chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was painful, has horrible reactions; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Feb-2023 Reporter's Comments: The patient self-reported the case via interactive digital media. Reporter's daughter got it, but reporter had just been given the vaccine against that disease which by the way was very painful and had horrible reactions.  The patient received information about the disease and when his/her daughter started with symptoms on her lower back, he/she immediately suspected that it was shingles, indeed the doctor confirmed it and gave her a very good medicine with a lot of care. The reporter said thank god nothing else happened.  Her recovery lasted a month.
1 wk post vax, pt broke out in chicken pox type rash on face, chest, and back area. Greater than 20 leisions. MD stated was chicken pox.
Fever 102 F, chills, later on at night some rapid heartbeat which dissipated after an hour or so.
Received second shingles vaccine Since then have required physical therapy to my left arm and shoulder for pain from the injection.
Administered VARIVAX (Varicella) vaccine rather than ZOSTAVAX vaccine, effectively under dosing intended vaccination. Contacting patient to return for ZOSTAVAX on or after July 10, 2013.
After Covid-19, and vaccination I had more frequent migraines dizziness and had fallen several times.
There were 6 recently drawn vaccine added to a tote of 3 expired vaccines (expired around 10 hours previously). The patient was given on of these vaccines.
20 minutes after immunizations, mom heard grunting/wheezing sounds, observed eyes swollen shut, swollen lips and face. Drove immediately to ER. Back/arms covered with hives. Notice red mark, size of large pea, on upper portion of arm-not sure which arm. At ER Benadryl was given. She was monitored for 4.5 hours.
Information has been received from a registered nurse concerning a 5 year old white male (birth weight 9 lb 7 oz.) who on 04/29/2002, in the PM, was vaccinated with his second measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine (second generation), subcutaneously in the right arm (Lot # 640170/1090L).  On 04/30/2002, during the night, the patient developed swelling at the injection site (right upper arm).  On 05/01/2002, in the morning, the patient's injection site was red, hot and swollen over the site covering about two inches.  Follow up information was received from the registered nurse who reported "per Mom", that on 04/30/2002, the patient developed swelling around the injection site, hot to touch two inch diameter with "little pricks" all around the site.  Subsequently, "a few days later", the patient recovered from his injection site swelling, hot injection site and rash.  Unspecified medical attention was sought.  No further information is available.
sore arm; change to his bowel movements; diarrhea; constant runny nose; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 21Jan2021 as dose 1, single for COVID-19 immunisation. Medical history included triple bypass, carotid artery surgery, thyroid condition and diabetes. It was reported that the patient was rather active and "not a couch potato". The patient's concomitant medications were not reported. The patient called to report the "peculiar things that were happening" to him after receiving both doses of the Pfizer-Biontech Covid19 vaccine. The patient experienced sore arm, change to his bowel movements which were daily and softer resulting in diarrhea for the remainder of the month, it was reported that the patient had "never been that regular in his life" and constant runny nose on an unspecified date in Jan2021 after the first dose. The outcome of the event constant runny nose was not recovered, and outcome of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mom called on 17FEB93 p/shots given on 15FEB94 stated pt had been crying x 2 days & was now hoarse; states pt had persistent inconsolable crying lasting longer than 3 hrs & that was high pitched on day immun recvd; fever 102;
RASH, RED BUMPS AT THE INJECTION SITE WITH OUT ITCH . ADVISED TO CONTINUE MONITOR THE SYMPTOMS, TAKE TYLENOL AS NEEDED. IF SYMPTOMS GET WORST THEN CONTACT THE PHARMACY AND/OR GO SEE THE DOCTOR.
On November 15, 2021, I had a cough, congestion, headache, and a runny nose. November 22nd, I had a telehealth visit with a doctor. I was told that I have a sinus infection. I was prescribed Amoxicillin and Mucinex. On November 24th I lost my taste and smell.
On Saturday, March 13, Woke up at 3 am with a severe headache, started having diarreah, vomiting that lasted until 7 PM that night.  Stayed in bed all day Sunday, March 14, ate a few crackers and drank some water. Had lower back pain and headache all day.  Had to call  out sick from work on Monday,  March 15. finally got up and ate some soup and took a shower. Rested the whole day. I have been absolutely exhausted and  weak all week long.
Within approximately 2 minutes of receiving vaccine, anaphylactic reaction began. Patient's cheeks became very flush/red, & her throat became itchy and tingly. Within the next minute or 2  she started vomiting.  She then felt tightness in her chest, and shortness of breath. Complained of lips feeling numb and "heavy".  Dr was present and ordered an IV to be started, and placed patient on oxygen and a cardiopulmonary monitor with pulse oxmeter after she used a ProAir inhaler.  Patient was given IV steroid SoluCortef,  IV Zofran for the vomiting, IV Pepsid, and IV Benedryl all for the allergic reaction. She also received 500 ml IV fluids. Symptoms lessoned within one hour, and she was observed for another hour and a half on cardiac monitor and pulse ox by nursing staff as well as Dr.  Vitals stable throughout event.
SX: sweating, pale, unresponsive, conscious, hypothermia. unable to obtain vital signs. symptoms started about 7 min after the administration during a 15-min observation period. Pt was help laying flat on the floor from a chair by two technicians. Epipen was administered after patient is unresponsive and EMS was called to the scene. Pt started to be responsive after the epipen administration and during EMS arrival in approximately 2 min. EMS obtained patient's vital signs and EKG was normal. Pt refused to go to the ER and waited for his wife to pick him up at the pharmacy.
Arm was going to fall off; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced arm discomfort (Verbatim: Arm was going to fall off). The outcome of the arm discomfort was not reported.   It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine.     It was unknown if the company considered the arm discomfort to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient hope the vaccine because he/she just got 1st shot and thought his/her arm was going to fall off. The follow-up could not be possible as no contact details were available.
Three hours after shot: clear runny nose- constant drip. Around 11pm same evening: woke up clammy  6:30 next day: Headache. Very Sore . Felt like I?d been tubing on the lake all day. Took ibuprofen and felt better.  Very tired. 9:00 pm: very bad stomach cramps. Diarrhea started around 11pm. Many times. 7:30am  next morning (3/10): faster heart rate. Stomach hurt but not as bad. Little headache. Hot and clammy.
Chills; back pain; muscle / painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 01May2021 (Lot number: EW0173, Expiration Date: 31Aug2021) as dose 1, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset May2021, outcome "not recovered", described as "Chills"; BACK PAIN (non-serious) with onset May2021, outcome "not recovered", described as "back pain"; MYALGIA (non-serious) with onset May2021, outcome "not recovered", described as "muscle / painful". Therapeutic measures were taken as a result of chills, back pain, myalgia.  Additional information: It was further reported that 2 days after the shot he was okay, nothing was happening or doing for few days. Two days ago, he thought like he felt chills and he had back pain. It's like the muscle and the back it was so painful it was been like 2 or 3 days already. Patient has been given some pain medicine and some cream to put on. Patient was scheduled to have his second shot this month on 22May2021.  No follow-up attempts are possible. No further information is expected.
Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 at 16:45 as dose 1, single (Lot number: EL1284), in left arm, on 14Jan2021 at 15:15 as dose 2, single (Lot number: EL3302), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 06Mar2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "depression" (unspecified if ongoing); "stable ascending aortic aneurysm" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing); "ongoing weight loss" (unspecified if ongoing); "Gi problems", start date: Oct2021 (unspecified if ongoing), notes: Gi problems since Oct2021. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 09Jul2022, outcome "recovering"; VACCINATION FAILURE (medically significant) with onset 09Jul2022, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (09Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Report about covid treatment reported as Yes. If Vaccine received and Other medication in 2 weeks reported as Yes. Anti-viral details: product: COVID 19 Treatment, brand=Paxlovid, Treatment start date: 30Jun2022, Treatment stop date: 05Jul2022, Indication: Treatment of COVID-19. Adverse event reported as rebound symptoms and positive home test 4 days after completing 5 days of Paxlovid 100-300. I tested negative on two different days and was symptom free during the 4 days. Known allergies reported as No.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
1248 C/O Nausea, generalized tingling, Dizziness. VS 155/86, HR 111, reg tachy, resp 21,days 97%. 1256 expressed improving. 1305 reports feeling generalized weakness, and tingling. Tearful requesting to go to the hospital Rescue called, client denies Hx.
The day after the vaccination, I got a bad case of facial acne (very unusual for me) centered on both sides of the nose.  Over the next 48 hours, the skin where the acne was concentrated dried and flaked off in largish flakes.
This spontaneous report was received from an approximately a 65 year old female patient regarding herself. There were no pertinent medical history and no drug reactions or allergies. Approximately on an unknown date in June 2013 (reported as about four months ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapy included levothyroxine sodium. On 05-OCT-2013, the patient experienced shingles. The patient explained that on 05-OCT-2013, she began experiencing pain and a burning sensation on her back and breast. On 06-OCT-2013, she noticed that she was experiencing more pain and that she had developed a blister on her back. On 07-OCT-2013, the patient reported that she had developed a rash on her back and breast and the pain in those areas had increased. The patient sought medical attention (office visit on 08-OCT-2013). The physician prescribed VALTREX (reported as generic VALTREX (manufacturer unknown, 1 tablet three times daily) to treat the symptoms of the patient. No lab tests were performed. Of her present condition, the patient stated that the blisters were drying but she still had a significant amount of pain. The outcome of shingles, burning sensation, rash on her back and breast was unknown. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
Had 1st HPV on November 4th, 2008.  she stated she didn't know she was pregnant.  Had a miscarrieage in December. (Came in today becase she is due her 2nd dose.)
He received anthrax #1 evening of 15Oct04. He had no local reaction. The next morning he started experiencing bouts of watery diarrhea. They numbered 6-7x/d and continued daily for 2 months. Initially he reports there was red in the stool but this stopped. At times symptoms were so severe that the diarrhea ran down pt's leg. If he ate spicy foods or exercised the symptoms worsened. He also states he had mild abdominal pain continuously that would worsen just prior to each episode then remit to previous level afterwards. He reports his weight decreased from 206 to 170lb, however, he performed all duties during this time. He sought medical care after 1 week of symptoms. He was given Immodium, which he used 3-4x/day for 2 months. He had multiple diagnostic tests in Oct04, they consisted of numerous blood tests, stool tests, scopes and bowel biopsy. He reports all results were negative. In Dec04 symptoms began to resolve. Currently he reports 1-2 episodes of diarrhea a month.
COVID-19 is positive which is likely the underlying cause of his acute worsening of his cough, dyspnea, and his new rhinorrhea and congestion. We will admit the patient to the Cardiology service for further evaluation and management.
Strong rash on my chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Strong rash on my chest) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 023M20A and 007B21A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included POLYVINYL ALCOHOL (LACRIMAL), CLONAZEPAM (KLONOPIN), DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ), TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), LEVOMEFOLIC ACID (L-METHYLFOLATE), VITAMIN B5 [PANTOTHENIC ACID] and VITAMIN D NOS for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021 at 2:15 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021 at 10:15 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Strong rash on my chest). At the time of the report, RASH (Strong rash on my chest) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included an unspecified cream of steroids to rub on the chest and an antihistaminic.
Pt developed muscle tightening and numbness in deltoid down to 4th and 5th finger with cramping within 6 hours. Resolved by next morning.
Initial report received from a health care professional on 22 July 2011. A female patient (age not reported) received an intradermal injection of ADACEL, sanofi pasteur lot number not reported, one week ago. The patient inadvertently was administered ADACEL instead of PPD intradermal. The patient developed redness, swelling and a nodule at the injection site. The outcome was reported as unknown. Follow-up information was received 12 September 2011 from a health care professional. The lot number for ADACEL administered to the patient was C3976AA. The patient had no known illness at the time of vaccination. The event began within 24 hours after vaccination, and the swelling and redness resolved within two weeks. Outcome was recovered. Documents held by sender: None.
Client vaccinated with Pfizer vaccines for Covid on 4/2 and 4/30/2021.  Developed nasal congestion and sneezing on 8/21.  Tested positive for Covid 8/22.  Reported as a breakthrough Covid case in a vaccinated woman.
Mother states pt became sleepy at 8PM and felt very warm.  At about 9Pm he started vomiting.  He vomitted about 4-5 times during night, couldn't keep fluids or Tylenol down.  Stated he felt hot and was shaking.  She didn't have a thermometer. Lasted until 5AM 8-15-02.  Mother states feels cooler this morning, and seems okay.
Staff described feeling tingles and coldness in extremities especially arms. Also became tachycardic.  Emergency service called and epi-pen administered per instruction. Staff left via ambulance for evaluation. Appeared stable at time of departure.
Excruciating body aches, could not walk,  Painful body aches Severe Chills Sharp shooting pains in my head Headaches Sore throat Blisters on Tongue Pain under arm Stomach ache Diarrhea  Symptoms lasted for over one week.  Today on 4/13, I feel a bit more myself.
This was my first dose of Covid Vaccine.  About 10 hours later, my arm began to hurt and I became cold.  I took my temperature and it was 101.9.  This high temperature remained constant the entire next day (Thursday 1/28/21) and peaked at 102.3 so I took Advil.  I had body aches everywhere.  Anytime the Advil wore off the temperature came back.  By Friday, my fever lowered to 100.5 - 101.  Saturday, I still had a low fever around 100.1.  Sunday I was good
Extreme flu-like symptoms, head-ache and vomiting. Dr advised pt not to get second dose in series due to severe reaction. Pt requested VAERS to be filled out
Sore arm, chills, headache, body aches, fatigue for more than 36 hours
round one was just extreme exhaustion for about 2 weeks which lifted the day before round 2 shot; round two was given on April 17. By April 23, I woke up with hives all around my mouth. Thinking it was contact dermititis, I evaluated anything and everything, hydrocortisone, etc. Nothing worked and it became painful and started to spread. My skin is swollen and cracked. Went to see the dr who confirmed side effect from vaccine
coughing like crazy; hot; dizziness; fatigue; vomited; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing like crazy), FEELING HOT (hot), DIZZINESS (dizziness), FATIGUE (fatigue) and VOMITING (vomited) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VENLAFAXINE, CLONAZEPAM and TRAZODONE for an unknown indication.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced COUGH (coughing like crazy), FEELING HOT (hot), DIZZINESS (dizziness), FATIGUE (fatigue) and VOMITING (vomited). At the time of the report, COUGH (coughing like crazy), FEELING HOT (hot), DIZZINESS (dizziness), FATIGUE (fatigue) and VOMITING (vomited) outcome was unknown.            Treatment drugs reported includes Cough syrup. Action taken with mRNA-1273 in response to the event was not applicable.
My Moderna booster was scheduled for 12:55 P.M.  I received my booster and waited for 30 min. before leaving as over 30 years prior I had anaphylactic shock episode.  I am 62 and have had an unidentified virus since 4/2020, as described earlier in form, and my PCP Physician Dr. recommended I receive  the booster, upon my asking her.  After 30 min, I left to drive home and approximately 10-15 min. later I started getting woozy, if I turned my head while driving.  Then I noticed my legs were weak and or rubbery.  I continued to drive to my home, possibly another 10 min.  I got out of my car to get the mail, and I stumbled, but did not fall, to the mailbox.  I was surprised that my legs wouldn't work.  I got back in my car, called Primary Care Dr's office, and it was her day off.  Receptionist told me to go to local health dept. in my same town.  I did so, and they couldn't help me.  Since I live alone, I decided to go to the local fire dept to see an EMT before driving home.  I also called the Vaccination Clinic number and spoke to an , I believe, who said it might be a reaction, to take a benadryl and drink a lot of water.  I told her I couldn't drive back to.  EMT said BP 16-something over 100,  No rashes.  Checked heart rate and oxygen.  I then decided to go home.  My daughter and son-in-law are physician assistants, so my son-in-law picked me up and I stayed overnight at their house for three days.  The feeling of stumbling didn't continue, however, the weakness and the feeling of numbness didn't go away for approx. six hours.  That was a Thursday.  Saturday in the afternoon out of the blue, the symptoms of the legs came back where I was weak and uneasy and afraid of legs giving out on me.  I woke up with the same symptoms on Monday and Tuesday mornings, and it lasted for several hours again.  When I woke up on Wednesday morning, 11-10-21, I didn't feel that immediately, but within an hour or so, I had the same symptoms.  The only time I felt woozy as in lightheaded was on the initial day of booster while I was driving home.  That symptoms didn't return.  This is a troublesome symptom as I almost feel as if my legs could give out on me, so I'm careful when I'm walking.
LETHARGY; FEVER; This spontaneous report received from a patient via a company representative 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: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the patient experienced lethargy. On APR-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy, and fever on APR-2021. This report was non-serious.