chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Autoimmune hives were triggered  after 2nd shot and had hives all over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Autoimmune hives were triggered  after 2nd shot and had hives all over the body) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced URTICARIA (Autoimmune hives were triggered  after 2nd shot and had hives all over the body). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; LORATADINE (CLARITIN [LORATADINE]) for Adverse event, at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency; CORTISONE for Adverse event, at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and MENTHOL, ZINC OXIDE (GOLD BOND) for Adverse event, at an unspecified dose and frequency. On 30-Oct-2021, URTICARIA (Autoimmune hives were triggered  after 2nd shot and had hives all over the body) had resolved.            She did not have side effects after the first shot.  Hives lasted 6 months. The Doctor prescribed the treatment medications including Antihistamines. No concomitant medication was provided by the reporter.   This case was linked to MOD-2021-414616 (Patient Link).
Pt became diaphoretic and stumbled to floor, never lost consciousness. Bp 70/50 able to sit up after being prone for 5". left clinic accompanied by mother.
Woke up between 5:30 and 6 am feeling more nauseous than the night before, chills and aches. Stood up to take my temperature and almost fainted (had to sit back down on bed, my ears were ringing and vision was grayed out, I may have been unconscious for a second or two). I was sweating and shaking from that, and went to the toilet and threw up a little bit. Dizziness/faintness persisted when standing until around 9 am.
On November 7, 2015 I woke up with puffy eyelids, blurred vision and extreme photosensitivity.  I was also very tired.  I was evaluated by my doctor who was unsure if the Prevnar 13 vaccine was the reason for the symptoms.  He ordered labwork which essentially was normal.  He placed me on cortisone/antibiotic eyedrops as well as a Cortisone taper dose for 9 days.  I saw my optometrist for an eye check to see if he could determine the cause for the light sensitivity; he said my exam had not changed from August but thought there may be something systemic as the cause.  On November 30 I again saw my family doctor who referred me to my ophthalmologist.  I saw him on Dec. 7 and he said I had dry eyes and put me on drops.  I had never had dry eyes prior to this event.  Symptoms persisted so my doctor ordered an MRI of my brain which did not reveal any abnormality.  I am told I may have Sjogren's syndrome and it will take time for symptoms to improve. My activities of daily living are very impacted.  I know time has passed since the vaccine but I feel there is a direct correlation to the Prevnar 13 vaccine.
This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 24-APR-2017, the patient was intramuscularly vaccinated with an expired dose of GARDASIL Injection (dose, frequency and route were not reported) lot # K010574 with expiration date of 08-APR-2017, for prophylaxis. No adverse effects were reported. Additional information has been requested.
This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, the patient experienced COVID-19. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive for COVID. Clinical outcome of the event COVID-19 was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Said he felt like his heart was "surrounded by needles" and every time it beat, it caused him a sharp pain. He said he had to lay down on his back for several hours, felt light headed if he tried to get up, and was in great pain with each beat of his heart for multiple hours continuously.  He refused to go to the Dr. to have his heart checked, he did not want to know if there was a problem and felt the Dr. "would not be able to do anything" if he was experiencing a side-effect from the vaccination.
This spontaneous report was received from a health professional refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 10-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L026741, expiry date: 18-MAY-2017). The temperature excursion details were reported as follows: temperature 0.6 degree C, time frame 30 hours, 20 minutes. COMVAX and GARDASIL appeared on the product list since they were involved in the excursion, however no improperly stored doses of these vaccines were administered. No adverse effect was reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
Noticed a couple days after receiving the second dose vaccine, arm that received the second dose in, couldn't sleep on the arm anymore/the arm gave the caller a lot of pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 (Lot number: EN6205) at the age of 65 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose: 17MAR2021,Lot: EN6206, Route of administration: top left hand arm), administration date: 17Mar2021, when the patient was 64 years old, for covid 19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Apr2021, outcome "not recovered", described as "Noticed a couple days after receiving the second dose vaccine, arm that received the second dose in, couldn't sleep on the arm anymore/the arm gave the caller a lot of pain".  Additional information: It was noticed a couple days after receiving the second dose Pfizer Covid Vaccine her arm that she received the second dose in, couldn't sleep on the arm anymore. States the arm gave the caller a lot of pain. It was thought she would let it go and it was now 4 months later and yesterday morning, 18Aug2021, the caller must have laid on that arm in the night, states it was like having a low tolerance tooth ache. Clarifies the arm pain was like having a low tolerance tooth ache in relation to pain. It was hoping the arm pain would go away. Yesterday morning, 16Aug2021, the arm pain was worse. Before it was just a little pain. 16Aug2021, it was like knowing you have a tooth ache pain. Clarifies the arm pain was like knowing you have a tooth ache in relation to pain. Patient was not visited any Emergency Room or Physician Office. Patient had not any other adverse event prior vaccinations.  No follow-up attempts are possible. No further information is expected.
First dose was given on 16-SEP-2022, 2nd dose not administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 16th September 2022).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: First dose was given on 16-SEP-2022, 2nd dose not administered). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-APR-2023 The reporter reported that the patient was late for the second dose of Shingrix vaccine which was not administered yet. The reporter stated the lot number of first dose was unknown. Till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
NONE Told must report as Hep A #2 given too early.  Hep A #1 given 3/3/08.  Hep A #2 given 4/2508 - no adverse events.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   The nurse reported that, on 28-JUL-2016, the patient received an improperly stored VARIVAX (Lot #: M008171; Expiration date: 16-FEB-2018) for prophylaxis (Dose, route and anatomical location were not reported). No adverse effects reported. Temperature/Time frame: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 46 hours 10 minutes (worst case) Previous temperature excursion:   >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 133 hours and 30 minutes (worst case) The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA005376:
Joint pain, continuos and throughout the body. No treatment has been effective. Per 1 year follow up: Pt did not recover. No change in symptoms.
Rash with itching, pain, burning on palms of both hands ,fingers,and between toes.  Treatment was a steroid shot .followed 5 days later by a steroid pack of pills and a steroid cream.  Total time of rash was  11 days.
symptoms like she had when she had corona itself; arm was really sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm was really sore) and VACCINATION COMPLICATION (symptoms like she had when she had corona itself) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included 2019 novel coronavirus infection in December 2020.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was really sore). On 16-Jan-2021, the patient experienced VACCINATION COMPLICATION (symptoms like she had when she had corona itself). At the time of the report, PAIN IN EXTREMITY (arm was really sore) and VACCINATION COMPLICATION (symptoms like she had when she had corona itself) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. In 2015 (also reported as multiple unspecified dates ranging from 01-OCT-2015 through 03-NOV-2015) the patients were vaccinated with improperly stored multiple unspecified doses of (Oka/Merck) VARIVAX 017145; expiry: 13-MAY-2017, L006383; expiry: 25-FEB-2017 (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
I received the current flu vaccine that Pharmacy was administering on 1/3/19. Within 5 to 10 minutes while I was in my vehicle in the parking lot, I began to get sharp acute jolting pain emanating from my lower back and moving upward and around to my chest. The pain was a number 9 on a scale of 10 being the most severe. The jolting pain would come almost every 3 seconds. It was so severe I was moments from calling 911 for assistance. In about 12 to 15 minutes, the pain began to minimize. I then drove home where I immediately began to feel extremely cold to the point of uncontrollable shivers. I also began to develop a severe headache along with body aches and fever that lasted through the day and through the night. By 7:00 am the next morning the conditions began to subside. Two year ago I experienced the same flu conditions that lasted 3 days. I am clearly allergic to something in the injection cocktail.
Information has been received from a nurse concerning a 19 year old female who on an unspecified date was vaccinated with a first dose of Gardasil (lot # 653938/0954F).  On an unspecified date the patient was vaccinated with a second dose of Gardasil (lot # 655617/1447F).  On 12-JUL-2007 the patient was vaccinated IM with a third dose of Gardasil (lot # 658100/0525U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 12-JUL-2007 the patient experienced a fever of 102 F and chills.  Unspecified medical attention was sought.  On an unspecified date, the patient recovered from fever and chills.  Additional information has been requested.
shingles; Information has been received from a lawyer referring to an elderly patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 28-JAN-2013 (at 68 years old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider at a healthcare facility for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of the event was unknown.
Paresthesia bilaterally of arms/hands and legs- very intense and persisted for several days, prevented normal sleep. He has no prior such reaction to annual flu vaccine.  Reval on 10/20/21 and he reported symptoms had stopped. Please note:  He had Moderna Covid 19 vaccine 2 shot series completed 5/18/21 without incident/adverse reaction.
occasional diarrhea; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (051529).  A 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN , MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "occasional diarrhea".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Squishy lump on collarbone; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 12Apr2021 at 14:30 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies. The patient did not receive any concomitant medication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 06:30, the patient experienced squishy lump on collarbone. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of these events.  The clinical outcome of the event squishy lump on collarbone was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient had redness and itching with possible swelling on upper left arm. Redness extended a good 6 inches down arm. Patient states redness started on 2/6/18 but continued to get worse when she reported to pharmacy on 2/9/18. Instructed patient to take BENADRYL and contact prescriber to evaluate reaction and further treatment.
1) Sore arm that went up into my shoulder blade  2) Chills 3) Fever  4) Headache 5) Pain in joints & jaw 6) Exhaustion 7) Red face  8) Simply don?t feel good at all  This this Monday 4/5/21... the symptoms lasted all weekend. This morning the pain in arm and joints has gone down but is still there; this is the first morning I woke without a fever  but low grade fever returned this afternoon as did the redness in my face & headaches.
NUMBNESS IN HAND AND ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced numbness in hand and arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in hand and arm. This report was non-serious.
8/18/21 diagnosed positive for COVID; received monoclonal antibody infusion on 8/23/21; seen in ED with increasing SOB and cough; on 5L O2 via NC in ED; pt's condition worsened over next few days and required intubation; condition  deteriorated and pt died in the hospital
I had nerve pain down my left arm; Injection site pain; Face numbness; I also still have a headache that has not gone away 3 days later.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on an unknown date in Jul2021 at 19:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included mild cerebral palsy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/norgestimate (SPRINTEC) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received cefaclor (CECLOR) for an unknown indication on an unknown date and experienced drug allergy. On 29Jul2021 at 00:00, after first dose, the patient experienced nerve pain down her left arm, injection site pain, face numbness and also still had a headache that had not gone away 3 days later. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nerve pain down her left arm, injection site pain, face numbness and also still had a headache that had not gone away 3 days later was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Acute macular neuroretinopathy; This is a literature report for the following literature source(s): "Acute macular neuroretinopathy following Pfizer-BioNTech COVID-19 vaccination", Journal of Ophthalmology Case Reports, 21; Vol:24, DOI:10.1016/j.ajoc.2021.101200.  A 20 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "vaginal ring" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Etonogestrel/ethinyl estradiol for birth control, notes: only significant for use of etonogestrel/ethinyl estradiol 0.12-0.015 mg/24 hr vaginal ring for birth control. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: ACUTE MACULAR NEURORETINOPATHY (hospitalization, medically significant), outcome "recovered", described as "Acute macular neuroretinopathy". The event "acute macular neuroretinopathy" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: fundoscopy: unrevealing; unrevealing, with no hemorrhages, retinal vascular, notes: sheathing, retinal or choroidal lesions, and normal appearance of the optic nerve head; revealed hyporeflective foci typical for acute, notes: macular neuroretinopathy (AMN); intraocular pressure test: physiologic; ophthalmological examination: there was no relative afferent pupillary defect or, notes: dyschromatopsia; both eyes were white and quiet and there was no, notes: evidence of anterior chamber or vitreous inflammation; optical coherence tomography: demonstrated corresponding parafoveal foci of, notes: outer nuclear layer hyperreflectivity with granularity of the underlying ellipsoid (There are triangular dark lesions in the superior macula with corresponding bilateral focal ellipsoid zone loss worse in the right eye.); slit-lamp examination: unrevealing; visual acuity tests: 20/20, notes: in both eyes; remained 20/20, notes: in both eyes; visual field tests: confirmed the presence of bilateral paracentral, notes: scotomata; showed stable bilateral paracentral scotomata. Therapeutic measures were taken as a result of acute macular neuroretinopathy.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of event Acute macular neuro-retinopathy cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.