chrisvoncsefalvay/vaers-outcomes huggingface dataset:
horrendous pain in his left shoulder which is where the vaccine was given, general muscle and joint point all over; general muscle and joint point all over; general muscle and joint point all over; would like to know if there has been any possible side effects or interactions with his cardiovascular medications pravastatin sodium 40 mg and Plavix 75 mg; on day 12 he also had difficulty getting out of his car.; This is a spontaneous report from a contactable consumer (patient himself). A 83-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) on unspecified date (at the age of 83-years-old) as single dose for COVID-19 immunization. The patient received first dose of BNT162B2 for covid-19 immunization on unspecified date with no adverse effect after first dose. Medical history included injury to shoulder. Concomitant medications included Pravastatin Sodium and Plavix for cardiovascular . Patient received both doses of the Pfizer COVID vaccine. Caller states the second dose was given approximately three and a half weeks ago. Caller would like to know if there has been any possible side effects or interactions with his cardiovascular medications pravastatin sodium 40 mg and Plavix 75 mg. He stated that he had a response to the pravastatin sodium 6 years ago where he had similar side effects to what he was experiencing now. He had no reaction to the vaccine during the waiting period at the vaccination facility. He stated that 10 days after receiving the vaccine he woke up with horrendous pain in his left shoulder which was where the vaccine was given. He also had general muscle and joint point all over. He stated that the pain in his shoulder was improving but was still present and he was unable to put on a coat or lift his shoulder and on day 12 he also had difficulty getting out of his car. The outcome of events was unknown and outcome of the event horrendous pain in his left shoulder which was where the vaccine was given, general muscle and joint point all over was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was reported from a pharmacy technician, refers to multiple unspecified patients of unknown ages and genders. Concurrent condition and medical history were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VAQTA lot# L001445, expiration date 15-FEB-2016 (strength, dose#, dose, route of administration, anatomical location were not reported). There was not a product quality complaint (PQC) involved. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
On 9/7/22, I had my bivalent booster shot voluntarily to better prevent myself from getting COVID-19. I got stung by a bee on 9/19/22 and had to be taken to ER  due to Anaphlaxis. I had never experienced all the severe allergic reactions previously. In 2013, I had hives and difficult in breathing by a bee sting. This time I experienced a fast speed in 1-30 mins of Anaphlaxis including fainting, low blood pressure 70/40, hives/rashes, dizziness, vomiting, nausea, difficult in controlling vowels, muscle weakness, headache,  Unable to stand up or walk, swollen head, hands, feet, arms, legs, face, eyelids, lips, and numbness and tingling fingers and toes.
Patient/Employee reported a "flu shot response" via email 10/13/2016 upon returning to work the next day. The following information has been copied from her email. "I mentioned this to person, and she said I should tell Employee Health so you can document reactions. I had a pretty severe reaction to the flu shot last night, worse than your typical immune response. Severe muscle, nerve, and joint pain all over my body, and my organs & bones actually hurt (bizarre feeling). Bad flu-like kind of headache w/dizziness, which I still have (dizziness has improved). I had a high fever I could tell (didn't take temperature because I couldn't move); was drenched in sweat but had severe chills. Very red eyes and fatigue. Nausea all day yesterday. I couldn't move my arm without significant pain all day. I'm better now, except for the headache. Didn't get much sleep. I always feel sick to some extent after I get the flu shot, but this was much worse than I have experienced. It felt like the full-blown flu."
Light headache; Light fever; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Light headache) and PYREXIA (Light fever) in a female patient of an unknown age 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 HEADACHE (Light headache) and PYREXIA (Light fever). At the time of the report, HEADACHE (Light headache) and PYREXIA (Light fever) had 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 were reported.  No treatment information was reported.  It was reported that the patient had reaction only after her 1st dose. The reaction lasted only less than 12 hours.
The following day around noon, had swelling and developed cellulitis.  Went to the ER for eval/treatment.
Localized rash, high fever. Went to see dr and is diagnosed with cellulitis. Currently on antibiotic. Called 4/7 - she is fine and free of infection.
red splotch on left arm: red, hot, itchy  3 inches below shot site,  applied Benadryl, started 3/8/2021 about 9:30 pm    Today it is palerand smaller but still red, hot and itchy.       This was shot # 2
C/O middle line mild chest pain for above 1 minutes and went away. No c/o short of breath
got into an accident after the 1st dose; This is a spontaneous report from a contactable consumer or other non-HCP (Patient) via Pfizer sponsored Program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 03May2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The second dose was scheduled on 24May2021. The patient medical history and concomitant medications were not reported. On an unspecified date, got into an accident after the 1st dose. The patient was having some transportation issue going to the vaccination facility. He wanted to know if getting into an accident and being wounded after the first dose, will that have any effect with the vaccine. Outcome of the event was unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.
pt received vaccine at 1008. at approx 1030 she began to feel her tongue tingle and swollen. worsened by 11:00 and reported it to us. BP, HR, pulse ox normal. allowed to rest, drinking water. checked back ~ 1115 - BP and HR elevated to 167/94 and 105. no SOB or wheezing but tongue becoming thicker, harder to swallow and talk. pt escorted to ER.  in ER, she was given IV pepcid, bendaryl and solumedrol. sxs improved and she was dc'd home w/ prednisone. her breathing was never compromised, no stridor or tripod positioning while in ER. vitals remained stable.
Initial misuse report received from a healthcare professional on 20 February 2014. (Reference number: 14-0110). A 60-year old female patient had received dose of FLUZONE (batch number UH920AC, expiration date 30-June-2014), route of vaccination not reported) in the left forearm SQ on 19 February 2014. The medical history of the patient included allergic to Penicillin and concomitant medications were not reported. The patient does not have any illness at the time of vaccination. it was reported that on 19 February 2014 accidentally used FLUZONE MDV instead of Tubersol for PPD. Inserted 0.1 ml into the left forearm SQ. Patient developed redness at insertion site. The nurse plans to advise patient to use cold compresses, Motrin. No other details about the area of redness. The laboratory investigation was not reported.  At the time of this report the outcome of the adverse event was not resolved. Documents held by sender: none.
Sore arm below site very mild red area < 1" round at inj. site. No drainage no lumps at inj. site. Muscle soft supple no lumps. Counseled pt on site s/s infection; use heat or ice for comfort and Ibuprofen.
vaccination provider administered the vaccine by her shoulder and "not in the muscle at all"; injection site has formed a lump and a little pain; injection site has formed a lump and a little pain; This is a spontaneous report from a non-contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on unspecified date on arm at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Caller received the first vaccine three weeks ago and is scheduled to receive the second dose this weekend. Caller reports that the vaccination provider administered the vaccine by her shoulder and "not in the muscle at all."  Caller states that the injection site has formed a lump and a little pain. Patient wanted to know if it would affect efficacy. Caller states that she is really anxious and this is very stressful for her. She has consulted with her HCP. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) Negative, notes: Negative test results; (23May2022) Negative; (24May2022) Negative; (25May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient did not receive other medications within 2 weeks of starting COVID-19 treatment. Anti viral details: Paxlovid, from 16May2022 to 21May2022, for COVID 19 treatment. After taking Paxlovid was getting negative test results on 21May2022 and 23May2022. On 24May2022 symptoms resumed and tested positive on 25May2022.
within about 15 hours i had fever and chills, nausea and emesis, rigors, lasting 3 days. I am uninsured, and did not seek medical care. I believe I may have had a seizure? brief loss of consciousness? something... I had NO INTENTION of getting second dose of vaccine, because i had covid, and THE SCIENCE say i dont need a vaccination. Some countries are recommending ONE vaccine for someone who has had Covid. But then my work said it would be mandatory. So i got the second dose. And i lost a lot of money missing work. This is BS that we cant get out appropriate information .."follow the science"  Give me a break. You should have to pay me for this but of course youre off scott free and i still feel like dying.
I have had constant tone tinnitus for 46 years/It had steadily/3 weeks after second dose the volume steadily increased; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FW0172) via an unspecified route, administered in Right Arm on 26Apr2021 at 09:30 (64-year-old at vaccination) as a Dose 2, Single for COVID-19 immunization. The most recent facility of COVID-19 vaccine administration was reported facility. The patient's medical history included essential hypertension and he have had constant tone tinnitus for 46 years as a result of noise exposure. The patient had no known allergies. The patient's concomitant medication(s) included Valsartan, Omeprazole within 2 weeks of vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: LR8733) via an unspecified route, administered in Left Arm on 05Apr2021 at 09:30 (64-year-old at vaccination) as a Dose 1, Single for COVID-19 immunization. On 29May2021 at 11:45 PM, the reporter stated that he had constant tone tinnitus for 46 years as a result of noise exposure. It had steadily dissipated over decades from a volume of 10 (on a 0 to 10 scale) to around 3. About 3 weeks after his second dose the volume steadily increased (same tone) to around 7 and was now hovering there with some modulation in intensity, kind of like a slow sine wave, sometimes down to 4 or 5. He cannot attribute this to any other event. Since the vaccination the patient had not been tested for COVID-19. No treatment medications received for resulted events. The seriousness of the event was reported as non-serious by the reporter. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information was expected.
About a week after the vaccine, and following a swollen lymph node in the armpit of the injection arm about 5 days after vaccination, had a delayed skin reaction in the injection arm around the injection site.  Skin was swollen and raised largely in an approximate 3-in ring around the injection site, with a few raised areas outside of the ring. Minimal itching and discomfort. Two 25mg capsules of antihistamine resulted in the elimination of the raised areas and reduced swelling in about 24-hours
mom reports p/pt recvd vax 8MAY92 leg became reddened w/in 3 to 4 hrs-temp & screamed as if in severe pain; MD contacted;
Tongue swelling and throat feeling tight. Patient report headache, fatigue, weakness, dizziness, and tremors in arms and legs since the reaction.
Spontaneous onset of recurrent diarrhea, vomiting, nausea. Patient also experienced sweating, feeling faint and eventually within course of 2-3 hours. Complete dehydration which caused radical decrease in BP, impairment of other vital signs. Radical seizing and cramping of most muscles and complete incapacitation. Taken by ambulance to ER, given IV anti nausea ect. Ongoing residual recovery. Still occasional diarrhea, overall weakness, impaired appetite and digestion. Note: Food, salmonella poisoning symptoms suspect but all food sources within last 48 hrs had been shared with spouse demonstrating no adverse  reaction, definitive high WBC response to infection, viral. ER's position conclusion was also an adverse reaction to previous days. Flu vaccine.
14JUL92 pt screened for hx of convuls, allergies to egg or meds; in good hlth given MMR approx 10 minutes later pt fell & hit head upon falling; regained consciousness in about 7-10 seconds; alert, oriented x 3 VS respt 16, P56, BP 88/50;
Patient was diagnosed with COVID-19 infection via positive PCR test result on 03/22/2021 and a second PCR test result on 03/23/2021. Patient presented symptomatic at place of work (long term care facility) 03/22/2021. This case is a confirmed breakthrough case as it meets the case definition with no known previous COVID-19 infection in the past 45 days and completion of vaccination (COVID19 Pfizer vaccine administration dates: 01/25/2021 and 02/15/2021). Times of vaccination and PCR tests are unknown. The Dept. of Public Health were made aware of this case and recommended the patient isolate per DPH/CDC recommendations. Resolution of infection is unknown at this time. The workplace clinic provider did not save a lot number for the vaccines administered to this patient.
pt recv vax & later was reported to still have redness down arm's length;no lump or raised area;17JAN97 f/u large area 5" oval shape rash (illegible) w/illegible) clear w/sharp borders;(illegible) on rt deltoid;not tender, not warm;
Patient report tingling  of the tongue and pain with swallowing. Right side tongue swelling and right side facial tingling with difficulty to swallow occurred 45 minutes after receiving the vaccine. Patient took 50 mg of Benadryl after 10 minutes there was improvement and after 30 minutes it completely resolved. She woke up the next morning with HA and diarrhea she took Tylenol and will monitor.
Very itchy body. Mainly scalp, neck, back, chest, forearms. No bumps or redness, just from scratching. It appears suddenly during the day.
Blood clot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) in a male patient of an unknown age 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, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clot) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  It was reported that after second vaccination, patient had a blood clot for 5 days which almost killed him.  Company Comment - This spontaneous case concerns a male patient of unknown age with no relevant medical history, who experienced the serious unexpected AESI event of thrombosis. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine, and the outcome was unknown. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no relevant medical history, who experienced the serious unexpected AESI event of thrombosis. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine, and the outcome was unknown. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Pt called complaining of soreness and swelling at the injection site. She then said she was dizzy and had nausea today also. 7/1/11- she went to the doctor and he said she had cellulitis.
MMR given at 17:00-17:50.  Complained of nausea, dizzy, sweats, throat felt like it was closing and chest pains.  Went to ER - Benadryl offered.  Felt sick to stomach next day but better.
I was unsure whether to enter this information as I do not think it is connected to the vaccine since it didn't happen until 2 months later, but after talking to the lady on the phone and also seeing neurological issues connected to the Johnson & Johnson vaccine, I decided it wouldn't hurt. I am still not sure what the issue has turned out to be as I am still undergoing treatment, but I went to the ER on 5/23/21, then again 5/29/21 for pain in my thoracic as well as URQ of abdomen. Many tests run, but my best guess right now is that it is a pinched nerve. I have seen 6 doctors, had many tests, and tried many medications, and we know it is neurological as Gabapentin is the only medicine to help. This issue is still ongoing.
Lightheadedness, nausea, SOB, seizure-like activity - stiffening,  arching back, rapid eye mvmt, not following commands.
First dose  January 6 2021, only pain in the arm.  Second dose January 28, 2021, day after the shot, had to leave work, chills, nausea, extreme weakness, joint pain, muscle pain.  By the end of the day and continuing into the next two days, joint and muscle pain, hard painful swollen lymph nodes in armpits, neck, collarbone area, behind knees, inguinal area.  Couch bound for 3 solid days.  Swollen nodes lasted approx 1 week.  Weakness persisted into week #2, about 10 days.  Weight loss.  Random bloodwork drawn for a physical on February 20, 2021 -  fasting blood glucose was 407.  Last two blood glucose levels, 2017 and 2019 were both 108.  March 6, 2021 fasting glucose 347, HgbA1C 13.8%.  March 15, 2021 fasting blood glucose 240, HgbA1C 10%.  Joint pain persists.  Started on Metformin 500mg po bid March 18, 2021.  BGMs range from 475+ to  361 until March 30, 2021.  April BGMs range 326-coming down to 209 and 198.  Metformin increased May 24, 2021 to 1000mg po bid.  bgms starting May 24, 2021 at 156, have come down to high 120s.   Weight December 8, 2020 was 198.  Weight loss of around 30 lbs, weight currently today 174.
Persistent, inconsolable crying, screaming cry lasting several hrs, fever 103 rectally-fever duration -2days, We will give pediatric DT in the future.
This spontaneous report was received from a registered nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The temperature of the RECOMBIVAX HB was of 19 °C for a time frame of 11 hours. Previous temperature excursion occurred; however, the temperature information was unknown by the reporter. No data logger was involved. No adverse effects were reported. This is one of five reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA007283: US-009507513-1705USA008598: US-009507513-1705USA008602: US-009507513-1705USA008605.
Whole body ache, skin tingling and painful to the touch, lethargy lasting two days.
pt recv vax;to MD w/ chicken pox 20-30 papular lesions, some vesiculated; child looked happy and had no fever;
Patient  states that she is experiencing neurological complications. Symptoms include jerking, loss of motility, and difficulty breathing
Swollen lymph nodes on side of injection for 4 days. Chills day 4&5, sore arm for 2 days. Narrative:
This spontaneous report as received from a licensed practical nurse refers to a 5 years old patient of unknown gender. The patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # 665622/1023Y, exp date: 18-JUL-2012). There was no adverse reaction. Additional information has been requested.
Patient was supposed to get a booster dose of 0.25ml and received a dose of 0.5ml
Injection given in left anterior thigh. Patient developed subsequent swelling, redness, pain begining on second day and discovered in late evening. Patient complained continually since injection, but parents did not view leg until bathtime 24 hours later. The swelling extended to the knee and involved the entire thigh.  This was the second MMR injection the patient had received and there had never been another reaction to this or any other vaccine or drug. Patient has no other known allergies. Swelling lasted 4-5 days.
The evening after receiving vaccine had headache, severe body and joint aches, chills. This lasted for 2 full days. Awoke on day#3 and symptoms were gone.   Left arm soreness and tenderness at injection site for 2 days.