chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Knocked him out; when someone was talking to him about something he could not remember what they were talking about; messing with his head so bad/ wiped him out mentally; takes away his ability to concentrate; He will need to sleep it off over the weekend; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "takes away his ability to concentrate", "Knocked him out", "When someone was talking to him about something he could not remember what they were talking about", "messing with his head so bad/ wiped him out mentally", "He will need to sleep it off over the weekend"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "takes away his ability to concentrate", "Knocked him out", "when someone was talking to him about something he could not remember what they were talking about", "messing with his head so bad/ wiped him out mentally", "He will need to sleep it off over the weekend". The following information was reported: SOMNOLENCE (non-serious) with onset 2022, outcome "unknown", described as "He will need to sleep it off over the weekend"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "Knocked him out"; MENTAL DISORDER (non-serious) with onset 2022, outcome "unknown", described as "messing with his head so bad/ wiped him out mentally"; DISTURBANCE IN ATTENTION (non-serious) with onset 2022, outcome "unknown", described as "takes away his ability to concentrate"; MEMORY IMPAIRMENT (non-serious) with onset 2022, outcome "unknown", described as "when someone was talking to him about something he could not remember what they were talking about".  Additional information: The First year the vaccines came out (2021), he works at a level 1 trauma center. The first dose knocked him out and stated that he had to go home from work. When he got the first shot, a hour afterward he said that when someone was talking to him about something he could not remember what they were talking about. He had the same problem with the second dose. Last year (2022) booster wiped him out mentally. It takes away his ability to concentrate. These vaccines are messing with his head so bad. It wipes out his ability to concentrate. It seems to only be happening to him. He said that 4 for 4  of his doses have had exact same thing. He will need to sleep it off over the weekend.    The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300355612 same patient/drug/AEs and different dose;
On 8/13/12 patient receive 2 vaccinations, GARDASIL in right deltoid at 4:30 pm. Increasing edema redness & pain developed 24 hours after. Returned to MD off 8/15/12 am. Size of swelling - 13 x 14 cms with redness/spots. Tx cool compresses and BENADRYL. Visit 8/17/12 - improved redness/edema now 7 x 8 cms.
Issues three days after dose one regarding heart racing. After dose two in April, chest pain, heart racing and falling. Two abnormal EKGs and a cardiac halo monitor. Scheduled for echocardiogram in Aug. Heart rate dropped and increased, dizziness, extreme fatigue, thirst, mental fog and cognitive issues.
Pain radiating down the arm. Still hasn't subsided as of today. Patient stated that it became sore the day after receiving the shot. He took a steroid dose pack the week after getting the shot and it did not provide any relief.
pt recvd 2 doses of vax & lab eval 6-7wks post vax revealed 11 neg titers & 6 equivocal titers;1 of the pt devel lesions;the nurse reported another pt who also devel lesions following vax
Client received 1st GARDASIL and 2nd VARIVAX vaccines afternoon of 8/5/09, experienced swelling of face, eyes, throat, itchy and tingling in mouth - difficulty speaking, taken to ER 12am 8/6/09
she woke up and couldn't taste anything; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9265, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 03Feb2021 at 10:30 (at the age of 75-years-old) as dose 1, single for COVID-19 immunisation. Medical history included blood pressure, diabetes type II, restless legs, fibromyalgia, and anticoagulant therapy all from an unknown date. Concomitant medications included pantoprazole, atorvastatin, pramipexole taken for restless legs, acetylsalicylic acid (BAYER ASPIRIN), clopidogrel taken for blood thinner, gabapentin taken for fibromyalgia, fluoxetine, valsartan taken for blood pressure, metformin taken for diabetes, ubidecarenone (COQ-10), fish oil, vitamin d3, and ascorbic acid (VITAMIN C); start and stop date were not reported. On 04Feb2021 between 5:00 AM and 6:00AM, the patient noticed she couldn't taste anything. The patient further reported that she lost her sense of taste. The patient then received second dose of BNT162B2 on 23Feb2021 and stated that she still does not have her sense of taste. The patient wanted to know when she will get her taste back and how long will this last. After her second dose, the patient went to the doctor for UT infection and asked the doctor about not being able to taste. The patient has not recovered from the event.  No follow-up attempts are possible. No further information expected.
I had pain in my upper left quadrant of my side. It was believed to have been an enlarged spleen but after an ultrasound that was performed at the local hospital, the spleen and pancreas were within the normal limits. I'm still experiencing pain and discomfort on my upper left quadrant on my stomach and down the lower left quadrant of my stomach. If I eat anything cold, the pain would trigger. Every time I eat, I feel bloated. If I have to go to the bathroom for a bowel movement, it's a very sharp pain and I'm  doubled over in pain and discomfort. And today 11/19/2021 we performed a CT scan with contrast without results yet. Currently waiting for results. My doctor thought that it would be a result of the vaccine, but he is currently unsure due to the timeframe of the vaccination and adverse event.
Patient experienced vomiting/dizziness within minutes after administration. She felt better after drinking water and eating crackers.
Headache- next day dizziness, weakness. nausea - the throwing up over a couple of hours. Generally feeling like I had the flu very sick.
The pt cried during the injection. Later the pt developed an injection site reaction characterized by redness and induration. No further information was available at the date of this report.
Headache, Myalgia, FATIGUE, SITE REDNESS Narrative:
At my June 2020 annual physical, my doctor performed a Hep C blood test which came back negative.  When I donated blood on March 4, 2021 (which I have been doing every two months for several years), my blood was tested by the donation center showed "reactive" for Hep C antibodies.  Subsequent tests by the center (HCV Supplemental Test and HCV Discriminatory NAT) were both nonreactive.  I was directed to show this information to my doctor, which I did at my June 23, 2021 annual physical.    My doctor discussed this with me and had another Hep C test performed that day.  We also discussed how this disease is transmitted (none of the transmission avenues were applicable to me), and that the donation center's test showed that I do not have the disease; only that I was exposed and my body made antibodies against it.  The test performed on June 23rd indicated the same results as those performed by the donation center.  The only thing  different from June 2020 when my test was negative until I donated blood on March 4, 2021 is that I received both doses of the Moderna vaccination.  I thought I should report this in abundance of caution.
Pt received Pfizer COVID vaccine #1 on 24 April 2021 and #2 on 15 May 2021.   She reports that she experienced 2months of amenorrhea after second dose of Pfizer COVID vaccine Normal menses 1-6May 2021 then  NO menses until 31July 2021  .
SIXTH DOSE FROM VACCINE VIAL ADMINISTERED WHEN VIAL INTENDED FOR ONLY 5 DOSES.
16cm x 17 cm indurated, hot, red, painful patch on left upper arm.
Redness noted underneath flu site injection. 3cm x 5cm in size, slightly warm to touch - Rt arm.
erythematous papular/vesicular rash to face, lateral neck, post auricular skin. Rash began on Friday and progressed through Monday when she was seen by a nurse practitioner. Facial swelling present.
Patient received pediatric dose (orange cap) of covid-19 Pfizer vaccine instead of the adult (purple cap) dose. The pediatric vaccine was also not diluted prior to administration. In addition 0.25mL was given instead of 0.3mL. The patient had no adverse reaction or symptoms due to the dosing error.
Cardiac chest pain. Burning, crushing 7/10 for 8 hours.  Gradual reduction in discomfort over 3-6 weeks. Sought medical evaluation 2 weeks after via telehealth recommendation ibuprofen and Tylenol. Pain decreased.  6 weeks after:Chest X-ray and full cardiac work with echocardiogram. Pain and discomfort down to a 1 or 2 out of 10 after two months. Continuing to be noticeable as of 8/20/2021
Expired vaccine administered; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029H21B, 047C21A and 041C21A) for COVID-19 vaccination.     The patient had no allergies. The patient never had COVID positive test or diagnosis.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2022-537607, MOD-2022-537958 (Patient Link).
Headache, Myalgia, Arthralgia, Fever, chills, fatigue, mouth soreness, left hand swollen (left delt inj site) Narrative:  Fever, headache, chills, arthralgia, myalgia, fatigue, mouth soreness; left hand swollen (left delt inj site); took tylenol and ibuprofen. Has history of lupis.
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  The vials were frozen, shipped in refrigerated temperature and then refroze for storage once arrive at facility. Further it was reported that vial was moved to fridge on 06-Oct-2021. Both 5.5 ml and 7.5 ml vials were received in partially thawed/liquid condition. Maximum or minimum temperature reached was 8 degree Celsius. Total duration of excursion was 4hrs.  No treatment medication was reported by reporter.
Pain upon administration; Flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain and flu-like symptoms. On an unknown date, the outcome of the injection site pain and flu-like symptoms were unknown.   It was unknown if the reporter considered the injection site pain and flu-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix, and it was painful upon administration. Also the patient had flu-like symptoms. The reporter did not consented to follow-up.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 10-DEC-2010, the patient was inoculated with ZOSTAVAX at a family physician's office as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUL-2016, the patient was treated by a physician at the same family physician's office for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Unusual itching on feet, lower abdomen, and back. Red welts lower abdomen, lower back, both forearms. Started BENADRYL 25 mg, 2-hours after welts appeared, continued every 4 hours x 2. After 6-hours, much improved, no more welts, just itchy red spots. After 24 hours, moderate itching on hands and feet, with minimal rash. After 36 hours, itching started again, slight redness, took BENADRYL 25 mg, 1 x. After 48 hours, no symptoms.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 84-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included shingles (experienced 12 times previously). Previously administered products included Zostavax (received 10 years before the date of reporting). On 14th May 2018, the patient received the 1st dose of Shingrix (intramuscular). On 11th August 2018, 89 days after receiving Shingrix, the patient experienced shingles, painful rash and erythematous rash. On 13th August 2018, the patient experienced local swelling, movement disorder, pain and tenderness. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the local swelling was recovered/resolved and the outcome of the movement disorder and pain were recovering/resolving and the outcome of the painful rash, erythematous rash and tenderness were unknown. It was unknown if the reporter considered the shingles, local swelling, movement disorder, pain, painful rash, erythematous rash and tenderness to be related to Shingrix. Additional details were reported as follows: The patient received Shingrix in the left deltoid. The patient experienced a rash on the nerve line and there was a red line up the nerve line and she was in horrible pain. The patient was diagnosed with Shingles. After 91 days of vaccination, the patient had a knot in her back on the right side which was sore until it went up her back. The patient could not move and it was tender and the pain shooted every once in a while but she was taking medication (unspecified) at the time of reporting. At the time of reporting, the patient still had trouble moving and initially she could not move her arm. The contact details of the physician was provided.
No adverse reaction to the vaccine. the vaccine is administered, after the deadline of April 1, 2022. Vaccine is not expired.
Tenderness; Swelling; This case was reported by a consumer via interactive digital media and described the occurrence of tenderness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tenderness and swelling. On an unknown date, the outcome of the tenderness and swelling were unknown.   It was unknown if the reporter considered the tenderness and swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-JUL-2022 Reporter's Comments: This case was reported by consumer via interactive digital media. The reporter wanted to know that, how long would the tenderness and swelling last after 1st shot. The follow up would not be possible as no contact details provided.
I received two Pfizer vaccinations, one Pfizer booster, and this last one was a Moderna booster. On April 18 I had a headache, diarrhea, and a fever of 101.5 F. I took extra strength Tylenol and took a home test for Covid, which gave a negative result. The next day I called my doctor?s office because I didn?t know what to do. The nurse gave me advice for diarrhea and told me if I still had a fever to call back the following day. My temperature on April 19 was 100.9 F and the next day my temperature was normal. The headache and diarrhea dissipated and I did not contact my doctor?s office.
24 hours post vaccine, developed bilateral eye swelling, itchy ness full body and right orbital pain along with the feeling of my heart racing. Swelling lasted 9 hrs, self medicated with Zyrtec (Benadryl makes my heart race) . Tylenol 1000mg every 4 hrs for headache pain. Headache is still present daily. Switched to 800 Motrin every 6 hrs. Headache and lower extremity muscle pain, as well as nerve twitches and cramping still occurring 8 days post vaccine.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning an eight-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 08-Jan-2012. On 08-Feb-2012, the patient inadvertently received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 26-Mar-2012: No adverse events were reported.
Patient was at the pharmacy. She received both a SHINGRIX (left deltoid) and a FLUZONE in the right shoulder. She was evaluated on 2-18-19 for increasing pain. She has had decreased ROM and pain since the injection on 9-25-18.
I have atopic dermatitis, and after receiving my booster shot, my symptoms became much worse. I have talked to one other person who experienced the same situation; I have atopic dermatitis, and after receiving my booster shot, my symptoms became much worse. I have talked to one other person who experienced the same situation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATITIS ATOPIC (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "I have atopic dermatitis, and after receiving my booster shot, my symptoms became much worse. I have talked to one other person who experienced the same situation".  Additional information: Reporter found some information online that also suggests the vaccine can cause increased symptoms of atopic dermatitis. No age provided by patient. No phone number available.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient reports feeling anxious prior to arrival, she reports "overthinking" the vaccine. Has history of vasovagal response with injections, blood draws or blood donations
(1) Dizziness unresolved after observation - (2) Cool/clammy -  collapsed to floor - (3) IV - (4) 911 -> Pru Rescue.
Stiff lower back noted on brushing teeth over wash basin. Flew by air for FB Game arriving about 5 PM. Symptoms got progressively more severe with low back spasms accompanied by severe unsteady gait by 10/17/2009 requiring my son's arm support while walking, and part time wheelchair use on that date. I had no "cold", GI, Headache or neck pain symptoms, but vomited 20 min after eating one slice of pizza about 8PM which unaffected my 2 sons. I returned home by air on 10/18/09 and continued with slow improved gait for 5 days. Back spasms and stiffness slowly improved until today 11/3/09 is first that I did not require Tylenol.
Woke up at 1:00am (11 hours and 10 minutes after the shot) with a 101.8 degree fever.  I took Ibuprofen, then slept for the rest of the night until 6:00 am.  When I woke up, my temperature was normal, and I had seated profusely.  (My pajamas and sheets were soaked.)
Pt gave birthdate a year later than birthdate given in the medical record. Possibility exists pt was 11 instead of 12 years when given first dose of Pfizer.