chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 63 year old female patient without drug reactions/allergies. ON 28-AUG-2014, the patient was vaccinated with the first dose of PNEUMOVAX23 (lot # K004148, expiration date 10-MAY-2015) injection (dose and strength not reported). Concomitant therapies included BENTYL, PROTONIX, cholestyramine resin and SYMIBCORT. The pharmacist reported that on 28-AUG-2014 the patient developed redness and swelling "the size of a half of a boiled egg" at the injection site within 45 minutes to 1 hour after receiving the vaccine. The patient was seen in the emergency room due to the redness and swelling. NARCO was given to treat the adverse events. At the time of this report, the outcome of the events was recovering.  Additional information has been requested.
Within 5 minutes of vaccination injection patient started to have a local reaction (redness and pseudopod) at the MMR and varicella injection site.  Pt was immediately assessed by Pediatric provider and was given 2.5ml oral Benadryl.  Pt's mother was instructed observe for further reactions and if needed go to local emergency room.
ED notes as follows:  31 y.o. female who arrived to the emergency department for Vaccine reaction.  The patient presented to the ED after getting her second COVID vaccination.  She reports feeling confused, nauseous, and having a racing heart.  She has never had a reaction like this before.  She reports having a tickling sensation in the back of her throat and both hands feel like they are tingling.  The patient denies any other known allergies.  The patient has a past medical history of anxiety, depression, PTSD, prior conversion disorder.  Patient denies any shortness of breath or chest pain but does report a headache. The patient denies any drug use, alcohol use, tobacco use.   Patient has no other complaints at this time.  The patient was given Benadryl, Epi, solumedrol, for anaphylactic-like presentation.  Patient also began on fluids and Zofran for possible vaccine reaction.  Patient symptoms began to improve over the course few hours.  At the 3-1/2-hour mark after initial arrival to emergency department the patient began to have similar symptoms to her initial presentation with tachycardia, dry heaving, and finger tingling.  The patient was also hyperventilating.  The patient was given 1 mg Ativan which relieved her tachycardia had resolved her hyperventilation signifying possible anxiety component to symptoms.  Patient was allowed to relax for 20 to 30 minutes at which time she was comfortable and felt like she was okay to discharge home.  Patient was instructed to follow-up with her primary care doctor that she could next week.  Patient was informed to return to emergency department if new symptoms arise or current symptoms worsen.   Dispo: Discharge home with PCP follow up on Monday  Initial Vital Signs [01/22/21 1424] Blood Pressure 161/99 Heart Rate 112 Respiratory Rate 24 Temp 36.4 °C (97.6 °F) Temp src Oral SpO2 99 %
On Tuesday night, June 21st, 2022, I was transported by Ambulance to Hosp. Emergency Room, where it was determined that I had an Ischemic Stroke. I did not connect it at the time that maybe it was from vaccine?? On Tuesday night, June 13, 2022, my husband and I were sitting at the dining room table, playing checkers. Suddenly I felt strange and I started to go lie down. When I was up walking my left ankle felt like it was begining to get numb, also my left hand. My blood pressure was extremely high. My husband called 911 and an ambulance and fire truck arrived. By the time the paramedics saw me, I was feeling better. I was taken by ambulance to Medical Center. My blood pressure was still high. I could see "a row of lights" more from my left. Later while at hospital, I could see the "lights" again, two or three times. My vision was being affected I suppose. Tests were run while I was there. I was diagnosed as having an Ischemic Stroke. The Neurologist thought it was caused from Atrial fib. I don't believe he knew about the vaccination I had the week before this all happened. Recently on the news I became aware that the Pfizer vaccines (are believed to may have) been the cause of Ischemic Strokes in people over a certain age 60 or 65 (?) who had received a dose of the vaccine. I really appreciate your concern about my having an Ischemic Stroke.
erythema mid portion lt upper arm & painful w/muscle activity;tender on palpation;no induration, warm to touch
approx 5hr of inc crying not r/t manipulation of injected leg;no local signs @ inj site;pt fine p/5hr;
Per MD follow up note,  2-9-22   1) COVID-19 (ICD-10: U07.1)   Patient is feeling much better after the steroids and abx. She feels her cough is much more mild. She has her energy back though not completely and did go to the gym yesterday which made her happy. She is traveling this weekend and feels well enough to go. Wished her well and recommended taking it easy overall.
Temperature of 105.7; This is a spontaneous report from a contactable consumer. This 62-year-old male consumer (patient) reported that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL9267) via an unspecified route of administration from 12Feb2021 at 02:00 pm to 12Feb2021 at 02:00 pm at single dose (dose number; 1) on left arm for covid-19 immunisation (Facility type vaccine: other). Patient was 62 years old at the time of vaccination. Patient's medical history included diabetes, coronary artery disease, kidney disease and covid-19 (If covid prior vaccination: Yes), known allergies: no true allergies, only unwanted side effects of certain medications (unspecified dates). Patient's concomitant medications were not reported (If other vaccine in four weeks; No, other medications in two weeks; Yes). Patient experienced temperature of 105.7 on 13Feb2021 at 06:00 pm. Treatment received was reported as yes (medication unspecified) for the adverse event. Adverse event did not result in emergency room or physician's office visit. Covid was not tested post vaccination. The outcome of event was recovered on an unknown date in Feb2021.
SkinRash arm red, swollen at injection site Narrative:  Reports arm red, swollen at injection site. Appeared 01/14/2021
about 4 days after receiving the vaccine developed severe vertigo. Primarily triggered when transferring from horizontal to vertical position or vice versa. spinning sensation subsides within a minute of remaining stationary, but the lingering nausea caused by it can last for hours afterwards. It became slightly better by the second day of symptoms but is still quite severe compared to any past episodes in my life.
Intense pain started in lower jaw left side and radiates upward to ear and temple and down neck. Worsening when exerting herself and eating. Ruled out dental concerns.
Patient was meant to receive varicella vaccine and received varicella zoster vaccine. Order was entered incorrectly by provider and administered as ordered in clinic. No harm came to patient.
Sore arm at injection site; Can not raise arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain and mobility decreased. On an unknown date, the outcome of the injection site pain and mobility decreased were unknown.   It was unknown if the reporter considered the injection site pain and mobility decreased to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm Intramuscularly. The patient received first dose of Shingrix 2 weeks ago. The patient experienced sore arm at injection site that got better with time but 4 days ago the arm felt sore again and got works to the point now cannot raise the arm. The reporter declined physician follow up. The reporter did not gave permission to follow up.
Ringing in ears, anxiety and all symptom that come with anxiety  Stated morning of  April 4th still occurring  Saw my GP and my Gyno they have put me on antidepressants and having an MRI April 30th
Multisystem inflammatory syndrome in children; This is a literature report for the following literature source(s):  A child patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. Linked Report(s) : US-PFIZER INC-202200572120 Same article/ drug/event and different Patient
This is a spontaneous report from a contactable physician. A 65-year-old male patient received first dose of PREVNAR 13 (lot number J49845, expiration date Mar2016, NDC number 0005-1971-02) on 26Nov2014 at 0.5 ml single dose via intramuscular route. Concomitant medications included unspecified blood pressure medication and unspecified diabetic medication. Medical history included diabetes and hypertension. On unspecified date in Nov2014 the patient experienced induration, erythema and tenderness around the injection site. On 01Dec2014 the patient also had rotating circumference around upper arm about 75%. The physician reported that patient took ibuprofen for symptoms, that were worse over the weekend before this report (Nov2014) but have improved. Outcome of the events was unknown. Follow-up (23Jan2015): Follow-up attempts completed. No further information expected.
red welt that was diagnosed as cellulitis around entire upper left arm. Resolved with antibiotics.
5 days later had rash to the hands and arms, burning and painful, slightly itchy.  medrol dose pak given, treatment in progress. still plans to get 2nd shot, moderate severity
This case was reported by a non-health professional via other manufacturer and described the occurrence of exhaustion in a 16-year-old male patient who received MENVEO (batch number M17041, expiry date unknown) for prophylaxis. On 6th July 2018, the patient received the 1st dose of MENVEO (intramuscular) .5 ml. On 6th July 2018, less than a day after receiving MENVEO, the patient experienced exhaustion (serious criteria other: per reporter) and fever (serious criteria other: as per reporter). On 14th July 2018, the outcome of the exhaustion and fever were recovered/resolved. It was unknown if the reporter considered the exhaustion and fever to be related to MENVEO. Additional information was reported as follows: The patient's medical history indicated that he was very healthy. The patient experienced extreme fatigue. The patient was not participating in any Novartis sponsored program. The reporter gave consent to be contacted if more information was needed for the report.
Significant sharp pain in surrounding area of injection site (temporary relief with ice packs and acetaminophen), slight headache, following morning fatigue and nausea upon awakening.
Pt c/o dizziness after receiving Hep B vaccine.  Pt put down on floor w/ supervisor assistance.  At 1445, bp: 123/73, HR: 50.  MD and supervisor was notified.  At 1450, BP: 119/67, HR: 56.  Pt denied any discomfort at this time, was able to eat and drink.  Pt left ward w/o assistance at 1505.
Information has been received from a registered nurse referring to multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. In November 2016, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L014878, expiration date 17-JAN-2018; dose and route not reported) for prophylaxis. The doses of vaccine were improperly stored as follow (date, temperature, Duration of temperature excursion): 1612 minutes 02-NOV-2016, 47 degree Fahrenheit (F), 25 min 02-NOV-2016, 48 F, 20 min 02-NOV-2016, 34 F, 91 min 03-NOV-2016, 34 F, 115 min 11-NOV-2916, 34 F, 1 min 13-NOV-2016, 34 F, 38 min 13-NOV-2016, 33 F, 35 min 14-NOV-2016, 34 F, 350 min 14-NOV-2016, 33 F, 240 min 15-NOV-2016, 33 F, 111 min 15-NOV-2016, 34 F, 307 min 14-NOV-2016, 33 F, 112 min 14-NOV-2016, 34 F, 212 min. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA007360: US-009507513-1703USA007361: US-009507513-1703USA007362: US-009507513-1703USA007363: US-009507513-1703USA007365: US-009507513-1703USA007063: US-009507513-1703USA000989.
Third and fourth fingers of left hand (vaccination arm) went completely numb for 2 hours.  Massaged for 2 hours and numbness changed to tingling for another 10 hours.  Within 24 hours of vaccination time symptoms cleared.
Pt received two doses of rubella virus vaccine live.  Subsequent to each dose the pts rubella antibody titer was found to be negative.
Patient received Smallpox vaccination 04/21/2006 in left deltoid (Lot number 4020072) in anticipation of deployment. On 05/03/2006, he developed feverishness, increased left arm pain and pleuritic substernal chest pain. Evaluated at Clinic, then a hospital. Subsequently transferred to another hospital. Transferred again 05/04/2006.  5/11/06 Received medical records from initial hospital which reveal patient admitted with chest pain, right arm pain & elevated ST.  Dx w/MI & transferred for cardiac cath.6/6/06 Received medical records from 2nd hospital which reveal final dx of acute myopericarditis, serum reaction, allergic reaction, anemia, abnormal reaction to vaccine and PMH of testicular cancer.  Family hx reveals patient's father had MI. 6/19/06 Received medical records from HC.  No new diagnosis. Date of Update: 8 August 2006. An initial VAERS was filled on this patient from hospital in May 2006 reporting myocarditis following receipt of Hep B, SPV, and Typhoid vaccines. I am including a hospital Clinical Summary with his history, as well as his most recent Cardiology evaluations. Please feel free to contact the undersigned with any questions.
evaluation of pneumococcal titers, all of which were low; drug interaction;   Information has been received from the authors of a published literature article, titled as stated above, regarding a 27-month-old male patient.  The patient's concurrent conditions, medical history and concomitant therapies were not provided.    On an unknown date the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) (route, dosage information and lot number were not provided) for prophylaxis.  On an unknown date, the patient was diagnosed with B-cell acute lymphoblastic leukemia (ALL), CNS 1, neutral cytogenetics and he was randomized to two cycles of blinatumomab (route, dose and frequency were not provided) in addition to standard chemotherapy. He received intravenous immunoglobulin (IVIG) twice for hypogammaglobulinemia.    Approximately 19 months after completion of blinatumomab, during cycle 1 of maintenance, he presented to the emergency department (ED) blood cultures were drawn and S. pneumoniae grew within 12.3 hours.  Ten weeks later, during cycle 2 of maintenance therapy, he again presented to the ED. Blood cultures grew S. pneumoniae at 12.1 hours.  Recurrent S. pneumoniae bacteremia prompted evaluation of pneumococcal titers, all of which were low (antibody test abnormal).  The authors mentioned it was likely that treatments he received for leukemia contributed to his low pneumococcal titers (drug interaction).  He received re-vaccination with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23). Four weeks later, vaccine titers demonstrated a normal humoral response.  A copy of the published article is attached as further documentation of the patient's experience.
Oxacillin-susceptible staph aureus abscess of left thigh extending retroperitoneally. Presented with left leg swelling, abdominal mass. Required open surgical drainage. Received 3 weeks IV oxacillin. Parents report that swelling occurred after vaccine; was progressive. Discharge summary on 05/02/04 states no new information.
No additional adverse events reported; Medical Assistant calling to report a limited adverse event on a dose of PROQUAD that was administered improperly stored during a temperature excursion found supported; This spontaneous report was received from a medical assistant and refers to a 4 year old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 05-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, lot # T034614, expiration date 10-APR-2021 for prophylaxis (anatomical location and route of administration were not reported).   The vaccine was stored at the temperature that was reported as from 6 degrees of Fahrenheit (F) to 14 degrees of F (8.5 degrees of F) for 18 minutes and at the temperature from 6 degrees of F to 14 degrees of F (11.9 degrees of F) for 1 hour. There was no previous temperature excursion reported.  No additional adverse events reported.
sudden bad h/a,rapid heart beat,neck stiffness,numbness & tingling in hands & feet w/in 2hrs p/4th dose;Naproxen given;5th dose not given rabies titer >1:50;also devel nausea
Brain fog; Cognitive issues; Fevers; Stated that he had a positive test to Covid; This is a spontaneous report from contactable consumer. A 61-Year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 25Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter stated that her husband's friend received his first dose of the Pfizer Covid19 vaccine on 25Mar2021 and was exposed to Covid-19 prior to getting the vaccine. Stated that he had a positive test to Covid on 02Apr2021 and he has been having significant Covid related brain fog, like cognitive issues and fevers. He rescheduled his second dose due to the infection and wanted to know if he should wait to take the second dose until he has no symptoms of the disease. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient developed acute itchiness and swelling around and near the injection site. Patient experienced pain and heat at injection site.
Redness slight swelling about 2 inches in diameter, slightly itchy and a little warm and sort. Not very painful
Taste the vaccine in her mouth; Smell the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Taste the vaccine in her mouth) and PAROSMIA (Smell the vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced TASTE DISORDER (Taste the vaccine in her mouth) and PAROSMIA (Smell the vaccine). At the time of the report, TASTE DISORDER (Taste the vaccine in her mouth) and PAROSMIA (Smell the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not reported. Treatment information was not reported.
pt recv vax 3DEC96;taken to PMD on 6DEC96 w/3 raised red bumps;reported by PMD on 10DEC96;
Initial report was received 30 September 2010 from a health care professional, who received the report from the patient's wife. A 74-year-old male patient who had a history of asthma and allergies to weeds and molds, had received a first dose of FLUZONE HIGH-DOSE (lot number, route and site of administration unknown at the time of the report) and an unspecified allergy shot on 21 September 2010. On 24 September 2010, three days post vaccination, the patient developed a slight fever which resolved the following day. According to the reporter, the patient went to bed on 26 September 2010 and the following day on 27 September 2010, six days post vaccination, the patient was found dead in bed. The patient had no concurrent illness at the time of vaccination. The patient had been taking EFFEXOR, FLOMAX, "NEURONTIN", Hydromorphone and "guiafesen"concomitantly. The patient had also received allergy shots in the past. At the time of the report, it was unknown if an autopsy had been performed. No additional information was provided at the time of the report. Documents held by sender: None.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 68-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date unknown) for prophylaxis. Concomitant products included B12 Injection. On 28th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 29th March 2018, 1 days after receiving SHINGRIX, the patient experienced injection site warmth, injection site pain, injection site swelling and injection site erythema. On 30th March 2018, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching, injection site warmth, injection site pain, injection site swelling and injection site erythema were recovered/resolved. The reporter considered the injection site itching, injection site warmth, injection site pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The patient received SHINGRIX vaccine on her right arm around 11:37 am. At the time of vaccination she was on maintenance medications and she had a B12 injection on 26th March 2018. The patient experienced swelling and redness at the injection site that was hot with pain. The pain and swelling occurred the day after the vaccination and then the patient had itching two to three days later.
Runny nose, congestion, cough, fever, inconsolable crying, sleepy but unable to sleep, difficulty drinking bottle due to congestion.
RECEIVED BOTH DOSES OF PFIZER VACCINE ON 01/28/21 & 02/18/21. ON 02/28/21 WENT ER FOR POSSIBLE SEIZURE ACTIVITY. AND DIAGNOSED WITH NEW ONSET SEIZURE AND THROMBOCYTOPENIA AND ADMITTED INPATINET INTO HOSPITAL.
Headache, stiff neck, nausea for 3 days following anthrax doses 1,2,3.
Chills,  achy,  body cramps everywhere,  pain keeping me awake at night, migraine headaches, throbbing headaches.,  Nausea.  Severe fatigue. Side effects started 24 hours after the shingles vaccine.  Have continued off and on since Wednesday August 10, 2022
After receiving the H1N1 vaccine the patient displayed the following symptoms: chills, dizziness, cough, vomiting, rash and increased heart rate. Patient received BENADRYL 50 mg IM. and PHENERGAN 25mg IM.
Start after 4 hours Pain in arm and numb in arm in morning when I woke up feel weak and sleepy, chill, headache, fever, eye mussels pain all they slept till now at 3:00 PM Saturday