chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu like symptoms at time of vaccination to include: Body aches. Shivers. Fever. Headache.  I was approximately 10 weeks pregnant at the time of the vaccination. My son was born on October 5th 2021 at 9lb 5oz. He was breached and born via c-section after 26 hours of induced labor.  For months prior I have been struggling with lightheadedness, dizziness with tunnel vision, extreme lack of energy. 4 September 2021 I was diagnosed with Pleurodynia after severe chest pains along with pain to my back and left shoulder. Unable to breathe I reported to the Hospital. I was prescribed Prednisone and Acetaminophen w/ Codeine. On 9 September I reported to the Medical Clinic after having severe pains during that week. They re-diagnosed me with Pericarditis and prescribed me 1000mg Naproxen for 1 month and Colcrys for 3 months.
Swollen, red, painful to touch, itchy surrounding area of injection site for 36 hours
Patient c/o sudden onset of headache to family and suddenly passed away immediately following statement made that she had a headache
Woke up 8 am the next morning with my tongue swollen on the left side only. I could barely swallow fluids. Swelling went away on its own over about 4 hours.
Large raised red warm-to-touch area, at injection site of influenza, tender to touch. Not impact on breathing. Child has received influenza vaccines yearly since birth with no previous reaction, as had all siblings. Strangely this child and all siblings reacted in the same way to this vaccination. Concerned about issues with the product lot.
RECEIVED EXPIRED VACCINE/PRODUCTS HAD REACHED THEIR LISTED EXPIRATION DATES; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: 213D21A expiry: 08-SEP-2022) dose was not reported, administered on 20-SEP-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. No concomitant medications were reported. On 20-SEP-2022, the patient experienced received expired vaccine/products had reached their listed expiration dates. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received expired vaccine/products had reached their listed expiration dates was not reported. This report was non-serious. This case, from the same reporter is linked to 20230149982, 20230150340, 20230150255, 20230150600, 20230150423, 20230150716, 20230150777 and 20230150588.
Data exchange was not properly working in EHR office procedure did not include reconciliation of immunizations. Causing extra dose to be given.
COVID-19 breakthrough. Initially started with congestion and a cough. Over the first 24 hours it transitioned to shortness of breath and fatigue. I had chills that felt like a fever. The congestion and cough developed into nasal drip. After 48 hours the only symptoms that remained were the congestion and cough. After 5 days I felt no symptoms.
Have become allergic to Polyethylene Glycol 3350 which is main ingredient in vaccine.  Broke out in raised and itchy hives after 3 hours of taking medication which only contains polyethylene glycol. This didn't happen prior to receiving 3 Moderna Vaccines.
08/18/2021 Routine Covid19 Testing = Positive/ Asymptomatic
cellulitis with flu-like symptoms (bodyache, fatigues, chill, fever)
2nd dose, Woke up following day with slight headache and some joint pain.  As the day progressed heading into the 24 hour mark of the shot my headache turned to migraine, soreness all over, joint aches- cramps in ankles, knees and hips, extremely tired but unable to sleep.  Slight congestion, soar eyes and headache continued for 2nd day- still present as of 5/2
Became red, blotchy areas on neck, face, trunk and limbs, 10 minutes, post vax. No respiratory distress. Observed for 30 minutes. Rash lightened and disappeared.
12 weeks of horrible pain from the 2 doses; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (12 weeks of horrible pain from the 2 doses) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis and Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN (12 weeks of horrible pain from the 2 doses). At the time of the report, PAIN (12 weeks of horrible pain from the 2 doses) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-395987 (Patient Link).
Ischemic Stroke; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from License Party.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: ISCHAEMIC STROKE (medically significant), outcome "unknown", described as "Ischemic Stroke".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  BNT162B2, BNT162B2 OMI BA.4-5 is under agreement with BIONTECH SE.
I started feeling weird after dinner. I passed out or had a seizure. And then went to the hospital. When I arrived I could barely move my body at all. I had to be undressed by nurses and picked up to get in bed. After three hours I was able to move again and went home.
Pain in his whole mainly in his mouth and toes. Staring to get a lot of mild sores that wont heal, always coughing, lost 20lbs. Having extreme pain in throat and mouth.
After 24 hours of only occasional stabbing head pains, I experienced 12 hours of fever and chills, followed by 36 hours of feeling well, then vomitting (only once) and diarrhea for 12 hours.  swollen arm -  red, swollen, hot, painful, itchy the size of my palm. Has diminished to a hard spot the size of a quarter 3 weeks after injection
Pain at injection site. Muscle aches throughout whole body and chills the night of the vaccine. The next day developed a rash on neck and upper chest.
Two months after the vaccine I got chills and fever and it lasted around 1 week. I got tested for COVID-19 about 5 times but they all came back negative. I went to the ER and the ER doctor diagnosed me with pancytopenia and he wanted me to see a hematologist. He prescribed me medication and I stared taking it but I wasn't getting better I got worse. I didn't think he diagnosed me correctly. I decided to go back to the ER two days later because I wasn't getting any better.  I was tested for Flu, Covid-19, and strep throat which were all negative. I had to be admitted because my  sodium levels were low, red blood cells were low, and my white blood cells were low. I was diagnosed with typhus. I was prescribed the correct medicine after that visit it took me about 2 months to feel better and get my energy back . I was tried a lot.
Patient was given the Booster Bivalent instead for the primary series Pfizer for the 1st shot
the tip of the GARDASIL 9 PFS broke; her finger was bleeding; The nurse cut her finger; the nurse pulled the GARDASIL 9 PFS out of the tray, the nurse realized that her finger was bleeding; This spontaneous report was received from a Merck FBE and refers to a 20-22-year-old female patient (nurse). No medical history, concurrent conditions nor concomitant medications were reported.  On 13-OCT-2023, the nurse grabbed a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 mL, 1 dosage form, lot #X019862 was valid for formulation pre-filled syringe, expiration date 14-FEB-2025) and the circular part of the tip of the GARDASIL 9 PFS broke (Syringe issue).   The nurse pulled the GARDASIL 9 PFS out of the tray, the nurse realized that her finger was bleeding (Wound haemorrhage). She cut her finger, but was okay (Skin laceration, Injury associated with device). The outcome of the events was unknown.  The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Developed Deep VEIN thrombosis (DVT) in the left leg and a Pulmonary Embolism.    Was hospitalized for 5 days and had to have a surgical procedure to insert a screen into my inferior vena cava
Patient describes red swelling and pain in approx. 6 inch band near injection site on left arm, advised patient to take anti-inflammatory and follow up with doctor or urgent care if not improving or worsening.
Muscle aches from elbow to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches from elbow to shoulder) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple myeloma. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), METOPROLOL FUMARATE (METOPROLOL [METOPROLOL FUMARATE]), DUTASTERIDE (AVODART), TAMSULOSIN, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), OXYCODONE, PANTOPRAZOLE, ACYCLOVIR [ACICLOVIR], ONDANSETRON, DEXAMETHASONE, BORTEZOMIB (VELCADE), ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D3, FISH OIL and FOLIC ACID for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced MYALGIA (Muscle aches from elbow to shoulder). At the time of the report, MYALGIA (Muscle aches from elbow to shoulder) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details was reported.
Pt reports 3 days post/vax, had sudden loss of hearing. Some hearing has returned to L/ear but no hearing in R/ear at all. As of 10/21/99, pt has essentially no hearing the right ear with a slight high frequency dip but otherwise fairly normal left ear.
BAD RASH EXTENDED 4 INCHES BY 2 INCHES, SWELLING, COULD NOT LIFT ARM AFTER TWO DAYS, EXTREME FEVER AND CHILLS, NAUSEA, SWELLING ON ARM - RASH, SWELLING, PAIN HAS LASTED 5 DAYS SO FAR .
today he is experiencing body aches.; This is a spontaneous report received from Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of Covid-19 vaccine (unspecified trade name or manufacture) via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The patient was experiencing body aches on 15Apr2021. Consumer called in to get help with his second appointment. His first shot was 11Mar2021. He has been waiting around to receive a call or email for his second shot. Outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
About 20 minutes after injection, noticed scratchy throat.  Approximately 40 minutes after, severe itching to arm, tightening of throat, hives in mouth.  Benadryl 1cc IM given.  Relief within 15 minutes. The follow up received on 12/23/03 states adverse event onset date was 11/19/03 that evening.
first dose June 2019, never had the second; Arm was swollen; small rash; Headache; Abdominal pain; This case was reported by a consumer via call center representative and described the occurrence of swollen arm in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced swollen arm, rash, headache, abdominal pain and incomplete course of vaccination. On an unknown date, the outcome of the swollen arm, rash, headache and abdominal pain were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the swollen arm, rash, headache and abdominal pain to be related to Shingrix.  Additional Information: GSK Receipt Date: 09-Aug-2022. Reporter's Comments: The case was self reported by the patient. The patient had arm was swollen and with a small rash. Also had headache and abdominal pain. These reactions that lasted three weeks. The patient had the 1st dose of Shingrix but never had the 2nd dose.  The patient asked as he/she protected just with one dose. The patient asked there had been three years since the 1st dose of Shingrix. Could he/she get the 2nd dose now after three years. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Pt is 46 yo female s/p full J&J COVID vaccination on 4/29. On 8/5, had hospital admission for surgery to remove kidney stone and place a stent. Discharged that day. Follow-up on 8/9, pt states that the kidney stone has improved but pt has developed upper respiratory symptoms and complains of extreme fatigue on 8/7. Reports feeling feverish, cough, fatigue, congestion. Pt tested for COVID on 8/9 and resulted back positive. Received casirivimab/imdevimab infusion on 8/11.
Acute Pancreatitis being treated with IV fluids, Zofran, and Hydromorphone
lt deltoid site of inject became red, swollen and hot 3-4 days p/inject;
Erythema and edema in left arm area of administration. Warm and tender to touch and a mild hematoma formed in the puncture site.
Itchy neck, arms, lower half of face; Hives on both arms.; Burning headache; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL8982), via an unspecified route of administration in the right arm on 27Jan2021 08:45 at a single dose for covid-19 immunization. Medical history included hypothyroid, allergies to nausea medication and COVID 19. Concomitant medication included levothyroxine. On 27Jan2021 12:00, the patient experienced itchy neck, arms, lower half of face., hives on both arms and burning headache. The patient did not receive treatment for the events. The events were assessed non-serious. The outcome of the events was not recovered.
vaccine leaked down arm during 2nd vaccine; syringe was loose; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (vaccine leaked down arm during 2nd vaccine) and DEVICE CONNECTION ISSUE (syringe was loose) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to unk dosage form. On 05-Apr-2021, the patient experienced UNDERDOSE (vaccine leaked down arm during 2nd vaccine) and DEVICE CONNECTION ISSUE (syringe was loose). On 05-Apr-2021, UNDERDOSE (vaccine leaked down arm during 2nd vaccine) and DEVICE CONNECTION ISSUE (syringe was loose) had resolved. Not Provided          No concomitant medications reported. No treatment medications provided by the reporter.   Action taken with mRNA-1273 in response to events was not applicable.
Fever and body aches for 24 hours. Fever reduced after a day and body aches for another 24 hours.
Patient was given an expired dose of IPOL expiration date was 07/21/2021,
Information has been received from a physician concerning a female who on 14-DEC-2006 was vaccinated by injection with the first dose of HPV vaccine (yeast). On 14-DEC-2006 the patient experienced fatigue after HPV vaccine (yeast) was administered.  The patient received the second dose of HPV vaccine (yeast) on 15-JAN-2007 and did not experience any further symptoms.  The patient sought unspecified medical attention. At the time of the report, it was unknown if the patient had recovered.  Additional information is not expected.
pt recvd vax & devel tightness in throat; abdo pain; to er; broke out in rash & had uvular swelling; given epi;
Fever for 24 hours of 101.5, extreme body aches, headache, nausea, sore throat, sinus congestion,  injection site very red and raised.  Lasted 40 hours.
dry cough; hot sensation in throat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Apr-2021 and was forwarded to the company on 08-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough) and THROAT IRRITATION (hot sensation in throat) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0U2B21A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No significant historical event reported.).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROAT IRRITATION (hot sensation in throat). On 06-Apr-2021, the patient experienced COUGH (dry cough). At the time of the report, COUGH (dry cough) and THROAT IRRITATION (hot sensation in throat) outcome was unknown.            There are no Adverse events to report after the first dose.
27JUN94 sore throat, ear ache, fever, malaise w/face, cheeks & neck swollen-started 24JUN94; PMD said poss mumps or mono; had sl pos monospot
The DTap and the Meningococcal was given in the left arm then the HPV was given immediately in the right arm. My daughter was on the exam table and the height was high enough there is a step stool to get on and get off the table for all patients. The nurse placed a band-aide onto the right arm after the HPV, said she was good to go. My daughter went to stand up onto the step stool and immediately eyes rolled to the back and she fainted continuing to fall face first onto the tile, the distance was approximately 2-3 feet. There was a loud cracking noise and slap from her landing face first, blood was coming out from both of her nostrils and mouth. I immediately grabbed papertowels by the sink and cleaned my daughter up. The nurse went to get the doctor. We were informed to go to the emergency room where the Xrays indicated a fracture in her nose and chip in her chin. Everything happened immediately after one another. She complained of dizziness, shortness of breath, headache, tooth ache and stuffy nose.
Upper extremity mass; Breast lump; Colonic polyp; Painful nodule; This spontaneous case was reported by a consumer and describes the occurrence of LIMB MASS (Upper extremity mass), BREAST MASS (Breast lump), LARGE INTESTINE POLYP (Colonic polyp) and NODULE (Painful nodule) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced LIMB MASS (Upper extremity mass), BREAST MASS (Breast lump), LARGE INTESTINE POLYP (Colonic polyp) and NODULE (Painful nodule). At the time of the report, LIMB MASS (Upper extremity mass), BREAST MASS (Breast lump), LARGE INTESTINE POLYP (Colonic polyp) and NODULE (Painful nodule) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Colonoscopy: 80 T0 90 POLYPS.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs Not Reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality with Humira for the event(s) of lump in elbow size of a dime, lump in left breast, 80 t0 90 polyps in colonoscopy and lumps in muscle joints hurted after vaccination/in legs, feet, hands and arms in extremities was not provided.  Treatment Drugs Not Reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Right arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm was sore) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Right arm was sore). At the time of the report, PAIN IN EXTREMITY (Right arm was sore) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.    This case was linked to MOD-2021-037061 (Patient Link).
"Patient states that he received the Covid vaccine today on left arm. Immediately after receiving it, felt his left arm went numb, then felt his lips on the left side going numb. Sensation progressed to his whole face, and down his neck, and back down to the whole left arm. He states that he even felt his truncal area, kidney, and part of his right foot  going numb. States that he went to the ER for further evaluation, and while waiting there for about an hour, the sensation resolved. He denies any tingling or painful sensation. Does not think he was weak at the time."