chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection given for influenza approx 1:15 pm. Pt presents to nurse @ 2:15 pm. Rash on neck & upper chest. Denies itching or dysnpea. "Feels hot around neck". Pt took BENADRYL 25 mg PO.
SYMPTOMS BEGAN 40-45 MIN. POST VACCINATION AFTER LEAVING FACILITY.  CLIENT REPORTS NUMBNESS/TINGLING BEGINNING IN LEFT ARM , PROGRESSING DOWN ENTIRE LEFT SIDE, UP RIGHT SIDE TO LEFT SIDE OF FACE AND HEAD, THEN DOWN RIGHT SIDE OF ENTIRE BODY , PROGRESS UP TRUNK.  DIFFICULTY SWALLOWING DEVELOPED- "THROAT FELT SWOLLEN"  NO DIFFICULTY BREATHING.  NO HIVES OR OTHER RASH NOTED.  NUMBNESS/TINGLING CONTINUES TODAY.  THROAT SWELLING SLIGHTLY IMPROVED, CAN SWALLOW VERY SMALL BITES OF SOLIDS, AND LIQUIDS.  LAST EVENING HAD CONTACTED PCP WHO ADVISED BENADRYL, WHICH SHE TOOK A DOSE 4/14/21 EVENING, AND AGAIN 4/15/2021 12:00PM.  ONLY OTHER SYMPTONS VOICED IS MILD SITE TENDERNESS.
Soreness in arm two months after shot. Pain comes and goes. Sometimes severe. Pain is in upper arm, exact place where I received the vaccination.
Headaches that night and the next day I had a sore arm but headache was gone. 11:00 - got extreme, intense headache and nausea and body aches (like ran over by a bus) - by that night (24 hours later)  intense chills and shivering. Just to touch my skin it hurt because my body aches were so bad. Really really painful. I had these symptoms for 24 hours. My work required me to get tested for COVID. I took Tylenol for headaches  but that didn't help.
VACCINE ERROR: DOSE GIVER OVER 6 HOURS AFTER VIAL PUNCTURED
redness, itching  and swelling at injection site. recommended ice pack and hydrocortisone cream and benadryl capsules and to follow up with pharmacy tomorrow.
feeling cold; vomiting; she was tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold), FATIGUE (she was tired) and VOMITING (vomiting) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke. Previously administered products included for an unreported indication: BABY ASPIRIN.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced FATIGUE (she was tired). On 27-Apr-2021, the patient experienced FEELING COLD (feeling cold) and VOMITING (vomiting). On 26-Apr-2021, FATIGUE (she was tired) had resolved. On 27-Apr-2021, VOMITING (vomiting) had resolved. At the time of the report, FEELING COLD (feeling cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Medical history included stroke. Treatment information provided was Baby Aspirin
I administered the vaccine at 12:35 patient called me at 7:00 said she was not feeling well her face was numb and she was very weak. She wanted to know if that was normal. I told her if she had someone to bring her in we could check her BP but I would not hesitate to go get checked out. Pt called ER and they told her they could not do anything. Through the night she said her face swelled, lips were numb and she felt weak the next day (10/15/14).
8pm-mild chills and nausea 10pm severe chills and sweating 10:15pm - threw up several times until empty 10:20pm - 102 degree fever, continued chills, nausea subsided  Took Motrin 12:00am - fever down to 100 8am - fever down to 99. My normal is 97.6 3-9-21 Tired and achey, injection site very sore.
This spontaneous report was received from a medical assistant and refers to a 61 year old patient of unknown gender. No information about the patient's medical history and concurrent conditions was provided. On 02-OCT-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # N013521 with an expiration date in 23-JAN-2019 or lot # N029303 with an expiration date in 21-APR-2019), for prophylaxis, that underwent a temperature excursion from 9 degrees Celsius to 25 degrees Celsius during 20 minutes. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported and no product Quality complaint (PQC) was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1801USA001566: US-009507513-1801USA001567: US-009507513-1801USA001568: US-009507513-1801USA001569: US-009507513-1801USA001570: US-009507513-1801USA001571: US-009507513-1801USA001572: US-009507513-1712USA003377.
Fainted, juice and crackers given rested with legs elevated. BP 130/78 returned to class.
red spots appeared first on legs then on arms, neck, chest & stomach, some of the lesions itch;
Pt given Tdap to (R) deltoid 1/9/14. Pt called on Mon. 1/13/14 c/o chest heaviness, fatigue at feeling short of breath over the weekend. She did not seek medical advice over the weekend and denies s/sx today. Resolved. Also c/o headache behind both eyes - resolved.
Information has been received from a pharmacist referring to a 66 year old female patient with no drug reactions/allergies. Information about medical history, other concurrent condition and concomitant medication was unknown. On 05-FEB-2019 the patient was vaccinated with PNEUMOVAX 23 (lot # R022232 with expiration date of 16-APR-2020, intramuscularly; dose and frequency were not reported) for prophylaxis. On an unknown date in February 2019 the patient complained of swelling in an unspecified upper arm, which moved down to around her elbow. She explained that it was like having fluid around the elbow. She sought medical attention via speaking with pharmacist. Unspecified treatment for the events was given. On 07-FEB-2019, she went to her physician's office due to swelling. The physician said she was fine. The outcome of the events was also reported as not recovered. The causality was unknown.
Patient had not symptoms or adverse reaction to the vaccine, he got an expired Moderna Bivalent Vaccine. The expiration date was of 6/18/2023 and date given was 6/19/2023
Case number PHEH206US033909 is an initial spontaneous report received from physician via phone call on 28 Dec 2016. This report refers to 65 year old female patient. Medical history and concomitant medication was not reported, current condition included sulphur allergy, penicillin allergy, meat allergy, fish allergy, Chocolates allergy and macrolides allergy. The patient was vaccinated with FLUVIRIN (batch number: 16-2021) at a dose of 0.5 ml intramuscular on 19 Oct 2016. After vaccination a month later (date not reported) noticed a lump under her skin which was a size of pea and was not painful. The outcome of the event was reported as unknown. The seriousness and causality of the event was not reported. Follow up received from physician on 24 Jan 2017: Current condition added (sulphur allergy, penicillin allergy, meat allergy, fish allergy, chocolates allergy and macrolides allergy). Suspect drug details updated (lot number, start date, route of administration, dose) and updated narrative accordingly.
A few hours after the vaccine, began having a headache.  The next day had severe body aches and chills, which continued for another 4 days.  I missed 4 days of work.  I began feeling better a week after the vaccine.  24 days after the vaccine, I was awaken with excruciating pain in my left abdomen, and had severe diarrhea.  The diarrhea lasted most of that day, the pain continued.  I went to an Emergency Room on 4/1/21, and a CT scan revealed what appeared to be a stomach ulcer, a kidney stone and a post-menopausal ovarian cyst, all of which were causing the pain.  I have been through many tests and seeing a variety of doctors, and currently am awaiting results and treatment plans for the stomach problem and the ovarian cyst.  The cyst has grown and is causing continued pain.  The stomach issue is being treated with Sucralfate 1 g 4 times per day and Pepcid 20 mg.
patient experienced headaches, cough and fever and tested positive for COVID on 18Oct2021; patient experienced headaches, cough and fever and tested positive for COVID; This is a spontaneous report from a contactable Other Health Professional. A 34-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318, Expiry Date was not provided), via an intramuscular route of administration, on 28Jan2021 (age at vaccination was 34 Years) as DOSE 1, SIN-GLE, second dose via an intramuscular route of administration on 18Feb2021 (Batch/Lot Number: EN5318) as DOSE 2, SINGLE for COVID-19 immunization. Relevant medical history and Concomitant medication(s) were not reported. It was unknown if patient received any other vaccines in four weeks prior to the COVID vaccine and diagnosed with COVID-19 prior vaccination. Patient has been tested positive for COVID-19 since the vaccination on 18Oct2021. On 17Oct2021, patient experienced headaches, cough and fever and on 18Oct2021, patient experienced tested positive for event COVID on 10/18/2021. The patient underwent lab test and procedure included COVID test (nasal swab) with positive result on 18Oct2021. Patient did not receive treatment for events. The outcome of events was not recovered for Headaches, fever and Cough while for tested positive for event COVID on 10/18/2021 under PT 'Vaccination failure' was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Covid-19.
flare of inverse and plaque psoriasis though milder than in the past ... worsening of some plaques that had been improving, and eruption of new plaques on my face and legs
Enlarged spleen significant enough to prevent me from functioning in normal capacity, going to work, engaging in normal activity. It is still enlarged now.
This spontaneous report was received from a nurse via a company representative and refers to a male patient of unknown age. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not provided) for prophylaxis (no details of the first dose administration were provided). On an unknown date, after the patient's second dose of GARDASIL 9, the patient experienced rash and was unable to walk. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported.
Patient received MMR & VARIVAX on 11/14/08.  2 days later was fussy, cranky.  On 11/18 developed fever than a small area of reddness on testicles on 11/19 left tests became tense and swollen, a febrile was referred to surgeon.  Ultrasound showed blood flow to testicle & no hernia.  Diagnosed with viral orchitis.
Red raised area around injection site. Came up slightly after injection. Does not appear to be getting worse. Some itching. No pustules. Advised covering and keeping watch. Let PCP know if it does not go away or gets worse.
Patient had a fever of 103 for 3 days straight even AFTER TYLENOL. She screamed all day and night long. She kept trying to rip her hair out and scratching profusely at her head while she screamed.
This spontaneous report as received from a physician in the format of a medical record refers to a patient of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. Reportedly, hepatitis a vaccine, inactivated (manufacturer unknown) was inferred to have experienced the a temperature excursions of 36.9 F for 10 minutes on 24-DEC-2016, at 00:31 hours and it was called out because of a digital data logger. On the same date, at 11:56 hours, the patient was vaccinated with the second, improperly stored, 0.5 ml dose of this vaccine (which had a lot # of M002268 with an expiration date of 20-SEP-2017), intramuscularly, in the left thigh, for prophylaxis. Despite this, no adverse symptoms were reported. All available medical records will be provided upon request. This is one of the several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA002579: US-009507513-1703USA011159: US-009507513-1703USA011160: US-009507513-1703USA011161: US-009507513-1703USA011162: US-009507513-1703USA010731.
Developed rebound COVID/Very dark line positive test; Developed rebound COVID/Very dark line positive test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2021 as dose 1, single (Lot number: ER8736), in left arm, on 18May2021 as dose 2, single (Lot number: EW0177), in left arm and on 31Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PBC" (unspecified if ongoing); "Lupus like" (unspecified if ongoing), notes: undifferentiated connective tissue disease (lupus like); "RLS" (unspecified if ongoing); "OA" (unspecified if ongoing); "Sjogren's disease" (unspecified if ongoing); "FM" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "RA" (unspecified if ongoing); "undifferentiated connective tissue disease (lupus like)" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; URSODIOL; HYDROXYCHLOROQUINE; SINGULAIR; TRAMADOL; DULOXETINE; VITAMIN D NOS; CALCIUM; MYRBETRIQ; ROPINIROLE. Past drug history included: Doxycycline, reaction(s): "known allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Developed rebound COVID/Very dark line positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Treatment of COVID-19; (11May2022) Positive, notes: Very dark line positive test on day 1; (16May2022) Positive, notes: Repeated after Paxlovid on day 6 and line very faint; (20May2022) Positive, notes: Rechecked test on day 10 and was dark line positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient received other medications within two weeks.  Conclusion: The complaint for lack of effect of the Pfizer Biontech Covid-19 Vaccine Injectables lot ER8736, lot EW0177,lot FE3594 were investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8736, fill lot EP8688, lot EW0177, fill lot EP8728 and lot FE3594, fill lot FF2555 and the formulated drug product lot EP8585, lot EP8609 and lot EY0909 respectively. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
2 1/2 days after receiving the shingles vaccine I broke out with the shingles.
Within 3 days of vax, the pt developed a lethargic reaction with a high fever for 2-3 days. On 1/24, the pt experienced a red/pink rash which started on the face then spread to other parts of body.
24 hours after vaccine, developed: Chills - unable to get warm Rash on left arm, middle, chest, stomach, and back One lymph node enlarged under left arm - size of a golf ball, lasted 2 days
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 20-JAN-2014 the doctor had administered M-M-R II (dose and route of administration were not reported) lot # 0705AA, expiration date: MAY 2013 to the patient. No adverse effects reported. The patient did not seek medical attention. This is one of two reports from the same source. Additional information has been requested.
Patient was at check out. She told that she felt faint.  Check out woman went around and caught her before she hit the floor and lowered her down. Patient was out for about 10 seconds. Patient reports a hx of fainting with vaccines. She has no hx of HTN. Her bp was 90/50 at 4:13 pm when she was assessed. Her oxygen was 97% and pulse was 60. 5 minutes later she was assessed again. bp was 100/60 oxygen 98% and HR 70. At 4:25pm her bp was 104/62. oxygen 99% and pulse 69.  She was still lethargic from the event. We had her picked up.
Called by county to report that above patient is being treated for poss. Guillain-Barre syndrome at hospital. Pt history of INFLUENZA given 1/4/11.
nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Caller stated she has APS and is a cardiac patient too" (unspecified if ongoing), notes: Caller stated she has APS and is a cardiac patient too; "Caller stated she has APS and is a cardiac patient too" (unspecified if ongoing), notes: Caller stated she has APS and is a cardiac patient too; "she is allergic to something vaccine." (unspecified if ongoing); "Caller asked if in stoppers or syringes may have latex." (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization, reaction(s): "Nausea", "Vomiting"; Bnt162b2 (DOSE 2), for Covid-19 immunization, reaction(s): "Nausea", "Vomiting"; Bnt162b2 (DOSE 3), for Covid-19 immunization, reaction(s): "Nausea", "Vomiting". The following information was reported: NAUSEA (non-serious), outcome "unknown"; VOMITING (non-serious), outcome "unknown". Additional information: The patient mentioned that she was vaccinated with the primary series and two boosters, all from Pfizer. She mentioned she got a reaction a couple of times, with nausea and vomiting all night, until 7:30 am. Last booster was in Jul2022. She was concerned about getting the Omicron vaccine and that she was allergic to something vaccine. It was asked whether stoppers or syringes might have latex. She just recently received a Flu shot and asked how long she should wait to get the new Omicron vaccine. It was said there were new two variants that have come out, so that was totally absurd, because the virus was constantly mutating, and that people were still getting COVID and Omicron, so it did not prevent anything. It was the main concern if she should talk it or not because she was afraid of getting the reaction and to be up all night. She also mentioned her doctors did not know how to treat or prevent the side effects from these vaccines. She had APS and was a cardiac patient too. She asked if the Pfizer Product got into the valves of the heart. Her last booster was in Jul2022 and asked when she could receive the bivalent vaccine. The patient asked how sick the people did who received that new bivalent vaccine, when they got infected with COVID. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient was hospitalized due to covid for 5 days.  Apparently stayed in hospital after that for non covid related reasons. v    **date of second vaccination was 3/12/2021
Patient reported chills and muscle aches starting around 9:00 PM on 12/24/2020. Symptoms lasted around 12 hours.
At 10:15 am on Nov. 7, 2007 I received the PPV immunization.  Through the day my arm got more and more sore.  By 6 pm I could not lift my arm more than a foot above my body.  I also started feeling generally sick, with a fever and chills and feeling pretty bad all around.  I went to bed about 11 pm, my usual time, having stayed on the couch the better part of the afternoon and all evening.  At 1:30 am the next day I woke with a pulsing, throbbing pain in my arm where I had received the PPV shot.  I went downstairs to take two aspirin to relieve the pain.  In the bathroom I blacked out twice but remained standing.  I went to the kitchen to get milk to take the aspirin with.  I blacked out and fell at least once, perhaps twice, in the kitchen while getting the milk.  Each time I woke up on the floor with no recollection as to how I got there.  Luckily I did not hit my head or any other parts of my body when I fell.  I was clearly not thinking rationally, and I was not thinking clearly.  I was driven to take the aspirin and get back to bed, but my brain was not functioning well.  Each time I awoke on the floor I remember thinking, I have to get up, but I had no feeling that things were not right.  I climbed upstairs toward our bedroom (although I have no recollection of walking or climbing the stairs), and I blacked out and fell again in the upstairs hallway.  Again, luckily, I did not hit my head on anything severely when I fell.  I awoke and found myself on the floor, but I did not know how I had gotten there.  Again my driving thought was to get back to bed.  My wife kept asking me if I was okay and I guess I said I was, but my mind was not functioning much at that time.  I was just driving myself to get back into bed.  I got into bed, where I broke out in a complete, drenching sweat over all of my body.  My fever also increased dramatically, but after the sweat came out completely I started to cool off somewhat.  I kept telling my wife I did not want to go to the hospital (although this was not a rational person speaking, especially when I was downstairs and just after I got back into bed).  I fell asleep fairly soon (~15 minutes or so) and slept fairly well that night.  My arm was very sore for the next 24 hours, and I could not lift it more than a foot or two all day.  I took four aspirins during the day to help relieve the arm ache.  I rested that entire day and did not work that day.  Toward that evening the pain where the shot was given started to decline, and I started to feel somewhat normal.  The next day I could lift my arm higher and the pain continued to subside.  By day three I was back to almost normal.  I had had no alcohol to drink on the day of my PPV shot and only the .5 milligram Ativan at night as per my usual routine, so I am sure it was the PPV shot that had caused my severe reaction.  My left arm, where I got my flu shot at the same time as the PPV shot, felt fine from the time of the shot.
SSNHL in Right ear happened within 30 minutes of onset of ringing in ear. Treated with oral Steroid and Direct Tympatic Injection. No significant hearing recovered. Severe debilitating Tinnitus 2 months from onset.
I got COVID in June 2022 and then I tried to donate blood and I had a blood clot back in September. I had to go to a blood specialty. My blood test has soon improved as of now. On October 5th my blood pressure went very high, so I had to go to the urgent care. My finger was really numb.
Itchy, hot red arm around injection site almost all the way around my arm, started within 2 hours of injection, maybe less.    Malaise, but maybe because I took 25 mg Benadryl, then another 25 mg. about 4 hours later. I sleep all afternoon and evening off and on.  I have been extra achey all overand still have a hot red upper right arm around the injection site. My neck seems to be more tight and achey today as well, and I've had some nausea.
I received my second vaccine on 3/19 at 5:45pm.  At 7pm the same day, my right lip began to swell up and my right side of my face feels tingly