chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The pain is so bad it woke me up in the night; she has a ball under her armpit and the left arm was where the vaccine was administered; She is good if she sits still. Any movement kills her. She can't get comfortable.; severe swelling under my left armpit/Extremely swollen lymph nodes under the left armpit; Soreness of injection arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 13:30 (Lot number: ER8733) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibroid cysts in chest" (unspecified if ongoing), notes: Verbatim: Fibroid cysts in chest: Diagnosed probably 8 years ago; "Flu and Pneumonia vaccines" (unspecified if ongoing); "soreness of the arm and fatigue" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 14Apr2021 04:00, outcome "unknown", described as "severe swelling under my left armpit/Extremely swollen lymph nodes under the left armpit"; LYMPH NODE PAIN (non-serious), outcome "unknown", described as "The pain is so bad it woke me up in the night"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "she has a ball under her armpit and the left arm was where the vaccine was administered"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "She is good if she sits still. Any movement kills her. She can't get comfortable."; VACCINATION SITE PAIN (non-serious) with onset 13Apr2021, outcome "unknown", described as "Soreness of injection arm". Therapeutic measures were taken as a result of lymphadenopathy, lymph node pain, vaccination site swelling, loss of personal independence in daily activities, vaccination site pain.  Additional information: Extremely swollen lymph nodes under the left armpit happened again last night at 1AM on 15Apr2021 until 6AM. Treatment had been taking one Aspirin every day. Took one Aspirin late on 13Apr2021 and one at 4AM on 14Apr2021. After that, she took another Aspirin around 7AM. Then took two Ibuprofen. None of it is helping. Aspirin Lot number NAA6R06, EXP date Aug21, tablets as formulation and Dose was given at 325mg per tablet. Clarified Ibuprofen as Motrin and Lot number either 0KE2397A or OKE2397A is hard to see, Formulation in the form of caplets and Dose was given at 200mg per caplet. Prior vaccinations within 4 weeks was none. History of all previously immunizations was None. Family medical history was none.  No follow-up attempts are possible. No further information is expected.
72 hours after the shot I suddenly became flushed and passed out at work. I came to quickly. I have never passed out before in my life. My vital signs and blood sugar were taken at work, which were normal. I was seen by an urgent care clinic about 2 hours after the event. My vitals remained normal. Orthostatic testing was normal. HCG showed no pregnancy. My WBCs on my bloodwork for slightly elevated at 11.5 and I had trace blood and ketones in my urine. I am following up with my PCP and the clinic that saw me in the coming days.
Patient developed shingles after receiving a Zostavax.  Treated with antivirals & received cervical nerve block for pain.
Pt. had 4 year IZS on 6/18/08.  Started 6/19/08 in AM with mild swelling of R arm, which progressed.  Temp 100.4.  Vomited x1.  TYLENOL for pain, ice to area.
Heart palpitations starting day after second Covid injection. Difficulty taking deep breath- chest tightness simplistic to asthma
Approximately 3 weeks of watery diarrhea with hypotension and increased serum creatinine. Hypotension may have been exacerbated by about 25 pound gradual  weight loss over course of prior 15 pandemic months without adjustment of BP meds in addition to acute dehydration with diarrhea.   Resolved with low residue diet and elimination of amlodipine and chlorthalidone and vitamin B12  sequentially over course of 2-3 weeks.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 17-SEP-2104 the patient was vaccinated with (Merck) VARIVAX (dose, units, route of administration, anatomical location, lot# and expiry date were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
High fever (103 degrees) for four hours overnight.  Body shaking for 2 hours.  alternated tylenol and ibuprofen every 4 hours.  Took 4 hours of home care and OTC medication to reduce fever.
1 week after covid vaccine,  I experienced a fairly severe shingles outbreak on my upper torso.
Pain in eyes when looking left and right (Optic Neuritis), Lightheaded, Diarrhea, Malaise, Upset stomach, and decreased appetite. **Referring pt to optometrist**
pt received rotavirus vaccine on 3/14/07. When pt returned for 4mo vaccines, parents reported that pt got diarrhea and vomiting 5 days after 1st rotavirus vaccine.  Parents saw physician and did have a postivie rotavirus stool test. Parents reported diarrhea and vomiting was severe but pt did not require hospitalization but did receive IV fluids in the ER.
Left arm has dull pain at injection site, now 2 but this morning 3. It is red, warm to touch, 9 mm in diameter.
Seizure - grand mal with loss of consciousness and postictal sleep. (2-3 minutes seizure, postictal -15 min). No neurological complications. Meds: VALIUM 5 mg po - q 12 H then, 1 - q 30 hrs then, 1 - q 48 hrs then, 1 - q 72 hrs, 5 tab total.
I don't know how much if any may have gotten in; Inadvertent exposure to vaccine; exposure via skin contact/ most of vaccine was ended up on patient's arm; Extreme body aches all over; Slight fever; Chills; Brusing; Sore arm; This case was reported by a nurse via call center representative and described the occurrence of general body pain in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 7F33X, expiry date November 2020) for prophylaxis.  On 12th November 2019, the patient received the 2nd dose of Shingrix. On 12th November 2019, unknown after receiving Shingrix, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.  Additional details were reported as follows: The day before reporting, the patient had 2nd dose of shingrix. When the injection went in, it sprayed out and over the patient's arm, which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. The patient asked, would she need another dose. This case has been linked with US2019AMR207351 and US2019206637, reported by same reporter.   Follow up information received from the nurse on 19th December 2019: The patient's demographic details were updated. The patient received the 2nd dose of Shingrix (intramuscular). Bathc number and expiry date was updated. The patient stated, the vaccine sprayed back while the pharmacist was administering it. The hub probably was not tightened and most of the vaccine was ended up on her arm and not in the muscle. The patient's arm was relaxed at the time. Then, a couple of days after this incidence, the patient received a full corrective dose of Shingrix and was correctly administered. After this dose, the patient had fairly severe side effects including body aches ll over, slight fever, chills and bruising which lasted for about a day. The patient also had sore arm and that lasted for a week. It was unknown if the reporter considered the general body pain, fever, chills, contusion and pain in arm to be related to Shingrix and Shingrix. This case was considered as medication error associated with adverse reaction. The VAERS details were updated.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019AMR207351:same reporter US-GLAXOSMITHKLINE-US2019206637:same reporter
a dose of PROQUAD was administered with VARIVAX for 8 different patients; This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 06-APR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot #U024221, expiration date 04-AUG-2023 (strength and route were not provided), with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) 1 dose, lot #U028179, expiration date 08-MAR-2023 (strength and route were not provided) for prophylaxis (overdose). The pharmacy technician reported the information was shared with her by a nurse at one of their facility's clinic. It was unknown if any product confusion occurred, that may have contributed to the error.   This is one of eight reports received from the same reporter.
This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a female patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain, neck pain and neck swelling. On an unknown date, the outcome of the injection site pain, neck pain and neck swelling were recovered/resolved. It was unknown if the reporter considered the injection site pain, neck pain and neck swelling to be related to BEXSERO. Additional details were provided as follows: The nurse told that her daughter (the patient) had arm pain at the injection site which travelled to her neck at some unknown time soon after receiving her first dose of BEXSERO. The patient's neck then became swollen and the pain and swelling lasted for two to three. The reporter said that her daughter was a freshman about to start college and that the BEXSERO dose had been administered at the patient's doctor's office. No further related details were provided by the reporter. The nurse gave permission to be contacted if necessary for related questions.
fatigue, headache, hip pain, site redness - all 8 hours - no treatment
Within 15 minutes of vaccination experienced: SOB, itching, chest tightness. She took Atarax and used inhaler, but was not getting any better.  Went to ER- given IV Atarax and prednisone at ED
7/27--presently admitted 73y.o. female admitted for anemia. Pulmonary was consulted for cough and dyspnea. Pt has a past medical history significant for recent COVID. Patient with history of multiple myeloma presented to the pulm oncology office for abnormal labs which included anemia possibly needing blood transfusion.  Patient also noted to have shortness of breath on exertion.  She tested positive about 12 days prior to hospitalization for COVID-19 and received monoclonal antibodies.  Patient continues to have lingering cough.  Patient is neutropenic and is in the neutropenic precautions."  Cardiology followed for congestive heart failure.  Patient has history of multiple transfusions.  Chest x-ray showed a small left pleural effusion. Patient continues to have dyspnea and cough and pulmonary was consulted.
COVID-19; COVID-19; Dose 5: Pfizer/BioNTech; Dose 4: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Apr2022 as dose 4 (booster), single (Lot number: 001M21A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Generalized anxiety disorder" (unspecified if ongoing); "panic disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tramadol, reaction(s): "known allergies: Tramadol". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Sep2022, outcome "unknown", described as "Dose 5: Pfizer/BioNTech; Dose 4: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective and COVID-19 and included treatment with PF-07321332/RItonvir (PAXLOVID).
fever; chills; fatigue; sore arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever, chills, fatigue and pain in arm. On an unknown date, the outcome of the fever, chills, fatigue and pain in arm were unknown.   It was unknown if the reporter considered the fever, chills, fatigue and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported.  The reporter did not wish to provide demographics or participate in a safety report. The patient received vaccine in unknown arm. The patient experienced fever, chills, fatigue and a sore arm. The reporter did not consent to follow up.
she had systemic urticaria; pruritus; indicated that she is breast feeding currently; This is a spontaneous report from a contactable consumer or other non hcp. A female patient (breast feeding mother) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, at single dose on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced systemic urticaria and pruritus on an unspecified date. The patient indicated that she is breast feeding currently. The outcome of the events had systemic urticaria and pruritus was unknown.   Information on the Lot/Batch Number has been requested. No follow-up attempts are completed; information about lot/batch number cannot be obtained.; Sender's Comments: Kindly review the seriousness of the case.(maternal exposure during breast feeding).
CLIENT RECEIVED PFIZER GRAY-CAP FORMULATION OF 0.3ML AT 11 YR 11M. PFIZER GRAY-CAP FORMULATION IS APPROVED FOR AGES 12 AND ABOVE.
I went to bed on 12/28, after receiving the vaccine feeling fine. I woke at 2:00 AM with chills and a 99.3°F temperature. At 5:00 AM I woke up extremely feverish and nauseous and recorded a 101.7°F fever. I walked downstairs to get water and began feeling very nauseous and dizzy. I sat down and woke up with a laceration on my head in two places. I went to the ER around 5:45 and had an additional syncopal episode upon arriving. I was assessed in the ER, received  7 stitches, a Tdap booster, and fluids. My temperature went down to 98°F, my blood pressure was 91/44. I was released at 9:00 AM
This is a spontaneous report from contactable consumer via a Pfizer sales representative. An elderly (70, unit unknown) male patient of unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced white blood cell count went up and arm got swollen both on an unspecified date in May2017 with outcome of unknown. The patient went to the emergency room due to the events. The information on the lot number has been requested.
Patient became dizzy and nausea. Then patient blacked out and became unresponsive. EMS was called and patient became responsive and taken to ER
had it /  even with vaccinations / does not "prevent"/Suspected Vaccination failure; I've had it 3 times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. Age at vaccination was not reported The reporter said this was false advertising.  Vaccine does not prevent shingles, but perhaps it could possibly lessen the reaction when getting shingles.  The patient stated that you could get shingles over and over.  The patient had it 3 times even with vaccinations. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details provided for follow up.
Mother reports infant received immunizations 9/25/07.  On 9/26/07 temperature  100 degrees for 3 days with crying, swelling of face, lips and left leg for 3 days with red quarter sized area on left leg.  Loss of appetite for 3 days.  Called PMD 9/28/07 and was seen by PMD 10/3/07.
Flu-like symptoms; light Headedness; Ears ringing; Passing out; Heart pounding; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Asthma and Shellfish allergy.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passing out) (seriousness criterion medically significant), PALPITATIONS (Heart pounding) and TINNITUS (Ears ringing). On 27-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and DIZZINESS (light Headedness). On 26-Mar-2021, LOSS OF CONSCIOUSNESS (Passing out), PALPITATIONS (Heart pounding) and TINNITUS (Ears ringing) had resolved. On 28-Mar-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved. On 31-Mar-2021, DIZZINESS (light Headedness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
shingles; painful/burning rash/painful, burning rash in upper right chest / shoulder area; This case was reported by a physician via sales rep and described the occurrence of shingles in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles and painful rash. On an unknown date, the outcome of the shingles and painful rash were unknown.   It was unknown if the reporter considered the shingles and painful rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but could be 59 or 60 years. The patient experienced shingles episode with evidence of mildly painful, burning rash in upper right chest or shoulder area within 2 days of receipt of dose 1 of vaccine that he got at a local pharmacy.
Patient states that the immunizer administed the injection very hard and in the evening the area became very swollen.  He states that he has limited range of motion cannot sleep on that arm and area still feels very bruised.
There were no adverse events.  I had called the CDC on the day the vaccine was given to see if we could give it.  I was told Rotarix could not be given so over 15 weeks old therefore can't start it.  I am not sure why it was given.  No clinic or hospital visits at all and no adverse events
I placed injection (IM) on 7-7-09 & received call 7-8-09 from pts mom c/o area Lg red & painful. "Can't raise his arm". I made Appt today with PA-C.
This spontaneous report as received from a health professional refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with M-M-R II dose 4 for prophylaxis. On an unknown date the patient experienced measles antibody negative, extra dose administered, mumps antibody test negative and rubella antibody negative. The outcome of measles antibody negative, extra dose administered, mumps antibody test negative and rubella antibody negative is unknown.; Sender's Comments: US-009507513-1708USA010123: US-009507513-1708USA010124: US-009507513-1708USA009693:
Immunization given late Thursday woke up in the night Fri night / Sat AM with itchy red, swollen face - responded to BENADRYL within 24 hours no sense of any swelling.
RUNNY NOSE; DRY COUGH; TROUBLE WAKING UP; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, and other pre-existing medical conditions included the patient had a shingles vaccine two weeks ago. it was reported that the patient may have been exposed to positive cases. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-JUL-2021, the subject experienced runny nose. On 28-JUL-2021, the subject experienced dry cough. On 28-JUL-2021, the subject experienced trouble waking up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the runny nose, dry cough and trouble waking up was not reported. This report was non-serious.