chrisvoncsefalvay/vaers-outcomes huggingface dataset:
real bad back problems, back pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported that a 77-year-old male patient (husband) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot and expiry not reported), via an unspecified route of administration on 23Jan2021 at single dose for covid-19 immunisation. Medical history included back issues (on and off). The patient's concomitant medications were not reported. It was reported that both consumer (wife) and patient (husband) received the first dose of Pfizer COVID19 vaccine on 23Jan2021. The wife reported that the patient been having real bad back problems, back pain that started 2-3 day afterwards (in Jan2021) and asked if that was one the side effect of the covid-19 vaccine. It comes and goes and was currently ongoing. The event was considered by the wife as non-serious. The patient did have a history of back issues on and off and they planned to discuss this further with his back doctor. Second dose was currently scheduled for 14Feb2021. The wife asked that due to back pain if the patient should get the second dose and/or could it be rescheduled. The outcome of the event was not recovered.  Information about lot/batch number has been requested.
nurse administered only the adjuvant portion of the SHINGRIX vaccine; nurse administered only the adjuvant portion of the SHINGRIX vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: nurse administered only the adjuvant portion of the SHINGRIX vaccine) and inappropriate dose of vaccine administered (Verbatim: nurse administered only the adjuvant portion of the SHINGRIX vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 18-JUL-2023 A pharmacist reported that he/she worked at a pharmacy that supplies medication to a long-term care facility. The pharmacist received a call from the long term facility, Facility reported that a nurse administered only the adjuvant portion of the Shingrix vaccine. The reporter consented to follow up. The patient only received adjuvant which led to inappropriate dose of vaccine administered and inappropriate preparation of medication.
Itching hives; Felt like was burning out her skin; Painful hives; Burning hives/Big hives that covered whole body from head to toe; fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching hives), SKIN BURNING SENSATION (Felt like was burning out her skin), PAIN (Painful hives), URTICARIA (Burning hives/Big hives that covered whole body from head to toe) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Lidocaine reaction: heart rate increase.) and Anesthesia (Once trouble waking up and another time woke up prematurely).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching hives), SKIN BURNING SENSATION (Felt like was burning out her skin), PAIN (Painful hives), URTICARIA (Burning hives/Big hives that covered whole body from head to toe) and PYREXIA (fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching hives), SKIN BURNING SENSATION (Felt like was burning out her skin), PAIN (Painful hives), URTICARIA (Burning hives/Big hives that covered whole body from head to toe) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking other medication.  Treatment medication included Benadryl, but did not help.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up received: Added patient height and weight, medical history, new events. Updated out come of the events from unknown to recovered/resolved.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. An 18-year-old male patient of an unspecified ethnicity received his first dose of TRUMENBA, via an unspecified route of administration at the age of 18-years on 27Jun2016 at 0.5 ml, single for immunization. The patient's medical history and concomitant medications were not reported. The patient had redness and swelling at injection site, fever, felt weak and body aches which occurred on Jun2016 after the first dose, and concerned about getting the 2nd dose. The patient missed 3 days of work. The events took place after use of product. The outcome of the events was unknown.
On 10/10/2022, I woke up expecting to feel badly from vaccines, but I felt worse than I expected. I felt like I was recovering from a marathon. I felt lethargic and my heart was racing. I have border line high blood pressure, so I thought it may have been that, so I was just monitoring that and other symptoms. For the next three days, things remained about the same. If I was standing, walking, or doing anything other than laying or sitting, my heart was racing. I was getting foggy, and it felt like I wasn't getting enough oxygen. My head would pound and throb when I was standing and walking. I ended up emailing my physician about my concerning symptoms, and the fact that they were lasting longer than previous vaccine side effects. I went in on 10/14/2022 and they performed an ECG. They sent me straight to the emergency room based on the results of the ECG. They were concerned I was having a pulmonary embolism from the vaccines. At the emergency room they ran a CT scan to check for blood clots but did not find any. They did a follow up ECG and saw similar results, but stated that I was not in immediate danger, so they sent me home and advised that I follow up with my primary care doctor. I basically feel back to normal now with the exception of when I walk long distances, I get winded.
It began with Proteins in my urine on 09/03/2021 that steadily increased just after injection, climaxing at about a month afterwards, and has continued at about the level of 300mg's per DL. I had an onset of Vertigo that has persisted since 09/10/2021, that my doctor has found no cause or process to treat. I was diagnosed in December with an Auto-Immune disorder that is likely causing damage to my kidney's. My nephrologist does not want to do a biopsy yet.
A 30-year-old male patient, with no illness at the time of vaccination, had received a left arm, intramuscular injection of FLUZONE SV 2007-2008, lot number U2526AA, on 15 November 2007. Two minutes post-vaccination, the patient stood up, began walking, and felt lightheaded and dizzy. He also experienced sweating and ringing in his ears. The patient's blood pressure was checked and found to be 90/72, sitting. He was provided to glasses of water to drink after which his symptoms began to subside. Subsequent blood pressure readings were 102/78, 100/78 and 110/89. After 30 minutes, the patient completely recovered. Follow-up information received on 20 November 2007 from a health care professional. The reporter confirmed that the patient had not died and that the death date was filled out in error on the VAERS form.
sciatica attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 25Feb2021, for COVID-19 immunization. The following information was reported: SCIATICA (non-serious) with onset 2021, outcome "unknown", described as "sciatica attack". Therapeutic measures were not taken as a result of sciatica.  Additional information: Caller said that her concern would have "nothing to do with that" [vaccine]. Caller mentioned she has had a "sciatica attack" wherein she has a "really bad and severe pain on the back and legs". She was advised by the Pharmacy not to take Advil after the vaccination, and Caller seeking clarification on this. It was reported that Caller received her 1st dose last 25Feb2021 and she received her 2nd dose today 25Mar2021 which is more than 21 days apart from her 1st dose. She is experiencing a severe back pain or Sciatica. She did not take any medicine. Now, she wants to know if it is safe to take Advil.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The women mentioned that since she had her second vaccine dose her eyelids have been twitching; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). An elderly non-pregnant female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 02Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On 03Feb2021 patient experienced twitching of eyelids. It was reported that since she had her second vaccine dose her eyelids have been twitching. No treatment was taken for adverse event. It was unknown if patient had other vaccine in 4 weeks or patient had COVID prior vaccination. It was unknown if patient was tested for COVID post vaccination. The outcome of event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
11APR90 vaccinated w/3rd dose of Hepatitis developed nausea & vomiting, remitted in 2 days, & chills x 1 wk; Approx 18APR90 ecchymosis, 1-2in, medially to lt deltoid inject site which was visable 1 wk later.
pt devel flu-like syndrome including fever; myalgias; sore throat & nasal congestion; seen in ER where T102.6 (oral) was measured
1 cm induration and swelling left thigh without redness or fever. Slight pain with walking onset 8-27-08
This spontaneous report as received from a pharmacist refers to a currently 69 year old male patient. The patient had no pertinent medical history, no drug reactions or allergies. On 23-MAY-2016, the patient was vaccinated with ZOSTAVAX, 0.65 ml, once, subcutaneously, lot # L035506, expiry date 16-DEC-2016. Concomitant therapies included lisinopril (manufacturer unknown), atorvastatin and zolpidem tartrate (manufacturer unknown). In approximately May 2016 (reported as unspecified time after receiving ZOSTAVAX), the patient experienced red spots all over his body that were itchy. There were no lab diagnostic studies performed. The patient took BENADRYL (also reported as manufacturer unknown) as treatment. The outcome of red spots all over his body that were itchy was reported as not recovered at the time of the report. The patient called the pharmacist to seek medical attention. The relatedness between the event and the suspect therapy was not provided. Additional information has been requested.
On my first day the site looked very nice. As a Nurse, the nurse did a really nice forearm intradermal injection. The site was a little bit red and continued to get more red till day three.  On day 4 the redness was reduced  but the site was swollen and a bit tender. The next day- day 5 the site was  hard and tender for about 1cm  from the site. This remained  till day 10 the site tenderness had reduced and  is now scabbing over?  Sort looks like it has dry skin around it and the site is darkened
Severe headache, body aches, chills x 2 days.  Upper R calf cramp like pain x 1-5 days post vaccine
This spontaneous report was received from a physician assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, while receiving GARDASIL 9, lot # L001312, expiry date 24-FEB-2107, parental, (dose, dose number unknown) the prefilled syringe leaked for an unspecified reason and the patient received half dose (underdose) The schedule of vaccination and dose number was not reported. No adverse effect was reported. This report was involved with a product quality complaint. Additional information has been requested.
ARM PAIN, FEVER 101, JOINT PAIN FOR 24 HRS. TOOK TYLENOL 500MG 2 TABLETS
Approx 5:30 pm developed lightheadedness, H/A, nausea. Approx 15 min later states "passed out" - fell to the floor, hit back side of his head. Thinks he may have been out for a few minutes. Rested in bed until 9:30 pm - felt better had toast and milk. Lightheaded, H/A and nausea started to subside. Wen to sleep - awoke 10/31 feeling better but still tired and with rt arm soreness at vaccination site. Noticed pain in rt foot - 1st 3 toes black and blue from the fall. Still tired and slept most of the day on 10/31/14. Denies s/s from back rt side of head - nothing seen on 11-3-14. Advised to phone PMD to discuss above incident and for evaluation. States he will.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. The patient was vaccinated with GARDASIL injection 120 Y(dose,route and lot#unknown) on 08-JUL-2013 and 24-JUL-2013. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. There was no PQC. It was unknown if the patient had sought medical attention. The outcome and action taken were not provided. Additional information has been requested.
Pt recvd 1st dose of Engerix-B 23OCT91 & 3 wks later pt exp hives; 2nd dose of vax recvd 3DEC91 @ 2PM & 12 hrs later pt exp stomach cramps w/vomiting; in 24 hrs pt exp hives under arms, waist area, back of knees & in scalp;
severe rash on left leg  and hip 4 days after shot.  Immediately after shot, pain in left hand.; severe rash on left leg  and hip 4 days after shot.  Immediately after shot, pain in left hand.; Shingles Variant; This is a spontaneous report received from a contactable consumer. This 47-year-old female consumer (Patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot_number=EN6207) at single dose for COVID-19 immunization on 25Mar2021 at 08:30 AM. Relevant history included high blood pressure and Bi-Polar II. Relevant concomitant drug received within 2 weeks of vaccination included Ambien, Linsilpril, Seroquel, Paxil. The patient experienced severe rash on left leg and hip 4 days after shot (on 29Mar2021 at 08:00 AM).  She was still diagnosing, but thinking a Shingles Variant which was  Very Painful.  She was awaiting dermatologist review. Treatment therapy included Triamcinolone, Gabapentin, Valacyclovir, prednisone. Outcome of events was not resolved. The event was assessed as non-serious. Due to the events the patient visited Doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID prior vaccination. The patient had not tested for COVID post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.    No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 12 month old female patient who on 3/17/04 was vaccinated with a dose of varicella virus vaccine live. On 3/30/04, the patient's mother brought her to the physician's office with a case of the chicken pox. The physician recorded that the patient's body was covered with 75 to 85 lesions, particularly in the extremities and cheeks area. The patient had some scabbing over parts of her body. There was no fever. Subsequently, the patient recovered. A product quality complaint was not involved. Additional information has been requested.
Heart palpitation 1st day Sleepiness     2  day Visions-hallucinations 3rd day Memory loss 2 wks later Confusion    3 wks later Forgetfulness   3 wks later
Patient developed shortness of breath, swelling sensation and tingling of the tongue. Vitals stable. Airway patent, no voice change, no wheeze. Symptoms improved with observation. Tongue symptoms continued with some swelling. Patient offered IM Benadryl which she refused. Patient transported to ED via EMS.
During 15 minute required wait time- experienced mild anxiety, slightly elevated HR and headache, was told to drink water and take tylenol if needed and was cleared to leave. About 10 minutes after leaving, approximately 1235, had facial and lip tingling followed by numbness. Numbness lasted for nearly 3 hours. At about 1250 experienced tinnitus, lightheadedness, mild shortness of breath and palipations. Used rescue inhaler (albuterol) and antihistamine, SOB resolved few minutes after use. Palpitations and tinnitus lasted for approximately 3 hours after onset. At 8pm, went to bed, headache and mild arm soreness present and felt off. By morning, headache and sinus congestion present, mild, increased arm soreness.
Patient states she developed a large lump on arm/shoulder. It was itchy and when she went home had trouble breathing which she thinks may have been from the flu shot, but she states it was only for a short period of time.
Patient had routine 2-mo immunizations on 3/24/14 -> admitted to hospital for intussusception on 3/29/14 and treated successfully via barium enema.
Body aches, chills, shortness of breath. Took ibuprofen for a day and then the adverse effects were no longer present.
mom called 17NOV97 & stated that on Saturday 15NOV97 pt had elevated temp & convuls;mom stated pt temp went from 100-104;
had numbness in my right hand for 2 days; This is a spontaneous report received from contactable consumer or other non health care professional by Pfizer from product quality complaint.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination, the patient had numbness in right hand for 2 days. The clinical outcome of event was unknown.   Information about lot/batch number cannot be obtained. No follow-up attempts are needed. No further information is expected.
GI upset- nausea, diarrhea - started approx. 24 post immunization, continued x 48 hours. No treatment.
Maybe thirty minutes later at home she was having a spotty rash through out her body. It was on her hands legs and on her chest. It did not seem to bother her. We do not assume it was itchy or painful. We contacted her PCP via tele conference at 05:15pm. They said to give 2ml of Children's Benadryl.  The medicine seemed to work and she went to sleep.  As of today the rash is completely gone.
Shortness of breath, chest pain 2nd day of shot August 2 Fever, chills , chest pain and shortness of breath August 3, worse at night Chest pain and shortness of breath August3, 4, 5, 6,7 Treatment Tylenol, DayQuil, breathing exercises, rest and lots of Powerade.  Emergent Vitamin C drinks one a day. Reported symptoms to Dr  on August 9
Initial and follow up information has been received from a RN concerning a 71 yr old white male pt who on 09Mar06 was vaccinated IM into the right deltoid with a 0.5ml first dose of pneumococcal 23v polysaccharide vaccine (651320/1008P). On 09Mar06 in the evening, the pt experienced swelling, redness and pain in the right arm at the injection site. The pt also developed cellulitis and injection site local heat. The pt was treated with cephalexin (Keflex) 500mg every four hours for 10 days and diphenhydramine hydrochloride (Benadryl) 25 mg every 6 hrs PRN. Subsequently, the pt recovered. No product quality complaint was involved. Injection site local heat and cellulitis were considered to be other important medical events (OMIC). Additional information is not expected.
16MAR93 pt recvd vax & started fever @ 1PM, t104.6 oral by MN; severe vomiting started 7PM, hallucinations, picking in air, screaming, arched neck; 17MAR93 t102 oral, hallucinating;
Headache, Myalgia, Arthralgia, Fever, chills Narrative:  At 6pm the day she received the vaccine, patient reported injection site soreness and chills. The following morning, she reported myalgia and  arthralgia, chills, headache, and a temperature of 102.8 (F). That day she took ibuprofen 400mg four times.
Several months after my second Covid vaccine, I began experiencing chronic hives over my face, neck, hands, and arms. Sometimes this allergic reaction seemed to be caused by products I have used for years without incident; sometimes it appeared out of nowhere. The sites can be raised welts, large inflamed patches of skin, a blistered looking rash, or all of the above. I've been prescribed various ointments. Only Tacrolimus worked on my face and neck, and only Neosporin seems to help the sores on my arms. This has been going on for about eight months now, and got significantly worse after my November Moderna booster shot.
Expired Product Use; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 47-year-old male patient who received HAV (Havrix) (batch number NZ7GR, expiry date 17-JUN-2023) for prophylaxis.   On 30-JUL-2023, the patient received Havrix. On 30-JUL-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Product Use). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 31-JUL-2023 The pharmacist reported the patient was administered a dose of Havrix, which had an expiration date of 17 June 2023, which led to expired vaccine used. The pharmacist was unsure which dose number this was in the series.  At the time of reporting, the dose was not repeated. The reporter consented to follow up.
Information has been received from a physician concerning a female who, before three months of age, was vaccinated PO with the first dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). The physician reported that the pts temp went up to 103.7 after being vaccinated. The physician also reported that, within 36-72 hours of receiving rotavirus, the pt developed diarrhea and vomiting. The pt was taken to the ER where she was treated with IV fluids. It was noted that the pt was hospitalized for an unk length of time and then released. The pt subsequently recovered in approx one week. the physician also considered the pts 103.7 temp, diarrhea and vomiting to be other important medical events (OMIC). Additional information has been requested.