chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US021407 is an initial spontaneous report received from a nurse on 23 Oct 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly at a dose of 0.5 ml on 02 Oct 2014. It was reported that on an unknown date after vaccination, she experienced fever, chills, muscle ache and fatigue. The events outcome was reported as complete recovery. The seriousness and causality were not reported.
The patient had general malaise since receiving immunization on 8/14/18. On 8/26/18 developed right side facial pain. Over last 2 days developed facial droop of right lower face. Seen in clinic today an diagnosed with Bell's Palsy.
About 5 hours after immunization in the left thigh, erythema and inflammation, irritability.
No additional adverse effects; received a pediatric dose of RECOMBIVAX HB; This spontaneous report was received from a medical assistant regarding an approximately 20-years-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 14-MAY-2020, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) strength: 5 mcg/0.5ml, dose: 5 microgram (0.5 ml)/once, lot number R031055 with expiration date on 04-JUN-2021 (route of administration and anatomical location were not provided), as prophylaxis.(Incorrect dose administered)  No adverse effects were reported.
Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021; Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 1:41 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 1:41 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   An age of patient was reported as 72.85 for dose administered on 07-Jan-2021.  No concomitant medications were reported. It was reported that for the vial Batch number of 025L20A, it was moved to fridge on 05-Jan-2021 that underwent temperature excursion on 07-Jan-2021 with temperature 34 degrees Fahrenheit from 09 AM to 10 AM. The product was moved to clinic on 07-Jan-2021 and beyond use date for the vial was reported as 27-Jan-2021.  The vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. The vials were only punctured right before administration. The vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
1st vaccine:  10 days of bad headaches & body aches, extreme nausea, and extreme fatigue - mild temperature first afternoon only.   2nd vaccine: 1st day was okay, 2nd-4th days extreme fatigue and mild nausea. Then I was fine!
Pt began to vomit on 5/22/15 continued to get worse, pt taken to ED was transferred to hospital. Pt underwent exploratory laparotomy manual reduction of intussusception, Meckel diverticulectomy appendectomy and colonoscopy.
this shot was much too high, barely in the deltoid.; immediate pain; This is a spontaneous report from a contactable physician (patient). A 72-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3247), via an unspecified route of administration at left arm on 21Jan2021 at 19:00 (reported as 07:00 PM) at SINGLE DOSE for COVID-19 immunisation. The patient was administered COVID-19 vaccine at the hospital. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior to vaccination. Medical history included Allergies: Penicillin. The patient's concomitant medications were not reported. The patient reported "Received first covid vaccine 21Jan. Nurse's technique was poor and I had immediate pain. I'm a physician, I know where the deltoid is and this shot was much too high, barely in the deltoid. I'm concerned about vaccine failure. Should we check antibody levels?" The event started on 21Jan2021 at 19:00 (reported as 07:00 PM). The reporter considered the events as non-serious. The patient did not receive treatment for the events. It was also reported that since the vaccination, the patient has not been tested for COVID-19. The patient had not yet recovered from the event immediate pain.
11/7/2021 My left arm was red, swollen, aching, throbbing, felt like fever and itching. It just covered half of my arm. I went to the doctor on 11/9/2021 and she put me on antibiotics. It took about five days for it all to go away.
Local redness, tenderness and heat to LUE at site of administration. Increasing in size.
Given high dose Flu shot in error - 4 hours after shot became nauseated - vomited repeatedly 12-6-10 until nothing left - recovered - back to work this AM - was fine prior to getting Flu shot.
headache, chills, hot sweats, loss of taste, loss of smell, pain around body--11:00 AM 2/19/2021--6:00 AM 2/20/2021
blood clots; A-fib; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 58-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation; and tofacitinib citrate (XELJANZ), via an unspecified route of administration from 2018 (Batch/Lot number was not reported) to an unspecified date at unknown dosing regimen for an unspecified indication. The patient's medical history and concomitant medications were not reported. The reporter stated that the patient had blood clots and A-fib (2021) while on Xeljanz. The reporter also mentioned that the patient had Covid vaccine on Feb2021 and the clots in Jul2021. It was added that the events took place after the use of the product. The action taken in response to the events for tofacitinib citrate was unknown. The outcome of the events was unknown.; Sender's Comments: Based on available information, a contributory role of suspect drugs bnt162b2 (BNT162B2) and tofacitinib citrate (XELJANZ), with the reported atrial fibrillation and thrombosis cannot be excluded. Additional information including complete clinical course, medical history, action taken with the suspect products, and event outcome, would be helpful in assessing this case.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 09/30/2022. I had a fever, aches and loss sense of taste. The bottom of my feet felt numb at times. I contacted my doctor and got a prescription for Paxlovid. I had no complications taking the medication. As of today, I have no lingering symptoms from COVID-19.
This spontaneous report was received from a female registered pharmacist who is the patient. The patient's medical history included chickenpox as a child. The patient, who was not wearing gloves while disposing a vial of ZOSTAVAX had right eye exposure to reconstituted ZOSTAVAX by rubbing her eye with her hand. She did not irrigate the eye at the time of the exposure. The pharmacist stated the right eye 'was a little itchy and watery'. No treatment was provided for the event. Laboratory diagnostic studies were not performed for the events. The patient did not seek medical attention. The events did not resolve at the time of this report. Causality was not reported for the events. Additional information has been requested.
Rash with hives entire body-relieved with Benadryl in 24 hrs.
Has tested positive; Has tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Husband is diabetic and has a heart condition; "Heart condition" (unspecified if ongoing), notes: Husband is diabetic and has a heart condition. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Apr2022, outcome "unknown" and all described as "Has tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) Positive, notes: She and her husband both tested postive. Patient and his wife both tested positive the husband (patient) was diabetic and had a heart condition. The receptionist offered monoclonal antibody without considering that they had received the booster dose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200591001 Same reporter/ drug/ event for different patients.
A week or two after receiving vaccines my daughter seemed to develop a cough/cold with mild elevated fever and sneezing and coughing. We brought her to the doctor 3 or more times because the cough, especially at night, has not gone away. Doctor and NP recommended and we tried Claritin, Zyrtec, Flonase, an inhaler prescription. None have worked
Pt experienced redness and hardness approximately 4 1/2 cm that persisted for three days.
Pericarditis (fever, chills, malaise, atypical chest pain and EKG changes) (Global J pint elevation & ST segment Changes). These symptoms developed 17 days post vaccination. Admitted to Hosp. NSAIA's and Prednisone.
Suddenly felt weak, needed to sit at once. Was told I was very red in the face. While sitting, felt like chest had a heavy book on it and inside my body, it felt as if there were sharp needles or pins flashing away from neck to top of my legs, especially in the stomach and bottom areas. These gradually dissipated starting from the neck area on down. All of this lasted perhaps 5 minutes. I did not sleep that night. The next day (6th) I had a headache, muscle pain, no appetite, slept. The following day (7th) I felt back to normal and have continued to feel that way since.
he could barely walk because it had caused so much pain and swelling after he received the shot/same thing happened with my moms neighbor; he could barely walk because it had caused so much pain and swelling after he received the shot/same thing happened with my moms neighbor; he could barely walk because it had caused so much pain and swelling after he received the shot/same thing happened with my moms neighbor; This is a spontaneous report from a contactable consumer. This consumer reported same events for two patients. This is one of the two reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that there was a man in physical therapy at the same time she (reporter) was. The man had gotten his second Pfizer shot. He could barely walk because it had caused so much pain and swelling after he received the shot. The same thing happened with this patient (reporter's mom's neighbor) and they both (man and this patient) had to get epidurals. The outcome of the events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101363148 same reporter/drug/events, different patient
Pt recv vax 20Mar98 & devel temp & rash. 3 other pt reported WAES98032507,98040053,98040054
On the afternoon of 10/24/05 got the following immunizations- DTAP, HIB, Prevnar, Fluzone. Approximately 11 hrs later developed a fever, approx 1 hr later temp checked = 105 registered.  Eyes rolled back in head but no shaking episode. Pt had Tylenol approx 2 hrs prior to temp being 105. was seen in ER-T=102 registered.
Dizziness, Myalgia, Fever & CoughWheeze Narrative:  Employee reports having no s/s until the morning after her first dose. Reports fever 99.3, chills sore arm, dizziness , cough and body ache.
About 5 minutes after injection, burning at the site that quickly dissipated. Approx 3 hours after, area was itchy and warm.  Upon uncovering site approx 6 hours after injection, site was swollen (3" dia around site), red, hard, and very warm to touch. Condition continues 41 hours after injection.
Patient felt drowsy and had chills, joints were achy and legs achy, began feeling better the next day, Saturday the 24th she developed small red spots on her leg.  Described as small round blotches like a "rash".
Initial report was received 17 April 2009 from a consumer, who is the patient's parent. An 11-year-old male patient (also reported as 12 years of age) with allergies to milk, eggs, and dairy products, had received an intramuscular injection of ADACEL (lot number reported) and an intradermal PPD injection (manufacturer and lot number not reported) on an unspecified day during June 2008, and moments after vaccination, the patient developed itching at the injection site. At 15 minutes post vaccination, the patient began sneezing and had nasal drainage. At 30 minutes post vaccination, the patient experienced a full blown asthma attack with labored breathing and wheezing. The patient returned to their physician's office and received Benadryl, Albuterol, Pulmicort and steroids as corrective treatment and subsequently recovered from the event (event duration not reported). The patient was evaluated by an allergist and had allergy testing performed. The allergist had been provided a sample of the ADACEL vaccine for testing (same lot number that was administered) and according to the reporter, the MD reported that a very, very small amount of milk found to be in the product. No additional information was provided at the time of report. Documents held by sender: None.
Immediately after client got her vaccine, she started feeling dizzy, and tingling "all over her body." She was monitored and placed in a reclining position which did not help her. At 11:30 am client reported feeling weak. EMS was called and client was transported to hospital. She was given IV fluids and monitored and released 2-3 hours after the incident. She has not had any other problems since taking the vaccine.
I took the 2nd pfizer vaccine on 8/9/21. I started experiencing soreness in both shoulders the next day. I also had pain a sharp uneasy pain off and on just below left outside breast area for a couple of weeks. I also experienced shortness of breath at random times while sitting where I felt it was harder to breath than normal. Exactly 2 weeks after on 8/23/21 (around midnight so closer to 8/24/21), I felt lots of pain in my right shoulder and then shortly thereafter experienced lots of pain around the right side of my ribs area (mostly in the back). I went to the emergency room, they took a CT scan of chest, and discovered I had pulmonary embolisms in both lungs. They further did an ultrasound on my legs and found a blood clot in my right leg on the back side of my knee area. I was on heparin on 8/24/21 and 8/25/21 and in the evening on 8/25/21, they switched me over to eliquis which I will now be on the for the next 6 months. I've never had a blood clot prior to this and do not have a family history. I am a reasonably active person and do have a desk job which but my habits/pattern have not changed and it would be some crazy coincidence if this didn't have anything to do with the vaccine given the timing of events. I am also concerned about what to do as far as when I need a booster shot down the road because I do not want additional blood clots and therefore I am concerned about how I will how to go about being unvaccinated down the road assuming the 2nd vaccine was the reason for my blood clots. Side note, I had no impacts after my first pfizer vaccine shot which was exactly 3 weeks prior to the 2nd pfizer shot. I was on tramadol at home through 8/27/21 (due to the pain) after I left the hospital on 8/25/21 .
Patient developed an acute ascending paralysis requiring intubation after respiratory failure. MRI reveals central necrosis of the brainstem. Infant now requires tracheostomy and possible life long ventilatory support secondary to paralyzation of respiratory muscle. A follow up report received 9/17/2003 adds: Still has limited use of extremities. Required tracheostomy, can be maintained off ventilator during day but not at night. Condition remains essentially unchanged. No additional theories have been advanced to explain this illness. Physician staff continues to consider the hep B vaccination as a possible cause.
Vomiting the first night and then vomiting started the following day. No fevers.
Broke out at injection site (left leg) with fluid-filled blisters on 3-15-2007, low fever, think it is at injection site of Varicella.
I had a runny nose and sneezing for twenty four hours and a low grade fever. I used my home COVID-19 test that came back positive, I called and had a telehealth visit. I was advised to treat it like a cold. They only residual symptom that I had that lingered is congestion that in my left nostril. Around June 15, 2022 I had extreme pain  in my teeth and jaw. I went to the dentist who said I have TMJ and he did prescribe an antibiotic that helped with some of the pain but it is still there. I went to see my PCP, she advised I do Ibuprofen but at day five it started hurting so bad I went to Urgent Care and got a steroid shot and steroid pills. The pain has eased up but is still there. The doctor at Urgent Care said the salivary gland may be blocked up.
Severe pain in entire arm where vaccine was administered.  Inabillity to lift arm after vaccine for several days.  Swelling that spread down the entire arm associated with heat and redness.
Pt admitted 3/9 for closed L1 compression fracture related to unwitnessed ground level fall. COVID test was done on 3/12 due to pt having cough and was positive.
Both vaccines were given in left deltoid, flu toward front, pneumo - rear. Pt stopped in 2 days later to show site - flu - red, swollen (slightly), itching.
Next day after vaccine, nerve pain on the shot arm, it felt like burning sensation down the entire arm's skin, extremely sensitive. Then began experiencing heavy fatigue, aches and pains, symptoms began to worsen on 9/29. Extremely sick on 9/30, dizziness, nausea, 99-100 degree fever, thursday vomited blood (large amounts), went to walk-in clinic because it was faster than the ER. Having extreme brain fog as well. 10/01/2021 called doctor and advised to go to walk-in clinic, extremely sick but turned away because of pending covid test. Went to ER, blood taken (was fine), given antinausea pill, given benadryl due to fluid buildup behind the ears.  Helped some but did not resolve all issues. Covid test came back negative.  Brain fog, fatigue, weakness, and still easily dizzy. Have not vomited since the first time.
Reddened/ raised area.  Warm to touch with tenderness - ADVIL given by caretaker - Warm compress applied - reaction appeared 8-6-09 to left arm.
At 3:00 pm I became violently ill with throwing up and diarrhea.  This lasted all night and at 6:00am the next morning my husband took me to ER.  I was admitted for 2 days and 1 night.  They stopped the vomiting but could do nothing for the dizzyness caused by my eyesight being off.
This spontaneous report was received from a healthcare worker refers to an unknown number of patients of unknown ages and gender. Since an unknown date in November 2012, the patient's were vaccinated with a dose of improperly stored PNEUNOVAX 23 (lot#, expiration date and route not reported). No adverse event reported. This is one of the several reports from the same source. Additional information is not expected.
Still get breakouts. I have had the shots/Suspected vaccination failure; Still get breakouts; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got them at 23 year and had them numerous time since).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 02-MAR-2023 Reporter's comment: This case was reported by a patient via interactive digital media The patient had the shots and still get breakouts.  Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.