chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st shot on 10/9/2019 in left arm.  He received the 2nd shot in right arm on 10/29/2019; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cyst (on 29th October 2019). Concomitant products included Herpes zoster (Shingrix).   On 29th October 2019, the patient received the 2nd dose of Shingrix. On 29th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and drug dose administration interval too short. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The patient received the 1st shot on 9th Oct 2019 in left arm.  He received the 2nd shot in right arm on 29th Oct 2019 .  He reported pain at injection site with second shot that lasted 3 to 4 days, the duration was less than recommended schedule, which led to lengthening of vaccination schedule. He also had surgery to remove cysts in his back on the same day he received the 2nd shot. The reporter consented to follow up.
Itching began 1/23/21 at site of injection. Upper arm became swollen in oblong shape around injection site, lasted 4 days. Oblong ring of red remains on arm and itchiness remains.
Soreness and swelling at site, achy all over, diarrhea the following day, nausea, feel generally awful.
Within 30min. after injection swelling, redness, "hot" down arm. In 12hrs - Shooting pain to neck and numbness in (2) fingers. Took ibuprofen/Tylenol. Diaphoretic all day. "Presented to ER 11/5 am. At 0300 11/5 she was completely diaphoretic. Chest tight and wheezing. Albuterol tx, IV steroids, po prednisone for 3 days.
patient reported whelps above and below the injection site which extend around the underarm. Patient reported whelps as painful. Patient seeking treatment by pcp.
Had severe pain in arm, extremely tired and could not get up, shivering, headache. Later in day had a fever and light headed.  By day 4 I had a rash on arm that was hot and my arm was extremely painful I could barely lift it.  Rash is still on arm and hot on day 6.  I hope it will be gone soon(Dr recommended cold packs and tylenol)
Narrative:  COVID infection following COVID vaccine series 01/25, Pfizer, dose #1 02/16, Pfizer, dose #2 09/30, Pfizer, dose #3 1/11 COVID swab, result: detected 1/11 pt cc: exposure: unknown
Pt admitted for Syncope/COVID 19, not requiring o2 or tx at this time
Patient went to the emergency department 2 days after receiving a varicella vaccine complaining of syncopal episodes, headache, dizziness, nausea, and  redness, swelling around injection site. She was treated with cephalexin and doxycycline.
receiving the 1st dose of the vaccine the patient developed urticaria dermatographia on the left hip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 23Nov2021 17:00 (Lot number: FH8027) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: No. The following information was reported: MECHANICAL URTICARIA (non-serious) with onset 29Nov2021 19:00, outcome "not recovered", described as "receiving the 1st dose of the vaccine the patient developed urticaria dermatographia on the left hip". Therapeutic measures were not taken as a result of mechanical urticaria.  Additional information:: 6 days after receiving the 1st dose of the vaccine the patient developed urticaria dermatographia on the left hip. adverse event start date 29Nov2021. adverse event start time 07:00 PM  No follow-up attempts are possible. No further information is expected.
The day the vaccine around  8pm Patient had chills and fever 100 degrees. Around midnight  he started vomiting, had chills, fever 101, headache, body aches, extreme fatigue, racing heart 140 bpm. I called ER and told them symptoms. They said to bring him in. We arrived at ER at 1am.  At ER they gave EKG, Tylenol, Toradol injection and IV fluids. They also gave him covid19 test. He started to feel better and he was sent home at 5am. Two days later he had rash going down his left arm where he received the vaccine. It was gone the next day.
blood blister on tongue, black looking in the middle of tongue slightly towards the left, raised about the size of the backside of a needle, no pain but feels something stuck on tongue.
Case number PHEH2014US009399, is an initial spontaneous report received from medical assistant on 05 May 2014. This report refers to 11 year old female child. She was vaccinated with MENVEO (batch number: M12103, expiry date: Sep 2014) 0.5 ml intramuscular on 05 May 2014. It was reported that the unreconstituted MENVEO reached 33.8 degree Fahrenheit for 8 hours and 31 minutes. No adverse event was reported following this mal administration.
Fever 103.4 mom said child was "out of it" seen at ER. not in this office- we were told of this 5-1-08 visit.
This spontaneous report was received from a medical assistant and refers to a 9-year-old non-pregnant female patient. The patient did not have any pertinent medical history, drug reactions or allergies. She was not taking any concomitant medications. On 18-OCT-2016, the patient was vaccinated with a dose of VAQTA lot # M015290, expiration date 20-SEP-2017 (dose, route of administration and anatomical location were not reported) to prevent HepA. On 18-OCT-2016, five minutes after receiving VAQTA, the patient experienced fainting. On the same day (reported as one minute later), the patient recovered from fainting. The patient sought medical attention by contacting physician but there was no treatment given for the adverse event. No lab diagnostics studies were performed. The relatedness between fainting and VAQTA was not reported. This was one of two reports received from the same reporter. Additional information has been requested.
Left arm very sore, hurts to raise arm. ***My lips are swollen, feel raw dry and sore.
Hives on face and neck 6 hours after vaccine. Also back of legs started around 10am. Legs subsiding this am after cold  shower. Face and neck still itchy but hives lessened.
It started with chills then my body got completely stiff and sore I had to get help to the bed when I got in the bed I was there for four days during that. I had extreme body pain from the feet to the top of the head my eyes hurt I started sweating about three days in to the point where I mean my mattress was soaking wet my sweat smelled horrible I started having Hallucinations about two times seeing things that were not there my vision was very very cloudy and blurry I can hardly speak I have cramps in my feet on the fifth day I woke up yeah my body didn?t hurts I was no longer sweating but I had a headache. I also did not eat anything and could not eat anything for all those days it wasn?t until six days later that I was able to move around And feel somewhat back to normal my vision is still cloudy
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with VARIVAX (merck) (lot number 671130/1220AA, expired date 26-JUL-2012) (dose and route were not reported) on 28-APR-2012. No other co-suspects were reported. No concomitant medications were reported. The reporter sated that the patient received an improperly stored VARIVAX (merck), the vaccine has been stored in the refrigerator since it was received in the pharmacy in February 2012. No adverse symptoms reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Narrative:  Updating previously submitted report. Patient's migraine progressed s/p leaving vaccination clinic and required visit to ER. Reported to RN "Her pain consisted of jaw and ear pain and was unable to drive d/t dizziness. Patient reports she was treated with Oxygen therapy, Benadryl, and Toradol. ..." "On reassessment patient states she is feeling much better. Sharp pain has resolved. Still some mild aching to the left side of her head. Would like some further medication and then go home to sleep. IM Compazine and oral Benadryl given. Reassuringly no meningeal signs or fever to suggest meningitis. Not worst headache of life. Feels like previous headaches. Not consistent with subarachnoid hemorrhage."
A report has been received from a Pharmacist concerning a 13 years old, female patient. Concomitant medications included influenza virus vaccine polyvalent (lot number UI1506AB), and quadrivalent human papilloma virus vaccine (L045700) and human papilloma virus vaccine. The patient's concurrent diseases included constipation, fatigue, heterozygous thalassemia and leg pain. On 14-Jun-2016, patient had received nasal FLUMIST Quadrivalent (intranasal), 0.5 DF (0.2 mL). Patient received FLUMIST 1/2 dose (not sure if it was expired) after this they got the Fluzone and HVP (first dose), 2 days later nose bleed, 4 days later hematemesis and, 12 days later dizziness and had poor sleeping habits and anemia on 15-Jun-2016. The patient recovered from the events hematemesis, nose bleed, dizziness, patient received 1/2 dose of FLUMIST, anemia, poor sleeping habits and perhaps expired med on an unspecified date. Company physician assessed hematemesis and nose bleed, to be serious with the seriousness criteria of important medical event and rest of the events to be non-serious. AZ physician suggested to capture additional non-serious event patient received 1/2 dose of FLUMIST and perhaps expired med from the source narrative. Summary of follow-up information received by AstraZeneca/MedImmune on 05-Jul-2016 from pharmacist via spontaneous source: Event seriousness of the event nose bleed was updated to serious with the seriousness criteria of important medical event. New non-serious events anemia, poor sleeping habits and perhaps expired med were added. Outcome and event onset date of the events hematemesis, dizziness, nose bleed and patient received 1/2 dose of FLUMIST were updated. Concomitant diseases were updated. Patient demographics updated. Narrative amended. Sender's Comments: Haematemesis is not listed in the company core sheet of the FLUMIST. There is limited information on medical history (immunization), trauma, congenital anomaly, etiological, clinical and diagnostic work up (esophagogastroduodenoscopy) which makes causal assessment difficult.
Numbness of arm where vaccine was given and pain of arm and down leg- the side of vaccine. Today, numbness has dissipated, but still has pain, but less which she feels especially on mvmt- walking.
Completely deaf in his right ear; Vertigo; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Completely deaf in his right ear) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy. Concomitant products included ALLOPURINOL for Gout.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jul-2021, the patient experienced DEAFNESS (Completely deaf in his right ear) (seriousness criteria disability and medically significant), VERTIGO (Vertigo) and VOMITING (Vomiting). The patient was treated with DIAZEPAM (VALIUM) for Dizziness, at an unspecified dose and frequency. At the time of the report, DEAFNESS (Completely deaf in his right ear), VERTIGO (Vertigo) and VOMITING (Vomiting) outcome was unknown.            The concomitant medications were reported as some unknown medications for blood pressure which the patient was taking since the age of 20.  The laboratory tests were reported as some unknown tests for brain tumor and the results came out negative. Also patient underwent several laboratory tests to rule out for virus, autoimmune disease to detect the reason behind deafness. The results were came out as normal. The patient consulted ear nose throat last week to rectify the reason behind deafness.  Company comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
6 hours after receiving the Pfizer booster, I experienced tightness in chest and slight difficulty to breathe as well as a fluttering heartbeat.  Chest tightness subsided, but the irregular/fluttering heartbeat continues throughout week.  Happens at random 10+ times per day - it feels like it "jumps" out of beat. It's not painful, but noticeable.
Patient is a 84 y.o. male patient of MD with history of Afib, HTN, CKD, Alzheimer's dementia currently at rehab facility presented to Hospital with altered mentation and elevated HR. found to be septic due to viral etiology most likely with COVID positive status.  He remained on room air throughout hospitalization and therefore not a candidate for most therapies and not a candidate for others due to renal function.  General surgery consulted to evaluate diverticulitis.  Although likely not the underlying cause of sepsis was placed on course of antibiotics.  MRI showed no stroke but did reveal likely NPH, from discussion with wife this appears to be a chronic process.  Neuro  Sepsis  Likely due to COVID infection, diverticulitis with possible contribution of aspiration pneumonia CT with findings concerning for aspiration pneumonitis Afebrile, WBC 18k , LA 2.5 on admission UA trace LE, few WBCs, rare bact  CXR without new focal consolidation or infiltrate  Urine culture with no growth Blood culture 1/2 positive coag negative staph, likely contaminant Repeat blood cultures: NGTD Lactic acidosis and leukocytosis resolved de-escalate to cipro/flagyl  No current surgical indication for surgery, plan for 10-14 days of Cipro/Flagyl   Covid-19 Virus Infection Date of onset of symptoms: 1/8 Symptoms present on admission: Altered mental status, fatigue Date of covid positive test: 1/9 Imaging: Chest x-ray: Emphysematous changes, no new focal consolidation Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: not indicated as not hypoxic also not a candidate for paxlovid due to renal function  Anticipated special isolation end date: 10/19
Information has been received from a registered nurse referring to 3 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 14-AUG-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot # 011529, expiration date: 03-JUL-2016), which were improperly stored for 11 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sterile abscess with drainage. Swollen supraclavicular lymph nodes. Swelling right arm (mild).
I95.9 HYPOTENSION 7/19/2022 ACALCULOUS CHOLECYSTITIS I95.9 HYPOTENSION 7/19/2022 HYPOTENSION
After getting the shot, I felt a numbing sensation go up the left side of my neck, and it settled in my jawline.  It was not numb like being at the dentist but just slightly.  At first I thought I imagined it.  It went away that night.  I did not seek medical attention.  I was fine otherwise.  A nurse suggested that I report it since it is not a listed side effect.
This case was retrieved via a search of scientific literature on 11 November 2011. The reporter for this case is the same for case numbers: 2011-11264, 2011-11267, 2011-11271, 2011-11272 and 2011-11371. "Background: TDAP vaccine was not licensed for use in adults aged greater than or equal to 65 years due to lack of sufficient efficacy and safety data. To characterize reports to the Vaccine Adverse Event Reporting System (VAERS) among adults aged greater than equal to 65 years who received TDAP vaccine 'off label' to assess for potential vaccine safety concerns. We searched VAERS for reports of adverse events (AEs) in subjects aged greater than or equal to 65 years who received TDAP vaccine from 9/1/2005 to 9/08/2010. Medical records were requested for all reports cases as serious (death, hospitalization, prolonged hospitalization, permanent disability, life-threatening illness). Proportional reporting ratio (PRR) was used to assess for higher proportionate reporting for AEs after TDAP compared with Td reports in subjects aged greater than or equal to 65 years. VAERS received 243 reports following TDAP administered to persons aged greater than or equal to 65 years. Eleven (4.5%) reports were serious, including two deaths. Most common AEs were local reactions in 100 (41.2%) reports. Seventy-eight (32.1%) reports contained coding terms that denoted inappropriate administration of vaccine. 'Cough' was the only term associated with disproportionately higher reporting after TDAP compared with Td. Six of seven Tdap reports containing the term 'cough' were non-serious. Clinical review of serious reports identified no unusual patterns of AEs. Our VAERS review of the 'off label' use of TDAP vaccine in adults greater than or equal to 65 years did not find any safety concerns that warrant further study. These date will provide useful baseline information to assist CDC and FDA with monitoring efforts as permissive recommendations for TDAP in older persons are adopted." A 66-year-old female had received DTAP vaccine (manufacture, lot number, route site and date of administration not reported) and two days after vaccination, presented with shortness of breath, which worsened in the following six weeks. The patient died two months after vaccination; the cause of death was indicated to be pulmonary hypertension due to acute interstitial lung disease.  Documents held by sender: None.
Systemic: mom only said pt got sick and nothing in detail.-Mild, Additional Details: mom was nondescriptive about pt.'s status /condition
Myalgia; Sleepiness; Fatigue extreme; Foggy feeling in head; Feeling jittery; Swollen arm; back pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Myalgia), SOMNOLENCE (Sleepiness), FATIGUE (Fatigue extreme), FEELING ABNORMAL (Foggy feeling in head) and FEELING JITTERY (Feeling jittery) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.      Medical history was not provided. .  Concomitant products included APPLE CIDER VINEGAR, WITHANIA SOMNIFERA ROOT (ASHWAGANDHA ROOT), SAMBUCUS NIGRA (ELDERBERRY EXTRACT), ZINC and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced MYALGIA (Myalgia), SOMNOLENCE (Sleepiness), FATIGUE (Fatigue extreme), FEELING ABNORMAL (Foggy feeling in head), FEELING JITTERY (Feeling jittery), PERIPHERAL SWELLING (Swollen arm) and BACK PAIN (back pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1000 mg. On 22-Jul-2021, BACK PAIN (back pain) had resolved. At the time of the report, MYALGIA (Myalgia), SOMNOLENCE (Sleepiness), FATIGUE (Fatigue extreme), FEELING ABNORMAL (Foggy feeling in head), FEELING JITTERY (Feeling jittery) and PERIPHERAL SWELLING (Swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
p/a few days of red hot spot w & 1/2 by 3" wide on the outside of arm; pt c/o only if is touched;
Aching every where/She's aching; she's cold, really cold; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Mar2021 14:45 (Lot number: EN6207) at the age of 64 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Head problems" (unspecified if ongoing), notes: She has head problems anyway and she already has medication for headache.; "Covid" (unspecified if ongoing), notes: She had already had covid. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 10Mar2021, outcome "recovered" (11Mar2021), described as "Headache"; PAIN (non-serious) with onset 11Mar2021, outcome "not recovered", described as "Aching every where/She's aching"; NASOPHARYNGITIS (non-serious) with onset 11Mar2021, outcome "not recovered", described as "she's cold, really cold". Therapeutic measures were taken as a result of headache.  Additional information: The patient took medication for her headache. She has head problems anyway and she already has medication for headache. No additional Vaccines was Administered on the same date. The events did not cause Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none.     No follow-up attempts are possible. No further information is expected.
Pain in right thigh; Pain moved down leg into knee and calf; Pain moved to right foot, felt like stone bruise when walking; Pain moved to left foot and leg; gums bleeding; very tired, no energy. Had 2 steroid shots; went to Podiatrist for Plantar Fascia; He detected possible blood clot.
This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. In approximately 2016 (reported as "may have occurred between 05-AUG-2016 and 20-SEP-2016"), the patients were vaccinated with PEDVAXHIB injection, lot # L038502, expiration date 16-AUG-2018, (dosage number, route and anatomical location of administration were unknown), which were improperly stored. The temperature of excursion was 11.3 C and the time frame was 965 hours 19 minutes cumulative since 05-AUG-2016. The temperature excursion was detected by a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Within a couple hours after injections, symptoms of encephalitis. Confusion, agitated, irritable. Severe depression within days and became withdrawn. Continued to regress socially over the next 2 years. Diagnosed with Autism Spectrum Disorder in October 2017.
I also received the Influenza vaccine at the same time in the right arm.  The metallic/electronic high pitched continuous buzzing in both ears started about 2.5 hours ago and it has not stopped despite changes in location.
Muscle fatigue, joint pain, extreme fatigue, whole body in pain and fatigued 24/7 now a month later and is worse than ever. No treatments yet
Fever of 100.9, fatigue, malaise, loss of appetite, body ache; Tylenol 500mg BID; symptoms resolved