chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slight redness in the shot; Light rash; A little tenderness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (A little tenderness), VACCINATION SITE ERYTHEMA (Slight redness in the shot) and VACCINATION SITE RASH (Light rash) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Patient is allergic to surgical paste and tomatoes.). Concomitant products included VITAMINS NOS and CALCIUM for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced TENDERNESS (A little tenderness). On 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Slight redness in the shot) and VACCINATION SITE RASH (Light rash). On 20-Jan-2021, TENDERNESS (A little tenderness) had resolved. On 02-Feb-2021, VACCINATION SITE ERYTHEMA (Slight redness in the shot) and VACCINATION SITE RASH (Light rash) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient uses unspecified eye medicine for glaucoma and peltex for bones as concomitant medicines.
Temperature of 102.7 and insomnia. Tylenol and IBU given.
New, daily headaches of varying degrees which continue today.  Some days are debilitating migraines.  When at it's worse, headache extends down the back of the neck.  Other times it's left,frontal, and parietal regions.
Information has been received from a physician concerning an 18 year old female who on approximately 30-APR-2007 was vaccinated with the first dose of Gardasil. It was reported that as the patient was leaving the medical office, she lost consciousness and fainted. The patient regained consciousness and remained in the office for a period of time for observation and was given liquids. The patient recovered and subsequently left the office. Additional information has been requested.
Dizziness, Myalgia, Arthralgia, Fever, Chills, Sweating Narrative: Reported injection site reaction after 1st dose on 12/31/20--8-12 hours after shot felt like golf ball under skin, very sore and immobilized arm for 24 hours. After the 2nd dose on 1/26/21 - awoke early morning of 1/27/21 with fever of 102.5, terrible chills, myalgias and arthralgias. Symptoms lasted for 8 hours. Ibuprofen 800 omg and Tylenol alternating every 2 hours helped with fever. Still noted fevers (100-100.5) throughout the day on 1/27/21, and continued myalgias/arthralgias. Additionally reported profuse sweating and dizziness. Symptoms lasted into the day on 1/28/21. Missed 2 days of work. No known prior covid infection
About one month after vaccination, mountain viral illness/strep 1 day later with peripheral neurologic symptoms. GBS severe. A 60-day follow up report received 7/31/2003 adds: Severe Guillain-Barre still with considerable defects both motor and respiratory. Are there any other similar occurrences? Please advise. The discharge summary received on 12/31/03 states respiratory distress, and atelectasis. Follow up in 2004: No information reported. Severe pain. Medical records state hypertension, respiratory failure, pancreatitis, neurogenic bowel, failure to thrive, nausea, vomiting and left-sided weakness. msv
Patient developed sudden onset of severe vertigo with nausea and vomiting.  She became very week.  Blood pressure was above usual level (149/88) and she had nystagmus with no other focal neurologic signs. She continues to be "dizzy" but no true vertigo now.  She is weak and fatigued.
Left arm was real sore after first dose injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2021 (Lot number: EK9231) at the age of 79 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "unknown", described as "Left arm was real sore after first dose injection".  Additional information: No other vaccines administered on same date with the Pfizer vaccine considered as suspect. Prior Vaccinations (within 4 weeks) or any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. Patient Medical History (including any illness at time of vaccination) Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity was None.  She was getting close to obesity if she would keep eating like that. Family Medical History Relevant to AE(s) was None that reporter was aware of.   No follow-up attempts are possible. No further information is expected.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt recovered in less than 1/2 hr. Checked his BP and pulse- normal. Pt and his cousin said he fainted after getting the first dose on 4/24/2021. He promised he'll see his PCP.
58 y/o white male c/o dizziness 10 mins after receiving the 2nd dose of the vaccine. He was immediately assessed by NP. He became diaphoretic and briefly passed out in arms of NP but quickly regained consciousness. He was transported via stretcher to area.
Patient received the first vaccine on 7-29-21. She received knots on her goin area. Mother treated at home. Took four days to resolve. After the second vaccination patient noticed the same reaction. They stated forming on 9/2/21. They are getting bigger. Patient went to the ER on 9/6/21. Patient was diagnosed with swollen lymnodes and was told to see PCP asap. She is running a fever and is having a hard time sitting and standing.
Pt received diphtheria/tetanus booster and developed large erythematous skin reaction at injection site that is very painful with and without touch.
This spontaneous report was received from a non-pregnant female patient of unknown age (who is also the physician) via company representative regarding herself. The patient's concurrent condition included asthma. On an unknown date in 2014 (reported as 2 years ago), the patient was vaccinated with PNEUMOVAX 23. On an unknown date, the patient experienced injection site reactions after receiving PNEUMOVAX 23. There was a "large red bump/induration" on the patient's arm and "swelling". The patient did not seek any medical attention and did not receive any treatment for the events. It lasted about one week and then it resolved on an unknown date. The outcome of the events was reported as recovered. The causality of the events was unknown. Additional information has been requested.
Large local reaction noted 2 days after vaccination in the L deltoid.  Erythema, induration, pain at the site.
Remnants of shingles / Suspected vaccination failure; Remnants of shingles; Painful part of my scalp; Hair issues; The indentations are still there; Felt 4 painful pimples on my scalp for about 2 weeks; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 21-APR-2023, the patient received the 2nd dose of Shingrix. In DEC-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Remnants of shingles / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Remnants of shingles), pimples (Verbatim: Felt 4 painful pimples on my scalp for about 2 weeks), scalp pain (Verbatim: Painful part of my scalp), hair disorder (Verbatim: Hair issues) and skin indentation (Verbatim: The indentations are still there). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolving and the outcome of the pimples was resolved (duration 2 weeks) and the outcome of the scalp pain was resolved and the outcome of the hair disorder was not reported and the outcome of the skin indentation was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pimples, scalp pain, hair disorder and skin indentation to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, pimples, scalp pain, hair disorder and skin indentation to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 03-JUN-2023 The patient received 1st dose of Shingrix end of December 2022. Patient had no other symptoms except felt 4 painful pimples on scalp for about 2 weeks.  Patient did not thought anything about it.  Patient saw dermatologist for a body scan and commented on the painful part of her scalp (as she sees her for hair issues too).  She noticed the marks and said it looked like remnants of shingles that were healing.  The indentations were still there as patient could feel them with her finger but no more pain. The reporter did not consent to follow up. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
pt started feeling dizzy and blurry vision a few minutes after vaccination. Dr observing instructed him to rest on the floor. BP low, felt cold hands. His BP increased and he stopped feeling dizzy/blurred vision a few minutes after laying on the floor w feet elevated on chair. Police detail called resucue team, but patient was feeling normal by the time paramedics arrived. Was able to stand up and sat under observation for several more minutes before leaving clinic.
This is a spontaneous report from a non-contactable physician via a Pfizer sales representative. A 54-years-old patient of an unspecified gender received PREVNAR 13, via an unspecified route of administration on 27Feb2019 on right arm at single dose for immunisation. The patient medical history was not reported. Concomitant medication included prednisone, anastrozole, calcium and cholecalciferol. The patient experienced blistered arms, swollen and spreading on an unspecified date. Patient was given BENADRYL 25 mg, cephalexin 500 mg to treat. The outcome of the events was unknown.   No follow-up attempts are possible; information on the batch number cannot be requested.
No adverse event; Patient received Bivalent booster instead of Primary series of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Bivalent booster instead of Primary series of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 51-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Bivalent booster instead of Primary series of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Bivalent booster instead of Primary series of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received Bivalent booster instead of Primary series of Moderna COVID-19 vaccine).    No concomitant medications were reported.  The patient informed the pharmacy staff that after being vaccinated with the Bivalent booster that she never had any COVID-19 vaccine previously. . No treatment information was reported.; Sender's Comments:  :CMOD22-04042 (crosslink case)
As of November 18th,2022 I went traveling, returning home on November 27th, 2022. The next day my wife and I were ill with a sore throat and body aches. We contacted telehealth and they suggested strep throat was the cause. That Tuesday on the November 29th, 2022, we felt worse sore throat, body ache, lethargic and with a fever. On November 30th, 2002, we went to our doctor and tested positive for COVID-19. They told us to take cough medicine and medicine for sore throat.
Patient developed intussusception with vomiting starting 3/5/2010 and requiring surgery for intussusception with bowel resection on 3/8/2010
fever, headache,  body pain, nauseas.  Since yesterday start Chest pain.    Today evaluated at hospital.  Transfer to PICU.
I had to go to the ER a few hours later due to having a rash spread over my entire upper torso from injection site and spreading over my body and under the skin with severe itching and burning. I received benadryl, solu-medrol, and plasma-lyte through IV catheter. Dr diagnosed it as an allergic reaction called Pruritis.
a metallic taste in mouth; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received Covid vaccine on 22Jan2021 and had a metallic taste in mouth in Jan2021- wondering if that was normal. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Headache tiny bit of nausea sore arm at injection sight...at 4 am on the  13th I went to the ER because I suddenly couldn?t breathe
Tightening in her chest, not like heart attack bad, but still some tightening/Tightness in the Chest; Muscle pain; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Jun-2021 and was forwarded to Moderna on 16-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightening in her chest, not like heart attack bad, but still some tightening/Tightness in the Chest), MYALGIA (Muscle pain) and CHILLS (Chills) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 036021A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced CHEST DISCOMFORT (Tightening in her chest, not like heart attack bad, but still some tightening/Tightness in the Chest), MYALGIA (Muscle pain) and CHILLS (Chills). At the time of the report, CHEST DISCOMFORT (Tightening in her chest, not like heart attack bad, but still some tightening/Tightness in the Chest), MYALGIA (Muscle pain) and CHILLS (Chills) outcome was unknown.            The patient has not taken any medicine for treatment and does not take any medications daily. Action taken with mRNA-1273 with respect to event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: The follow-up was received on 16-JUN-2021 and had non-significant information: Updated patient contact information
"Fever, chills, body aches began 2 hours after TDAP administration and lasted 4 days"
Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 25-SEP-2016, the patient was vaccinated with improperly stored VARIVAX (lot # M012990, expiration date 14-MAR-2018, 0.5 ml, once, subcutaneous). The vaccine was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. This is one of several reports received from the same reporter. Additional information has been requested.
received the adjuvant without the active antigen; received the adjuvant without the active antigen; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-Jul-2022 Reporter's Comments: The reporter was a pharmacist.  She was regarding the administration of 3 different patients who received the Shingrix adjuvant without the active antigen component.  The reporter had limited information.  Lot numbers unknown. Additional Supportive Information:  The patient only received shingrix adjuvant without active antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022106113:Same case/same reporter US-GLAXOSMITHKLINE-US2022AMR106415:Same case/same reporter
First pregnancy (7 months pregnant)  Due/had baby in November of 2017 Baby birth weight was 8 lbs   Morning after shot, I had intense worse than flu like body aches. Felt like someone was sitting on my chest. Cold chills with uncontrollable shaking. Loss of appetite. Last for 12 hours. Almost went to the er because I could barely move
Beginning the following morning after my vaccination, at approximately 8:30 am, I began having severe stabbing chest pains. Feeling as though I was being stabbed dead center of my chest and it came out my back.  I had trouble breathing or felt like it hurt more when I tried to take a deep breath. This was very severe for about 2 hours then eased off  and was off and on for about two days. My arm did not get sore until the third day after my vaccination and remains sore still. I?ve experienced a headache in severity ranging from a nuisance to temple throbbing since the day after vaccination.  I have taken my naproxen for the chest pain and headache.  I ran a temp of 99-100 occasionally but never for a long period of time.  I?m still experiencing some chest pain  occasionally but nothing as severe as  the first two days.
4/13/06 Around 8:00 PM, child c/o "aching in L upper arm, slight erythema, minimal swelling and warmth. 4/14/06 Child c/o increased discomfort, increased swelling and erythema L upper arm. Applied cold compress and gave Tylenol. 4/15/06 Woke up with increased swelling from tip of scapula to 1" above elbow. Increased erythema and bluish tinged. Saw PCP at 09:30 AM. Dx'd cellulitis L shoulder; on po antibodies qid x 10 days.
pancreatitis; This is a spontaneous report from a contactable Physician.  A 44-years-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on arm left on 21Jan2021 07:00 at SINGLE DOSE for covid-19 immunisation. Medical history included migraines and seasonal allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), montelukast sodium (SINGULAIR), norethisterone (ORTHO MICRONOR) and topiramate (TOPAMAX). The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Dec2020 on left arm for covid-19 immunisation (age at vaccination: 44 years). The patient experienced pancreatitis, moderate mid-epigastric pain and elevated enzymes on 28Jan2021 18:00. The patient underwent lab tests and procedures which included enzymes: elevated on Jan2021 and labs: unknown result on an unspecified date. Therapeutic measures were taken as a result of pancreatitis, abdominal pain upper and elevated enzymes. Outcome of the events was recovered on Feb2021.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported pancreatitis with symptoms of moderate mid-epigastric pain and elevated enzymes and the administration of the COVID-19 vaccine, BNT162B2, considering the reasonable temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
On the morning of the July 10th I woke up with mild headache and very scratchy throat, but I also have seasonal allergies so thought it might be that. I have a 6 week old grandchild and my main concern was to test before going over there, but tested negative for COVID-19, I was worried the headache might turn into a migraine so I took my migraine medication preemptively. Monday, Tuesday, Wednesday I continued to have a low grade headache and sore throat, but Thursday morning when I woke up I had a definite headache, a very bad sore throat and a fever of 101.8. I took an at home COVID-19 test and it came back immediately positive. I talked to the nurse practitioner at doctor's office, and prescribed Paxlovid but to not take my Lipitor, or Lunesta, or Xanax. My fever continued and the chills were so bad that my hands were shaking, I was struggling to notify my employment because my hands were shaking so bad. The nurse practitioner wanted me to have a tele-health appointment and she re-iterated about the medications, she checked on my fever which was still high, and told me to stay hydrated. I continued to work when I could but I was still really tired. By Monday, the fever the was gone and the sore throat. I'm still having bad night sweats, Tuesday by noon I was eating peanut butter toast and suddenly felt weak in the knees and knew I would pass out if I didn't go sit down. I took my blood pressure, it was 86/60. I immediately called my doctor and they were surprised that I had still been working (I work from home and had a lot of deadlines). They suggested complete bedrest and not to go back to work at all until the following Monday. I am experiencing brain fog and fatigue and still not feeling better. I have stopped taking my blood pressure medication and will not start again until my blood pressure gets back to normal. Overall this experience has been going on for about 3 weeks. This morning my blood pressure was 99/61 and my heart rate was 80.
Patient called several hours after receiving vaccine from home and said her face was swelling. She was advised to see doctor and she did. she was given Benadryl , prednisone  and famotidine
This 66 year old female received the Covid shot on 3/26/21    and went to the ED on 4/17/21     and was admitted  on 4/17/21 with the following diagnoses listed below. R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC) N17.9 - Acute kidney failure, unspecified R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction