chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer (subsequently medically confirmed), describes the occurrence of injection site rash (a rash with just a little raised area), injection site swelling (rash started to be raised again) and injection site pain in a 41-year-old female patient who received mRNA-1273 (batch# 014C21A) for COVID-19 immunization. No medical history reported. On Apr 22, 2021, patient received the first dose of mRNA-1273, (intramuscular); 1 dosage form. On Apr 23, 2021, patient experienced injection site rash (a rash with just a little raised area). Apr 23, 2021, patient experienced injection site pain. On Apr 30, 2021, patient experienced injection site swelling (rash started to be raised again). The patient treated with Benadryl (diphenhydramine hydrochloride), at an unspecified dose and frequency and ibuprofen, at an unspecified dose and frequency. On Apr 28, 2021, injection site pain resolved. At the time of the report, injection site rash (a rash with just a little raised area) and injection site swelling (rash started to be raised again): not resolved. The action taken with mRNA-1273, (intramuscular): unknown. Concomitant medications also included Zyrtec. Reportedly, patient due for the second dose on May 21, 2021.
COVID arm - red rash, warm to touch , itchy , tender .  Went away in a week on its own.  Numb jaw which she will seek medical attention if it does not go away.
I experienced a hypoglycemic event of 58 at 10:40 PM; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EN5318), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 09:15 AM as dose 2, single for covid-19 immunisation (at the age of 46-year-old). Medical history included type 2 diabetes mellitus, dairy allergy, obesity from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included insulin degludec, liraglutide (XULTOPHY), lisinopril (LISINOPRIL), metformin (METFORMIN), rosuvastatin (ROSUVAS-TATIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (Lot number EN5318) in arm right on 27Jan2021 10:30 AM as dose 1, single for covid-19 immunisation. Reporter stated that I experienced a hypoglycemic event of 58 at 10:40 PM on 25Feb2020 as recorded. Previous value was 214 post meal at 7:13 PM. Following glucose support value resolved to 84 at 2300. No medical intervention was given other than self-administered glucose tabs. The treatment was not received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovered.  No follow up attempts are possible; No further information is expected.
Injection site reaction: hard, painful red lump that showed up overnight; Arm hurts to move/ very painful to the touch; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient received BNT162B2, via an unspecified route of administration, administered in arm left on 30Sep2021 07:00 (Batch/Lot Number: ER8733) at the age of 39 years old, as dose number unknown, single for COVID-19 immunization. Medical history included migraine and known allergies included sensitive to some adhesives. Patient was not pregnant. Concomitant medication(s) included topiramate taken for an unspecified indication, start and stop date were not reported; influenza vaccine (FLU) taken for an unspecified indication on 22Sep2021. No COVID prior vaccination and not COVID tested post vaccination. On 01Oct2021 05:30, the patient experienced injection site reaction: hard, painful red lump that showed up overnight and arm hurts to move as expected from any injection, but was very painful to the touch. No treatment provided for events. Outcome of the events were not recovered.
Pt was admitted with nondisplaced fractures of the right obturator ring. Prior to rehab transfer pt required a COVID test, but that test was positive. Pt was asymptomatic.
Mom noted  that she was mildly fussy and had currant jelly like stool - maroon colored with mucous in it about 4-5 hours after she received her vaccines. She had no fevers, no vomting.
I heard patient coughing about 10 minutes after his vaccination so I sent the staff member to check on him. I went to his room,I told the staff to call 911. He had started eating his lunch and felt that the food was stuck at the notch at the bottom of his neck. I prepared to give the EpiPen. He stopped coughing and said he was feeling better, but the staff member . said he didn't sound right. I decided not to give the EpiPen.  The Depot Runner asked to see his throat and tongue and agreed that he didn't need the EpiPen. Several other staff members came.  Asked a staff member to take his vitals. EMS arrived and took him to the ER.
Child began with redness at the site of injection on right arm on 5/10/19 started with a fever tmax 102 on 5/12/19, irritability,  decreased appetite  cough and congestion at time of injection has not worsened
8/24/06: Warm, rosy checks, non pruritic rash on arms and thighs. Over the next few days rash progressed and the palms and soles became tender and began to swell. Walks gingerly. 8/27/06: sore throat, submandibular adenopathy, painful to swallow.  2/5/07 Received medical records from allergist which reveal patient evaluated on 8/29/06.  She had developed facial warmth & tingling hands.  Then developed rash on face which spread to entire body.  Developed swollen glands in throat & mild fever. Exam revealed a diffuse maculpapular rash over trunk, legs & feet with purple cool toes.  Positive lymph nodes were palpable in neck & groin.  Tonsils noted to have exudate.  Treated w/antibiotics & steroids. Final DX: ?strep infection vs ?active viral infection w/yellow fever (doubt).  Return vs on 8/31.  Strep neg, monos not increased.  Patients feet had improved but now w/erythema multiforme on thighs.  Now had diffuse slight macular petechial rash on trunk & increased pharyngitis.  Antibiotics d/c & continued w/tapering prednisone. Return on 9/5/06 revealed old rash on feet, new lesions on lips.  patchy palmar rash (solar line) w/peeling finger tips.  Continued on prednisone.  Further f/u was done by phone on 9/7, 9/8 & 9/11.  Which revealed rash & peeling were almost done. FINAL DX: ?erythema multiforme like reaction c/w yellow fever vax.
This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 49-year-old male patient who received ENGERIX B adult (batch number EA3Z2, expiry date 19th February 2017). Previously administered products included ENGERIX B (Dose 1). On 8th January 2015, the patient received the 2nd dose of ENGERIX B adult. On an unknown date, the dose was an unknown dose. On 8th January 2015, an unknown time after receiving ENGERIX B, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional information: HCP stated that this patient received the 1st dose of ENGERIX-B on 8/28/14. He presented to the pharmacy today (1/8/15) and received the 2nd dose of ENGERIX-B. Therefore, the product is not being given according to the recommended schedules in the product label.
decreased sensation and tingling from head to toe on left side of body. Patient also reported slight weakness to extremities on left side. event occurred right after administration of vaccine approximately 10:00. Reported continued s/s to This RN at 1500. Patient seen by provider encouraged to hydrate and rest.
I feel as bad as when I actually had covid. Pain, nausea, I couldn't sleep because the pain was so bad. I couldn't move my body for a little while. My mother had the same reaction. I was shaking really bad, shivering even though I am not cold. I am still feeling terrible.
Neurologic symptoms started in my left hand within 2-3 weeks of a vaccination in my left arm. It started with lots of tremors and then certain fingers in my left hand stopped any extention.  My entire hand became clumsy and lacked fine motor control  After about 7 months I still have some symptoms. My left middle finger does not extend and the hand is still clumpsy. It is a very frustrating feeling and prevents me from doing some things important in my life. 5/11/10 Follow up: Neurologic symptoms continue in left hand and arm so I still have trouble using that hand.
She experienced pain on the inside of the upper left arm along with red, painful palpable lymph nodes up into her left axilla.  Within 2 days the redness and tenderness went away, but lymph nodes were still palpable for at least 1 week afterward. Had received the Moderna COVID vaccine on 1/2/2021 and 1/30/2021 and the Tdap vaccine on 12/14/2020.
This spontaneous report as received from a female patient of unknown age regarding herself. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. in January 2016, the patient was vaccinated with ZOSTAVAX (strength, lot#, expiry were not reported) 1 shot subcutaneously. She stated that ever since she received the shot she, "hasn't felt right". She stated that she did not experience any of the most common listed side effects given in the Prescribing Information. But in January 2016, the patient has lowered WBC result when blood testing was done and had issues with her thyroid as well. She stated that she also felt a "pins and needles" sensation in her arm. The outcome of the events was reported as no recovered/not resolved. There were no product quality complaints (PCQ) involved. Additional information has been requested.
pt recv vax 11/22/98 & pt was observed to exhibit resp distress w/tachypnea about 1 1/2hr p/vax given;mean BP was about 31;pt recv normal saline for hypotension & transferred to neonatal ICU;
Arm pain, diarrhea, Insomnia, Decreased appetite, short of breath, Chills,  Feeling unwell, dizziness, muscle soreness, Tiredness
There was no adverse reaction and provider stayed to observe patient for 30 minutes. The VAERS report is being submitted because the  patient had received a first dose of Pfizer, but was vaccinated today with Moderna. The patient said the first dose she received previously was Moderna, but it was Pfizer. Vaccination of second dose was not the same manufacturer.
RECEIVED EXPIRED VACCINE; This spontaneous report received from a health care professional 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 not reported, batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced received expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received expired vaccine was not reported. This report was non-serious.
itchy rash on her thigh/itchy rash and top of both hands; little spots at the bands of the elbow; Body ache; Mild headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH PRURITIC (itchy rash on her thigh/itchy rash and top of both hands), RASH MACULAR (little spots at the bands of the elbow), PAIN (Body ache) and HEADACHE (Mild headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028420A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN (Body ache) and HEADACHE (Mild headache). On 25-Jan-2021, the patient experienced RASH PRURITIC (itchy rash on her thigh/itchy rash and top of both hands) and RASH MACULAR (little spots at the bands of the elbow). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), RASH PRURITIC (itchy rash on her thigh/itchy rash and top of both hands), RASH MACULAR (little spots at the bands of the elbow), PAIN (Body ache) and HEADACHE (Mild headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator; 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.
Patient received both the Adacel and Zostavax injection in her right arm on 5/26/16. On 5/28/16 she came to the pharmacy because the injection site where she received the Zostavax (the back portion of her right arm) had become red. She stated that it did not hurt, nor did it itch or feel hot. It was just red around the area. She stated that if symptoms progressed further she would return and let us know. The patient's physician was notified.
Initial report received from a health care professional (nurse) on 02 Dec 2010: This patient was vaccinated with only the MenCWY liquid conjugate component of MENVEO (batch number: 100001) intramuscularly without being reconstituted with the MenA conjugate component. No adverse events were noted following this medication error. The patient was scheduled for re-vaccination, however she had not received it yet.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 06-APR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to temperatures excursion of 0 Celsius degrees for 168 hours and 1.1 Celsius degrees for 840 hours with lowest temperature recorded of 32 and 34 Fahrenheit degrees respectively. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
had Pneumonia; Initial information received on 09-Oct-2020 regarding an unsolicited valid serious case received from a consumer (patient). This case involves patient (unknown demographics) who experienced pneumonia, while received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event pneumonia was unknown.  Information on lot number was requested; Sender's Comments: This case concerns a patient (unknown demographics) who presented with pneumonia after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information on patient's medical condition at time of vaccination, concomitant medication and investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Shortly after patient received vaccination he went to get up. He didn't look well, so I asked him to sit back down. Then as I was about to tell him to lie down on the floor, it appeared to me as if he fainted in the chair. We were able to lie the patient flat on the floor and raise legs on a chair. He stated he immediately felt better. He also stated he never lost consciousness and that he had bad anxiety and that this has happened before due to his anxiety in the past. They checked out the patient and the patient walked out on his own accord and did not leave with the paramedics.
nausea; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced nausea on an unspecified date. The outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained
Blurry Vision in Both Eyes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 18-year-old female patient received BNT162b2 (BNT162B2), on 29Jun2022 as dose 1, single (Batch/Lot number: unknown) at the age of 18 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VISION BLURRED (non-serious) with onset 30Jun2022, outcome "recovering", described as "Blurry Vision in Both Eyes". Therapeutic measures were not taken as a result of vision blurred.  Additional information: Reason for no lot number: of Covid 19 Vaccine: Complainant does not have the product with them at the time of call. Vaccination facility type was Pharmacy/Drug Store. There was no history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines was administered on same date of the Pfizer Suspect. The time of onset of AE'S was 12 Hours later. Patient did not require any AE(s) to a visit to Emergency Room. Prior Vaccinations (within 4 weeks): None. Patient did not had any AE(s) following prior vaccinations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Hives and itchy. Had previous reaction to first dose. BP 140/90; HR 89; RR 20. Given Benadryl 25mg PO at 13:50 when symptoms occurred. Benadryl 25mg IM at 14:12.
24HRS AFTER VACCINE, SHE TOOK OF THE BANDAGE AND THE BLISTER IS ABOUT TWO INCHES, THE SIZE HAS NOT INCREASED. NO THERAPY, Derm. physician prescribed cream for itch, however she is hesitant to take.
Fatigue, chills, fever, hypotension and fainted. ER visit on 2/25/2022. 2L fluids received.
Approximately 30 minutes after receiving vaccine experienced severe chest pain and spasms in chest wall, sweaty and light headedness.  Went back to pharmacy and they called the emergency number.  About 45 minutes later and after 2 Nitroglycerine sublingual tablets and gel on chest, pain began to subside.  Stayed overnight in hospital for observation and tests.  Went home next day.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-JAN-2016 the patient was vaccinated with an improperly stored dose of VAQTA 50U/1ml (lot # L0018498, expiration date 28-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 368 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Fever started 8/1/03, gagging, vomited, not eating or sleeping well. Taking to emergency room on 8/4/03 at 7:51 AM. Returned to emergency room 8/4/03, temp 100.4, rash. Diagnose with Steven-Johnson Syndrome. Hospital discharge summary states pneumonia, atelectasis and bacteremia.
He got his 4th vaccine, that night after about a few hours starting to get a high fever, got really  hot and told his wife he thought he had a fever.  She had a splitting headache between  his temples.  He took 1000 mg of Tylenol as he cannot take any other kind of pain reliever.  It then came back again and kept taking it to get rid of the headaches.  He did not measure his temperature and knew that he had a fever.  Felt like he had a virus or the flu.  He did a COVID test and that was negative, but just felt bad.  He thinks that his immune system was kicking in 100%.  These symptoms lasted on and off for the last few days.    A few days after the vaccine, he was going to the bank an ATM and was driving down the highway, was OK, 40 miles until he got to where he was going.  He got into the parking lot where the bank was and coming up to the machine and everything went black, passed out going into the bank and drove through the side window of the bank, storage room.  Somebody came around right away who witnessed the event and called 911.  Glass was falling into his car, tried to get out of the car and fell on the road onto his back in the parking lot.  The ambulance took him to the hospital and asked if he was wearing a seatbelt which he was.  The doctor in the ER said that he had syncope.  They informed him that his electrolytes were messed up and gave him magnesium, potassium and other medicine through IV's.  He stayed in observation over night.  They did CAT scans of his brain and also did one of his heart checking for a blood clot or heart attack.  His BP was high when the paramedics came and it was 200/100 something.   He cannot drive until he goes back to his PCP and is given the clearing to do so.    He now has a home health nurse coming 2 times a week to check his VS to see if he is OK.    He has never had an events after the vaccines.  The last one had a slight fever, but nothing too bad.
pt devl fever of 103 right p/vax given; had a generalized sz in 16 hrs; pt cont fever 36 hrs;
10/16 am woke up with stom pain.(sharp).  Felt "tired", body achee that increased throughout the day.  By 5Pm could not stand up, slept for 3 hours in the afternoon.  Felt "hot" and "cold".  Woke up at 5AM today 10/17/2008 heavy perspiration, aches are gone, some nausea
Presented to healthcare with c/o N/V throughout the night.  VS show tachycardia and fever.  156/87, 108, 20, 101.3.  IV fluid for hydration, Zofran for nausea and Tylenol for fever.  Monitor