chrisvoncsefalvay/vaers-outcomes huggingface dataset:
almost died; high level of nickel in blood; This serious case was reported by a consumer via call center representative and described the occurrence of near death experience in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   Concurrent medical conditions included nickel allergy.   On an unknown date, the patient received Influenza vaccine. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced near death experience (Verbatim: almost died) (serious criteria GSK medically significant) and blood heavy metal increased (Verbatim: high level of nickel in blood). The outcome of the near death experience was not reported and the outcome of the blood heavy metal increased was unknown.   The reporter considered the near death experience to be related to Influenza vaccine. It was unknown if the reporter considered the blood heavy metal increased to be related to Influenza vaccine.     The company considered the near death experience to be related to Influenza vaccine. It was unknown if the company considered the blood heavy metal increased to be related to Influenza vaccine.   Additional Information: GSK receipt date: 27-JUL-2023 The reporter was the patient. She stated that in the past she almost died because of an unspecified influenza flu shot. She said that the flu shot used was a multi dose product which contained the metal nickel. She said that she had to get the nickel out of her brain and chest because it made her feel like she was dying. She said that blood work was drawn they ran a heavy metal test and her nickel blood level was higher than it should be higher than a factory worker, enough to kill her. It was unclear if she was hospitalized. No further details were reported.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 25-APR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, 0.5 ml lot # L0026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information had been requested.
facial swelling day after vaccine, patient stated she will take benadryl and follow up with primary care md or urgent care if needed
School nurse called mother, told come for child abnormal scratching, whelps, things maybe reaction to varicella - observed very few whelps, no open areas - possible mosquito bite, resolved with using Caladryl.
slightly dizzy; tingling in arms and legs; a bit shaky; Soreness on the spot only if i touch it; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 14:45 (Lot number: en6208) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "low blood pressure (really low)" (unspecified if ongoing), notes: low blood pressure (really low); "mild heart murmur" (unspecified if ongoing), notes: mild heart murmur. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 15Mar2021 16:00, outcome "recovering", described as "slightly dizzy"; PARAESTHESIA (non-serious) with onset 15Mar2021 16:00, outcome "recovering", described as "tingling in arms and legs"; NERVOUSNESS (non-serious) with onset 15Mar2021 16:00, outcome "recovering", described as "a bit shaky"; TENDERNESS (non-serious) with onset 15Feb2021 16:00, outcome "recovering", described as "Soreness on the spot only if i touch it". Therapeutic measures were not taken as a result of dizziness, paraesthesia, nervousness, tenderness.  Additional information: Patient did not receive any other vaccine in four weeks. Patient has taken other medications in past two weeks which include  multivits & herbal supp t-48Hr; muscle relax t-24h. She was not diagnosed with COVID-19 prior to vaccination and was not tested positive post vaccination.  No follow-up attempts are possible. No further information is expected.
PT REPORTED ON 4/12/21 THAT DURING THE 15 MINUTE WAIT SHE WAS EXPERIENCING CHEST PAIN AND ELEVATED HEART RATE.  HER HUSBAND TOLD HER IT WAS HER ANXIETY.  ABOUT TWO HOURS LATER SHE DEVELOPED DIZZINESS AND COLD SWEARS.  SHE IS ALSO EXPERIENCING LYMPH NODE PAIN.
Went to be and was sick all night long. Got up, forced herself to go to work. Left at 2PM, went home and went to bed. Has been in bed ever since.; Has not had anything to eat yet. Had once cracker yesterday. Is trying to eat.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Nov2022 at 14:30 as dose 5 (booster), single (Lot number: GH9697) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 25Sep2022 as dose number unknown, single. Vaccination history included: BNT162b2 (DOSE:1, Pfizer Covid-19 vaccine:, First Dose: 05Feb2021, LOT: EL9264, NDC, EXP: Unknown), administration date: 05Feb2021, when the patient was 79-year-old, for COVID-19 immunization; BNT162b2 (DOSE: 2, Second Dose: 26Feb2021; 1115A, next to date on vaccine card, LOT: EN6203, NDC, EXP: Unknown), administration date: 26Feb2021, when the patient was 79-year-old, for COVID-19 immunization; BNT162b2 (DOSE: 3, Third Dose: 25Sep2021, LOT: FF2589, NDC, EXP: Unknown), administration date: 25Sep2021, when the patient was 79-year-old, for Covid-19 immunization; BNT162b2 (DOSE: 4, Fourth Dose, Booster: 04Apr2022, LOT: FJ6369 , NDC, EXP: Unknown), administration date: 04Apr2022, when the patient was 80-year-old, for Covid-19 immunization. The following information was reported: ILLNESS (non-serious) with onset 09Nov2022, outcome "recovering", described as "Went to be and was sick all night long. Got up, forced herself to go to work. Left at 2PM, went home and went to bed. Has been in bed ever since."; DECREASED APPETITE (non-serious) with onset Nov2022, outcome "recovering", described as "Has not had anything to eat yet. Had once cracker yesterday. Is trying to eat.". Therapeutic measures were taken as a result of illness, decreased appetite: Treatment: Took Tylenol. Additional information: Family Medical History Relevant to Adverse Events (AEs): No. Got flu shot 25Sep2022, was over 4 weeks prior to this last booster shot. Just takes her regular medications. At her age, does not want to be getting Covid. Patient has been in bed ever since and missed work today (at the time of report on 11Nov2022). Has been sick in bed at least 2 days with it. Got all the other 3 and never had this problem.
I had a breakthrough case of Covid-19 I started having a really high fever with a raging headache I didn't have any energy or appetite I was prescribed Paxlovid.
Pain first 9pm on 11/10 then burning, itching, redness, warmth at site. Temperature 100 at 10am 11/11. Used cool compress and took Benadryl in pm of 11/11. States area less red.
Pt recvd 3 doses of Engerix-B & following dose 3 exp inc BP w/no hx of same,vertigo & tachycardia; resolved in 24 hrs;
Patient reporting generalized fatigue and wrist tenderness that started almost immediately after vaccination was received and has yet to resolve as of 2/20/2019.
HCP reporting misuse AE for VAQTA. Caller reported an adult patient received less than the recommended dose on 02/03/2023 and will be revaccinated. No additional details provided. Patient demographics were not provided. No additional AE. No PQC.; No additional AE.; This spontaneous report was received from Consumer and refers to an adult patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, HCP reported misuse AE for VAQTA. Caller reported an adult patient received less than the recommended dose on 03-FEB-2023 and will be revaccinated. No additional details provided. Patient demographics were not provided. No additional AE. No PQC.
This happened 11 years ago but I wasn't aware of this reporting system until now.  I'm looking to get the pfizer covid vaccine tomorrow and am concerned about another potential bad reaction to it, since I don't know which ingredient in the Twinrix vaccine I reacted to. I've asked 2 nurses, 2 pharmacists, 3 doctors, and I've called Moderna and no one can give me a definitive answer regarding how I may react. The reaction I had to the twinrix vaccine, happened on my birthday that year.  My roommate had gotten us tickets, and I was MISERABLE.  The night we were supposed to leave, I started having these bizarre symptoms where my entire body hurt A LOT, it felt like my nerves were being electrified.  I couldn't sit, stand, or lay down without being in extreme, weird, full body pain.  We went ahead, but we had to leave early as I felt like terrible in a way I never had before or since.  It felt like a bad combination of the flu, and being electrocuted.  It went away approximately 2 days later and then I was back to normal.
Patient had complain of feeling fatigued after first shot. Patient still wanted 2nd shot. 2nd shot was administered 8/25. Patient's Wife called on 8/26 to say that patient had a fever of over 102 degrees, and extreme joint pain.
After first dose, just sore arm. After second dose, sore arm within a couple hours. About 8 hours after, started to feel febrile and chilled, which continued through the night. The following day had muscle aches, fatigue, headache, and mildly nauseated (did not vomit, just felt a little sick to my stomach). I started feeling better in the evening, so maybe 36 hours post-inoculation.  Felt completely normal the following day.
Hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030a21a) for COVID-19 vaccination.     Previously administered products included for Shingles: Shingrix (Shingles Vaccine). Past adverse reactions to the above products included No adverse event with Shingrix. Concurrent medical conditions included Asthma since 1996, Hypersensitivity reaction, Allergy to antibiotic (Avelox allergy Facial swelling, lip swelling, eye lid swelling), Overgrowth bacterial since 13-Apr-2013, Hay fever and Hives. Concomitant products included MELATONIN from April 2020 to an unknown date for Sleep problem, VITAMIN D3 from April 2015 to an unknown date for an unknown indication.    On 10-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). The patient was treated with SALBUTAMOL (nasal) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) from 10-Mar-2021 to 13-Mar-2021 for Hypersensitivity reaction, at a dose of UNK, prn. On 13-Mar-2021, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had headache and fatigue for 3 or 4 days.Event was recovered on 26-2021. Patient experienced similar events after second dose.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Of note, the patient's medical history of previous hypersensitivity reactions is a confounding factor that may play a possible contributory role.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: ADR form was received on 17-JUN-2021. Patient's demographics such as race, ethnicity, weight, height was added. Patient's relevant medical history, concomitant medications was updated. Patient was diagnosed with hypersensitivity reaction, so this event was included. Event outcome was updated. It contains significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Of note, the patient's medical history of previous hypersensitivity reactions is a confounding factor that may play a possible contributory role.
Patient rec?d Adult Hepatitis A vaccination. Appropriate questions asked and patient declined issues. Went to front desk to pay, started trembling and appeared in distress. Someone called for a nurse and she with the help of significant other assisted patient to chair with legs up. No fall or further injury occurred at this time. Wheelchair grabbed as patient was diaphoretic, pale, and syncopal, and patient assisted to patient exam table significant other in room.  Vital Signs 0136: BP 98/70, P70. Legs up, ice pack applied, sucker given. Patient declined advanced medical attention at this time  Vital Signs 0150: BP 118/78 P82, O2 99% on Room Air. Patient?s significant other states she has fainted several times in the past, as much as 5+ times in the last few years.  Patient stated further she has a lot of anxiety about shots and that she did not eat today. HIGHLY encouraged patient to have let her medical team know PRIOR to vaccination that she is prone to fainting to protect herself from injury.  Water given. Legs still up.  Vital Signs 0155: Sitting: BP 110/80 P78 O2 99% RA. All color returned to face, patient feeling better.  Vital Signs Approx 0158: Standing BP 112/80. Feeling well, patient wants to leave. Declined advanced care.  Patient left 0200pm with ambulation with significant other to private vehicle. Reinforced need to eat and hydrate, and to let medical staff know prior to vaccinations know she is prone to fainting. Patient declined further workup or any residual adverse symptoms.
@ 5:18pm: Pt called saying that she had the flu shot around 4:30 and thinks that she is having a reaction towards the shot. The back of her mouth feels "weird/fat throat feels scratchy", and she says it started on her L side of her chin. She is not allergic to eggs or prior flu vacc. 5:28PM: MD called Pt back and was told to take some Benadryl and head to the ER.  ER: was given 1 liter of normal saline, IV Benadryl 25mg and Solu-Medrol 125mg IV. Was given Benadryl and some prednisone
Left shoulder pain constant since covid shot j and j shot worsens with overhead and abduction and activities, and sleeping at night.  Improved with Aspercreme.  He has not seen physical therapy. Musculoskeletal:  Shoulder exam: Left inspection: Anterior head carriage no deformity ecchymosis or effusion of the shoulder, no evidence of scapular dyskinesia.  No atrophy of the thenar or hypothenar eminences palpation: No tenderness to palpation over the bony landmarks of the shoulder including AC joint, greater tubercle, or scapula.  No tenderness over the long head of the biceps insertion  AROM/PROM : abduction : Intact, painful at 90 degrees to 180 adduction: Intact external rotation: Intact  internal rotation intact flexion: Intact  extension: Intact Strength: 5 out of 5 strength in deltoid, triceps, biceps, and intrinsic hand strengt.                   Able to oppose thumb (ok sign), thumbs up  Sensation: Intact to the upper extremity Pulses: 2+ radial pulses Special tests: Biceps: Speed's negative, Yergason's negative Impingement: Positive Hawkins Labrum: Negative O'Briens   Rotator cuff: Supraspinatus: Negative empty can for weakness, positive for pain, negative drop arm Subscapularis: Negative belly off/negative Napoleon's/negative pain with resisted internal rotation of the shoulder Infraspinatus/teres minor: Negative pain with resisted external rotation   Shoulder pain:, Chronic began in April 2021.  Left, suspect vaccine related shoulder injury as correlated temporally with Johnson & Johnson vaccine.  Physical exam maneuvers today with pain with empty can, no weakness, positive impingement test with Hawkins.   Plan: X-ray today PT referral Offered CSI injection, versus watchful wait.  Patient would like to hold off on CSI injection and follow-up if symptoms are not improved with PT. We will notify vaccine adverse events reaction system of his symptoms.
Vaccine liquid spilled during the administration; Vaccine liquid spilled during the administration; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine liquid spilled during the administration) and DEVICE CONNECTION ISSUE (Vaccine liquid spilled during the administration) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced UNDERDOSE (Vaccine liquid spilled during the administration) and DEVICE CONNECTION ISSUE (Vaccine liquid spilled during the administration). On 05-May-2021, UNDERDOSE (Vaccine liquid spilled during the administration) and DEVICE CONNECTION ISSUE (Vaccine liquid spilled during the administration) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 80-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date 12th April 2021) for prophylaxis. On 26th October 2018, the patient received the 2nd dose of SHINGRIX. On 27th October 2018, 1 days after receiving SHINGRIX, the patient experienced fever and injection site rash. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the injection site rash was not recovered/not resolved. It was unknown if the reporter considered the fever and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional stated that one day after receiving SHINGRIX, the patient experienced fever and red rash at the injection site. The healthcare professional stated that the patient stated the red rash had not resolved and was getting worse. The reporter did not consent to follow up.
The morning after the first dose, about 12 hours after, I experienced severe chest pain around the heart and shortness of breath. I head difficulty breathing but was able to tell husband that I couldn't breath well and had chest pain. He gave me a low dose aspirin pill, Bayer, and shortly after I was able to regain my breath and the chest pain went away.
pt recvd vax & had sz w/ apnea w/in 15-20 min; went to er for sz control; conts w/ szs;
Blood levels increased; blood sugar levels have increased; blood sugar levels have increased; This is a spontaneous report from contactable male consumer (patient) reported for himself. A male patient of unspecified age received first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Batch/lot number: Not Provided, Expiry date: Not Provided), via an unspecified route on 09Aug2021 as a single dose for covid-19 immunization. Medical history included patient is diabetic and had his leg amputated in Mar. He was in wheelchair because he had his leg amputated about 5 months ago, before receiving the Covid 19 vaccine. Concomitant medications included blood pressure pills, Losartan Potassium for the heart, Metoprolol and acetylsalicylic acid (ASPIRIN EC). Maybe because last week, since Friday, until yesterday he did not take the Metoprolol. He mentioned that the pharmacy ran out of pills. On an unknown date in Aug2021, after taking first dose patient experienced blood levels increased and blood sugar levels have increased a little bit, yesterday. Patient was asking if this is a side effect with the vaccine. The patient underwent lab test and procedure which included blood pressure measurement: unknown, blood level increased in Aug2021. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Received 2nd dose of Varivax on 10/13/00 and then received steroid shot in foot on 10/18/00 by other provider. On 10/15/00, had red papular rash on bilateral forearms X 2 days. Then on 10/21/00, noted erythematous papular rash extending on trunk, upper extremities and face with pruritus X 5-6 days. Treated with Zyrtec 10mg po gd.
called clinic and stated she woke up on 12/24 with numbness to her right lip, cheek and chin.  She is an RN - denies any wheezing, SOB, lightheadedness.   Denies any swelling of lips, tongue or throat;  no trouble swallowing;   Denies any facial drooping or eye  symptoms;   denies any slurred speech Spoke to her on 12/26 an d12/28 and encouraged her to come here to empl health or to ED or to her PCP;   She declined to do so and was working ;   Will followup with her today
Patient reported immediate soreness at site of injection right deltoid, 10/12/08 noted increased soreness, no swelling. Two weeks after getting worse, increased pain,  #7 scale of 1-10. Pain now down elbow. Suggested that she visit her Doctor for evaluation and gave her our number to inform us of the outcome of that visit.
c/o body pain all over, weakness and changes in sensation since second dose of pfizer vaccine in august.
Left deltoid sorness; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Left deltoid sorness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] and IBUPROFEN for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Left deltoid sorness). At the time of the report, VACCINATION SITE PAIN (Left deltoid sorness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported   This case was linked to MOD-2021-201340 (Patient Link).
Significant aches and pains all over my body, tired, loss of appetite, mild nausea.  No fever.  No respiratory problems. Subsided in about 36 hours.  Back to normal in about 48 hours.
I was driving home and I started feeling flush and hot. My lips, nose and cheeks started feeling tingling and numb. My nose tip is still felling numb. I didn't have any fever.