vaccine was kept in the freezer after delivery and thawed overnight and kept in the fridge till vaccination / drug stored in inappropriate temperature was not reported. This report was non-serious. This case, from the same reporter is linked to 20210605120, 20210604703, 20210605010, 20210605028 and 20210605104.
From telephone contact with reporter patient received Tripedia lot # UO311DA on 08/15/01. Patient experienced local reaction of redness and swelling of the left thigh. Physician prescribed Benadryl and Tylenol
12 days after getting my 2nd vaccine I starting having lymph node enlargement on my left neck and left occiptal area. It was painful and then a rash started on my left jaw, ear and skull area.  It is now 9 days later and it has gotten somewhat better but still concerning to me
pt recvd vax & devel redness, swelling & warmth in the arm of inject;
Patient developed chest pain 3 days after her 2nd covid vaccine and was found to have elevated troponin consistent with myocarditis. She had sub sternal chest pain that lasted for about 5-7 days after her vaccine. She had normal vital signs and exam on the day she was seen in clinic and through out her course.
Sore arm around injection site, Tinnitis and degraded hearing when waking the following day after shot (About 14 hours).
My arm is very sore; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2020, the patient received Shingrix. In December 2020, 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 not recovered/not resolved.   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. The age group was not reported but was selected as an adult as per vaccine indication. A day before reporting, the patient received Shingrix vaccine and the patient's arm was very sore. The patient asked what they could recommend to help ease that pain.
SJOGREN'S SYNDROME; COVID-19; This spontaneous report received from a patient via other manufacturer (Company) concerned a 3 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis flare ups, and sjogren's syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, and expiry: unknown) dose was not reported, 1 total, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number: 1159243 expiry: UNKNOWN, batch number: 1160362 expiry: UNKNOWN) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. Age at time of vaccination 27 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced sjogren's syndrome, and covid-19. The physician believed that the vaccine trigger sjogren's syndrome. Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from covid-19, and the outcome of sjogren's syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220658612-Covid-19 vaccine ad26.cov2.s - Sjogren's syndrome. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Less than 24 hours later, started menstruation early,?heavier flow and worse cramps than previously.
Had TRU shot in (R) deltoid; started with rash, redness, swelling and pain to area by same afternoon; also had a difficulty lifting up (R) arm; states legs swollen and painful today. No fever, no wheezing or SOB.
8 hours after IM flu vaccine injected into left deltoid swelling, inflammation, itching, 24-48 "later site measures 30x60, induration.
Information has been received from a physician concerning a 21 week old male with no pertinent medical history or drug allergies who on 03-MAR-2008 was vaccinated PO with his second 2.0 ml dose of ROTATEQ (lot# 657977/1195U).  Concomitant vaccinations administered on that same day included a dose of PEDIARIX and a dose of PREVNAR.  On 30-MAR-2008 the patient experienced one bloody diarrhea.  The patient was seen by the physician for medical attention.  Lab diagnostic studies included a Rotazyme test and a culture.  Subsequently, the patient recovered.  There was no product quality complaint.  Upon internal review, bloody diarrhea was determined to be an other important medical event.  Additional information has been requested.
Patient came in around 3pm this afternoon on 10-22-19 with his grandmother and she wanted the nurse to look at his arm because he received a Pneumovax 23 this morning around 9:00 am and it looked swollen. When looking at the patient arm it was visibly swollen and was warm to touch and hard with an induration of about 3" wide and 4" long. Patient had a temp of 100.6 and b/p 90/40. Told grandmother to take child to the E.R. or Primary Care Physician as soon as she leaves the Health Department. Grandfather came and took child to the E.R. Talked with grandparents around 4:35 or 4:40 pm the child was being seen at the E.R. Between 6 and 6:20pm the grandmother contacted supervisor, RN and stated the child had been released and was doing fine and that he received medication for his fever and benadryl for the swelling. Grandmother contacted supervisor, RN on 10/23/2019 in the am and stated the child had been to his regular pediatrician and stated that the swelling had went down and the child would be fine just to give him medication for his fever and plenty of rest.
PATIENT WAITED APPORIATE AMOUNT OF TIME BEFORE LEAVING THE OFFICE. WENT HOME AS ALL OKAY, PATIENT WENT TO BED AND AROUND 9:00 PM PATIENT STARTED WITH ABDONIMAL PAIN, NAUSEA, VOMITTING AND DIARRHEA
Within 24 hours pt developed an injection site reaction characterized by a 2 inch area of redness and slight tenderness which resolved within 4 days without treatment.
Gave MMR and Varivax IM instead of SQ - No reaction just wanted to report
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 08-DEC-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L009544, expiration date: 19-MAR-2017). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Suspected vaccination failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had a case of shingles in 2017) and shingles (had shingles on forehead and cheek and also had sore arm post vaccination in September 2020, refer case US2021AMR197172).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix (intramuscular). In September 2021, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The age at vaccination was not reported. In 2019, the patient received 2 doses of Shingrix in left arm. In September 2021 the patient again had a case of shingles. The patient stated that the current case of shingles, involves shingles on the left side of the face, two lines across forehead, around the left eye, on the left side of the nose but not on the bridge of the nose, under the chin, chest, left side of torso, and right arm and were not resolved. The patient did not have the exact date of administration; therefore, it could not be determined how soon were the shingles experienced post vaccination. The patient stated that she had an appointment with eye doctor and was told that shingles were surrounding the left eye, but not in the eye. The reporter gave a consent to follow-up with health care professional. The patient does not have an email address to health care professional. The patient provided her personal email. The patient provided contact information to the pharmacy where she received both doses of Shingrix. The reporter consented to follow-up. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR197172:same reporter
Complete body and muscle aches, headache and extreme fatigue. I?ve had this reaction for each of my 3 vaccinations.
Subject BIT010019, a 22 year old female with a medical history of hyperthyroidism, received the 1st dose of Anthrax vaccine (lot FAV038) on 06/17/1999. The pt also received the 1st dose of Rabies vaccine (lot PO989) on the same date. The pt's previous reactions to vaccines are unknown. The pt was taking no concomitant medications at the time of the event. On an unknown date in June 1999 after receiving the immunizations, the pt experienced worsening symptoms of hyperthyroidism that included sweating, increased weight loss, acne, diarrhea, hyperreflexes, and increased hot flashes. In the summer of 2000, the pt also experienced insomnia, vision changes, anxiety, and hand tremors. The outcome of these events is unknown at this time.
some weeks after the vaccine was administered systemic body itching happened. various drs were consulted but the itching is still present to this day although not a severe
Information has been received from a registered nurse (R.N.) concerning a 17 year old female with no pertinent medical history or drug allergies who on 28-JUN-2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot #654535/0960F), on 29-AUG-2007, was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot #654535/0960F) and on 21-DEC-2007, was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL (lot #657621/0387U).  Concomitant therapy included MENACTRA.  In January 2008, the patient complained of numbness, cold hands and feet, joint pain in ankles, knees and wrists.  The patient was seen by a rheumatologist and in April 2008, and she was diagnosed with Raynaud's lupus.  Smith antigen antibodies test indicated positive. SM/RNP antibody was positive.  The patient's Raynaud's lupus persisted.  No product quality complaint was involved.  Raynaud's lupus was considered to be disabling due to numbness and joint pain.  Additional information has been requested.  10/21/08 Reviewed rheumatology outpatient clinic records of 04/02-7/30/2008. FINAL DX: mixed connective tissue disease w/components of both lupus & RA Records reveal patient experienced color changes & numbness of hands/feet in cold weather; progressively worsening joint pain, swelling & stiffness since 1/08; fatigue; weakness; lymphadenopathy of neck, resolved; HA w/photophobia; nausea; weight loss following flu-like illness 1 mo prior; irregular periods on BCP.  Tx w/plaquenil, nsaids, methotrexate & folic acid w/improvement.   9/9/06 Reviewed PCP medical records of 6/28/07-7/10/2008. FINAL DX: Records reveal patient experienced general good health on date of 1st HPV & menactra vaccination.  RTC 10/2/07 w/fatigue, falling asleep inappropriately, runny nose, cough, ear pain & sore throat x 3 days; vomiting & diarrhea week before.  Also complaining of numbness of hands.  Exam revealed tender lymph nodes, reddened throat.  Dx w/viral illness.  RTC 10/19 w/continued c/o of exhaution, fatigued going up stairs, left side abdominal pain intermittently, sweating, occasional HA.  Boyfriend had mono.  RTC 12/21 for final HPV.  C/O spotting few days prior to menses for past several cycles.  RTC 1/25/08 w/pain in hands/feet, discoloration of hands, pins & needles, difficulty opening/closing hands, sweaty palms.  Dx w/probably Raynaud's.  RTC 2/25 for hands turning purple when cold then white & painful.  When warm, hands get red, sweaty & swollen.  Also c/o facial acne.  RTC 3/12 w/sore throat, vomiting, dizziness, HA, runny nose.  Dx w/pharyngitis, probably viral.  RTC 3/18 & 7/10 s/p labs, achy, hands numb in AM, sun sensitive.  Dx w/probable connective tissue/autoimmune disorder.  Encouraged to d/c oral contraceptiives & switch to IUD.  Started on PLAQUENIL & referred to Rheum. Daily pain. Lupus. Rhuematoid arthritis. Aching muscles and bones.
Information was received from a pharmacist, referring to a 69 year old male patient. On 07-JUN-2017, at an unspecified pharmacy, the patient was administered reconstituted ZOSTAVAX vial 19400 PFU, PNEUMOVAX23 and sterile diluent in the right arm for prophylaxis (product use issue). On approximately 12-JUN-2017 (reported as "5 days later"), the patient developed constant pain in the right buttocks that radiated down his right leg and was incapacitated for 2 weeks. The patient remained in constant pain and he was not able to complete his normal daily task or drive his car. The patient was treated by his physician for low back pain/sciatica on 10-JUL-2017 with an oral steroid medication without relief. The pain has worsened since he received treatment. No lab diagnostics or studies was performed. No additional information was provided. The outcome of the events was reported as unrecovered. The reporter considered the events to be significant disability or incapacity.
My nose started bleeding heavily/Seriously bleeding from my nose; I coughed up blood; I got red blotches on my neck yesterday; brusing on my arm and leg for no reason; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6207), via an unspecified route of administration, in right arm on 07Apr2021 at 14:30 (at the age of 58-years-old) as single dose for COVID-19 immunisation. The patient's medical history included asthma and allergies. The patient had known allergies to milk, mold and red dye. Patient was not pregnant at the time of vaccination.  Concomitant medications were not reported. The patient received first dose of BNT162B2 (Lot number: EN6206), administered in right arm, on 17Mar2021 at 02:30PM The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The patient did not receive any other medications within two weeks of vaccination. On 13Apr2021 at 14:00 she coughed up blood, got red blotches on her neck and bruising on her arm and leg for no reason. On 15Apr2021 at 14:00, the patient's nose started bleeding heavily. There was no treatment received for the adverse events. Outcome of the event bleeding nose was recovering and outcome of all other events was recovered.  Follow-up (21Apr2021): This follow-up is being submitted to amend previously reported information. Lot number for second dose was changed to EN6207, updated relevant medial history, adverse event start date and outcome for the event 'bleeding nose'.  No follow-up attempts are needed. No further information is expected.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: After 3-5 min from the shot she was waiving her arms and unresponsive. I then gave her a epipen.  Then a few seconds later she was breathing and talking.  blue lips and labored breathing was noticed. 911 was called and assessed her. father declined taking her to er.
Broke out in itchy hives on 3-10 & seen in clinic.  Given Benadryl & calamine lotion. Increased spreading of rash and itching on 3-12 prompted visit to urgent care clinic.  Rash spread to extremities and trunk.  No difficulty breathing or wheezing.  Started prednisone with taper.  Follow up visit on 3-13 indicated rash/hives were resolving.
Extremely persistent and vivid dreams on a nightly basis similar to those associated with Mefloquine.
sick; This is a spontaneous report from Pfizer-sponsored. A Non-contactable consumer reported that a female patient (Grandmother) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient got very sick and can't make it to second dose appointment.  The outcome of event was unknown.  No follow up attempts are possible; information about lot number/batch number cannot be obtained.