chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suffered damages as they paid for a product that was not effective for its stated purpose.; Suffered damages as they paid for a product that was not effective for its stated purpose.; Information has been received from a lawyer and the patient (pt) regarding a case in litigation involving a female patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.     On or about 23-OCT-2017, the pt received vaccination with a dose of zoster vaccine live (ZOSTAVAX) for the long-term prevention of herpes zoster (or shingles) (strength, route, frequency, lot/batch # and expiration date were not reported).  On an unknown date, the pt suffered damages as it was paid for a product that was not effective (vaccination failure) for its stated purpose; she suffered actual damages, including economic damages, physical pain and suffering and/or other damages (adverse event). The outcome of vaccination failure, adverse event and pain was nor provided.  The reporter considered vaccination failure, and an the unspecified adverse event to be related to Zoster Vaccine Live (ZOSTAVAX).
antibody assay with negative results; This spontaneous case was reported by a physician and describes the occurrence of ANTIBODY TEST NEGATIVE (antibody assay with negative results) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 dosage form. On 16-Feb-2021, the patient experienced ANTIBODY TEST NEGATIVE (antibody assay with negative results). At the time of the report, ANTIBODY TEST NEGATIVE (antibody assay with negative results) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Antibody test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received contains No new information
Immediately after shot tasted a medicine like taste, felt slightly sick to my stomach, and experienced a slight pain in my right temple.  About 8:00 began to feel a slight headache.  Woke up feeling pain at the injection site, but nothing else.  Was walking out of one room and began to feel very dizzy, steadied myself and began to walk feeling dizzy again.  Had to quick episodes after that.  Some stomach irritation.  But went away once my dizziness stopped.
This spontaneous report as received from a physician via company representative refers to a 16 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date (reported as when she was 15 year old), the patient was vaccinated with a dose of GARDASIL 0.5 ml (lot#, exp. date and route were not reported). Subsequently, on unknown dates, she received the second and the third dose of GARDASIL 0.5 ml (lot#, exp. date and route were not reported). On an unknown date, approximately June 2015 (also reported as Summer of 2016), after the patient completed her GARDASIL series (vaccinated 3 times), the doctor found cervical cancer cells in the patient's uterus. All the cancer treatment's were provided. The outcome of the patient event was not reported. The relatedness between vaccination with GARDASIL and the patient event was not reported. The reporter considered the patient's event as cancer. Upon internal review, this adverse event was considered medically significant. Additional information has been requested.
no AE; a temperature excursion involving VARIVAX (...) the VARIVAX was administered; This spontaneous report was received from a registered nurse and refers to patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On 22-FEB-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (lot # T021821, expiration date: 25-JUN-2022) (route of administration was not reported) for prophylaxis. Administered doses of vaccine experienced the temperature excursion of -7.4 degrees Celsius for 3 hours and 54 minutes. The event was reported due to digital data logger. There were not previous temperature excursions. There was no product to retrieve and no other adverse events (AEs) reported.; Sender's Comments:  US-009507513-2102USA008721: US-009507513-2102USA008774: US-009507513-2102USA008793: US-009507513-2102USA008814: US-009507513-2102USA009013:
01/19/22 presents to ED for "hypoxia" "COVID concern" "no significant"
12/7/22 - Started late morning, Noonish -  with a very sore throat, just raw, lots of post nasal drip, muscle and joint inflammation,  Became progressively worse during the day.  Started taking a decongestant; Ibuprofen.  All symptoms progressively worse throughout the day.   12/8-10/22 -- had a low grade fever,  Bad cough started.  All above symptoms much worse, hitting bottom on 12/10/22.  Added Robitsum cough syrup, throat lozenges, Tea with honey, chicken soup.  All helped 12/9/22 spoke with Dr's office to review symptoms; action plan if I got worse.  the NP I spoke with did not think I was sick enough to go to the hospital.  We reviewed the "flags" and reviewed the two hospitals near me. So I had an action plan if things worsened over the weekend.    While I was really sick -- I would describe it as 7 -10 days like a severe bronchitis or walking pneumonia.   by way of comparison, In 11/2019 I had a severe case of a viral bronchitis which made the rounds.  I was sick for 6-8 weeks. This was as bad as that -- Only this time I have had a bad cough.  I got better the week of the 13th.  Today is the 27th, and I still have a cough, fatigue and some inflammation.  I tend to have malabsorption issues with the IBS.  So I have upped my Vitamins particularly D and E.   When I'm low on Vitamin E, I get bleeding around my finger nailbed cuticles.  I can sense this on-coming and take Vitamin E and in an hour it starts to subside (I have had it for years.)  With Covid I have had to take Vitamin E twice a day to address.  So either the Malabsorption is worse with Covid or it just blows through the Vitamin E.   The recovery is on going still have a cough and inflammation.  every day is a bit better.
This spontaneous report was received from a healthcare worker and refers to an unknown number of patients of unknown age and gender. On an unknown date, an unspecified amount of doses of PROQUAD (Merck) (dose, route, lot numbers and expiration dates were not provided), that underwent a temperature excursion, were administered to an unspecified amount of patients. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: GJ6796), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Patient received Paxlovid treatment for COVID 19 from 15May2023 to 19May2023, patient received other medication in 2weeks product Nyquil, Tylenol, probiotics, ester C, vitamin D, Patient did not have Known allergies.  No follow-up attempts are possible. No further information is expected.
approx 7-10day p/vax pt began to exp migratory arthritis & arthralgias;s/s slowly improved w/anti-inflam over time;
Pt. was super anxious about vaccines and was crying after her 3rd (HPV). She started sweating (1 min) and looked pale and crying louder/moaning. C/O stomach ache and wanting to vomit. I had pt rest on my shoulder and gave her water and took her shirt off. Brought some cool compresses. Took BP 2 times. Had pt wait in office x 30 min. We were so worried that we forgot to give FLUMIST. Pt r/s appt OTP for 11/26/13.
Employee received the vaccine 12/31/2020 and on 01/09 she said the skin on her hands and feet began sloughing off. It is painful, burns, stings and has a tingling type feeling. She has not changed medications, no new laundry soaps, she believes the only change has been the COVID vaccine. She also explained what she described as "electricity" the afternoon following the injection. She said the best way to describe it was the sensation as if she put her tongue on a battery however much more intense and throughout her whole body.  She has had extreme fatigue as well as body aches as well.
Narrative: COVID infection following COVID vaccine series 5/01 Janssen, dose #1 (non agency) 08/22 COVID swab, result: detected 08/22 CXR impression: Streaky right basilar opacity may be due to atelectasis versus early infiltrate. Please note a viral pneumonia may not have significant radiographic findings. Clinical correlation is recommended. 08/22 pt admit to medicine cc: Cough, lethargic dx: COVID-19 Pneumonia LOS: 2 days 08/22 pt cc: cough, dyspnea exposure: unknown 08/22 SARS-COV-2 Variant Sequencing result: pending 08/23 troponin i result: <0.016 08/23 DDIMER result: 0.39 08/23 procalcitonin result: 0.07 08/24 FIBRINOGEN result: 440 08/24 DDIMER result: 0.30 08/24 ESR result 26 08/24 SARS-COV-2 Variant Sequencing result: pending 08/24 SARS-COV-2 IGG result; 0.01 08/25 FIBRINOGEN result: 469 08/25 DDIMER result: 0.37 08/25 ESR 11
Temp elevation-pt unsure how high; sore red swollen arm from shoulders to elbow; dizziness, vomiting, weakness; Seen by MD arm sore 3-4 days other acute sx gone in 2 days;
Swollen lymph nodes (throat) - most apparent on day 3 after vaccine. Fatigue, unable to fall asleep.
Patient was admitted for worsening respiratory failure and respiratory distress.  Does have COPD and chronically wears 2-4 L nasal cannula at baseline.  Did test positive for COVID-19  Chest x-ray did not show acute intrathoracic process but did show significant emphysematous changes.  At most required 3 L nasal cannula to maintain oxygenation.  Had significant pan expiratory and inspiratory wheezes. Received remdesivir and Solu-Medrol. Also received bronchodilator therapy.  Had drastic improvement in her wheezing and her shortness of breath.  Weaned to her baseline oxygenation of 2 L nasal cannula.  COPD Exacerbation in addition to COVID.  Discharged home 2/2/22. Previously vacc: Pfizer 3/18/21, 4/8/21, 12/20/21
headache chest pressure severe headaches face pain jaw pain neck pain abdomen pain nausea fatigue all over aching
had a pigment discoloration on her forehead and hairline; red splotches all over her body; low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team.   A 56-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 56 years 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 immunization. The following information was reported: PIGMENTATION DISORDER (non-serious), outcome "unknown", described as "had a pigment discoloration on her forehead and hairline"; RASH MACULAR (non-serious), outcome "recovered" (2021), described as "red splotches all over her body"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever".  Additional information: She had the second dose of the Pfizer-BioNTech COVID-19 Vaccine and had a pigment discoloration on her forehead and hairline. She is asking if anyone has reported this and when it could return to normal. The Lot number and expiry dates were not provided. Onset dates for all the events were unspecified. Caller stated that after the second shot, she had red splotches all over her body, and a low-grade fever. Caller stated after the splotches went away, she had pigment discoloration around her forehead, near her hairline. Caller asks, is that a normal effect, and will she get the pigment color back? Caller agreed to be transferred to Medical Information. Caller declined to complete a safety report at this time. Caller stated that she would like to know when her pigmentation will return, and if anyone else has reported pigment discoloration? Investigation Assessment was not provided.  Follow-up attempts completed. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of numbness of upper extremities in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced numbness of upper extremities, tingling of extremity, injection site erythema and injection site pain. On an unknown date, the outcome of the numbness of upper extremities, tingling of extremity, injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the numbness of upper extremities, tingling of extremity, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in an unknown arm and experienced injection site pain and redness but it was accompanied by the numbness or tingling. The pharmacist was looking in the package insert and he was not able to find if there was a percentage of patients who experienced numbness or tingling in the injection arm.
loss of strength and muscle size in entire left arm and shoulder to point where he could not lift anything overhead.  Numbness.  Parsonage-Turner syndrome
developed a fever and tested positive for covid on binax rapid antigen test 12/3/2022
Received vaccine on 01/12/2021 at 1530 - woke up at 0330 01/13/21 with chills, body aches, headache, nausea, dizziness. This lasted for 48 hours.
Delayed anaphylaxis. Patient reported trouble breathing, throat closing 5 hrs after vaccination. No local rxn - no rash?
Patient woke up with nausea, vomiting, and a headache this morning. OTC treatment, not see by physician.
Body Aches, Extreme Fatigue, Night Sweats, Fever, Headache
Pt. had syncopal event immediately S/P vaccine administration. Pt. became very pale and hypotensive. Pt. given fluids and fully recovered.
Child became aggressive, uncontrollable, extended temper tantrum, changed personality, trouble sleeping, waking up during sleep and cries.
This spontaneous report as received from a consumer refers to a male patient of unknown age. On 09-NOV-2017 the patient was vaccinated with ZOSTAVAX, subcutaneous for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown). On an unknown date the patient experienced feeling abnormal. The outcome of feeling abnormal is unknown.
CHILD UNDERAGED FOR VACCINE. DOB REPORTED INCORRECTLY ON CONSENT BUT DOB IS DIFFERENT.  CHILD RECEIVED SECOND PFIZER DOSE AS WELL ON 8/20/2021 (LOT#EW0177.)
On 2-20-21, nine days after vaccination, there appeared a "hot pink" blotch on my left arm about an inch below the injection site.  It was not swollen or painful but was a little warm.  I called the on-call doctor who suggested cold compresses and wait to see if any other changes.  By Monday 2/22/21 it appeared less red but still warm and no change in shape.  continue to monitor.  Called doctor's office to report same.  (My doctor on leave)
Tinnitus that started the same day or next day after the vaccine was given and continued for two weeks.
Patient reported having small rash and swelling at vaccination site. Started the day after getting the vaccine and lasted for a few days. Slightly painful to touch and was also "hard." Went away on its own after a few days.
69 yo male who presents to urgent care with redness, swelling, throbbing and mild pruritus at the left arm that began 1/9/16. Patient received PREVNAR 13 vaccination on 1/8 in left deltoid. He notes a HA and malaise developed that night. He notes fever of 101.5 F on 1/9 and 100 F on 1/10. He endorsed a sore throat 1/14 and was seen by a family medicine practitioner. At visit, he endorsed self medicating with CIPRO left over from a previous infection, BENADRYL and hydrocortisone cream with mild relief. After several doses of abx, he noted a reduction of redness and swelling. Headache, fever, skin rash, rash, urticaria pruritus and cellulitis. Cephalexin 500 mg QID, diphenhydramine 25 mg prn.
I have had pain electric shocks from my spine. Burning all across my back lighting shocks. They last 10 seconds.
pain in her right arm at the time of injection and has continued to hurt since the injection.  she discribed a throbbing pain and could not put pressure on arm.  it hurts constantly and will get worse when her arm is in use.  she says it has gotten better but it has not resolved completely as of yet.   she has been taking a lot of motrin in order to control the pain.  she has been in contact with her doctor and may be getting a steroid script soon.
Facial numbness    30 min  post  1st dose of  Moderna  COVID vaccine .  This sensation still present but can migrate on the face  and less prominent now . Predominantly on the left side now
Urticaria all over his body except than chest, belly and back; Urticaria all over his body except than chest, belly and back; This spontaneous report was received from the patient's grandmother referring to her grandson, a 4-month old male patient. The patient had none concomitant medication, pertinent medical history or drug reaction/allergies.  On 13-JUN-2019, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R034878 (expiration date: 11-SEP-2020), orally, for prophylaxis.       On 14-JUN-2019, the patient experienced urticaria all over his body except than chest, belly and back. The patient was taken to the local emergency room on that same date, where the patient was administered unspecified steroids (no laboratory diagnostics were performed). Then, the urticaria subsided on that same date, but the symptoms reappeared on 15-JUN-2019. The patient was again taken to the local emergency room on that same date. It was mentioned that the patient did not experience any adverse events with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  At the time of the report, the vaccination with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was discontinued on 14-JUN-2019. The outcome of the second urticaria episode was not reported. No causality assessment was provided.
Sore muscle near injection site. Evening of day of shot.  Difficulty sleeping. Tenderness / soreness continued to third day.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/3/2021, 2/24/2021, and 11/17/2021. Patient tested positive at nursing home on 1/13/2022. Presented to ED on 1/20/22 for abdominal pain and hypoxia. Admitted for septic shock, acute respiratory failure, and renal failure. Received oxygen supplementation, dexamethasone, antibiotics, and pressors. On 1/21/2021, patient requested comfort care. Family in agreement. Expired 1/21/2022 at 1255.
Information has been received from a registered nurse concerning an 11 year old female student with no allergies and no past medical history who on 8/30/96 was vaccinated SC with a first dose of varicella virus vaccine live (lot # 617260/0563D). There was no known illness at the time of vaccination. On 4/16/04, the patient developed a mild/moderate case of varicella. Unspecified medical attention was sought. The patient was diagnosed with a chicken pox rash with fifty plus lesions. Laboratory tests were not performed. Subsequently, the patient recovered. A product quality complaint was not involved. Additional information is not expected.
This is a spontaneous report from a contactable patient reported for herself. A female patient received PREVNAR 13 at 0.5ml single dose for immunization on an unknown date in around 2011. The patient medical history and concomitant medications are unknown. On unknown date around Dec2013 the patient experienced pneumonia. The outcome of the event was reported as recovered.
Mother reports that when the child woke on 04/11/2002, the left arm had a purple spot about the size of a pencil eraser at the site of injection and a red ring around it. Today 04/11/2002, the arm is red approximately 3 inches below the site of injection warm to touch. No fever or other symptoms.
Felt dizzy and like she would pass out  Felt faint and nauseous and very sweaty.  MOM noted she was obviously sweating and left wet marks from her arms on the table  Did have a syncope episode
Sore arm; This is a spontaneous report from a contactable female consumer (patient) via Pfizer-sponsored Program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 29Jan2021 as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included formoterol fumarate, mometasone furoate (DULERA), montelukast and fluticasone propionate (FLONASE, formulation: nasal spray). It was reported that the patient received vaccine last Friday on 29Jan2021, she is on immunosuppressants and antihistamines, 2 steroids nasal spray fluticasone (FLONASE), DULERA inhaler and Montelukast. She is now wondering if using this will interfere with the efficacy of the vaccine. She did have sore arm on an unspecified date after the vaccine. She is asking how long will side effects last. She also wants to know how long until these medications are cleared from her system. The patient wants to know if the side effects stop after 7 days. The outcome of the event was unknown.  Information on lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Extreme fatigue, head ache, heart racing, dizziness. Still happening 8 days later
Patient was seen 48 hours after vaccine given. His right thigh had a severe local reaction with induration and erythema 9cmx12cm. Leg circumference 3cm bigger than left leg. Patient admitted to hospital for IV antibiotics and for cellulitis for 24 hours. Oxacillin for 9 days and PO Keflex.
Patient in to this office on 10/27/2011 to report problem. Patient complains of inability to lift right arm over head or to shoulder height without severe pain described as "deep muscle ache" since receiving flu vaccine. Patient also complains of pain when rolling onto arm. Patient reports seeing primary care physician regarding arm pain. Patient states "He said I should talk to you about it since I got the shot here". No redness, warmth, hardness, induration, or swelling noted to injection site of right deltoid; patient denies pain to the touch.
Severe pulmonary hypertension; pneumonia; Guillain-Barre syndrome; CRPS; Severe neuropathy; asthma.