chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccine 9/1/09 at 6:44pm.  Symptoms began 9/2 at 8:00am and I still have them.   Periods of severe vertigo where entire room is spinning.  Between episodes of vertigo I am constantly dizzy.  Severe nausea, have not eaten a normal meal since vaccination.  Severe ear pain, occasionally hear a high pitch tone, when I hear the tone the pain becomes so severe I almost feel as though I will convulse (I have NO history of seizures).  Hard to walk straight.  Extreme fatigue.  Difficulty thinking and formulating thoughts/sentences.  Vision blurry periodically.  Periods of intense sweating and I normally never sweat, even after a long workout at the gym, and when I have these sweating spells I do not have a fever, I always take out a thermometer and check.  My heart rate periodically will rise very high (as high as 140 BPM), this happens daily, and I know I am giving an accurate heart rate reading because I am checking it on a fingertip pulse/oximeter.  My mouth, tongue, cheeks, and lips frequently go completely numb.  All of this has completely disabled me, I have been unable to do anything, it is a struggle to just to make my be and to shower.  I went to the ER on 9/2 and the doctor basically just ascertained that nothing life threatening was going on and advised me to follow up with my Primary Care Physician.  I saw my PCP 9/4 and he was not sure what it was, thought it perhaps was some sort of weird allergic reaction, so he prescribed the Medrol dosepak which did not help.  I saw a neurologist 9/8 and he did not know what it was either and requested that my PCP prescribe some Otic-Edge drops for my ears and some Phenergan for the nausea.  My neurologist did a full exam and ordered blood work.  I see him again in about 3 weeks.  My neurologist also referred me to a neuro-otologist.  My PCP called in the ear drops and Phenergan for me and neither helped.  I tried Meclizine and that did not help.  I saw a neuro-otologist this past Tuesday (9/15) and he said it might be Labrynthitis, but he was not sure as he had not seen a reaction like this before.  He prescribed the Trans-dermal Scopolamine patch to see if it would help to get more food in me as I have lost about 10 pounds since receiving the vaccine because I have been too nauseated to eat.  They have helped a little.  I have a follow up with the neuro-otologist on 9/22.  These symptoms have completed disabled me and I know it is from the flu vaccine because I had none of these symptoms prior to receiving the vaccine.  I have spent a lot of money on the ER visit, doctors visits, and prescriptions and I still am confined to the couch.  I am afraid to drive because I never know when a vertigo attack will hit me and even when I don't have the vertigo, I am so dizzy and fatigued.  This has completely taken over my life and not knowing for certain what it is, I have no idea how long it will last, if and when I will feel better, and my worst fear is that it will get worse than it already is.
pt presented on 8/9/99  told MD when had vax arm became red 7 swollen had fever, chills, sweating, aching;
while I had the typical vaccine symptoms after my second dose - my menstrual cycle was different from normal with more intense PMS and heavier flow. I typically feel PMS like cramps. bloat, diarrhea, heavy flow with thick dark blood and moodiness for 1-2 days. After my second dose, I noticed I had the same PMS but each symptom felt much more intense and lasted for 3-4 days. The length of days of my cycle was not affected and it started when expected.
pt recv vax20JUL98 had has soreness in lt arm;lt deltoid has a 1 1/2cm knot;ROM is full;denied any problems w/1st hep b inj given 1JUN98;
After 1st shot: Significant Pain in arm to the point of it being immobile.  After 2nd shot: Waited the 15 minute observation time, got in car, drove about 10 minutes, whole body flush, metallic taste in the mouth, became unsteady feeling and woozy, then was in bed for 2 days with fever/ chills flu-like symptoms.
Information has been received from a health professional concerning a 36 year old male who was vaccinated with a first dose of pneumococcal polysaccharide vaccine (lot # 0364N). Subsequently, the patient experienced hives and possible systemic and local reactions (also reported as injection site reactions). The patient was treated with prednisone. There was no product quality complaint involved. Upon internal review, the patient's hives and possible systemic and local reactions were considered to be other important medical events (OMIC). Additional information has been requested.  Follow up on 12/19/03: "Follow up information on 12/03/03 from the health care professional indicated that she "only knows that the pt was not hospitalized, but was seen in the ER for a fever and swelling at the injection site.  The pt was treated with prednisone and has since recovered.  The reporter indicated that she cannot recall the pt's name and therefore has no other information to report.  Upon internal review, the pt's hives and possible systemic and local reactions, fever and injection site swelling were considered to be other important medical events.  No further information is expected."  "Follow up information from the physician's office indicated that on 27OCT2003 at 18:30, the pt called and reported that he developed sweats, temperature 100.4, chills, headache, rash, swelling at the site and was achy all over. He was seen in the emergency room and was treated with IV fluids, ceftriaxone sodium and methylprednisolone sodium succinate injection. Some shortness of breath and lightheadedness were noted. Unspecified laboratory tests were performed in the emergency room. He received prednisone at a follow up visit on 28OCT2003. The patient received a nebulizeer at his follow up visit on 30OCT2003. It was reported that the patient recovered on 31OCT2003 or 01NOV2003. Upon internal review, the patient's adverse events were considered to be other important medical events. No further informationis expected.
small outbreaks of blisters/shingles; Blisters; Inappropriate Schedule of Vaccine; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and Shingrix, the patient experienced shingles, blister and product supply issue. On an unknown date, the outcome of the shingles and product supply issue were unknown and the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the shingles and blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced after 1st dose of Shingrix 1 to 2 small outbreaks of blisters or shingles since receiving the 1st dose at an unknown date. The 1st dose of Shingrix received approximately 9 months ago and was unsuccessful at receiving 2nd dose at his local pharmacy due to availability. The reporter consented to follow up.
Within 15 mins I started to get light headed and dizzy. I went to urgent care. My left side went numb. I had a big lump in my neck and I had ear pain on my right side.
Patient came to the clinic for the administration of her 2nd dose of Moderna vaccine. The nurse administered a lower-than authorized dose (volume) of the correct formulation (0.25 ml) instead of the full dose (0.5ml). After noticing the patient was oriented and as directed by CDC administration error guidelines, the dose was repeated immediately in the contralateral arm.
Information has been received from a consumer concerning her 6.5 year old son who was vaccinated with three doses of measles virus vaccine live(Ender-Edmonston). Secondary suspect therapy included three doses of MUMPSVAX and MERUVAX (Wistar RA 27/311). The monovalents were given at 12, 13 and 14 months, on approximately January 2004, February 2004, and March 2004, respectively. On an unspecified date, the patient experienced "late talker", with developmental delays and trouble with word retrieval. The outcome of the events and action taken were unknown. No further information is available.
pt recv vax & had a sl fever & sore legs that evening & the next day; pt left for camping trip; Father found pt face down w/back arched; pt blue & unresponsive; no resp or pulse detected-father started CPR; pt again became unresponsive
received booster shot and reported severe illness; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "received booster shot and reported severe illness".  Additional information: Patient received booster shot and reported severe illness for approximately 2 weeks after receiving dose. Event took place after use of product.  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.
Pt received yellow fever vaccine 2/4/13. Developed urticaria & redness (L) injection site 2/6/13 > conferred with MD. Instructed to observe x 1 wk. Sxs faded & reappeared after 1 wk. Pt applied cortisone cream (has used before without event). Injection site became bright red & swollen saw MD 2/11/13. Prescribed ZYRTEC sxs resolved after 24 hours. Today 2/13 injection site ecchymotic, sore, tender to touch.
Tinnitus in both ears developed on the date indicated (November 2021) after a head cold the week prior and vertigo the morning of the onset of tinnitus. I had not ever had either vertigo or tinnitus before. Have had audiologist exam and hearing test. The tinnitus has been constant since onset.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # N008077, expiration date: 09-MAR-2019, for prophylaxis (dose number and route of administration were unknown); which was reconstituted with properly stored sterile diluent. The dose was stored between 6 Fahrenheit (F) degrees and 14 Fahrenheit degrees for 6 hours and 15 minutes. The temperature excursion was detected by a digital data logger. No previous temperature excursion was performed and no adverse effects were reported.
Received booster 10/8 at 12:15PM and developed vertigo; Received booster 10/8 at 12:15PM and developed vertigo; Received booster 10/8 at 12:15PM and developed vertigo; This is a spontaneous report received from a contactable nurse (patient). This nurse reported events after the second and third dose. This is the second of two reports (dose 3). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number 30145BA), administered in left arm on 08Oct2021 12:15 PM (at the age of 68-year-old) as dose 3 (booster), single for COVID-19 immunisation. The patient was not pregnant. The patient's medical history included high blood pressure (HBP), irritable bowel syndrome (IBS), hypothyroid, and sinus infection, all from unspecified date, vertigo from 2013. The patient had no COVID-19 prior vaccination, and she had no known allergies. Concomitant medications included amlodipine besilate, nadolol, levothyroxine sodium (SYNTHROID) aliskiren, acetylsalicylic acid (ASA), all from unspecified date and taken within two weeks from vaccination, influenza vaccine inactivate split 3v (FLUZONE HD 65+Pf) on 28Sep2021 as single dose for influenza immunization. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6208) on 14Mar2021 12:15 PM (at the age of 67-year-old) as dose 1, single for COVID-19 immunization, and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733) on 10Apr2021 10:00 AM (at the age of 67-year-old) as dose 2, single COVID-19 immunization and she experienced severe vertigo, nausea and heavy breathing on 12May2021 required an emergency room (ER) visit and treatment received due to the events included intravenous (IV) diphenhydramine (BENADRYL) and ondansetron (ZOFRAN) for nausea and dizzy. She developed several other vertigo events on 17Sep2021 and 20Sep2021 also requiring ER visits with similar symptoms. It was reported that patient received booster on 08Oct2021 at 12:15 PM and developed vertigo at 03:00 AM 09Oct2021. Vertigo continued for next several days with relief from meclizine. She went to ER on 11Oct2021. Vertigo went away on 13Oct2021 after treatment with diazepam (VALIUM) 2 doses 2.5 mg. Vertigo started again on 27Oct2021 with no relief of meclizine or VALIUM. Vertigo continued. She had seen internist and otolaryngologist (ENT) without any relief. The outcome of the events was not resolved.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and Immunization, Vertigo, disease recurrence cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101465313 Same reporter/SD, Different potential/AE
Rash started on ears bilaterally, then spread to cheeks and upper arms over next several days.
Patient called on 8/21/2020 to let me know she noticed a swollen right eye and sinuses after her shot yesterday evening.  She took an antihistamine and has had no issues today.  She just wanted it documented.  She states she has idiopathic angiedema and gets swelling for no obvious reason sometimes.  No breathing issues reported at any other time.  Did not feel need to contact md.
Burning sensation in my feet; Felt very weak; Wrong Vaccine Administered; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 01Nov2022 as dose 3 (orange cap, booster), single (Lot number: FF9442Z) at the age of 35 years, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE, Anatomical location: Right arm), administration date: 30Nov2021, for COVID-19 immunisation; Comirnaty (DOSE 2, SINGLE, Batch/Lot number: Fd7639, Anatomical location: Left arm), administration date: 02Sep2022, for COVID-19 immunisation. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 01Nov2022, outcome "unknown", described as "Wrong Vaccine Administered"; BURNING SENSATION (non-serious), outcome "not recovered", described as "Burning sensation in my feet"; ASTHENIA (non-serious), outcome "not recovered", described as "Felt very weak". The events "burning sensation in my feet" and "felt very weak" required physician office visit. Therapeutic measures were taken as a result of burning sensation, asthenia.  Additional Information: Patient had administered booster dose and since after 3 month has burning sensation in feet. Patient feel it every day in evening and felt very weak, ice massage help him out. Patient's doctor prescribed him multivitamin for that but nothing helped. And issue still persist.  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-202300273026 same patient, different dose/event (LOE);US-PFIZER INC-202300273025 same patient, different dose/event (At Risk);US-PFIZER INC-202300273027 same reporter, different patient/event/dose;
Patient had covid vaccine x 2. Last dose on 2/8/21. Admitted to Hospital on 08/15/2021 with covid symptoms. Positive COVID specimen on 8/15/2021. Patient expired at hospital on 8/18/2021.
Swollen, warm to touch, erythema left arm/shoulder.  Warm compresses/MOTRIN
COVID positive.  Cough, tired, aches, low fever for one day.  Was ill for 3 days, cough for 2 weeks.
really tired; excessive heat production; blocked/clogged ears; trouble hearing; face was red; sweating; Headache; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team. The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Jan2022 19:45 (Lot number: FL8094) at the age of 10 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Covid vaccine: 03Jan2022, Lot Number / Expiry Date: FK5618/unknown, Route, Anatomical Location: right arm), administration date: 03Jan2022, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 25Jan2022, outcome "not recovered", described as "really tired"; FEELING HOT (non-serious) with onset 24Jan2022, outcome "not recovered", described as "excessive heat production"; EAR DISCOMFORT (non-serious) with onset 24Jan2022, outcome "recovered" (24Jan2022), described as "blocked/clogged ears"; HYPOACUSIS (non-serious) with onset 24Jan2022, outcome "unknown", described as "trouble hearing"; ERYTHEMA (non-serious) with onset 24Jan2022, outcome "recovered" (24Jan2022), described as "face was red"; HYPERHIDROSIS (non-serious) with onset 24Jan2022, outcome "not recovered", described as "sweating"; HEADACHE (non-serious) with onset 24Jan2022, outcome "not recovered", described as "Headache".  Additional Information: Additional vaccines administered on the same day and prior vaccination within 4 weeks was reported as none. The reporter stated that about 20 minutes later while driving home, the patient complained of excessive heat production and blocked/clogged ears which caused trouble hearing, ''hard for me to hear, mommy I'm too hot''. At home, the patient's face was red, was sweating only a little bit but not profusely. The reporter went to wake her child up, he was still tired, and he had no fever.   No follow-up attempts are possible. No further information is expected.
Not enough sterile diluent was added to the Pfizer vial prior to administration to the patient. It is likely that not enough MRNA was administered to qualify as a booster.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 10:35 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 10:35 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 52.02.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time and temperature were 09AM: 34 and 10 AM: 37 respectively. total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021 and vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021. On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44 , 4 PM: 44 and 5 PM: 43. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Received injection in Left Deltoid. 5 hours later had extreme pain in the whole arm. Cound not lift arm up. Pain radiated across shoulder and could not move neck. Became Short of breath, weak, sick to stomach and anxious with heart racing. 3 days later still doesn't feel like self.
IRRITABILITY; FACIAL NUMBNESS; LIP TINGLING; NUMBNESS IN THE BACK OF THE THROAT; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. Patient had no any medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-NOV-2021, the patient experienced irritability. On 19-NOV-2021, the patient experienced facial numbness. On 19-NOV-2021, the patient experienced lip tingling. On 19-NOV-2021, the patient experienced numbness in the back of the throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from facial numbness, lip tingling, numbness in the back of the throat, and irritability. This report was non-serious.
Patient's immune thrombocytopenia was quiescent 15 months but relapsed 2 weeks after receiving first and only dose of Pfizer Covid vaccine. Non-critical GI bleed.  Also neutropenia. Treated with IVIG and high dose prednisone with response.
Patient reports all symptoms started the morning of 5/20/10. Weakness and pain in both legs.  Alternates taking ibuprofen 800 mg x 3-4/day and the enxt day takes Percocet 5/325 x3/day.  Takes ibuprofen and Percocet every other day on alternate days.  "Leg pain is sometimes unbearable." Loss of bladder control.  Wets self during night when sleeping & decreased control during day.  Wears Poise pads. Slurring of speech.