chrisvoncsefalvay/vaers-outcomes huggingface dataset:
48 hours after my vaccine in the afternoon, I started sneezing for 12 days and had nasal congestion and sore throat. I continued to be sick for 18 days and those symptoms sort of let up except sore throat and I called my doctor one week before my 2nd vaccine. I told my doctor during the virtual visit that I thought I was having a reaction and she said yeah because I never had any kind of allergy before. She told me to take Flonase and that did help my symptoms and they went completely away. I was afraid to get the 2nd dose because I had been sick but after awhile it was letting up but not all of the way. I had the burning sore throat, and post nasal drip.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received SHINGRIX (batch number 32GR4 ?, expiry date 4th July 2020,GSK note: the reported lot number did not match with any GSK lot number). On 18th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 18th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were recovering/resolving. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. After receiving SHINGRIX, the patient experienced difficulty moving arm. The reported batch number of SHINGRIX (32GR4) did not exist in the sales database and was updated to 32GR4 ?
PFIZER VACCINE HEART RACING AND NAUSEA CHILLS FELT CHEST PAIN AFTERWARD
pt recv vax; rash at site of immunization on lt leg(anterior) then on oth leg;26th of may had full blown measles; fever & was inconsolable; did not see MD;child acting w/ little rash;
Extreme muscle and bone pain for 4 days, then gradually letting up. Could not use arm. Used pain meds and heat. Affected whole body. Miserable for almost 2 weeks!
THE NEEDLE USED TO GIVE PATIENT HER FLU SHOT WAS USED ON ANOTHER PERSON. BOTH WAS SENT FOR LAB WORK (HIV, HEP B & C) CROSS CONTAMINATION. BOTH PATIENT LABS CAME BACK NEGATIVE.
I was tired and my arm was sore but I ended up getting loose stool. A week and a half later I called the doctor and they told me it would pass. I missed one day of work, and just rested for a few days. The stools have not been the same since then. I have taken fiber and probiotics. I had to have a colonoscopy and was told to watch my diet. I was not prescribed any medications.
hives; swollen face; red bumps on her face; eyes were swollen; This is a spontaneous report from a contactable consumer ( Patients Grandmother). A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration was not reported), via an intramuscular route of administration as a single dose for COVID-19 immunization. The patient's medical history included allergy to pencillin. Concomitant medications were not reported. It was reported that consumer calling on behalf of her granddaughter who received the first dose of the Pfizer vaccine on Friday, after 24 hours by Saturday night she had hives, swollen face, red bumps on her face, her eyes were swollen, (all reactions on her face) it was severe for like 2 days and next three days was not so severe and began to cool down after 3 days. She had appointment on 30Apr2021 for next vaccine, is there anything she can do or take prior to the vaccine to prevent it. She had allergy to penicillin she would get hives. last time she had penicillin was about 5 or 7 years ago. Is there any information about getting the second vaccine after side effects after the first dose, A lot of people have a problem after the second dose. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I have experienced weight loss after receiving my second Pfizer vaccine shot on March 4, 2021. I weighed 132lbs before getting this shot. I have since lost 6lbs. I have been unable to regain this weight regardless of diet. In  October I started to regain  and had gain 1.5lbs. I decided to take the booster shot on October 6, 2021. The weight loss has started again and as of October 9th, I have lost 2lbs. The only change I have made was the booster shot.
Starting 12 hours after I got my second shot, I got chills, fever, fatigue, body aches in my joints, and I developed a swollen lymph node under my left arm. The symptoms remained in varying degrees for 84 hours. The swollen lymph node remains swollen and painful.
Patient felt fine at time of the vaccination.  Approximately 5-6 hours after receiving the vaccine, patient complained about being unable to walk, weakness, cough/bronchospasms/sputum production, fevers, chills, dizziness and fatigue.  Patient has not been back to work  since because the symptoms still persist
Death; This serious case was reported by a physician via sales rep and described the occurrence of unknown cause of death in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 14-OCT-2023, the patient received Arexvy. On 16-OCT-2023, 2 days after receiving Arexvy, the patient experienced unknown cause of death (Verbatim: Death) (serious criteria death, GSK medically significant and life threatening).  The patient died on 16-OCT-2023. The reported cause of death was unknown.   The reporter considered the unknown cause of death to be related to Arexvy.     The company considered the unknown cause of death to be related to Arexvy.   Additional Information: GSK Receipt Date: 18-OCT-2023 Sales Representative called after leaving doctor's office and reported that 67 year old healthy patient received Arexvy and died. The reporter believed that death happened on Monday but provider's office was very busy and she was really rushed but MD (doctor of medicine) was agreeable to follow up by GSK. The reporter believed Arexvy was administered 48 hours prior to death on Saturday at a pharmacy. The reporter consented to follow up. No further information was available regarding patient, product or event.; Reported Cause(s) of Death: Unknown cause of death
right eye pain - started 2 days after first vaccine, foreign body sensation, urgent care visit to r/o corneal abrasian (negative), using topical eye drops, advil - self resolved after 5 days similar symptoms after 2nd dose, started 24hours after second dose, resolved within 48 hours of second dose
Extreme fatigue Numbness and tingling in left arm Eyes and mouth incredibly dry Irritation Migraine Racing heart
Pain and swelling in lymph nodes in injected arm underarm, feeling of pins and needles, stiffness in whole arm (like the feeling you get when you need to stretch, but no relief after stretching), hot red itchy rash and swelling around injection site that started 1 week after injection.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 37-year-old female. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 20-Nov-2011. On 09-Jan-2011, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was obtained on 24-Apr-2012: the reporter stated that the patient did not experience any late occurring adverse events. The patient was offered to be revaccinated, but she refused.
Severe sinus symptoms without fever; severe flushing; severe back and knee pain; severe joint pain and swelling; twitching of muscles (uncontrollably); severe weakness (has been in bed since); severe dizziness; numbness of face and arm; chest pain with tingling.
No additional AE reported; received RECOMBIVAX HB via subcutaneous route instead of intramuscular route; This spontaneous report was received from a nurse referring to a 18 year old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 21-SEP-2022, the patient was vaccinated with improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) via subcutaneous route today instead of intramuscular route (0.5 ml, lot number U001837 which was determined to be valid, with expiration date: 21-NOV-2022) for prophylaxis (incorrect route of product administration). No additional adverse event (AE) information was provided.
Information has been received from a physician's assistant for the merck pregnancy registry, concerning a 18 year old female who on 04-MAR-2008 was vaccinated IM with a 0.5 ml dose of GARDASIL (lot# 659441/1446U). It was reported that the patient now is pregnant. Medical attention was sought via office visit. The patient's outcome is unknown. Follow-up information was received from an Office Worker who reported that the patient received on 17-APR-2008 a dose of GARDASIL (previously reported as 04-MAR-2008) and had a pregnancy test done, the reporter stated "she had a positive hCG (serum beta-human chorionic gonadotropin) that day". Follow-up information was received from the Medical Assistant who reported that the patient had a Cesarean Section on 24-NOV-2008 but did not know the indication for the Cesarean. It was reported that there were no prenatal complications. The Medical Assistant added that the patient never returned to the office for her 2 week post-operatory check up nor her 6 week post-operatory check. The last time the patient was seen in their office was on 18-NOV-2009 (as reported), prior to the Cesarean. The Medical Assistant was unable to provide any information about the baby. Upon internal review, cesarean section was considered an other important medical event. Additional information has been requested.
dizziness; vertigo; bad headache; nausea; injection site was sore all weekend; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site was sore all weekend) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (injection site was sore all weekend). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (injection site was sore all weekend) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
She started with a runny nose, and congestion and then she started getting spots on her face. I took her to the doctor, and they diagnosed Impetigo. They said that it could be Strep too, but the medication would cover both. They prescribed cephalexin. She got better and then the spots popped back up again, but this time she had more bumps, fatigue and a fever and I took her back to the doctor again. They told me it wasn't chicken pox, and they diagnosed a reoccurrence of Impetigo again, but they cultured it this time. When the culture back it read that she had Strep. Sulfamethoxazole trimethoprim and mupirocin. We stopped the sulfamethoxazole trimethoprim and continuing the mupirocin. We are still dealing with this at this time, but she is showing signs of improvement.
Night of the shot I had night sweats and chills. Woke up the following morning with 100 deg temperature.  Experienced body aches.  Temperature went away 2 days after vaccine.
Not sure of time and day of onset. May be 11/3/15. Circular red silver dollar sized "welt" at site of injection which felt hard and hot and itched in the very center.
Initial report received on 06 July 2009 from a health care professional. A 4 month old male patient received a second dose of PENTACEL (lot number C3292AA) in the right thigh and PREVNAR (manufactured Wyeth, lot number not known) in the left thigh on an unspecified date. Post vaccination, the patient's right leg was swollen and red. The infant was crying insolubly when the site was touched. Four hours post vaccination, the patient's mother discovered that the swelling and redness was actually on the left leg in which PREVNAR was administered. No further information was provided. Recovery status was not reported. List of documents held by sender: none.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD rHA, lot # R002937, expiration date 29-JUL-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between -14 to -10 degrees Celsius for 25 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA007385: US-009507513-1806USA007386: US-009507513-1806USA007388: US-009507513-1806USA007389: US-009507513-1806USA007390: US-009507513-1806USA007391: US-009507513-1806USA007392: US-009507513-1806USA007393: US-009507513-1806USA001032.
PATIENT FELT NORMAL AMOUNT OF SORENESS ASSOCIATED WITH VACCINE IMMEDIATELY FOLLOWING VACCINATION (11/06/18). THEN THE NEXT MORNING (11/07/18) SHE WAS AWOKEN DUE TO AN EXTREMELY SORE ARM. AT THAT TIME SHE NOTICED A BLACK AND BLUE MARK WHERE THE SHOT WAS GIVEN AND A REDNESS BELOW THE BLACK AND BLUE MARK AS WELL AS A BUMP WHERE THE INJECTION WAS INJECTION. THE BUMP WAS HOT. SHE WAS STARTING TO FEEL CHILLS AT THIS TIME AS WELL. PATIENT TOOK TYLENOL TO HELP IT FEEL BETTER AND HELP WITH LOW-GRADE FEVER. SHE WENT TO WORK THAT DAY, BUT DID NOT FEEL WELL. SHE DESCRIBES FEELING AS TIRED AND "FLU-ISH."  PATIENT CONTACTED PHARMACY ON 11/07 TO GET RECOMMENDATION, WHICH WAS TO ADD ADDITION OF ICING THE AREA AND KEEPING AN EYE ON IT. AFTER WORK THAT NIGHT, THE FEELING CONTINUED TO GET WORSE. THURSDAY (11/09/18) WAS EVEN WORSE, CHILLS AND SWEATS WERE STILL PRESENT. SHE CALLED IN SICK TO WORK ON THURSDAY, CONTINUING TYLENOL THIS WHOLE TIME. PATIENT DID GO TO WORK ON FRIDAY (11/10/18), BUT STILL FELT UNWELL. STILL FEELING UNWELL ON 11/10/18.
Severe back pain emanating from spine to left ribs with movement of leg and raising/reaching with arm, rating pain a 10 out of 10. I grimaced out loud with any movement. It felt like a vise grip that would break my back apart. Initially, it began as slight pain at 8 am as I was working at my desk. The pain increased in intensity, duration and occurrence over the next 10 hours. I tried several remedies at home. First, I took a 10 mg cyclobenzaprine tablet and laid down for 2 hours from 11:30 am - 1:30 pm. At 2pm, I used 1%voltaren gel on my back.  At 3pm, my husband (a retired pharmacist) gave me 600 mg of ibuprofen and I applied ice pack to my back. At 4 pm, I took 5 mg prednisone. At 7 pm, I took 600 mg ibuprofen.
Patient stated that it is his first dose and he has to have it because he is going to a party and afraid that he catch the disease during the party. After giving him the vaccine we discovered that he had the first dose in another pharmacy on 06/25/2021 and the second dose is due on 07/15/2021. He got the second dose only 9 days after the first one
pt recv vax & awoke the next day w/a very puffy eye lid & was only able to open the eye halfway;2 days post vax the other eye became puffy;pt recovered by the 3rd day post vax;
Initial report was received 06 November 2009 from a consumer who is also the patient. A 32-year-old pregnant female patient had received an injection of FLUZONE SV (lot number, route and site not reported) on 30 October 2008 and four days later, she developed decreased vision in her right eye which progressively worsened. On 07 November 2008, she went to the emergency room and had a "cat scan' performed. On 08 November 2009, she returned to the emergency room where she was evaluated by a ophthalmologist and had an MRI performed. She was then hospitalized for five days and received intravenous steroids as corrective treatment. The patient has had ongoing tests and visual problems since 03 November 2008. According to the patient, due to the stress of her visual problem, her baby was born two months premature (also reported as 10 weeks premature) on 03 February 2009; the baby weighed three pounds four ounces. The EDC (expected ate of confinement) had been 06 April 2009. The patient had been taking prenatal vitamins concomitantly and she had not received any other vaccines within four weeks of FLUZONE SV. The patient had no concurrent illness, no medical conditions and no known allergies at the time of vaccination. The patient had previously received one dose of FLUZONE when she was 24 years of age with no adverse events experienced. At the time of the report, the patient had not recovered. Documents held by sender: None.  11/20 and 11/24/2009  ED record for 11/7/2008. Dx blurred vision rt eye Patient with c/o's blurred vision rt eye, headache and eye pain.
Developed herpes zoster of right arm-treated in office 6/13/03 with Zovirax and Keflex. Rechecked on 6/20/03 resolved.
reported to occupational hlth service 1 day post vax w/quarter size raised reddened area which was warm to touch;advised to use ice to area & take APAP for discomfort;called 4 days post vax & reported alleviation of discomfort;
Left arm is swollen 2 weeks after my second dose of the Moderna vaccine which was on 05//17/2021. Severe jaw pain. Severe miagraines on a daily basis. I take 2 Tylenol for treatment.
Lethargic for few minutes; This non-serious spontaneous safety report was received by a partner on 25-OCT-2021 and forwarded on 26-OCT-2021 from a nurse.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of two month old baby received a dose of Vaxelis and had a reaction.  Further information is expected.  FOLLOW-UP INFORMATION was forwarded on 12-NOV-2021 from a nurse.  The case is maintained as non-serious.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of Lethargic for few minutes.  No further information is expected.
feels a little hot; Itching; 2-3 days of fever; nausea; sore arm; Coughing; This is a spontaneous report from a contactable consumer (patient). This 78-year-old female consumer received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FC3184, Expiry date: Unknown) via an unspecified route of administration on 11Oct2021 in the afternoon between 13:00-15:00 (age at vaccination was 78-year-old) as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809, Expiry date: Unknown) via an unspecified route, administered in left arm on 03Feb2021 and the patient received  bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6203, Expiry date: Unknown) dose 2 via an unspecified route, administered in left arm on 24Feb2021 for COVID-19 immunization and after second dose patient experienced lung disease/ lung disease is Bronchiectasis, a couple days of nausea, arm hardly a sore, GI issues and dermatological issue. 2.5 weeks before the booster patient had the flu shot, had it on 24Sep2021 for immunization, but didn't think it had anything to do with that. Patient previously took histamine (the itching, this happened to her about a year before due to histamine reaction but she hadn't had an issue since then). On an unspecified date in Oct2021 the patient experienced sore arm on the day or 2 after, a week later 3 days of coughing. Patient had about a day of itching, 2-3 days of fever and nausea on 22Oct2021. On 27Oct2021 patient still feels a little hot but she does not registered a normal temper normally. On an unspecified date the patient underwent lab tests and procedures which included body height: shrunk (she use to be 5ft 10.5 inches), influenza: negative, respiratory syncytial virus test: negative and sars-cov-2 test: negative. Therapeutic measures were taken as a result of coughing. The patient remarks that everything that happened could have been related to her previous issues but was not her normal pattern. She experience things similar but each thing was not her normal, they were a little more than her normal. The outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Pain noticed at the very top of buttocks. After several days, I was asked to look to see what it was because it "felt like a scab" - I took a photo that showed what appears to be two broken blisters that were open wounds.
The patient is having major issues with her diabetes control. Her Endocrinologist told her he has seen this after the Moderna vaccine.
3RD DOSE PFIZER COVID VACCINE GIVE 12/02/2021; pt brought to ED via EMS for worsening SOB; states was dx earlier in the week with COVID and treated outpaint with Paxlovid; EMS states pt's O2 saturation was 87% on 4L O2 via NC; CXR showed atelectasis and pneumonia; O2 supplementation; given Remdesivir, dexamethasone and supportive vitamins; developed aspiration pneumonia and staph bactremia; given broad spectrum ABX; worsening respiratory status that required a rapid response; NRB; ICU; DNI; transitioned to comfort measures
pt taken to ER PM of 21JUL96 w/t105, red & swollen limbs from knees to feet & wrist to finger tips & distended vein;given Motrin for temp down 101;
I know 3 people died because of the vaccine; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported same event for 3 patients. This report is for 3rd of 3 patients.   This consumer reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Reporter was reading a letter from FDA dated 23Aug2021, asking for the ingredients of COMIRNATY. The reporter asked when was Comirnaty going to be available and why was it already FDA approved then it was not available right now It's scary because people are dying because of the vaccine. Reporter knew 3 people died because of the vaccine. Reporter also mentioned she was concerned about the liability of Pfizer since the available one was the Pfizer Biontech COVID 19 vaccine. Reporter was unsure if it was Pfizer. It was unknown if Autopsy Done. The outcome of the event was fatal.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101265404 same drug,AE, different patient;US-PFIZER INC-202101266047 same drug,AE, different patient; Reported Cause(s) of Death: I know 3 people died because of the vaccine
bottoms of both feet turned dark brown third day  (normal reactions first and second day like low fevers and fatigue)
My Mom received the J&J Vaccine.  Apprx 10 days later fell, fractured hip, Surgery April 3rd - On April 5th doctor at medical center said she has a blood clot and low platelets.   Was in Hospital from April 2 to April 12th
10 days after vax, pt developed quarter size welt, hot and red; pt instructed to use cold wash cloths at site. Tylenol for fever/pain.