chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Uncontrollable shaking; Felt sadness; Very depressed; This is a spontaneous report from a contactable consumer (patient). A 96-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267) via an unspecified route of administration, administered in right arm on 10Feb2021 at 10:45 (at the age of 96-year-old) as dose 2 single for covid-19 immunisation in doctor's office/urgent care. Medical history included congestive heart failure, 4 way bypass. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) via an unspecified route of administration, on an unknown date Jan2021 (four weeks prior to suspect vaccine), as dose 1 single for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. On 10Feb2021 at 17:30, the patient experienced uncontrollable shaking lasted for 3 hours, the patient felt well enough to go to bed. Patient took 2 tylenol and slept through the night until 9:00. Along with the shaking patient felt sadness and very depressed. The patient took 2 tylenol as treatment for the event uncontrollable shaking. No treatment medication was received for the events felt sadness and very depressed. Post vaccination, the patient had not tested for COVID-19. The outcome of the events was resolving.  Follow-up attempts completed. No further information expected.
Soreness at injection site; Vomiting; Diarrhea; Low grade fever; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150), via an unspecified route of administration in the left arm on 08Apr2021 at 18:00 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history included IBS (irritable bowel syndrome). Concomitant medications were not reported. The patient previously received augmentin and cefprozil on an unknown date for an unknown indication and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 21:00, the patient experienced soreness at injection site, vomiting, diarrhea, low grade fever and chills. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care visit. The clinical outcome of the events soreness at injection site, vomiting, diarrhea, low grade fever and chills was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Inflamation around the smallpox site. With a diameter of 8cm. With No fever, No chills, No chest pain, No nausea, No vomting, No night sweats, No headaches, Pt admits on scratching around the wound site and tapping it.
Information has been received from a nurse practitioner concerning a patient who was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient's spouse developed a "shingles like rash."  Subsequently, the patient's spouse recovered from the shingles like rash.  Additional information has been requested.
Developed heart rate of 260 bpm; unresponsive to medication or cardioversion. Required placement on 2 long term cardiac medications.
hives from head to toe, was on 3 rounds of steroids and taking 60 mg of zyrtec and pepcid and now having to get monthly xolair injections
Feels like Covid pneumonia all over again; Feels like Covid pneumonia all over again; Feels like Covid pneumonia all over again; Sore arm; Extreme chills; Body and muscle ache; Body and muscle ache; Diarrhea; This is a spontaneous report from a contactable consumer (patient herself). This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number EW0182), via an unspecified route of administration in left arm on 10May2021 10:45 as single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient medical history included COVID-19. Concomitant medication included (paracetamol) TYLENOL. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via unspecified route in left arm on 19Apr2021 24:00 (Batch/Lot number EW0171) as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 11May2021 23:00 the patient experienced with felt like COVID pneumonia all over again, sore arm, extreme chills, feels like ice in blood, Body and muscle ache and diarrhea. Treatment received was reported as no. The outcome of events was recovering.
After I received my second dose of the COVID vaccine I noticed some spotting/breakthrough bleeding just days later. I was cleared at my 6 week postpartum checkup so I don't think it is related to typical postpartum bleeding. I was breastfeeding a 2 month old on demand at the time and have not yet had a menstrual cycle postpartum. Bleeding while breastfeeding is abnormal for me as I have breastfed 3 other children and my cycle does not return until I stop breastfeeding usually around 13 months postpartum. I have had breakthrough bleeding ever since the first event off and on. Never more than a couple spots of blood, but again, not typical for me.
death N17.9 - Acute kidney failure, unspecified D69.6 - Thrombocytopenia (CMS/HCC)
My son got a hard lump in the arm where his shot was administered, he threw up twice three days after his shots (19th), He had no appetite until 12pm 07/25/2014. The morning of 7/27/2014 he had a rash appear on his arm by the lump that resembled ring worm. He got a sudden fever by 7pm and spiked up to 102 degrees by 8pm so I took him to the ER. They confirmed he had a allergic reaction to the MMRV shot (they took no tests). The fever lasted 14hrs only. On 7/28/2014 the rash on his arm was gone but a heat looking rash started on his neck. So I took him to his Dr., the Dr. said it was just a virus (he took no tests). The fever got worse when we got out in the heat to our car. By evening my son had a rash all over his face and his stomach, and back. The rash had small red pinpoint spots and eraser size spots. The rash lasted 3 days. He still has the lump in his arm. But otherwise he seems to be doing "better".
Pain in upper two shoulders and neck/upper body joint pain, both sides; Generalized weakness; Pain in upper two shoulders and neck; This is a spontaneous report from a contactable physician reporting for herself. This 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot/batch number not provided) on the morning of 20Dec2020, intramuscularly in the left arm at a single dose, for COVID-19 immunization. The patient's medical history included arthritis, esophagitis and esophageal ulcer, from unspecified date and unspecified if ongoing. The patient's concomitant medications were not reported. On 20Dec2020, the patient (physician) called to report two side effects: pain in upper two shoulders and neck, generalized weakness. She developed an upper body joint pain, both sides. She got the injection on the left but both her shoulders had joint pain and weakness. She did not receive treatment for the events. She had the COVID test on 19Dec2020 or 18Dec2020 (reported as "yesterday" and "2 days ago") but the results were not back as of 20Dec2020. The outcome of the events was unknown. The reporter assessed the events as related to the vaccine.  Information on the lot/batch number has been requested.
Sudden onset of physical weakness, with muted sounds.   In trying to walk, I fainted.  Fainting lasted seconds.  the whole episode from onset to awakening from fainting lasted less than 5 minutes.    Upon awakening, allergic reaction had ended, with no residual symptoms.
4 x 6 cm area of induration, redness with warmth and rash, itching x 10 days.
rash at injection site; pain at injection site; This case was reported by a physician via sales rep and described the occurrence of injection site rash in a adult 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 injection site rash and injection site pain. On an unknown date, the outcome of the injection site rash was unknown and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site rash and injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. After receiving the Shingrix vaccine, the patient developed a rash at the injection site. The patient also developed pain at the injection site that has lasted for 1.5months. The reporter did not have any additional details regarding the event or the patient. This case has been linked to US2020015870, reported by the same reporter.
Staff member gave patient pfizer vaccine without diluting it. Patient waited 30 minutes and had no adverse reaction.
Patient due for 3rd and final dose of Engerix in the Hep B 3-Dose Series.  Had received one single Peds Dose as a child 2003, a second Adult Dose as an adult in 2023 and was in clinic to finish up series with 3rd (Adult) Dose of Engerix B. Patient inadvertently immunized with Pedictric Dose of Hep B which is half the strength/concentration of the adult dose. RN immediately notified patient and contacted in patient Pharmacist for advice on how to proceed. With advice of Pharmacists and patient consent, a second dose of Pediatric Engerix was administered in deltoid muscle on alternate arm. With these two doses, patient was immunized with appropriate concentration of vaccine for Adult age.
Tingling numbness all over whole body starting Saturday morning, currently still experiencing, nothing makes it better or worse
a patient who died from the vaccine; tissue damage; This is a spontaneous report from a contactable consumer or other non-health professional received from Pfizer sponsored program. A patient of unspecified age and gender received BNT162B2 (COMIRNATY, Solution for injection), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.The reporter knows an immunologist who has a patient who died from the vaccine, but it was not labelled a vaccine death. The reporter knows that the vaccine causes coagulated blood and a lot of kidney damage.The reporter read that the vaccine is causing autoimmune diseases and if you are having an autoimmune disease, it means you are a vaccinated individual. A Physician the reporter knows sent a patient blood work before the vaccine, after the first shot and second shot and then after the third shot and it shows that there is tissue damage. The reporter knows that the antibodies plummet after the second dose. The booster dose is the death shot. The patient died from the vaccine on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: a patient who died from the vaccine
pt  tipped  his head back and then  fell & caught himself ( maybe fainted for 2 seconds)  extremely white, clammy, sweaty, light headed. sat with him and he drank water ,for 15 minutes friend brought him home.
The patient is a 13 m/o male who received MMR, Havrix and Varicella vaccine on 09/14/07 and was seen on 09/18/07 for a one day h/o generalized rash. Non pruritic, no irritability, no inconsolable crying. PEX: generalized maculopapular rash, erythematous sparing palms/soles, no skin desquamation. No vesicles. See again on 9/20/07. Rash improved. No treatment needed.
fainting and hit head....pt opened eyes within 30 seconds of fainting- no difficulty breathings. called EMS due to patient hitting head
sore throat, cough, sinus congestion, runny nose starting 12/27/21
Became flushed, lightheaded, approx 10 mins post administration, lied down to rest with cold packet to head, recovered within 20mins.
Right thigh red, swollen, hot to touch, and itchy. Infected area approx 5" x 5".
Under the EUA to receive COVID-19 Moderna vaccine on 12/23/20 dose 1 of 2. On 12/30/2020 at 4pm, patient noticed left upper arm reddened & itching at the injection site. It first appeared as a red oval, then over the next few days turned more blotchy & scattered over the left upper arm. She took Motrin & Tylenol every 6 hours for 2 days. On Saturday, 01/02/21 patient awoke with stiffness in her neck & pronounced pain in the joints of both hands. She had done nothing out of the ordinary the previous day. Pain felt dull & constant but it worsened when she tried to open/close her hands. She took Aleve on 01/02/21 & 01/03/21 for the symptoms. By 01/04/21 joint pain & redness/itching at the injection site had eased off.
fatigue; back spasm; pain; Booster (3rd) dose; This is a spontaneous report from a contactable physician (patient). A patient of unspecified gender and age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 on an unspecified date for COVID-19 immunization and experienced arm soreness, COVID-19 and drug ineffective. The patient was also previously vaccinated with the second dose of BNT162B2 on an unspecified date (within weeks of having positive Covid test) for COVID-19 immunisation and caused similar side effects. The patient received the booster (3rd) dose on an unspecified date. On an unspecified date after the third dose, the patient experienced fatigue, back spasm and pain for about a day that later subsided. It was reported that second dose happened within weeks of having positive Covid test and caused similar side effects, but not as severe as this booster dose. Events took place after use of product. The outcome of the events fatigue, back spasm and pain was recovering. It was also reported that the patient was still happy and felt the reaction meant his body had a robust response to vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & exp burning/itching @ site which radiated down arm; has been c/o for 2 wks now states reporter;
Initial information received on 24-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 11 patients of an unknown demographics who received  a dose of FLUZONE HIGH DOSE which was might be unstable due to extended time in transit may be unstable due to extended time in transit time reported as 9-5. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patients received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ024AC expiry date: 29-Apr-2019 via unknown route. It was a case of actual medication error due to incorrect product storage. No known symptoms were reported for any patient. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Caller reporting an AE for PROQUAD being administered after an excursion that occurred; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 02-MAY-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number U024509, expiration date 02-FEB-2023 (dose and route of administration not reported) for prophylaxis (product storage error).   The temperature excursion was of -2 degrees Celsius (°C) for 1 hour and 12 minutes. The vaccine had another previous excursions as follows:   -10°C up to 8°C (8.1C) for 2 hours 58 minutes; -10°C up to 8°C (7.3C) for 2 hours 37 minutes; -10°C up to 8°C (0.7C) for 2 hours 56 minutes
Rash ("whelps")-arm-onset 10/27/07-per mother's report-contacted PMD--gave Benadryl & went to ER-rash also on neck area--improvement past Benadryl--mother says PMD told her that rash might not be related to vaccine. Rash resolved & no further problems.
Patient reported throat/lip tingling and headache within 10 minutes of receiving vaccine. Patient was given benadryl and observed. Condition improved.
FATIGUE, BODY ACHES, LOSS OF APPETITE, CHEST PAIN, AND DIFFICULTY BREATHING
Around 4pm, patient started feeling dizzy.   Last night got up and felt dizzy; patient sat on the floor since could hardly walk.   Patient got up this morning and felt dizzy still.   Patient tried to rest, keep hydrated but did not take any medicine.   Patient has same amount of dizziness today.    Planning to contact doctor doctor but doesn't feel well enough to drive.
Had Expected Sore Arm for 1 Week, Had  Flu like Symptoms for 3 Days as expected.  Have had Much Higher Blood Glucose Readings since Vaccine, On  Day 8 Developed  extreme GI Issues with Nausea and Watery Diarrhea  which is better now at Day 14.  Have had Heart Palpations since Vaccine.  Then today on Day 14 Developed Rash at Injection Site .  My Back Pain has been much more pronounced since Vaccine as well.
patient received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30-day use by date) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30-day use by date). On 18-Aug-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Additional information reported for Date of refrigeration as 05/07/21  No concomitant medications reported.  No treatment information was provided.   This case was linked to MOD-2021-363780 (Patient Link).
Pt received anthrax vaccination on 11/6/07. On 11/7/07 pt noted swelling, induration, erythema, and a draining sore. Seen 11/8/07 and taken to ER. Treated for cellulitis with clindamycin 300mg qid for 7 days and warm compresses.
tested positive for covid-19 after administration of a PCR test; tested positive for covid-19 after administration of a PCR test; scratchy throat; she was really sick for two weeks; cough; This is a spontaneous report from a contactable consumer (patient). The female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 08Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. This female diabetes educator, who is also the patient, reports testing negative on a rapid test prior to receiving her first dose of the Pfizer covid-19 vaccine on 08Jan2021. On 09Jan2021, she experienced symptoms of covid-19 and then tested positive for covid-19 after administration of a PCR test. She does not feel getting covid-19 is related to receiving the covid-19 vaccine. She reports her covid-19 symptoms included scratchy throat, cough, and she was really sick for two weeks but now just has a little scratchy throat and cough still continuing. She is scheduled to receive her second dose of Pfizer covid-19 vaccine on 29Jan2021.the patient queried if she could get the second injection of Pfizer covid-19 vaccine when it is due since she got COVID-19 disease after the first injection or is that a contraindication. The outcome of the events was unknown.  No follow-up attempts are possible, information on batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. While reporter causality is noted and it is very likely that the vaccine may not provide protection yet, further clinical information is needed for meaningful medical assessment.
Information has been received from a medical assistant concerning a 7 year old white female with no known allergies or past medical history, who on 26-MAY-2000 was vaccinated in the right arm with a first dose of Varivax (lot # 632725/1860J) (diluent lot # 634822/0390K). There was no illness at the time of vaccination. On 25-SEP-2006 the patient developed 50+ pox on her back and scalp. No further information was available. Additional information has been requested.
consumer rpt that a pt was vax approx 2 yrs ago (9/97) w/2 doses of varicella virus vax line & in 4/98 pt lab tests revealed a negative varicella antibody titer.
patient has profound dent in her right arm at the injection site.  Pt will schedule an apt w/ her PCP to find out if there is a problem with the muscle in her arm.
w/in 4hr p/vax pt devel an inj site rxn characterized by an area of erythema & induration measuring 50mm in diameter;pt had recovered @ the date of this report;this is 1 of 4 pt from this site to devel an inj site rxn p/flu vax;