chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 15 min of the vaccine patient became diaphoretic extremely shaky & confused. Blood pressure 150/100 & afebrile. Within another 10 min tongue became swollen & discolored. Pt was rushed to the ER where his BP 185/100 O2 93%. Epinephrine, BENADRYL, steroids, PEPCID administered IV for anaphylactic reaction. Kept for 2 hrs for observation.
Information has been received from a physician concerning a 77 year old female who in 2006 was vaccinated with a dose of ZOSTAVAX (Merck) subcutaneous injection (lot# and dose not reported). In May 2010, the patient developed ophthalmic shingles even though she had a vaccination. Medical attention was sought. At the time of report, the patient's ophthalmic shingles was not recovered. The patient's ophthalmic shingles was considered to be disabling by the physician. Additional information has been requested.
Patient experienced nausea, tremor, sweats, body heaviness, skin paling for 5-10 minutes.
This spontaneous report was received from a other health professional nurse practitioner, concerning a 6-month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies. On 28-DEC-2021, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, at a dose of 0.5 milliliter (ml) (lot number T030749, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 16-MAR-2023) (route of administration and anatomical location were not reported), as prophylaxis (product use issue). No additional adverse events were reported.
Expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The facility received the vaccine in October 2021. The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder on Moderna the expiration date 14-Aug-2021. The nurse said that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program on Moderna that showed the expiration date as 14-Oct-2022. The PC number was reported as 16069. It was reported that the vial did not undergo any temperature excursions.  No treatment information was reported.
Covid arm small area; Sore ankle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm small area) and ARTHRALGIA (Sore ankle) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm small area) and ARTHRALGIA (Sore ankle). At the time of the report, VACCINATION SITE REACTION (Covid arm small area) and ARTHRALGIA (Sore ankle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. With side effects (slight)
Information has been received from a 68 year old male registered nurse with penicillin allergy and a history of aortic stenosis, gallbladder cholecystectomy, laminectomy and total knee replacement on 20-SEP-2010 at 11:00 AM was vaccinated subcutaneously in his right arm with 0.5 ml PNEUMOVAX 23 (lot# 665707/1407Y). Concomitant therapy included DIOVAN, LIPITOR, doxazosin mesylate and finasteride. On the same day, a few hours after, he stated that his right arm was very stiff, painful, swollen and warm to the touch. He stated "it was almost like I had compartment syndrome". He stated he saw his physician this morning. He was advised to take two ibuprofen and apply ice. He stated his swelling went down 30% this morning. There was no laboratory test performed. At the time of the report, he stated his muscle was edematous and hard. The outcome was reported as not recovered. Follow-up information has been received from a health professional concerning the 68 year old male with aortic stenosis, cholesterol levels raised, diabetes, morbid obesity and hypertension and no illness at time of vaccination who on 20-SEP-2010 was vaccinated in his right arm with the second dose of PNEUMOVAX 23 (lot# 665707/1407Y (Lot # also reported as 14074)). On 13-SEP-2010 at 10:18 AM, the patient was vaccinated in his left arm with a dose of FLULAVAL (LOT# AFLLA603AA). On 20-SEP-2010 at PM, the patient developed an area of erythema, extending from the top of the right shoulder down to about one inch above the elbow crease, over the anterior surface and extending ? ways around. On 20-SEP-2010 patient called after hour's number with complaint. He described compartment syndrome. He was instructed to go to the emergency room (ER) right away. Patient followed-up in my office the following morning. Diagnostic: local reaction "v." cellulitis. Injection site was cleaned with rubbing alcohol in contrast for what patient stated. Patient was started on BACTRIM DS and clindamycin. Patient responded well. There was no relevant lab data. On 22-SEP-2010, the patient recovered. Follow-up information has been received from the retired registered nurse who reported that the previous PNEUMOVAX 23 was given to him 5 years ago. His arm swelled to max size and began to worry about compartment syndrome. He had taken 600mg Non-steroidal anti-inflammatory drug (NSAID). The "next day" he recovered. According to the reporter, cellulitis, arm swelling to max size and local reaction were considered to be other important medical events. This is one of several reports received from the same source. No further information is available.
Abdominal discomfort persisting for about 1 month. Blood in stool on one day. Occasional diarrhea and lack of appetite
Shortness of breath/breathing problems; This is a spontaneous report from a contactable consumer or other healthcare professional (patient). A 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6198), via an unspecified route of administration on 27Feb2021 (at the age of 81-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included heart and blood pressure, depression and asthma. Concomitant medication included metoprolol taken for heart and blood pressure from Jan2021 and ongoing, escitalopram taken for depression, start and stop date were not reported and medication for asthma.(allergy drug for asthma). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EM9810), via an unspecified route of administration on 06Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. On 04Mar2021 the patient began to experience shortness of breath/breathing problems. On 06Mar2021 she was seen in the emergency department and evaluated for her shortness of breath. On an unknown date in Mar2021 she underwent computerised tomogram (CT) of her lungs which resulted normal (found nothing wrong). She received montelukast 10mg as treatment for the event. Stated that she began experiencing shortness of breath on 04Mar2021, she thought it was just normal so she did not do anything, states it continued and on Saturday morning, 06Mar2021 she went to the emergency room. On an unknown date in Mar2021 they did all the tests, CT of her lungs and everything and they found nothing wrong. She followed up with her family doctor who told her it was not an allergic reaction to the vaccine because if she was going to have one it would have been closer to when she got the vaccine. States she was then started on an antidepressant and an allergy drug for asthma. Clarifies she began escitalopram 5mg, and a medication for asthma, Montelukast, 10mg at night time for breathing to take at night, clarified this was all back in Mar2021. Caller stated she had been on medication since then, and it helped some. She wanted to know have other people had this problem from taking the vaccine, have they reported shortness of breath after the vaccine. She stated tomorrow she was going to the cardiologist. At the time of report, outcome of the event was not resolved.
Bilateral Pulmonary Emboli-- 1 blood clot in both lungs. Recently have been referred to Hematology dept (June 2021) due to a suspected blood clotting disorder after follow up labs were completed.
Itching to under arm, then bumps on top of left arm and down the left side, painful to touch. Bumps red with little white heads.
Extreme muscle aches, low grade temperature of 94°, highest temp up to 99.7°, extremely low energy. Next morning, sore ears and throat. Temperature down to 95° on second day. Craving salt. Still extremely low energy, but aches are more mild.
no adverse events at the time of this report.  Medication error - 11 y/o child received adult dose of pfizer COVID-19 vaccine.
Approximately 2 1/2 days after receiving the vaccine: woke up in am with L injection site soreness and L lower arm and hand tingling with mild numbness and within 3-4 hours the numbness and tingling progressed to all my extremities along with low grade muscle weakness(heaviness) in limbs particularly distally (elbows to fingers and lower thighs to toes); also had intermittent tingling in face primarily L side and heat sensation/burning in chest and medial upper arms; symptoms have varied in frequency and intensity from day to day and continue to this day. I am having good and bad days.
12 hours after 2nd vaccine: 102 fever, nausea, chills, sweats, body aches, headache, tired
Fast Heart rate after an hour and half of injection and shortness of breath . Next morning i woke up sweating and my heart rate was 130 and shortness of breath followed. I then developed a rash the same day which was red and bumpy i also felt really lethargic and fatigued.  Day three  the rash had a line straight through the middle of it and was itchy the rash was spreading horizontally.  After day three I felt  better with the only  side effect being shortness of breath from time to time.  Now on the 7th of Jan I develop the rash again except its raised, the line is back and it itches internally.  I don't feel bad , it's just concerning that it came  back stronger all the sudden. I don't know if I will be allowed to get the second dose.
switched Trumemba to Bexsero, injection site side effects; This case was reported by a physician via sales rep and described the occurrence of injection site reaction in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 6-Feb-2023 Reporter's comment: The reporter reported that his practice had recently switched from Trumemba to Bexsero and there had been some patients had complained about side effects at the injection site. The physician would like to know if there was any clinical data in the side effect profile at injection site of Bexsero in comparison to Trumemba, the efficacy of the first dose of Bexsero versus 2nd dose. Please provide all clinical data. No patients identifiers, practice data, mentioning of adverse events, filed adverse events as conservatory. The reporter consented to follow-up. The case was kept valid for injection site reaction and did not kept interchange of vaccine product as additional event as the case was for unspecified number of patients as we did not have the dose number of prior vaccination .
Typical "COVID vaccine arm" symptoms 1/14/21 - woke up with injection site swollen and itchy with hives.   1/15/21  - 2 inch, well demarcated hard, red, very hot.  Located more in the skin than deep.  No pain.  Treated with ice, tylenol, 1% hydrocortisone topical cream. 1/16/21 - area still hard, HOT, redness spread toward armpit, mild joint and injection site pain.  Treated with ice. 1/17 - 1/18/21 - decrease in all symptoms, though redness continued to spread toward armpit.  Site now swollen deep to site rather than in skin.  Treated with ice. 1/19/21 - faint redness, less swelling and heat. 1/20/21 - symptoms mostly resolved at injection site.  Still some warmth and pinkness in area near armpit.  Site soft.
Pt stated he felt dizzy about 10 minutes after shot.  Pt laid down for about 30 minutes.  All vital signs stable.  Pt still dizzy when standing after an hour.  At 3:30pm, pt stated his throat "feels tight."  Benadryl 50mg IM administered and 911 called.  Pt transported to HCF.
Nausea for a week, muscle aches since shot was given in back/spine (still present), headaches
SEVERE DIZZINESS, NAUSCIA  AND FAINTED AT 5:30AM.    FELL INTO BATHROOM SINK CABINET HITTING MY HEAD VERY HARD.    HUSBAND FOUND ME COMPLETELY KNOCKED OUT COLD.    911 CALLED AND I WAS TRANSPORTED TO HOSPITAL FOR CT SCAN OF HEAD/NECK AND OTHER TESTS.   THEN 1-WEEK LATER, I DEVELOPED UNUSUAL RASH SPOTS ON MY NECK, CHEST UPPER/LOWER BACK, ON LOWER HALF OF LEGS.   RASH SPOTS VERY ITCHY AND SORE ENTIRE MONTH OF APRIL 2021.   URGENT DR. APPT. WITH DR. ON APR. 30.    UNDETERMINED DIAGNOSIS HOWEVER POTENTIALLY ADVERSE EFFECTS FROM 2ND DOSE MODERNA VACCINE. 4/30/2021 DR.   PRESCRIBED PREDNISONE 10MG TABS TWICE PER DAY FOR 5 DAYS.
No history of allergy to gelatin or Neomycin. Patient called said had 24 hour fever 2 days post injection and 6 inch diameter redness & swelling at injection sight. I had her contact Dr. To follow up ie Benadryl or topical hydrocortisone might be needed.
Next day - Restless Leg started.  Had for at least one year.  Didn't notice until did physical work house cleaning week or so later - muscles felt damaged - extreme soreness that would not go away.  Went to gym couple months later and did very minor arm workout.  Again, muscles extremely sore and would not heal.  At this point, couldn't get to ground, walk well, walk any distance, reach overhead, lifting.  In the past, was extremely active.  Only regained halfway normal life after started Cymbalta after about a year and a half.  Still very limited.  Doctor I go to now said fibromyalgia, though have no other symptoms.  Started right after Shingrix vaccine #1 (obviously didn't get 2nd).  No doubt in my mind was from the vaccine.  Too close timewise to be a coincidence.  Still have the restless leg occasionally.
Varicella; medication error Information has been received from a physician concerning a 7 year old female with a healthy medical history and no allergies who on 15-SEP-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) that the reported noted had been ordered through the local hospital and did not think was transported properly to the office. There was no concomitant medication. It was reported that on 07SEP-2005 the patient experienced breakthrough varicella of about 20 crusted lesions and no fever. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested. Body temp 09/07/05 no fever
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided.
On May 5th and May 24th, my daughter syncope'd randomly and this has never happened before. I took her to her general practitioner and her EKG is now abnormal. It never was in the past. We will be taking her to a cardiologist and neurologist for further testing.
Parent provided in person verbal consent that child was 16 years of age and desired vaccine. Child vaccinated before noticing that the age was only 15 and they would not be 16 until August. 2nd dose appointment cancelled and informed they could receive after turning 16 years or EUA advised otherwise.
This spontaneous report was received from an office manager, referring to a 44 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 15-JAN-2018, the patient went to the reporter's Facility to get a tuberculin purified protein derivative (PPD) test and instead of this she was injected with 0.1cc of GARDASIL 9 in the left forearm intradermally (lot number reported as 12093, no expiration date was provided). The patient was notified as soon as the error was found, on the same day. On 17-JAN-2018, the patient was called and stated she had been nauseated with blurred vision. She was advised to be checked out by a physician and said she would call back to schedule an appointment. The patient went to the reporter's Facility 2 weeks later for something unrelated. At the time of the report, the patient's outcome was reported as recovered. The reporter did not assess the causal relationship between therapy with GARDASIL 9 and the events of nausea and vision blurred.
can still get the flu even though you get the shot, both type A and B few years ago; Initial information regarding an unsolicited valid non-serious social media case was received from a non-healthcare professional (patient) via social media on 06-Dec-2020.  This case involved a patient of an unknown age and gender who reported that can still get the flu even though you get the shot and developed both type a and b few years ago (Influenza), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), it was reported that someone could get the flu even though that person got a flu shot and the patient had both type A and B of flu few years ago (Influenza).  No relevant laboratory details were reported.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown for the event of influenza.  There will be no information available on the batch number for this case.
Within 6 hours of the booster shot, I started having numbness in my fingers, pain in my neck and down to my elbow. I started running a fever of 100.5. The next morning I couldn't get out of bed; couldn't lift my head off the pillow. Fever still at 100.5 throughout the second day. Third day fever was gone but the extreme fatigue continued to get worse. Fourth day again extreme fatigue and nausea. Also started bloating. On the 5th day again extreme fatigue. Continued pain in my neck and back and down my arm, as well as general aches and pains throughout my body. My heartrate has risen to 112 beats per minute, and my blood pressure as been around 100/73. I have been having a hard time getting a deep breath. It feels like I am always short on oxygen. My oxygen level has been 93 most of the day. I also have gained 7 pounds since the booster shot. 133 pounds to 140 pounds. Nausea has continued to get worse as well.
The day after the 2nd dose of COVID19 vaccination series this person had a seizure while at work.  EMS was called and he had another seizure for them before they could transport him to the hospital.  He also had a fever38.6.  The individual was admitted and overnight became increasingly agitated and confused.  Family reports that that after discharge from the hospital he has not returned to his normal functioning.  Prior to this episode he was living alone and working.   Now he cannot be left alone as his neurological status has quite deteriorated . He has had a ?substantial disruption of the ability to conduct normal life functions? Family have had to take time off of work and make arrangements to care for him.
Patient had one dose of Pfizer COVID 19 vaccine primary series 11/11/21 and was given one dose of Moderna COVID 19 vaccine 9/7/22.
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Fever-Medium, Additional Details: Started with Swelling in face-then itchy neck-now itch neck, shoulders and back-continued swelling in lower lip. Fever 100.4 (12/10/2022)
no additional AEs; patients received doses of VARIVAX vaccine on 8/9/22 while improperly stored outside recommended storage temperature range; This spontaneous report has been received from a registered nurse regarding a 22 months-old patient of unknown gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 03-AUG-2022, varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to -14 Fahrenheit (F) up to 46 F (14F) for 4 hours (h) 15 minutes (min). On 09-AUG-2022, the vaccine was exposed to 14 F up to 46 F (45F) for 4 h 45 min. On the same day, the patient was vaccinated with one dose of a stored outside the recommended storage temperature range of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, subcutaneously, on the left deltoid at a dose of 0.5 milliliters (ml), once (lot number: W011626, which was verified to be valid, with an expiration date: 06-APR-2024; strength was not reported) (product storage error). The reporter called for an evaluation of vaccine temperature stability. There was no additional adverse event (AE) reported, and no further information was provided.  This is one of several reports from the same reporter.