chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Stroke-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Unable to Sleep-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: 2 days after receiving 1st dose had a stroke, went to Hospital had 3 more light strokes, loss of vision in left eye, shuffles to walk, BP not under control,  patient was discharged and following up with PCP.
Blood pressure shot up to 165/110, there were several measurements taken and most of them were in the range of 158/95 to 165/110; Blood sugar level it was 50; Pulse shot up to about 100; Tingling sensation after about 15 minutes at the site of the shot.; tingling was followed by severe shortness of breath; Feeling of numbness in my lower legs; Extreme weakness; This is a spontaneous report from a non-contactable consumer or other non hcp.   A 47-years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EL9264, Pfizer NTEC), via an unspecified route of administration in Arm Left on 22Feb2021 14:45 as 1st dose, single dose for covid-19 immunisation. Medical history included obesity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had no known allergies. The patient do not have COVID prior to vaccination. Since vaccination , the patient was not tested for COVID-19. On 22Feb2021, at 15:00, after about 15 minutes, the patient experienced tingling sensation at the site of the shot, tingling was followed by severe shortness of breath, Pulse shot up to about 100, Blood pressure shot up to 165/110, there were several measurements taken and most of them were in the range of 158/95 to 165/110, feeling of numbness in the lower legs, Extreme weakness. When the emergency staff checked the blood sugar level it was 50, although she had taken lunch before the shot. Adverse events resulted Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment received for adverse events. The outcome of the events were recovering.
vaccinated 1/2/2021.  Positive COVID PCR on 1/7/2021.
This case was reported by a physician via sales rep and described the occurrence of cellulitis in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), erythema of extremities and swelling arm. On an unknown date, the outcome of the cellulitis, erythema of extremities and swelling arm were unknown. It was unknown if the reporter considered the cellulitis, erythema of extremities and swelling arm to be related to SHINGRIX. Additional details were provided as follows: This patient received SHINGRIX from a pharmacy. The patient then called physician's office and told his arm was red with swelling. The patient was diagnosed with a cellulitis according to physician. The physician said that this was different in his estimation than redness and swelling. The reporter did not agreed upon follow up from GlaxoSmithKline.
Tenderness and swelling at the site High fever for 4-5 days Fever up to 103 deg.
Pt complained of difficulty swallowing, lump in throat, and increasing heart rate.   VS 98.9 181/100 87 99 RA.  Activated Alert, brought to the ED.  Epi and  benadryl given.
I woke up with a hive near the injection site that gradually grew into a large itchy hot welt .  Prominent for 3 days then gradually faded away.
This is in follow-up to report(s) previously submitted on 11/14/2008. Information has been received from a nurse concerning a female who was vaccinated with the third dose of 1 tube of oral ROTATEQ when she was 9 months and 27 days old. No symptoms were noted. No product quality complaint involved. Additional information has been requested.
Joint aches for 48 hours; Fever & chills followed by severe headache beginning 8 hours post injection and continuing all night and next morning. Terrible. Truly painful and worse than a flu. Followed by intense Fatigue fir an additional 24 hours. And brain fog. Hungry but eating food made me nauseous. Total duration 48-72 hours scariest part was racing heart fir 8-12 hours, incredible thirst but water added to nausea.
The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 25-FEB-2014 was vaccinated (Oka-Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Moderna COVID-10 EUA patient stated "The spot was red and there was a lump/welt, it was slightly warm but not Hot! It did itch and it did hurt to touch or lay on it. Small red area day after being given (Wed.), then darker and bigger (Thurs) very faint but still sore (Fri)
Within a week he stopped progressing in speech and motor skills, became aggressive, poor modulation, unable to participate in activities, excessive eczema, GI problems.
Patient received vaccine yesterday. Today, he was noted to have decreased appetite and was sleeping more than usual. Was warm to touch but not febrile. Threw up once. Seems uncomfortable. No other symptoms at this time.
Information has been received from a registered nurse concerning a female (age not reported) who on 30-JAN-2007 was vaccinated with the second 0.5 mL dose of HPV vaccine.  Concomitant therapy included unspecified hormonal contraceptives. On 31-JAN-2007, the patient developed a rash under skin that covered entire body except her legs.  The patient sought unspecified medical attention.  At the time of this report, the patient had not recovered from the event.  The nurse did mention that the patient "did not have a reaction to the first injection of HPV vaccine. Additional information has been requested.
From telephone contact received on 3/1/02 at manufacturer, it was reported that an 18 month old male received Tripedia in the left thigh and IPOL in the right thigh on 2/28/02. Patient developed a rash with hives and welts all over his body. Both thighs were swollen. Seen by the doctor today, 3/1/02, Benadryl and Oraprez syrup prescribed. From additional correspondence received on 11/18/02, it was reported that the pt has one sibling, and weighed 7.15 pounds at time of vaccination. Pt received two previous doses of IPOL, this was his third. During data entry of the follow-up info, it was noted that the pt's age at the time of vaccination was 20 months and not 18 months as previously reported. No additional info was provided. It was  not reported whether the pt recovered.
Pains; Fatigue; Fever; Chills; Aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pains), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches and pains) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Lasted for 2 weeks) from November 2020 to December 2020. Concomitant products included NADOLOL, ALOPURINOL and LEFLUNOMIDE for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN (Pains), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches and pains). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 20-Mar-2021, PAIN (Pains), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches and pains) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reported. It was unspecified whether the patient had sought any medical attention. There was no product quality complaint involved. Follow up information has been received from office manager, who stated she may call back or fax information as it becomes available. Also, reported that MMR II was not mentioned in the original call, but did not experience a temperature excursion. No further information was available at the time. Follow-up information as received from office manager refers to a 19 months old patient. On 13-JUN-2014 the patient was vaccinated with a dose of improperly stored MMR II (lot # J011332, expiration date 13-SEP-2015) (strength, dose and site of administration were not reported). This is one of several reports from the same course. Additional information has been requested.
I had double vision. Ejection fraction was at 40-40% at the doctor in August of 2020. Mid February I went into the hospital with the double vision. No treatment was given, just a change in medication for the ejection fraction. I was told to go home and it should clear up on it's own.
Pins and Needles/ sunburn feeling in shoulder and upper arm. Tender area where shot was given. Skin is hypersensitive flu shot given.
received a Covid-19 Booster vaccine; received a Covid-19 Booster vaccine; nausea; This is a spontaneous report from a contactable consumer (patient sister) reported for a consumer(patient).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on 24Sep2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccines included COVID-19 VACCINE (MANUFACTURER UNKNOWN) dose 1 and dose 2 (Primary Immunization series complete but unknown manufacturer) both doses taken for COVID-19 Immunization. The reporter stated that her sister (patient) received a Covid-19 Booster vaccine last Friday and that she also experienced nausea after that vaccine (on an unspecified date in Sep2021). Outcome of event nausea was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (06Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
developed redness, swelling, itching, hot to the touch, and hardness on his RIGHT Outer thigh,
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 83-year-old male patient received BNT162b2 (BNT162B2), on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 83 years for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing), notes: on thyroid pills; "blood pressure" (unspecified if ongoing), notes: On some blood pressure pills and few other medication. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 02Feb2021, when the patient was 82-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 26Feb2021, when the patient was 82-year-old, for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "not recovered", described as "itch"; RASH (non-serious) with onset 2021, outcome "not recovered"; CONDITION AGGRAVATED (non-serious) with onset 2022, outcome "not recovered", described as "It has worsened over the last 2-3 weeks"; HYPOACUSIS (non-serious), outcome "unknown", described as "hard of hearing". Additional information: He asked his primary care doctor and he told him he thought it would be a good idea to get the COVID vaccines. The patient just thought the rash and itch would go away. He had a rash and an itch that started sometime after he took the booster dose of the vaccine. It didn't start right now. It got a little better and then came back. Over the last 3-4 weeks, it got really bad. He had no bumps it just itches. It had worsened over the last 2-3 weeks. He hasn't received his pneumonia or flu shot. At first it wasn't that bad. It was just a little itch. It was not like it was now. He had it every day and night now. It doesn't last all day and night but always comes back. It was also reported that he was hard of hearing. He was on some Blood pressure pills and few other medications. He had little issues before, but it usually goes away. Nothing had been as bad as this one. He doesn't know if any of his medications have anything to do with it. He was on thyroid pills. He was on something to help him relax and rest if he needs it. He takes those more often. Vaccine was administered on left shoulder. The patient had no additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks). The patient had no investigations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: stroke, and concurrent conditions included: many allergies, and allergic to chromium in needles. The patient was previously treated with acetylsalicylic acid for stroke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious.
Fever above 100.4 with onset at day 6 after injection.; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0158) via an unspecified route of administration on 12Apr2021 (vaccination at the age of 41-year-old and non-pregnant at the time of vaccination) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history included COVID prior vaccination, breastfeeding after recent pregnancy and known allergies to oranges (mild). Concomitant medications were not reported. Not tested for COVID post vaccination. On 18Apr2021, the patient experienced fever above 100.4 with onset at day 6 after injection. The outcome of the events was unknown.   No follow-up attempts are possible. No further information was expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021444637 Exposure During Breastfeeding
Herpes zoster ophthalmicus, which started within 7 days after administration of the vaccine. Prior to lesion outbreak, pt had significant redness and swelling at injection site. She had not had shingles previously. Please contact pharmacy directly for lot and manufacturer number. She DOES  have a history of chickenpox.
Positive for Covid19. Started with sudden onset of Bronchitis, then 5 days later moved into a sinus infection, then a week later started to feel like a head and chest cold.  Was sick from 12/26/21 and felt better enough to go to work on 1/10/22. Treated with steroid and cough meds.   Still had cough  until 2/1/22.
Information has been received from a physician concerning his son a 13 year old male with NKDA and a Hx of a twisted right knee on 02/27/2005 who  on 11/22/1995 was vaccinated in his LL with a 0.5ml dose of varicella virus vaccine live. Concomitant therapy included Medrol Dosepak. On 03/03/2005 the pt developed chickenpox that began with hot, red, vesicular nodule behind the right ear that became diffuse. Unspecified medical attention was sought. A RX of acyclovir was called in . At the time of the report the pt had not yet recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2005. Information has been received from a physician concerning his son a 13 year old male with no medical history or allergies who on 22-NOV-1995 was vaccinated inhis left thigh with a 0.5 mL, first dose of VARIVAX (Merck) (lot# 612211/0752B). There was no illness at the time of vaccination. Concomitant therapy that became diffuse. It was reported that thnt has greater than 100 pox. Unspecified medical attention was sought. A prescription of acyclovir was "called in". there were no laboratory diagnostic tests performed. It was reported that "chickenpox is active in the school". There were no adverse events following prior vaccination. Subsequently, "approximately two weeks later", the patient recovered. Information received on 04-MAY-2005 contained the following adverse experiences: anterior cruciate ligament tear (27-FEB-2005). Additional information is not expected.
Patient given 0.5cc, adult dose of Sanofi H1N1 vaccine, instead of 0.25cc pediatric dose.
Lost range of movement in right arm.  Extremely painful . Went to ER on 4/3/2021 3am . ER Dr said it was from the injection being given to high.  Still have no range of movement in arm. Talked to primary Dr following up with. Neurologist from medical.
Information regarding Flu Shield was received from a consumer, a 51 year old female pt, who experienced injection site reaction, the "site was big, red, hot." At 51 years of age, the pt received a dose in 2001. The event resolved with "rubbing and massage." No additional info was available at the time of this report.
Public Health Nurse RN gave MD wrong dose/type of H1N1. Patients should have received 0.25 ml preserv and instead she gave MD 0.5 ml H1N1 with free preservative.
on second day p/vax severe chills, sweating & uncontrollable shivering for several hr;regular blankets, electric blanket, & hot showers required to stop chills;muscle pain @ point of vax;other muscle pain also;
Chilss, nausea, fever - 100 degrees, stomach cramps for 3 days.  Took 8 pack of zithromax.
My left leg will not work anymore; I can''t use my left leg; My foot started getting numb; my leg started getting tired; This is a spontaneous report from a contactable consumer or other non hcp.   A patient of unspecified age and gender received bnt162b2 (BNT162B2), (BNT162B2, Formulation: Solution for injection, Batch/Lot Number EN6198) dose 1 single  via an unspecified route of administration on an unspecified date for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced my left leg will not work anymore, I can't use my left leg, my foot started getting numb, my leg started getting tired reported. Patient  stated, "I am having some bad adverse effects of this COVID Vaccine that I took. My left leg will not work anymore, when I walked in there to get the vaccine, everything was fine, ever since then, I can't use my left leg.  It was reported that patient stated as the date they gave it to me, 01Mar2022 or something like that oh 21 I mean (further not clarified the date for first vaccine). Then I got the second shot. I got my second shot on 22Mar2021.When probed if the consumer started facing the side effects after the first or the second shot, Patient stated, I guess my leg started, my foot started getting numb, my leg started getting tired and then none of it wants to work right now and it kept getting progressive, progressively worse. The first shot I got went too bad, the second shot I got, it was even worse and a week down the road, it was even worse, 2 weeks down the road, it was even more worse, it keeps getting worse. The outcome for all events was unknown.
Patient reports feeling nauseous, dizzy, flushing, no palpitations. Reported feeling better after 10 minutes- cleared by EMS
Approximately 2 weeks post vax pt experienced a rash consisting of 50 skin lesions, described as vesicular in type that were spread evenly over the pts entire body.
R arm swelling with swelling up into the shoulder and collar bone area very tender. No redness noted. No fever. Mild to moderate pain. Symptoms lasted one week and then was gone.
Presented to ER on 11/26/21 and was admitted. presents with a several day history of worsening dyspnea and cough.  Patient is reported to have tested positive for COVID 19 in the outpatient setting.  Is vaccinated but yet to received booster. She was noted to be hypoxic on arrival with a pulse oximetry as low as 84% on RA.  She is now on 2L NC and O2 sats remain in the low 90s.  She has an unremarkable laboratory workup at this time. Was placed on azithromycin and ceftriaxone. Received remdesivir and dexamethasone. On 12/2/21, Pt is alert and oriented, denies pain. Denies headache, nausea and vomiting.Denies recent fall. Patient vitals within normal limits. Will be discharge this shift with home oxygen. Pt currently at 4 liters of o2-saturating currently at 93%.
After recieving the second COVID vaccine on 9/18/21 on October 21, 2021 she started experiencing phantom smell of rotting meat (phantosmia). It comes and goes.  She experiences it with certain drinks/foods. She has no other symptoms, illnesses, or underlying conditions.
Fever (102), chills, headache and extreme sleepiness started ~21-22 hours after shot and lasted about 8 hours
Approximately 10 minutes after vaccination, child C/O feeling "not right". While attempting to assist him from standing to sitting, he became limp, slumping to the floor, seated, then fell back hitting his head (back of the head) on the floor; was unaware of surroundings for 15 seconds or less; sits up on his own despite efforts to keep him lying down. Mom and nurse at his sides; C/O pain to occipital area at site of impact. No swelling noted, BP 80/60, P 120; mild twitching and muscle rigidity in arms while unaware of his surroundings. 10:45 - BP 80/60 P 100 R even unlabored; 911 call; mom states she believes his had seizure activity at least twice in his lifetime, unrelated to vaccination and undiagnosed. Ice pack to contusion; no meals eaten today, only a popsicle. 10:48 - EMS crew here; no other C/O of pain other than back of head; states he feels "normal". 11:05 - child walks himself to gurney; episode appears to be syncopal due to vasovagal response to injection. Transported for evaluation of head injury and reported history of seizure activity in the past. 11:30 - Reported incident to doctor. 12:45 - Spoke to mom; child released home with ice pack to head post fainting spell.