chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 antibody test negative; complained he felt like he had the flu; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a 50-year-old male patient (reporter's husband).   A 50 year old male patient had received second dose of BNT162B2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 13Apr202 as single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient previously took BNT162B2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 23Mar2021as single dose for COVID-19 immunization. On 13Apr2021, the patient had experienced felt like he had the flu, but then in a couple of hours it was gone.  On 03Sept2021, the  patient underwent lab test and procedures which included blood test with unknown result and SARS-CoV-2 antibody test with negative result. The reporter also reported that Comirnaty and the Pfizer-BioNTech COVID-19 Vaccine may not protect everyone. According to the U.S. Centres for Disease Control and Prevention (CDC), if your body develops an immune response to vaccination, which was the goal, you may test positive on some antibody tests. Some antibody tests would only detect antibodies from infection, not from vaccination with the virus that causes COVID-19. The CDC states that antibody testing was not recommended to determine if a person is immune to SARS-CoV-2 (the virus that causes COVID-19) following COVID-19 vaccination because the usefulness of these tests in vaccinated people has not been established. In addition, antibody tests currently authorized under an EUA are not authorized to determine immune responses in vaccinated people. The outcome of the events were recovered.  Investigations: Caller says that for the dates of the antibody tests, her husband and her did not go the same days. The reporter said her husband went and got tested after hers was negative and his were the same tests that she had: SARS CoV 2, IgG NUCLEOCAP, IgM SPIKE, QL as the top one, then indented on the next line it says SARS CoV 2 AB (IgG), NUCLEOCAPSID, QL then SARS CoV 2 AB IGG for specific test with negative next to that, then another title that says negative as well. Caller says that their tests both said negative as well for each result, and her doctor said this morning if one of the two results for the test said positive it would be good, they just did not want both results on the test to say negative. Date for her husband's negative COVID-19 antibody test either not provided or not captured by call handler.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I was having chills and my blood pressure got very low and I had hypotension. The EMT did an EKG and I was sent to the ER because my bp was so low and I was freezing to death and couldn't get warm. I was dizzy and unbalanced. My bp bottomed out to 75/40 at one point.  I was awaiting for a bed to be admitted but by the next morning my bp came up and I was discharged. I followed up with my primary care doctor and he said he thinks it was a reaction from the booster shot.
All 3 vaccines were give less than 1 inch apart per patient and were all able to be covered by 1 band aid. Patient's arm was hot to touch, painful, red/purple, and swollen to the size of a baseball. Patient was advised to apply ice, take Tylenol, and wait a couple of days to allow initial  symptoms to resolve on their own. If it gets worse see PCP.
- Patient was given Covid-19 Bivalent (grey top) Vaccine which was beyond the usage date of 01/11/2023, lot #GJ6738.  Patient has been notified. No adverse effects reported. Reports filed. -  ?Pulled a report of all administered vaccines by lot number and verified those that were administered past the BUD.  - Pulled all vaccines in fridge and placed a ?Do Not Use? sign on them while we completed investigation - Sat with each MA within the clinic going over the following: o Training on administration workflows to include ? entering vaccine information into System prior to administering vaccine, always having a team check which includes verification of vaccine, verification of patients age, timeframe between vaccines, BUD, dosage o BUD versus expiration date versus puncture expiration o Dosage of maroon top, orange top and gray top for monovalent and bivalent o The difference between monovalent and bivalent o Storage instructions o Workflow associated with what to do when clinic receives the vaccine o Training on lot manager and immunization system reconciliation o Training on how to enter information into System when a provider places an order versus immunization clinic - Reached out to Pfizer who is recommending all patients who received an expired vaccine get re-vaccinated due to unknown efficacy - Clinic will reach out to all patients letting them know about the situation and offer to have them come into the clinic free of charge for re-vaccination or to a sister clinic if they prefer?
Cough; Very tired; tested positive 27Jan; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received first dose of bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 22Jan2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 25Jan she started with symptoms. She was told that she could get second shot, but she is hesitant to get it as she still had cough and very tired and just tested negative. She had been unable to get a real answer when she should get it. Her question is should she wait 90 days to get her second shot and will she have to start over or get it now. The patient underwent lab tests which included sars-cov-2 test result as positive on 27Jan2021 and sars-cov-2 test as negative on 23Feb2021. The outcome of the event tested positive was recovered on an unspecified date and cough and very tired was not recovered.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
no aditional AE; freezer underwent an excursion and they did not realize the excursion until later/temperature excursion for VARIVAX and PROQUAD/ VARIVAX and PROQUAD may have been administered to multiple patients; This spontaneous report has been received from a nurse, concerning a 3-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 15-MAY-2023, the reporter's freezer underwent a temperature excursion; in which varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) were stored. On that same day, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W035466 and W017567 with following expiration dates 06-MAY-2024 and 29-NOV-2023, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided).  Other suspect therapies included varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039723 and W031812   with following expirations dates 15-DEC-2023 and 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided) (product storage error and no adverse event).; Sender's Comments:  US-009507513-2306USA004082: US-009507513-2306USA004090: US-009507513-2306USA004086: US-009507513-2306USA004087: US-009507513-2306USA004088: US-009507513-2305USA007959: US-009507513-2306USA004085: US-009507513-2306USA004084: US-009507513-2306USA004083:
Patient later developed PPPD Persistent Postural Perceptual Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: PERSISTENT POSTURAL-PERCEPTUAL DIZZINESS (hospitalization, disability), outcome "unknown", described as "Patient later developed PPPD Persistent Postural Perceptual Dizziness". The event "patient later developed pppd persistent postural perceptual dizziness" required physician office visit and emergency room visit. Clinical course: The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Coarse tremor in right arm primarily in a pronation supination pattern that is intermittent and aggravated with certain movements to include typing, driving, and lifting objects.  Symptoms improving with time.  Patient has tried heat and ice as well as Tylenol and ibuprofen as needed.
Hives, 5 minutes after shots. Benadryl 50mg po STAT.
On the evening of 11/09/00, patient noted that left deltoid began hurting. She reported to the health office on the morning 11/13/00, and area was still hot to the touch and red. Patient states she had fever and blisters on her arm.
Received pneumovax and influenza at 11:40am on Sept 5. By 9pm had sore arm. Next day, awoke with redness spreading over entire deltoid area of 5X5 inches. Also had body aches and red lines running from the injection site. Temperature of 100. Feel awful. Taking Benadryl and going to bed.
VACCINE LEAKED OUT OF SYRINGE AND LEAKED ALL OVER PTS ARM, NEEDLE WAS INSERTED HOWEVER VACCINE LEAKED OUT OF HUB AND NO VACCINE ENTERED INTO PTS ARM AND LEAKED ALL OVER ARM, SYRINGE USED WAS DROPSAFE 3ML 25 G, 1 INCH, MFR HTL-STREFA S.A. LOT 0325250001 8-1-2025, VACCINE WAS IMMEDIATELY READMINISTERED WITH NO ISSUE
This spontaneous report was received from a medical assistant, referring to a 48 year old patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 08-OCT-2018, the patient was vaccinated with PROQUAD (route, dose, frequency, and anatomical location were unknown) with lot # N028446 for prophylaxis. The patient was vaccinated outside the recommended age according to the prescribing information. No adverse effects reported.
Facial paralysis/Bells palsy, left side o Left side, stable from onset two weeks ago by history o See #2 o Discussed potential spontaneous resolution with time o Normal intraocular exam     2. Paralytic lagophthalmos of left upper eyelid  o Secondary to #1 o 1mm lag with lid closure, no improvement with forceful closure.  o No pain or redness noted, but epiphora OS noted.  o Trace PEE seen in clinic, discussed excess tearing a sign of dry eyes o Begin ATs TID with gel lubrication or tape for lid closure at bedtime. o Will continue to monitor.   3. Visual disturbance, left eye o Patient complaining of blurred vision in far periphery of upper temporal quadrant of left eye (1 year duration). Never diagnosed with concussions, but plays hockey and has been hit on the head before. No progression from one year ago. o No retinopathy seen.  o Will do HVF next visit.  o Will continue to monitor.    4. Hyperopia, both eyes o Not amblyogenic o No need for glasses at this time
1-10-18 noted lump, red ring about 3" diameter around site of varicella. Some itching described as "sore itch". No fever. No breathing difficulties. 1-12-18 review site of reaction. Pt. said was fading in color, less sore. Still about 3" diameter.
This spontaneous report as received from a registered nurse refers to a 6 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
Resident complained of shortness of breath and stated that it started early in the morning of the 13th of April.  Pulse ox at time was 94%.  No complaint of chest pain.  Lung sounds were  diminished.  Vital signs were within normal limits.  NP was notified and she advised to continue to monitor.  The resident stated that the SOB subsided and no further issues were noted.
The day following her second injection, she developed axillary adenopathy. Over the next 2 weeks she developed symptoms of headache, nausea, fatigue, frequent urination and dyspnea.
No additional AEs; VARIVAX administered after temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 28-APR-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) after temperature excursion, lot number U022321 and expiration date of 15-JUL-2023 00:00, at a dose of 0.5 milliliter, subcutaneously for prophylaxis (anatomical location was not reported). The vaccine was exposed to a temperature excursion of 6°F with a time frame of 30 minutes. There was no previous temperature excursion. No additional adverse events were reported. There was not product quality complaint involved.
CLIENT HAD TWO DOCUMENTED DOSES OF VARICELLA AND WAS GIVEN A THIRD DOSE-NO ADVERSE REACTION
8 days post vaccine the site became swollen, red, hard, itchy, and warm to the touch
extremely fussy cried cont, site was red & swelled to the size of baseball; temp to 104; MD stated this was a reaction to the DTP;
Rash covering entire back, short of breath. Treated with Benadryl. Rash lasted about 12 hours. Shortness of breath lasted about 24 hours.
A little tired, first vaccine/ only felt a little tired but not too much; Pain on left side of shoulder, intense, first vaccine/ had intense pain on his left side of shoulder; This is a spontaneous report from a contactable consumer, the patient.   A 52-years-old male patient received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 05Mar2021 at 11:00-11:30 (not specified) as dose 1, single (age at the time of vaccination 52 years) for covid-19 immunisation in the left upper shoulder. The patient medical history included prostrate. He also stated he had a history of bronchitis since he was small. The bronchitis was worrisome with bad weather and a month prior there was bad weather and he had the chills. The patient stated his family did not have any medical history to report. Concomitant medication(s) included tamsulosin and finasteride started about a year and a half ago for his prostate. The patient stated with his first vaccine on 05Mar2021 he only had intense pain on his left side of shoulder, it was still there on Saturday and by Sunday the pain was much better. By Monday he was back to normal, only felt a little tired but not too much and he was able to do things on an unspecified date. Tuesday/Wednesday he was fine. The patient did not undergo any lab test. The patient did not take any therapeutic treatment for events. No additional vaccines were administered on same date as of the Pfizer suspect. No other vaccinations were taken within four weeks prior to the first administration date of the suspect vaccine. The patient did not visit emergency room or the physician's office. The outcome of event pain on left side of shoulder was recovered on an unknown date in Mar2021 and event only felt a little tired was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Site: Redness at Injection Site-Medium, Systemic: Chills-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient felt the above sysmtoms after her 1st dose, after the epipen, she felt better. Waited at the store for 30 minutes, felt calm afterwards. No 911 call.
My mother never had a reaction with the 1st shot and after the 2nd shot doing fine Thursday afternoon and Friday. She began having sx Saturday and passed Sunday early morning
Large knot at site of injection - red hot, swollen, sore. Night fevers - general malaise for 4 weeks. Continues to have achy-dull, throbby pain, wakes me out of my sleep. Has never stopped hurting and remains painful to touch.
This spontaneous report as received from a registered nurse refers to a 69 years old male patient. On an unknown date the patient was vaccinated with PNEUMOVAX23, dosing regiment unspecified (lot # L029306, expiry date 23-JUN-2016). On an unknown date the patient experienced redness and swelling localized at the injection site. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was reported as recovering/resolving. The causality assessment was not provided. This is one of the several reports from the same reporter. Additional information has been requested.
Patient had an anaphylactic episode with difficulty breathing and diffuse urticaria. Patient was starting to drip her blood pressure. EPIPEN was administered along with BENADRYL with improvement in symptoms at 15 minutes intervals. Epicutaneous test with undiluted FLULAVAL Intradermal injection 0.02ml of 1:100 dilution.
Patient received vaccine and within 3 minutes experienced a syncopal episode which lasted less than 1 minute. On presentation patient is alert and oriented X 3 stating she feels fine .EMS on site vital signs 123/77, pulse 87, pulse ox 99% room air. Patient placed in Trendelenburg position and PO fluids encouraged. After  20 minutes of observation vitals were 122/74, pulse 80, pulse ox 99% on room air. Patient maintains that she feels no symptoms, denying chest pain, palpitations. She denies any past medical history including cardiac. She agrees to follow up with her PCP if signs or symptoms return.  Patient allowed to leave as a passenger with her mother driving.
Severe muscle pain, headache, nausea, stiffness, fatigue, dizziness. Remained for several hours. Headache, body aches, lasted for several days. Headaches persisted for weeks.
Patient developed body aches, sore throat,  fatigue, and cough after receiving his 3rd dose of covid  vaccine.
arm hot to touch; a big blotchy rash; Itchy; Dizziness; nausea; Muscle aches; CHILLS; FEVER; was a little tired; headache/stronger headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), DIZZINESS (Dizziness), FEELING HOT (arm hot to touch), RASH (a big blotchy rash) and FATIGUE (was a little tired) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Allergic reaction to antibiotics and Tooth extraction on 16-Apr-2021. Concomitant products included AMOXICILLIN, CLINDAMYCIN, VALACYCLOVIR [VALACICLOVIR], IBUPROFEN and TRAMADOL for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (was a little tired) and HEADACHE (headache/stronger headache). On 23-Apr-2021, the patient experienced DIZZINESS (Dizziness), NAUSEA (nausea), MYALGIA (Muscle aches), CHILLS (CHILLS) and PYREXIA (FEVER). On 25-Apr-2021, the patient experienced PRURITUS (Itchy), FEELING HOT (arm hot to touch) and RASH (a big blotchy rash). At the time of the report, PRURITUS (Itchy), FEELING HOT (arm hot to touch), RASH (a big blotchy rash), FATIGUE (was a little tired), HEADACHE (headache/stronger headache) and MYALGIA (Muscle aches) had not resolved and DIZZINESS (Dizziness), NAUSEA (nausea), CHILLS (CHILLS) and PYREXIA (FEVER) outcome was unknown.            The patient treatment data was not provided.   This case was linked to MOD-2021-090293 (Patient Link).
Employee states on 3/2007 noticed 2 small red indented marks to left deltoid area. Denied any pain, swelling or itching to site. State in June 2007 noticed some tissue loss to the area. No on 6/27/07 went to see a dermatologist but no treatment was given. Then on 7/24/07 returned to dermatologist due to continued changes in the tissue and had a skin biopsy done. Employee was then referred to an orth specialist who she saw on 8/1/07 and had an x-ray done. Result was area consistent with selective muscle atrophy secondary to vaccine injection (See notes enclosed from her doctors). She is to follow-up with doctor in 2 months.
P.t has blurry vision, chills, weakness, shortness of breath and elevated blood pressure.
Fever (100F) started evening of 3/12/21 and has continued to this date..  Using Tylenol extra strength.
Received shot in late afternoon, and before bedtime began feeling sick.  Symptoms overnight progressed to chills, fever, bad headache, sore left arm, muscle aches like the flu, very achy and tired, felt so bad not able to sleep.   Symptoms lasted about 24 hours, but took about 2 days to finally feel back to normal.    The first dose of vaccine made me feel achy from first evening for 24 hours like coming down with flu but not severe as second dose.
Approximately 1 week post vax pt developed fever with rhinitis. Three days later the pt experienced approximately 24 fluid filled rash with itch.
soreness in right arm, arthritis pain in right hand aggravated overnight and into the following morning.  Resolved within 24 hours of injection.
MMR Vaccine given as post hematopoietic stem cell transplant vaccine schedule when patient was still receiving chemotherapy. MMR only recommended if patient on observation due to it being a live vaccine.
FATIGUE & DIARRHEA DAY OF VACCINATION AND DIARRHEA CONTINUED THIS DAY (08/01/2012).
I got up in the middle of the night (2:30) to use the bathroom. After using the bathroom I lost sight, hearing, and passed out. I was out for what felt like 5 minutes. Upon waking I began dry heaving. Once I was able to stand I was having body shakes for at least 30 minutes.
Swelling, redness and pain at injection site were present about 5 hours post injection, but less severe than initial vaccination. Fever, headache, and muscle aches began the morning following vaccination, and were even worse than with initial vaccination. Was bedridden for a day, then felt lousy and weak for 2 more days.