chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022 14:36:33; Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022 14:36:33; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022 14:36:33) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022 14:36:33) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.     On 27-Jan-2022 at 2:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Jan-2022 at 2:36 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022 14:36:33). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022 14:36:33). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022 14:36:33) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022 14:36:33) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event.  It was unknown if other vaccines were given on the same day as Moderna COVID-19 Vaccine to the patient.  It was unknown if patient received other vaccines within one month prior to any dose of Moderna COVID-19 Vaccine.  On 27-JAN-2022 14:36:33, the patient received a booster dose (Lot: 066H21A and expiry date 04-APR-2022) of Moderna vaccine.  Reported that patient received Vaccine past its 30-day expiry date, vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021.  No treatment drug information was reported.   This case was linked to MOD-2022-542869 (Patient Link).
Eyelids got very puffy, as did under the eyes, want to shut eyes; Eye pain; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 13Mar2021 at 13:30 (at the age of 43-years-old) and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 13:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety and adrenal insufficiency. The patient did not have any allergies to medications, food, or other products. Concomitant medications included unspecified supplements for adrenal support and bupropion hydrochloride (WELLBUTRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, after first dose of vaccine, the patient felt eyelids got very puffy as it was under the eyes, it was making him want to shut his eyes and patient also had eye pain. On 03Apr2021 at 14:30, after second dose of vaccine, the patient again experienced the same events of puffy eyes and eye pain. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events eyelids got very puffy, as did under the eyes, want to shut eyes and eye pain was resolving at the time of this report.  No follow-up attempts are needed; information about lot number cannot be obtained.
Nausea, vomiting, feeling out of it, body aches, fatigue.
LOSS OF BALANCE; BLURRY CLOUDY VISION; DIZZINESS; This spontaneous report received from a patient concerned a 67 year old female. 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: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced dizziness. On 13-APR-2021, the subject experienced blurry cloudy vision. On 15-APR-2021, the subject experienced loss of balance. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blurry cloudy vision, dizziness and loss of balance was not reported. This report was non-serious.
Pt had cramps in right foot and upper thighs, bilaterally, X several hours.
On the day of my adverse event I was getting my hair cut. I mentioned to my Barber that I was feeling light headed and extremely uncomfortable. I sat up and she had mentioned that she would get me a cold water. As she was coming back I was slouched in the barber chair unconscious. She was yelling "hey" multiple times and eventually I regained consciousness to her tapping my arm. She resumed cutting my hair and within 2 minutes time limit I had became unconscious again. This time convulsing in the barber chair, limbs locked. I was unconscious and convulsing for approximately 10-15 seconds. Once I regained consciousness my barber was mentioning she was going to call an ambulance. I told her not to and to just give me a minute. She escorted me back to my house where I felt extremely tired for the remainder of the day and what felt like not myself. Extremely delayed to reaction, slurring speech and very little energy to even walk or stand up.     Since the vaccination I have had mild memory loss, finding myself loosing track of what I was thinking mid sentence and not being able to recall even what I was talking about. Also daily headaches and fatigue. Everyday I feel as if I am on the urge of passing out. I find myself challenged to even process what I am being told.
metallic taste in mouth beginning approximately 10 days after vaccine and still persisting 10 days later; This is a spontaneous report from a contactable consumer.   A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 12Mar2021 12:45 as single dose for covid-19 immunisation. The patient medical history was not reported. No covid prior vaccination, no covid tested post vaccination. No allergies. Concomitant medication(s) included Diltiazem ER 240mg, Rosuvastatin 10mg, Fortest 50. The patient experienced metallic taste in mouth beginning approximately 10 days after vaccine and still persisting 10 days later on 20Mar2021 with outcome of not recovered with no treatment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Vaccinated with Moderna on 2/6/21 and 3/6/21.  Symptom onset 7/6/21 with cough, loss of smell, headache and fatigue.  Tested positive for Covid-19 on 7/10 2021.
Very swollen upper arm down to elbow. Same area very reddened. Low grade fever. Upset stomach. Lethargic. All symptoms lasted from Wednesday night through Friday night.
A report was received from a health care professional on 08Nov02, concerning a female vaccinee who inadvertently received Fluvirin SC on 07Nov02. On 07Nov02 the vaccinee received 0.5ml Fluvirin SC. No adverse reaction was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment. Cross reference with: PJP-2002-00731, PJP200200729, PJP200200799, PJP200200792, PJP200200791, PJP200200720, PJP200200745, PJP200200690.
12x14 cm induration at the injection site, extending distally. Superficial skin reaction causing blistering and subsequent excoriation of 4 cmx6 cm. Treated with ice, topical cortisone, and oral benadryl x 4 days. Induration resolved by day 4, skin healing still in progress at day 8. Picture available upon request.
Quick onset sx, headaches, "extreme dehydration", dizziness, also developed bronchitis w/in 2 days sx occurred approximately 5 hours after administered vaccines.
Information has been received from a office manager responsible for vaccine storage referring to an unknown number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date(s), the patients were vaccinated with RECOMBIVAX HB 2.5/0.5 (unit not provided) (lot # L048848, 0.5 ml, once, exp. date 09-AUG-2018, data logger) for prophylaxis, following a temperature excursion of 33 to 35F for a total of 25 days. No adverse effects were reported in any patients. Temperature and time frame: 35F for 12 days and 33 to 34F for 13 days. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA002039.
Felt a little bit fluey; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 08:00 (Lot number: EN6204) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mast cell activation syndrome" (ongoing); "Several autoimmune situations" (ongoing), notes: The tissue autoimmune to thyroid, bone, liver and nerve to sheath. Patient has had for many years. There were no concomitant medications. Vaccination history included: Flu vaccine, for Immunization, reaction(s): "little bit fluey"; Rabies booster (the rabies booster was a good 20 years ago), for Immunization, reaction(s): "little bit fluey". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 11Mar2021, outcome "recovered" (12Mar2021), described as "Felt a little bit fluey". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Vaccine was not administered at special Facility. No additional vaccines administered on same date of Pfizer suspect. No other vaccines received within 4 weeks prior to Pfizer vaccine. Patient felt a little bit fluey after receiving first dose Adult Pfizer Vaccine. The patient stated feeling a little bit fluey began on 11Mar2021, the day after receiving the first dose and went away within 24 hours and the caller recovered 100% completely. Investigation Assessment was reported.   Follow-up attempts are completed. No further information is expected.
left knee started becoming swollen; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (left knee started becoming swollen) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (Right knee replacement.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced JOINT SWELLING (left knee started becoming swollen). At the time of the report, JOINT SWELLING (left knee started becoming swollen) outcome was unknown. Few hours after injection, patient's left knee started swelling. Difficult in walking as the joint is swollen. Used ice packs on her knee and took ADVIL and she also elevated her leg by sitting in a recliner. After 3 days, It subsided and can walk now but with a cane.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patients reports using ice packs on her knee and she took ADVIL
Pain left arm when reaching up and across her chest. Painful to the touch, sligh redness. Site is 2 inches down from shoulder. She went to the Dr.
Starting 11 Aug2022, my nose was stuffed up, sore throat and fever it was 99. something. I am fatigued. It lasted for 3 days. I had just came back from a trip and started to get congestion and the fever. I did telehealth on 8/12/22 with the doctor and the doctor asked if I wanted to the anti viral. I indicated that I was feeling better and he said I did not need that,
Face turned red, swelling and very hot to the touch. Redness and swelling in the right arm. These started approximately 21 hours after the shot.  I started taking Benadryl 50mg every 4 hours until the heat and swelling came down. The redness is still apparent, but no more swelling or heat.
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-APR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021826, expiration date: 25-JUN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
syncope; feeling of heat rising into throat; feeling of heat rising into throat; lightheaded; chills; mild pain at injection site; This is a spontaneous report from a contactable pharmacist reported for self. This 67-year-old female patient (no pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 13:45 PM on Arm left via Intramuscular at single dose (Lot # EL9269) for covid-19 immunisation. Medical history included Osteoporosis, known allergies: Sulfa, flu vaccine for immunisation. No COVID prior vaccination. Concomitant medications included alendronate sodium (FOSAMAX), ergocalciferol (VITAMIN D), calcium, magnesium, biotin, bifidobacterium lactis (PROBIOTIC). No other vaccine in four weeks. Past similar reaction from Flu vaccine 8 years ago (2013) for immunisation and treated in ED, had no problems with any other vaccine such as HepB (Hepatitis B), DTAP, pneumococcal 23, Shingrix all for immunization. On 17Feb2021 14:15 PM, feeling of heat rising into throat, then lightheaded- EMT on-site monitored BP, heart, oxygen then administered IV Benadryl and zofran - signed out in 2hr, developed chills and syncope for next 4 days and mild pain at injection site. Self treated with Tylenol/ advised by MD to not get 2nd dose. Events resulted in emergency room/department or urgent care. Treatments were received for the events. Treatment included IV Benadryl and IV Zofran. Outcome of the events was recovering.; Sender's Comments: Based on a temporal association, a causal relationship between the events of feeling of heat rising into throat, lightheaded and syncope, and BNT162B2 cannot be completely 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.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date in 2015, an unspecified number of patients might have been vaccinated with a dose of improperly stored ROTATEQ, route default to oral, lot # L004453, expiration date 27-MAY-2016 (doses, dose numbers not reported). ROTATEQ was improperly exposed to temperatures of 90F for 24 hours on 28-MAY-2015 and 91F for 24 hours on 29-MAY-2015. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Extremely sore arm, could not lift arm without pain, lasted about 48 hours. Also had nausea and a lot of fatigue.
Localized reaction That lasted about 3 days. Then a larger, red, warm and painful area return to week later and is spreading
Information has been received from a physician concerning a 71 year old female with a history of canker sores who on 07-Sep-2007 was vaccinated with Zostavax.  There was no concomitant medication.  On 08-Sep-2007 the patient experienced canker sore.  She sought medical attention.  A culture was taken (results not reported).  She was recovering as of 18-Sep-2007.  Additional information has been requested.
Received vaccine on 4/16/15 by 4/17/15 arm was red, swollen, tender per mom. Seen in office on 4/18/15 - skin pink, induration, covers all of left upper arm - no cellulitis lines - amount of swelling unchanged in 12 hours per mother.
Injection arm sore, body ache, high fever for a day, arm pit lymph node swollen, headache, increased heart beat.  Low fever and headache again after five days, heart not comfortable
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 at 14:00 as dose 1, single (Lot number: ER8133), in left arm and on 24Apr2021 at 14:00 as dose 2, single (Lot number: ES0164) at the age of 46 years, in right arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 06Nov2021 at 18:00 as dose 3 (booster), single (Lot number: 071F2A1), in right arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma - using albuterol and Flovent inhalers. Concomitant medication(s) in 2 weeks included: AIRBORNE, start date: 01Jun2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Apr2022. The patient had any known allergies was reported as none known. The patient was not pregnant at the time of vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Negative, notes: Tested negative twice; (26Sep2022) Negative, notes: Tested negative twice -Second time 3pm Monday 26Sep; (28Sep2022) Positive, notes: Out of sheer curiosity retested on 28Sep and tested strongly positive, again on 29Sep; (29Sep2022) Positive, notes: Out of sheer curiosity retested on 28Sep and tested strongly positive, again on 29Sep; (01Oct2022) Positive, notes: again on 10Oct. Strongly positive on all tests. Therapeutic measures were taken as a result of covid-19. Clinical course: Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, treatment started on 20Sep2022 and stopped on 24Sep2022, Indication: Treatment of COVID-19. It was reported that, completed Paxlovid series on Saturday 24Sep.  No follow-up attempts are possible. No further information is expected.
Lump at injection site, pain with touch and redness; 1 week later  - Lump at injection site with 2in x 2in round with warmness and redness. Has begun to fade since yesterday 01/10/21; lump is not there anymore
Leg jerks. Arm jerks. Whole body shake/tremor. Jerking and shaking events now occur every 6 to 8 days.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days Exp date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2022 at 6:43 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Mar-2022 at 6:43 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     No concomitant medication information was provided. No treatment medication information was provided.