chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen uvula; This is a spontaneous report from a contactable consumer reported for his wife (patient).   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter mentioned that he and his wife, already received their 1st dose of the Pfizer COVID Vaccine 3 weeks ago and have been doing well. He mentioned that they have completed the side effect text tracker things. They were due for their 2nd dose on Monday and he mentioned that his wife came down with a swollen uvula the morning after getting vaccinated with their 1st dose. According to him, it might not be related to the vaccine and maybe caused by her snoring or other things. He is asking if this is going to be contraindicated for the 2nd dose. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
woke up with symptoms of headache, chills, feeling like she was hit by a truck.
Livedo reticularis developing 2 days post-vaccine on both arms and both legs.
I had a headache the night that i got the shot, wasn't too bad. over the course of a few days i started to get a differnt kind of headache though. and my neck / bottom of the head is swollen / stiff. the My right side ( opposite of injection side) my nick is swollen at the bottom of my head similar to like when you sleep wrong i guess is the best way of describing, and i get a headache. But also the left side its the pain / headache aswell. it comes and goes.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Pfizer product on 01/05/2021 and 01/26/2021. They tested positive for COVID-19 via both antigen and PCR testing on 01/04/2022 at the long term care facility at which they were a resident. They died on 01/08/2022.
Fillings in my teeth on the left side of mouth began to hurt after shot. Pain continued for over 2 hours post shot and while completing this form.
18FEB devel raised red rash as in hives from the waist to the knees than spread to chest & arms;19FEB given DPH;rash disappears;20FEB rash returns to stomach & hips, took DPH & rash disappears;22FEB no rash but itches;
10JAN96 fever 102-reduced to 101.2 w/APAP;also vomiting & diarrhea cont thru 11JAN96;saw PMD on both 10JAN & 11JAN96;given Motrin & put on Pedialyte;12JAN95 sx subsiding today-stools still loose but not watery;low urine output
Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008CZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient received 1st dose of vaccine in deltoid region  Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-313106 (Patient Link).
rash that keeps pooping/red rash, itching; Itching; Chills; Tiredness; little bit of sweat; did have problem with back of my neck;  but it got worse since I got the vaccine; did have problem with back of my neck;  but it got worse since I got the vaccine; This is the spontaneous report received from contactable consumer (patient).   A 63-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 31Mar2021 (Batch/Lot Number: ER8730) (at the age of 63 years old) as single dose for COVID-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing, problem with back of neck (unknown if it's part of breast cancer) from an unknown date and ongoing (it got worse since she got the vaccine). The patient had received the first dose of BNT162B2 on 10Mar2021 (Lot # EN6203) for COVID-19 Immunization. Concomitant medications included anastrozole (ANASTROZOLE) taken for breast cancer, start and stop date were not reported; rosuvastatin (ROSUVASTATIN) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRINE) taken for an unspecified indication, start and stop date were not reported; brimonidine tartrate/timolol maleate (COMBIGAN) taken for glaucoma, start and stop date were not reported; brinzolamide (AZOPT) taken for glaucoma, start and stop date were not reported; levetiracetam (LEVETIRACETAM) taken for headache, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported; and multivitamins (unspecified).  The patient developed rash that keeps pooping on since 12Apr2021 on her back. She had red rash, itching. She had it for less than a couple of nights and it was constantly itching. She also had little bit of chills on 31Mar2021, little bit of sweat (unspecified date in 2021) and little bit tired (unspecified date in 2021) and they all went away. The patient previously had problem with back of her neck (not sure if it was a part of her breast cancer) and it got worse since she got the vaccine, and she had to see a spine and back specialist. She did not receive treatment for the events. She called her dermatologist to get some relief from the itching but she couldn't get in until the end of May. She wanted to get some advice, something to put on her back for itching. The events chills, sweat and tiredness were resolved on an unspecified date in 2021. The rash/red rash, itching were not resolved. The outcome of the problem with back of her neck was unknown.  No Follow-up attempts are needed; no further information is expected.
Extreme fatigue, muscle pain, joint pain,  headache, shivering (no fever), loss of appetite; flu-like symptoms
no additional adverse effects; the patient received one dose each proquad and varivax during the same office visit; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 13-FEB-2020, the patient was vaccinated with one dose each of: measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: recombinant Human albumin  (rHA) (PROQUAD) lot # S003172, expiration date 30-JUL-2020 (exact dose, dose # and route of administration were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, dose #, route of administration, lot # and expiration date were not reported) both for prophylaxis. The vaccines were reconstituted with sterile diluent (STERILE DILUENT) (strength, dose, frequency, route of administration, lot # and expiration date were not reported). No additional effects reported.
Injection site pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm (Lot number: EN6205) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: takes a regular medication, one little pill; "Diabetes" (unspecified if ongoing), notes: takes medication, she was in her late 40s that she got diabetes; "COVID-19", start date: Jan2021 (not ongoing), notes: recovered before she got the vaccine. The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain". Additional information: The patient had pain at the injection site on the arm muscle. The patient will get the second dose on 30Mar2021 and she is afraid of the side effects of the vaccine and afraid of getting COVID again. She is worried about possible side effects from second dose of the vaccine. Patient takes unspecified medications for diabetes and blood pressure.  No follow-up attempts are possible. No further information is expected.
Loss of balance while walking, especially when turning; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Loss of balance while walking, especially when turning) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (Loss of balance while walking, especially when turning). At the time of the report, BALANCE DISORDER (Loss of balance while walking, especially when turning) had not resolved.            No concomitant drug was reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment drug was reported.
Vaccine Administered from A Punctured Vial Beyond the 6 Hour limit; A spontaneous report was received from a pharmacist concerning a 36 year old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced vaccine administered from a punctured vial beyond the 6 hour limit.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273  on 31 Dec 2020 for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient received the Moderna COVID-19 vaccine in the unknown arm on 31 Dec 2020 from a vial that was used beyond the 6 hour limit. The vial was first punctured on 30 Dec 2020.   Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The event, experienced vaccine administered from a punctured vial beyond the 6 hour limit, was considered resolved on 31 Dec 2020.; Reporter's Comments: This report refers to a case of a 36-year old female consumer who received Moderna's COVID 19 and experienced vaccine administered from a punctured vial beyond the 6-hour limit. The vaccine lot number and the consumer's medical history were not provided.  There were no reported AEs associated with this case of female consumer who received Moderna's COVID-19 vaccine and experienced vaccine administered from a punctured vial beyond the 6-hour limit.
pt recv vax & devel emesis & diarrhea became much worse & dehydration followed;pt had to be adm to hosp to recv IV fluids for 23 hr to correct the gastroenteritis w/dehydration;
PATIENT STATED THAT SHE RECEIVED 2ND MODERNA AT HER PHARMACY ON 11-8-21, ON 11-9-21 SHE STARTED TO HAVE FEVER AND CHILLS. SHE WENT TO ER ON 11-10-21 DUE TO ARM SWELLING, REDNESS, AND HOW SHE FELT.  THEY ADMINISTERED BENEDRYL AND SENT HER HOME WITH AN ALLERGIC REACTION. SHE FOLLOWED UP TODAY WITH PCP,  AND WAS GIVEN A STEROID SHOT. SHE STILL HAD AT LEAST 6 INCHES OF REDNESS, SWELLING, AND HEAT IN HER LEFT ARM. AFTER QUESTIONING PATIENT, HER 2ND DOSE OF MODERNA WAS ONLY GIVEN AFTER 21 DAYS INSTEAD OF 28 DAYS.
redness around the injection site; This is a spontaneous report from a contactable pharmacist.  A patient of unspecified age and gender received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced redness around the injection site on an unspecified date.  The outcome of the event was unknown.  Information on the batch number has been requested.
A nurse reported the occurrence of an injection site reaction in a 5 year old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The vaccine provider submitted this report directly to the local health department. The subject had no relevant medical history, concurrent conditions, or concurrent medications. On 5/17/03, the subject received his fifth injection of Infanrix (lot DTPA586A9) in the left arm. On the same date, he received an injection of inactivated poliomyelitis virus vaccine in the left arm and an injection of MMR in the right arm. On 3/18/03, 24-hours post immunization, the subject developed an injection site reaction characterized by pain, swelling, and inflammation. The subject's left arm was stiff. The subject also experienced irritability and a low grade fever. The events resolved on 3/20/03. The reporting nurse considered the events to be related to Infanrix administration.
The last 3 hurt after she received them; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 23Apr2021 as dose 2, single (Lot number: EW0172) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Factor V Leiden bleeding disorder" (unspecified if ongoing), notes: not on blood thinners or statins. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single, Lot number: EW0150), administration date: 01Apr2021, when the patient was 61-year-old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "The last 3 hurt after she received them".  Additional information: In 1977, her mom got the first flu shot, and 30 years later got Guillain-Barre from the shot. The vaccines hurt except for the first one. The last 3 hurt after she received them. Body Weight (kg): 50.8.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300218053 Same patient/vaccine, different dose and event;US-PFIZER INC-202300218569 Same patient/vaccine/event, different dose;
After the shot I was very light headed , and was taken to the side. Ate some candy , and felt better after. About 6 days later is when I woke up with really puffy eyes. Then next day I noticed swelling on the bottom of my mouth , on both sides. Also , my whole right side of my face is swollen with a lot of pressure in it.
patient states arm is extremely sore cannot lift it, injection site is hot to the touch, running a low grade fever for 2 days post vaccine. and she is in a lot of pain
flu shot given 29OCT93 lt deltoid; stiff neck on lt side onset approx 2PM same day; duration approx 6 days; no other sx;
This case was reported by a medical representative and described the occurrence of rash in a patient who received FLUARIX. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to FLUARIX. Additional information: provider did not give any patient information.
Pt c/o left axilla swelling/bump that gradually worsened a day after injection. Also c/o visual changes.  Had chills, body aches 3 hours after vaccine, but has resolved. Seen in urgent care 3 days after injection.
No Adverse reaction occurred, however the vaccine given was unapproved for the patient's age. The patient arrived and filled out her patient intake questionnaire and prior to vaccine administration, I reviewed the wrong patient's questionnaire. This patient is 17 years old and I administered the Moderna COVID-19 vaccine to her. I followed up with the parent and notified them of the event and they reported she is doing well and no adverse reaction has occurred.
Presented difficulty breathing and some pressure on the chest. Started 24 hours after the vaccine. The symptoms lasted 48hours.  No treatment was taken, symptoms disappeared after 48 hours
Within 12 hours of injection, while sleeping, woke up in severe pain coming from L Shoulder; same as injection site. The pain was severe and had very limited range of motion, the pain radiated down the left arm. Was seen by a doctor two weeks after injection and was given Gabapentin for the pain, thinking it was nerve damage, the radiating pain was resolved but the pain to the shoulder persisted. After a month on 10/29/2018, went back to the doctor due to the continued pain and limited range of motion and was given a cortisone injection to the L shoulder, x-rays were also taken and no abnormalities were shown. The  cortisone injection relieved the pain and complete range of motion resumed. The pain returned on 2/2019 as well as the limited range of motion, not as severe as the previous times but still enough to cause sleep disturbance. Returned to the Doctor and was recommended that I do physical therapy but the pain is still there and no improvement on full range of motion.
Patient awoke next morning with scratchy throat, pain under arm & swelling under armpit. No visible reaction at injection site. Doctor visit after 2 days - pain decreased arm motility returned. Patient given KEFLEX 500 mg 1 QID & ZYRTEC 1 daily.
LOST ALMOST COMPLETE FEELING IN ARM, PARTS OF FACE, EAR LOBES, CHEEKS, TIP OF NOSE,; LOST ALMOST COMPLETE FEELING IN OUT SIDE OF LIPS; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced lost almost complete feeling in arm, parts of face, ear lobes, cheeks, tip of nose. On 06-APR-2021, the subject experienced lost almost complete feeling in out side of lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost almost complete feeling in arm, parts of face, ear lobes, cheeks, tip of nose, and lost almost complete feeling in out side of lips on 06-APR-2021. This report was non-serious.
I felt very lethargic, flu-like symptoms like head cold, body ache, fatigue, dull headache, and a low-grade fever. I took an at-home COVID-19 on 12/04/2022 which came back positive. I called my doctor that next morning and was prescribed Paxlovid. I finished my prescription and tested negative on 12/09/2022. I started feeling the same achy flu-like symptoms a couple of days later on 12/12/2022 and tested positive again for COVID-19. My doctor informed me I caught a rebound case of the virus and prescribed Paxlovid again. My symptoms were identical to the first time but felt more aggressive. I finished the regime and finally tested negative again on 12/22/2022.
Severe stomach cramping; Toxic diarrhea; Arm was very sore after the shot; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Severe stomach cramping), DIARRHEA (Toxic diarrhea) and PAIN IN EXTREMITY (Arm was very sore after the shot) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced PAIN IN EXTREMITY (Arm was very sore after the shot). On 31-Aug-2021, the patient experienced ABDOMINAL PAIN UPPER (Severe stomach cramping) and DIARRHEA (Toxic diarrhea). The patient was treated with SIMETICONE (GAS-X) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. In September 2021, ABDOMINAL PAIN UPPER (Severe stomach cramping) and DIARRHEA (Toxic diarrhea) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was very sore after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Approximately 24 hours after receiving the injection, the patient developed severe stomach cramping and toxic diarrhea which continued for five days. The patient drank Gatorade, ate soup, slept and took Tylenol and Gas-X. The patient suspected it as food poisoning but, when it continued for more than a day and a half, the patient knew it was not. The patient consulted with the physician who advised to consult if it continued. The patient was considering about not receiving the second shot.
This case was reported by a physician via sales rep and described the occurrence of Bell's palsy in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 22nd May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 29th May 2018, 7 days after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant). The patient was treated with prednisone. On an unknown date, the outcome of the Bell's palsy was unknown. The reporter considered the Bell's palsy to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 60 or 61 years. The reporter had the patient that went to the emergency room on 29th May 2018 and was diagnosed with Bell's Palsy. She was given an eye patch. She was not hospitalized overnight. The reporter only wanted to be contacted via the telephone, he did not want to receive a letter. Field representative was unable to provide additional information.