chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shortness of breath/ chest pain/ burning throat and SOB/ diagnosed as allergic reaction or possible asthma flare; shortness of breath/ chest pain/ burning throat and SOB/ diagnosed as allergic reaction or possible asthma flare; overwhelming fatigue; This is a spontaneous report from a contactable consumer, based on information received by Pfizer(manufacturer control number: US-AMGEN-USASP2021052927), license party for etanercept (ENBREL).  This non-serious spontaneous report (USASP2021052927) was reported on 06/APR/2021 by a consumer and involves a 29 year old female patient who experienced had shortness of breath/ chest pain/ burning throat and SOB/ diagnosed as allergic reaction or possible asthma flare [PT: hypersensitivity] while receiving Enbrel with Single Dose Prefilled Syringe and Aimovig with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included psoriatic arthritis, migraine, and asthma. No concomitant medications were provided. The patient's co-suspect medication included Covid-19 Vaccine. The patient began Aimovig with Single Dose Prefilled Autoinjector on an unknown date in JUL/2018. The patient started taking Enbrel with Single Dose Prefilled Syringe on an unknown date in 2020. On 15/MAR/2021, the patient received her first Pfizer COVID-19 vaccination. On 25/MAR/2021, the patient took her latest Enbrel injection. On 27/MAR/2021, the patient took her latest Aimovig injection. On 28/MAR/2021, Sunday, the patient started experiencing shortness of breath (SOB) and chest pain which lead her to see her physician the following Monday. On 29/MAR/2021, the patient performed electrocardiogram (ECG) at the physician's office which was normal. On 29/MAR/2021, on Monday night, the patient went to the emergency room with a burning throat and SOB and the patient was diagnosed with an allergic reaction or possible asthma flare, and she was prescribed a prednisone taper which she did not take and baclofen. The patient had been taking the baclofen and using her Xopenex (levosalbutamol hydrochloride) rescue inhaler as needed for SOB. The patient also reported that the SOB and chest pain was getting better but still had issues. On an unknown date in 2021, the patient also reported that she had been experiencing overwhelming fatigue and was scheduled to receive her second Pfizer COVID-19 vaccination on 09/APR/2021. The outcome of the events hypersensitivity was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Syringe was reported as unknown for the events hypersensitivity. Action taken with Aimovig with Single Dose Prefilled Autoinjector was reported as unknown for the events hypersensitivity. The causal relationship between the events hypersensitivity, and Enbrel with Single Dose Prefilled Syringe was not provided by the consumer. The causal relationship between the events hypersensitivity and Aimovig with Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up is not required.
Pt developed redness, tenderness, and swelling around injection site. She has been advised to take BENADRYL and use ice. Pt received vaccine today around 2pm and pt noticed around 6pm.
Lower back pain started on 12/20 then on 12/21 had fever (99.4), chills, aching muscles for 3-4 days. On 12/26 both arms started tingling and right arm is still tingling 01/05/2010.
Infant admin Rotateq after recommended maximum age of 14 weeks, 6 days.  No adverse reactions noted following admin.
Moderna was given to patient 1 day after expiration day on vial. Called manufacture and they recommended no need to revaccinate patient.
We noticed she was feeling feverish on July 2nd, 101.2, and we gave her Tylenol.  It was bedtime and she went to sleep.  She slept through the night.  When she woke up she still had fever of 101.4.  We thought it was normal vaccine reaction.  Gave her Tylenol.  Fever through July 3rd.  She woke up crying and was disoriented.  She had fever of 103.7, super thirsty.  We gave her Motrin.  Then about an hour she was comfortable enough to go back to sleep.  When she woke up the next morning  fever was 103.8.  Took her to Urgent Care on July 4th.  While there, she had bad diarrhea.  Her energy level seemed normal, but a bit irritable.  We saw the doctor about 10:45am.  Her temp had gone down and examined her ears. and regular physical exam.  Due to the fact she had an ear infection in June and ears still red, we saw another doctor.  On July 5th she woke up with temp of 103.  Doctor said her ears were clear, not infected.  This doctor was unsure why she had a fever.  Throughout July 5th we dosed her with Motrin throughout the day and her fever broke last night and this morning, July 6th, she had no fever.  We sent her to daycare today.
Myalgia, Fever, CHILLS, ARM PAIN, TIRED Narrative:
Pt. started having fever that evening, headache, and lower back pain (significant). Yesterday drove to  ER   due to continued severe lower back pain and pubic pain. On the way to the ER, she started bleeding a lot. At the hospital, she had a sono and was told she had an abortion. They performed a D&C.  She was 10wks. This is 2nd pregnancy, which was uncomplicated pregnancy.
Redness and swelling and stiffness at injection site - extending around arm from shoulder to elbow. Slightly warm to the touch.
fever/My dad reached up to a 103; My dad was sleepy and tired after he got the shot yesterday in the morning; My dad was sleepy and tired after he got the shot yesterday in the morning; This is a spontaneous report from a contactable consumer via Medical information team. An 83-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 13Feb2021 as single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication was not reported. Historical vaccine included first dose of BNT162B2 for Covid-19 immunization. reporter (daughter) stated, "I am calling for my mom and dad, both of them received the second Pfizer shot yesterday and they both have the same age, they both (birth year withheld) born. They both had fever just last night like this early morning. My dad reached up to a 103. My dad was sleepy and tired after he got the shot yesterday in the morning. He was sleepy and then in the evening he starts getting fever on 13Feb2021. They took tylenol for it. The patient underwent lab tests and procedures which included height: 5'5, 5'3 as well, temperatures: 103 and Weight: about 200 lbs on an unspecified date in 2021. The outcome of the events was unknown.  Information on Lot /Batch Number has been requested.
Patient was vaccinated on 10/1/18 and was possibly about 6 weeks pregnant, she had not been to OB/GYN yet, but home test was positive, vaccinator didn't realize. On 10/3/18 she was spotting and went to ER where they couldn't confirm or deny anything, ultrasound didn't show anything. Going to OB/GYN 10/5 for more detailed test. information from patient's friend/coworker.
Before receiving the vaccine, the patient was worried she would have a severe reaction, even though she had no reported history of vaccine allergy or reaction. To ease her mind, we observed her for 30 minutes after vaccine administration. She felt fine and went home after the 30 minutes. The patient reports that when she got home her throat closed up, she had trouble breathing, her blood pressure rose to 173, her tendons became sore, her feet swelled up, and she developed a fever. She says she did not call 911 as advised, but rather drank vinegar to help her throat open up. She later called her doctor, who concurred that it was a severe reaction and prescribed a Zpak, steroids, Benadryl, an inhaler, and cough medication. She reports she is still having vocal cord issues and trouble with elevated blood pressure 10 days after vaccination.
Lost sense of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost sense of taste) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced AGEUSIA (Lost sense of taste). At the time of the report, AGEUSIA (Lost sense of taste) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details were provided.    Reporter did not allow further contact
Patient reports loss of smell one week after receiving first Pfizer vaccination. Patient has not regained sense of smell. Patient denies COVID infection.
Pt vax w/ hepta B on 18Oct89; 29Nov89 exp increase in ALT.  Listed as mild in severity.  18Apr90 recd last dose.  Investigator feels that reaction was unrelated to vax.
Persistent Fever for 3 days with maximum temperature of 103.3 and papular pruritic rash to neck, chest, and upper abdomen. Non-erythematous rash. Onset of fever approx 36 hours after vaccine administration and onset of rash 48 hours after vaccine administration. Fever Responsive to NSAIDs but returned once medication wore off.
After she waited 15 minutes after having the injection, she was fine. Starting driving home, she had a light headache. She had itching, tenderness, body rash and fever. She went to ER.
I had the fist shot in the arm that had the surgery, within  10 minutes I was in a lot of pain were the surgery was preformed. Felt like it went to my joints such as my knees. Chills, weak and been unusually tired, this never went away.  My second Covid shot was May 13, the same thing happened same arm, 10-15 minutes later pain shoots down my arm to my wrist where the surgery was performed. Then my joints, so much pain brought me to my knees in tears. Experienced chills and ached all over Exhausted with periods its hard to stay awake. Now I feel like it has settled in my joints especially my knees where fibromyalgia is the worst, I need an cane to walk. I received ab cortisone shot in each knee on 5/21/21. no help, now my right calf hurts to walk even with cane.  On May 26 I started my period. I havent had an period in 6 years, I'm 59 years old.
Pain started by the next evening (about 36 hours) . By the time 48 hours passed, pain was severe and patient can't lift arm to the side. She continutes to have severe pain, burning across shoulder blade and tingling down arm to fingers at times. Pain is so severe she's not sleeping./
Hives, red rash and itching on entire body, joint pain, runny nose, slight facial edema. Patient reports taking Benadryl 50 mg PO liquid every 6 hours.
This spontaneous report as received from a healthcare worker concerning an unknown number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of VAQTA (dose, frequency, strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The healthcare worker reported that on an unknown date, an improperly stored VAQTA may have all been administered. The healthcare worker that she would call back once she knows for sure which vaccines had been administered. The healthcare worker reported that the VAQTA was exposed to a temperature of 1.5C for 25 minutes. No adverse effect reported. Additional information has been requested. These are one (1) of five (5) reports from the same reporter. (MARSS 1405USA012173, 1406USA000568, 1406USA000569, 1406USA000570 and 1406USA000571).
Fatigue, axillary LAN, general malaise, no appetite, fever, weight loss, rash.
Pfizer on 12/30/20 and 1/20. Positive on 10/20
Presented w/ n/v , fatigue, SOB, cough, hypoxia X  8-9 days, recently tested COVID+, tx w/ O2, Decadron, Remdesivir
This spontaneous report has been received from a registered nurse referring to an unspecified number of unspecified patients. No concurrent or medical history was reported. On unspecified dates were administered unspecified number of improperly stored doses of VAQTA (lot number K009506 - expiration date 22-SEP-2016), dose, route, frequency and anatomical location were unknown. No adverse event was reported. No further information was provided. No product quality complaint was reported. This is one of several cases received from the same source (MARRS numbers: 1507USA010114, 1507USA010882, 1507USA010883, 1507USA010884). Additional information has been requested.
The patient received PREVNAR 13 0.5ml IM today in Left Deltoid. aaox3, nad, Left ar on proximal humeral have edema, pink fading erythema, warm area that cover the circumference of the arm 3 inches wide. No suppuration, no pustula, no fluctuation under skin. Local reaction to PREVNAR 13, will be treated with ice for 20 minutes tid, for 2 days, TYLENOL 500 mg tid for 3 days and Tramadol q8hrs prn for pain. Symptoms: Fever and redness, itching, swelling at injection site. Treatment: Acetaminophen 500 mg tid, Tramadol 50 mg prn.
May 2010-Allergy-type symptoms in patient with no allergies, weak, sneezing.  No history of same; have been in the area for 20+ years.  Followed by severe coughing and wheezing. July 2010- Treated for upper respiratory but unsuccessful using 3 different antibiotics/breathing treatments.  Hospitalized with pulse/ox of 89. Diagnosed with asthma in November 2010. May 2012 - dependent on daily asthma meds, condition is permanent.
Arm is red, hot and large knot. Also felt dizzy all day Sunday and mild headache on Monday. Still red , knot, and hot today.
Per vaccinator, vaccination needle separated from syringe. No vaccine received by patient. Dose readministered.
I developed covid in July of 2022. the CDC rep who called after my last V-Safe check in said that since I had 3 covid vaccines and then got covid that I needed to fill this form out as an adverse reaction.  My sx were fever up to 101.7, chills, headache, muscle aches, fatigue, cough, chest congestion, runny nose and lasted for 4 days.  The headache and fatigue lasted weeks longer and it took a good 2 months before I felt back to normal.  I was on a low dose of BP med prior to covid but since covid my BP has been out of control and I am not maxed out on my first med (Lisinopril ) and Amlodipine  has been added.
Information has been received through the Merck pregnancy registry for GARDASIL from a registered nurse concerning a female patient who on 17-JUN-2008 and 24-OCT-2008, was vaccinated with first and second dose respectively of GARDASIL (dose, route and lot number not reported). The registered nurse reported that the patient found out that she was pregnant in February 2009, but "the baby stopped growing at 10 weeks" and she lost her pregnancy in March 2009. It was reported that the patient waited for one month following the loss and had became pregnant again (WAES 0906USA02053). The registered nurse reported that the patient was not pregnant at the time of her previous two vaccinations. Upon internal review, the baby stopped growing at 10 weeks and she lost her pregnancy were determined to be other important medical events. This is one of two reports regarding the same patient. Additional information has been requested.
HOT  AND WARM TO TOUCH; PAINFUL RASH; PAIN AT INJECTION SITE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included downsyndrome.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced hot and warm to touch. On 06-MAR-2021, the subject experienced painful rash. On 06-MAR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful rash, pain at injection site, and hot and warm to touch. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
first dose administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (first dose administered after temperature excursion) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (first dose administered after temperature excursion). On 21-Sep-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (first dose administered after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Flu like symptoms , body aches, very tired, sore throat, fuzziness in brain, memory loss , appetite loss, always cold
About 10 minutes after the vaccination, the patient fainted in the pharmacy and hit the side of her head. She came to immediately upon prompting by pharmacy staff. I administered 25mg diphenhydramine and gave her a bottle of water. We left her supine for 10 minutes, and then sat her in a chair and checked her blood pressure and it was 110/60. She never stopped breathing or lost a pulse. Patient stated that she had been dieting and hadn't eaten at all that day yet. I obtained permission to call her parent and she came to the pharmacy immediately. We monitored her for an additional 30 min in the pharmacy and she had no breathing difficulties, no rash, no itching, and said she felt fine. So after the 30 minute waiting period, we let her Mother drive her home. I followed up several times that evening and daily for 2 additional days. Other than a black eye from falling, and needing a day post-vaccine to rest from fatigue, she felt fine today.
One week after the shot my arm became red and itchy.  It has lasted two days and is better today.
I have massive stiffness and pain my my neck, shoulders, back and hips. I spoke my doctor on 04/04/2022 and she put me on prednisone on 04/19/2022. She has continued to raise the dose every few days. I also have an upcoming appt with my doctor.
Sore arm; Muscle cramps all over the body; Sugar was very high; Dehydrated; This is a spontaneous report from a contactable consumer (patient's mother). A 46-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 27Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history included heart attack (at the age of 39) and had couple of stents (and the things done) later after that, and Lyme disease (past this Summer). The patient was taking several concomitant medications (unspecified). The patient's mother was calling for her son (patient) as he works out on the road, but he has had a heart attack at 39 years old and has had some other problems. The patient got his first Pfizer shot and about 2 to 3 days later while he was working, he first just had the sore arm on 03Mar2021. The patient worked in fiber glass repair on pools and it was very warm, and he started having muscle cramps all over the body on 03Mar2021. The patient ended up in the hospital on 03Mar2021 and his sugar was very high, and he was dehydrated. As treatment taken for the events, they gave him fluids through an IV and they gave him metformin medication 500 mg. The patient underwent laboratory tests and procedures (his doctor did the laboratory work), and they did laboratory work at the hospital where he went. It was clarified that they just did blood work on 03Mar2021, but the patient's mother didn't know what it was. The patient was just held for observation and was out the next day (04Mar2021). That was only the first shot, so the patient was really afraid to get the second shot one. The patient's mother told him she will try to find out something about it. patient's mother looked up the side effects and she did not see that as a side effect. At the time of reporting, the patient still had cramps once in a while. The patient had not recovered from "Muscle cramps all over the body". The outcome of the other events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
FELT SICK, CHEST PAIN, EYE TWITCH, SWELLING AT INJECTION SITE, UPPER ARM SWOLLEN AND RED, BURNING, ITCHING, FEVER.
I started developing multiple viruses. It began in March 2022. I first developed a cough, sore throat, and low grade fever. I went to my doctor once my symptoms started to worsen and I was having upper respiratory chest problems. I was diagnosed with pneumonia and was given prednisone. Around April 2022, I was diagnosed with parainfluenza. In May 2022, I was diagnosed with pneumonia again and given prednisone. In August 2022, I had flu-like symptoms and I was diagnosed with C-diff in that month as well. In September 2022, I was hospitalized for 6 days. I was diagnosed with colitis and developed pneumonia for the third time. They found pneumonia in both lobes and diagnosed with rhinovirus. I was very close to developing septic shock. I took multiple tests during this time and throughout the last few months. I was given steroids and antibiotics. I have recovered from pneumonia as of October 2022.
Covid; Initial information received on 23-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via global digital media.  This case involves an unknown age and gender patient who experienced covid, while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (unknown dose, formulation, via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date ,the patient developed a non-serious covid (covid-19) ( latency: 2 days) following the administration of INFLUENZA VACCINE.  It was reported"yea two days later i had covid"  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Covid).  At time of reporting, the outcome was Unknown for the event covid.
A seven year old was inadvertently given a full dose of the Moderna vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A seven year old was inadvertently given a full dose of the Moderna vaccine) in a 7-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A seven year old was inadvertently given a full dose of the Moderna vaccine). On 04-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A seven year old was inadvertently given a full dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitants and Treatment medication were reported.