chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a burning sensation every time I urinated, I felt a lot of urgency to go to the bathroom, I had to go to the bathroom up to five or six times a night, I felt the sphincter of the penis felt very sensitive and painful, Since the symptoms did not go away I had to go to a clinic where they did a urine culture, and days later I was called to start taking antibiotics for 7 days, most of the symptoms have passed but I continue with a little urgency when I have to urinate. I was taking Cefdinir 300 Mg twice a day for 7 days
Initial and follow-up information has been received from a healthcare worker concerning a 58 year old male lawyer with allergies to penicillin, tetracycline, AUGEMENTIN, sulfa, NAPROSYN, cephalexin, prednisone, iodine, erythromycin and a history of myalgia who on 06-NOV-2006 at 11:15 a.m. was vaccinated IM in the right deltoid with the second dose of Pneumovax 23 (0.5 mL) (Lot# 651357/0391F) (first vaccination with Pneumovax 23 was in September 2000).  There were no illnesses at time of vaccination.  Concomitant therapy included AMBIEN and SKELAXIN.  On 08-NOV-2006 the patient was seen in his physician's office with complaints of fever, rash on his chest and chills.  It was also previously reported that the patient complained of a headache along with redness, swelling and pain of the right arm.  The patient was given amoxicillin 500 mg three times daily and an injection of KENALOG in the left hip as the patient had been seen on 25-OCT-2006 with complaints of a rash on his chest with complaints of a possible allergic reaction from MUCINEX.  Subsequently, on an unspecified date, the patient recovered.  There was no product quality complaint involved.  No further information is expected.  This is one of three reports from the same source.
Shot given R arm 5/21.  Had minor local reaction now c/o tingling & strange feeling R arm.  Started 3-5 days after shot.
Arm pain on the left side, back pain, neck pain, headaches and then a dry cough developed several days later.
The employee received 1st Covid Vaccine today at 1804 1834: Patient complained of a "severe headache and suddenly not feeling well".  She told staff she hadn't eaten recently and was given crackers and 120ml of orange juice. 1845: Patient was assisted from the chair to a wheel chair and moved her to a cot in the back of the conference center. Her vital signs were stable at T-96.9F-HR-87 RR-20 BP: 145/78. She was responsive to questions, but had trouble opening her eyes. She did complain of feeling very cold and blankets were placed on the patient. 1905: Vitals remain stable. Patient was only responsive with direction. She was flushed in the face for a short duration, 3-5 minutes. She denied shortness of breath or trouble breathing.  Notified patient's husband she was going to be transferred by EMT to Hospital for further evaluation.  2300-Spoke to patient and husband.  Patient was discharged home in stable
Persistent headache , getting very strong when I stand up. I need to be lay down in bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Jun2021 10:15 (Lot number: EW0178) at the age of 15 years as dose 2, single and administered in arm right, administration date 15May2021 10:00 (Lot number: EW0161) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT. The following information was reported: HEADACHE (non-serious) with onset 06Jun2021 07:00, outcome "not recovered", described as "Persistent headache , getting very strong when I stand up. I need to be lay down in bed". Therapeutic measures were taken as a result of headache.  Additional information: Patient was not received any other vaccine within four weeks prior to COVID-19 vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient had no known allergy. Other medication within two weeks of vaccination includes Zoloft. Vaccination facility type was Pharmacy or Drug Store. Patient was not tested for COVID-19 post vaccination. The event was treated with Tynalol.  No follow-up attempts are possible. No further information is expected.
Low platelet, thrombocytopenia - from 320 in 2019 to 108 in November 2021 Undiagnosable digestive syndrome - pain, blockage, bloating, nutrients are not getting digested
Patient was given 2nd dosage of Pfizer vaccine 7 days before required dosage due.
No additional AE; Expired vaccine administered to a patient; Prior temperature excursion; This spontaneous report has been received from a nurse referring to a 2-year-old patient of unknown gender. The patient's concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On 16-JUN-2022, the patient was vaccinated expired vaccine of hepatitis a vaccine, inactivated (VAQTA) syringe (lot # T031201 with expiry date 14-JUN-2022) (strength, dose, and route of administration were not provided) for prophylaxis (expired product administered). This vaccine had a prior temperature excursion (product storage error), but there was no information on the matter. There was no additional adverse event (no adverse event).
Last PM, around 8 PM, 10/26/06, pt felt warm and T 102, received Flu shot at approx 2:30 10/26/06 at 0230 AM, temperature (rectal) was 104.5. This AM (10/27/06 at 0930, T 103.2) In office, T 98.9 rectal.
1 week after injection I started to experience redness, itching, and swelling around the injection site. It is thought to be a delayed allergic reaction.
The patient received his flu vaccine on 10/27/12 & returned to the office with a 3x2 1/2 inch erythematous, warm, swollen area at the site of the vaccination.
I am suffering most of the side affects from my shingle shot; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27th February 2020, the patient received Shingles vaccine. In February 2020, less than a week after receiving Shingles vaccine, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient experienced most of the side effects from shingle shot and wanted to know how long these side effects might last.
Swollen and soreness  at injection site; Swollen at injection site with soreness; Slight fatigue; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN8730), via an unspecified route of administration, in left arm on 26Mar2021 (at the age 0f 66-year-old), as single dose for COVID-19 immunisation. Medical history included Psoriasis. The patient was allergic to sulfonamide. Concomitant medications included tamsulosin (MANUFACTURER UNKNOWN), cyanocobalamin (MANUFACTURER UNKNOWN), pseudoephedrine hydrochloride (SUDAFED)), Ibuprofen (MANUFACTURER UNKNOWN), colecalciferol (MANUFACTURER UNKNOWN) and retinol (MANUFACTURER UNKNOWN); from unknown date for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198), via an unspecified route of administration in the left arm on 05Mar2021 at 10:45 (at the age of 66-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since vaccination, the patient had not tested for COVID-19. On 27Mar2021, the patient experienced swollen injection site with soreness and slight fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the events swelling at injection site with soreness and slight fatigue were recovered on unknown date.   No follow-up attempts are needed. No further information is expected.
After receiving vaccines, patient fainted while seated. Placed in reclined position and cool compress placed on nape of neck. After 10 minutes patient attempted to stand and he fainted a second time. Placed in recliner for 20 minutes.
by 3pm the next day after vaccine injection, my underarm started to hurt- by that night it started to swell and the pain continually got worse. I went to urgent care where I saw APRN who told me my lymph node had swollen as my lymph nodes were working at fighting off the vaccine.. swelling went down by Wednesday, 12/23/20 and pain gone by 12/25/20.
Woke up on 9/25/14 in the morning was very lightheaded, dizzy and nauseated. Patient called to report at 9:07 am. As day progressed was feeling better but ran low grade fever 99.8. 9/26/14 - 8:30 woke up again feeling dizzy/nauseated. Will continue to monitor.
At about 1:10pm, 20 year old patient received the Moderna covid19 vaccine.  Moments later, about 14 seconds after she left the room, patient collapses/faints to floor.  Another customer screamed, which caught my attention, and I heard something hit the floor.  I immediately left the pharmacy to the waiting area, where the patient fainted to attend to her and access the situation.  I also immediately pointed and told , the certified pharmacy technician to call 911.   I helped her off the ground and helped her to a chair where she sat down.  The patient visibly was perspiring above her lip.  I asked her are you having any difficulty breathing, to which she responded no.  She said she was nauseous and wanted something to drink .  I gave her water to drink.  She initially appeared pale.  Eventually her color came back.   I told her that the paramedics were on their way, and that I was there for her to help her anyway I can.   She mentioned to me that she had not had breakfast today, which may of contributed to her fainting.  At about 1:13 pm, I asked her if she was feeling better or worse, to which she responded, "better".  I asked her if she wanted more water, to which she said yes, and I brought her more water to drink.  Around this time , her color was returning.  I asked her again at about 1:18pm, if she felt better, to which she smiled and said yes.   She ran out of water again, & I offered to bring her more water to drink.  At 1:23pm , the paramedics arrived on the scene.  At about 1:33pm , the patient left the pharmacy after the paramedics helped her feel better.
Drug ineffective; "I am not well either I have COVID or I don't know"; Not well at all; Terrible headaches; Fever; Flu; This is a spontaneous report from a contactable pharmacist (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), for dose 1, single; dose 2, single; and dose 3 (booster), single - all via an unspecified route of administration on an unspecified date (lot number was not reported) for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included RSV vaccine administered on 03Nov2021. The patient reported that he/she is a pharmacist and had a question. He/she received an RSV vaccine from a trial on 03Nov2021. Then, she got his/her 3rd shot for Pfizer booster on an unspecified date (reported as Tuesday). On an unspecified date, he/she was not well like at all. He/she had been having terrible headaches and fever. The patient was showing with this because he/she didn't feel like this with the first two vaccines, so he/she said that it was an interaction with the RSV trial vaccine which was also Pfizer and the booster. The patient reported that the clinician told him/her that it was ok and just wait for a couple of days which he/she did, but he/she was not well either he/she have COVID or he/she don't know. The patient reiterated that he/she was not well, he/she had flu. He/she have interaction with the vaccines or he/she don't know. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events suspected COVID-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.  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.
Developed something that looks like eczema on my chest, my left arm, and my thighs
Pt exp h/a w/nausea twice a wk x 1mo following 1st dose of Engerix-B; also exp rise in BP; h/a described as high occipital from back of head to eyes & some neck soreness; no aura, no scotoma; h/a somewhat relieved by APAP;
Mild soreness at right armpit noted on day 5 or 6 post vaccine  administration. Day 7 noted right upper arm swelling, redness,  firmness warmth. Day 8 redness swelling and warmth increased w odd sensations locally.  Intermittent chills no fever. Apt w PCP to evaluate diag cellulitis. ATB odered. Doxycycline 100 mg 2x day for 7 day
Our practice's immunization schedule gives the 2nd Hepatitis A vaccine at the 2 year well check. This patient came for a travel consult before traveling internationally, and was given the 2nd dose. When he came in for his 2 year well check, the nurse was unaware of the vaccine given off-schedule and administered a 3rd dose by error. No adverse reaction occurred. MD followed up with parent 2 days later and child was doing well.
This is a spontaneous report from a contactable Family Medicine PA via Pfizer sales representative. This Family Medicine PA reported similar events for two patients. This is the second of two reports. A 15-year-old female patient of an unspecified ethnicity received TRUMENBA, intramuscular on 15Aug2016 at 0.5 ml, single for immunisation.  The patient medical history was not reported.  There were no concomitant medications.  The patient experienced arm was warm and arm was a little achy/ arm was painful on 15Aug2016. It was not known if any treatment was given. The patient recovered from both events on unknown date.
I then called for someone to get the Dr.  pt was unconscious for approx 1 min.  pt awoke shaking hands cringing in pain.  Gave pt a lollipop and a can of pop.  After 5 mins pt appeared to have more color, was alert.  I assisted him to get up.  pt walked approx 10 ft stated "I can't see anything, and lost consciousness".  Got pt to Exam 1 seated pt was unconscious for approx 30 sec.  pt stated he could hear ringing in his ears and c/o a ha.  Dr. was called again to exam pt.  pt was asked to stay seated with head between legs.  Taking sips of pop on & off.  Pt was talking, alert, color was good.  pt was unaware of what happened.  pt stayed seated for approx 15 min.  pt was able to walk out of office.
PT STATED SHE HAD SWELLING IN RIGHT ARM AND UNDER RIGHT ARM, UPON EXAM NOTHING APPEARED TO BE SWOLLEN, PT STATED IT WAS SWOLLEN BC IT FELT "TIGHT".  AFTER WAITING 5 ADDTIONAL MINS, PT STATED ALL SWELLING HAD RESOLVED AND SHE WAS FINE NOW AND  WANTED TO LEAVE THE PHARMACY WITH PERSON THAT ACCOMPANIED HER TO HER IMMUNIZATION
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 years old female patient who received two combined 0.25 mL doses of FLUZONE QUADRIVALENT (lot number, expiry date, dose in series and route was not reported) in right thigh on 24-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to Wrong technique in product usage process. No reaction was reported. 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.
mom called 24MAR94 stated that pt cired all noc starting around 9PM the noc of 16MAR93 p/vax; mom called pt's MD who stated it was probably a reaction to pertussis & pt is to receive no more pertusis or may consider DTAP;
This case was reported by a physician via a representative and described the occurrence of an unspecified adverse event in a subject of unspecified age and gender who was vaccinated with Fluarix. On an unspecified date the subject received unspecified dose of Fluarix (unknown). At an unspecified time after vaccination with Fluarix vaccine, the subject experienced an unspecified adverse event. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 13 December 2007 via a healthcare professional who reported that the subject was a 70-year-old male who was vaccinated with FLULAVAL (Glaxosmithkline) on 29 October 2007. The subjects's medical history included adult onset diabetes mellitus, gastroesophageal reflux disease and smoking. On 29 October 2007 the subject received a dose of FLULAVAL. On the same day that the subject was vaccinated with FLULAVAL, the subject experienced extensive swelling of the vaccinated limb, pitting edema, injection site redness, hotness at injection site, and fatigue. The healthcare professional described the swelling as "edema" +3 from shoulder to elbow. As of 02 November 2007, the reporter stated that the events had resolved on their own. The reporting healthcare professional considered the events to be related to vaccination with FLULAVAL.
Expired Drug Used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 34l52, expiry date 06-JUL-2023) for prophylaxis.   On 14-JUL-2023, the patient received Shingrix. On 14-JUL-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired Drug Used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-JUL-2023 The reporter was a medical assistant. The reporter stated that the patient was accidently administered an expired dose of Shingrix at the time of reporting. The reporter consented to follow up. This was 1 of 2 cases, reported by the same reporter. The patient was administered with expired dose of Shingrix, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2023097103:same reporter
He complained of "twitching" feeling; He complained of soreness for a day in his right arm (dominate arm); He complained of headache; This spontaneous report was received from the patient's wife, refering to her husband, a 28 year old male patient. The patient had not any pertinent medical history, concurrent condition, drug reaction/allergy and was not taking any concomitant medication.      On 01-MAY-2019, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for catch up on immunization due to the recent measles outbreaks locally and worked outside in the heat. On this same vaccination date, the patient then, complained of a headache, twitching feeling (muscle twitching) and soreness for a day in his right arm (dominate arm) (pain in extremity). He did not take anything for the headache, soreness or the twitching feeling. No laboratory studies were performed neither medical attention was sought.  By the next day, on 02-MAY-2019, the symptoms had resolved.   The causality assessment was not provided.
STOMACH UPSET; CHILLS; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-SEP-2021 09:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-SEP-2021, the patient experienced stomach upset. On 08-SEP-2021, the patient experienced chills. On 08-SEP-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, stomach upset, and chills. This report was non-serious.
Body Stiffness in legs, knees, arms, could not raise arms to comb hair, left leg felt heavy, right leg stiffness, could not bend to pick anything up from floor.  After getting out of chair could not walk immediately, had to stake small steps to get stretched out.
1st day: Headache and nausea (both mild). 2nd day:  Arm pain (slight); 101.6 fever (no other symtoms). 3rd day: Arm swelling and pain. 3rd-4th day: Itchiness/irritation at injection site (left arm). Presently (almost 2 weeks later), itchiness, less swollen after massaging arm on 3/19/21, huge red ring around injection site.
PT reports having pain at injection site since vacination was given. About 6 days later, he notice area was skin was red and hot to touch, still painful.
Pt did not respond to primary series of Hept-vax, recv 1 booster dose of vax & lab values cont to show no titers. 2nd booster given 4Mar91.
Almost 24 hours after receiving I got really itchy all over my body and had hives on my inner thighs.