chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Raised and red body rash on neck, torso, back, and chest; Raised and red body rash on neck, torso, back, and chest; headache; nausea; major fatigue; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 13Apr2021 at 15:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included hodgkin's lymphoma in 2016 and unknown if ongoing. The patient had no known allergies to medications, food, or other products. Concomitant medications included colecalciferol (VITAMIN D3), ascorbic acid (VITAMIN C), cyanocobalamin (VITAMIN B12) and fluoxetine hydrochloride (PROZAC); all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 23Mar2021 at 15:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 07:00, about 36 hours after injection, the patient experienced raised and red body rash on neck, torso, back, and chest and also had a headache, nausea and major fatigue which subsided after 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event raised and red body rash on neck, torso, back, and chest was not recovered while the events headache, nausea and major fatigue were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Lethargy 4-5 hours post shot; hypotonic and pale. Group B streptococcus meningitis and septicemia. The 60 day follow up received on 5/29/03 states pt was admitted for sepsis, meningitis, had Grp Bstep. Treated with IV antibiotics. Discharge summary received on 3/30/04 states acute respiratory failure and respiratory arrest.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Exhaustion / Lethargy-Severe
Systemic: Other- Pt stated blurry vision, Full UE numbness and LE numbness, flacid, BP 100/50, cool, clammy, sob, dizziness.  Lasted 1 day
Major swelling of right bicep that moved down to elbow of patient, swollen and warm to the touch, symptoms since 8/25 and still continuing 2 days after injection
I did not know I was pregnant until the week after the vaccine; mild arm soreness; This is a spontaneous report from a contactable other health care professional (reported for herself). A 40-year-old pregnant female patient received first dose of BNT162B2 (COVID 19, Pfizer, Formulation: Solution for injection, Lot number: EL3302) via an unspecified route of administration on 11Jan2021 at single dose to her left arm for Covid-19 immunization. The patient's medical history included polycystic ovarian syndrome (PCOS) and Covid-19 (prior to vaccination, the patient diagnosed with COVID-19). Patient's last menstrual period date was 01Dec2020, pregnancy due date was 13Sep2021 and gestation period when reaction/event was observed in the fetus was six weeks. Concomitant medications (other medications the patient received within 2 weeks of vaccination) included metformin, minerals NOS/vitamins NOS (PRENATAL VITAMINS), curcuma longa (TURMERIC) and fish oil. Facility the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. It was reported that, first dose had no issues, mild arm soreness, she did not know she was pregnant until the week after the vaccine in 2021. On advice of her OB that she could take TYLENOL for any possible fever side effects, she decided to take the second dose. Outcome of the event mild arm soreness was recovered on an unspecified date in 2021whereas other events was unknown.
Information has been received from a consumer concerning her daughter who was vaccinated with the first and second doses of Gardasil. The consumer reported that a week after the second vaccination, her daughter's pap test came back HPV positive. No further information was provided. Additional information has been requested.
severe headache; fever; chills; aches; This case was reported by a consumer via call center representative and described the occurrence of headache in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th January 2020, the patient received Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced headache, fever, chills and pain. On an unknown date, the outcome of the headache, fever, chills and pain were unknown.   It was unknown if the reporter considered the headache, fever, chills and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 81 or 82 years. The patient received Shingrix and had side effects of severe headache, chills, fever, aches. She would be scheduled for breast cancer surgery in 2 days and she wants to know should she reschedule her surgery or would the side effects be gone by then.
Pt. had pain in left arm, which was intense in 1st week, which diminished. Pt used Tylenol w/pain, with some relief. Patient still has some residual pain 2 months after
fully vaccinated (Pfizer, 4/2/21, 4/23/21); onset of symptoms on 8/2/21
on Saturday afternoon patient began feeling like had the flu.  Patient had body aches, sore arm and nausea.  Sun day patient had sore arm and still felt tired.  Monday arm ached. Patient said never ran a fever.  Patient reports that her arm was never red and never swollen.
Fever of 102.  Chills at 1800 and fever at 2100.  She has a history of reaction.  Last year she was hospitalized.  She also missed a night of work.
Client awoke morning after receiving vaccine with left swollen to the elbow and what she describes as a band around her arm just above elbow.  The lymph nodes under left arm were also swollen.  She stated this lasted for 9 days.  She went to primary doctor and was told she had an allergic reaction to vaccine and probably should not receive the second dose.  She was not given any medication for treatment.
LM WITH PATIENT. Patient received expired vaccine (12/06/22). Was taken out of freezer without checking expiration date (11/24/22). Called Moderna, who said that for most cases it is fine with no change in efficacy due to short timeframe of expiration date until administration and that it was taken out of freezer on administration date. Called and left message with patient.
triedness, muscle pain, headache, shivering, fever, stomach pain, and nausea.
Unknown which vaccine was given. Pt reported two weeks after vaccine he developed red dot rash on ankles and feet.  He went to rheumatologist and diagnosed with a vasculitis.  The rash resolved with corticosteroid cream.
Vaccine given 6/9/07 - 6/11/07 had localized redness, (cellulitis) on left thigh Ice, Ataset, Keflex.
Headaches, dizziness, fatigue, pain of left breast area radiating to back to scapula. Mild relief with Tylenol 650mg q4 hours, no ER visits done and no calls made to my PCP.
Family reports that he had a stroke and they feel it was due to his Covid 19 vaccine. They were not told by hospital staff that this was the case. He had supportive and rehabilitative care at hospotal
No adverse outcome.  5/8 needle used instead of 1-11/2' needle based on gender, age and weight.
Patient had episode of vasovagal syncope approximately 3 minutes after the vaccine. Pharmacist assisted dad in comforting patient. Patient was placed flat on the floor. 911 was called by technician. Patient aroused before EMS arrived on scene approximately 2 minutes after syncopal episode. Patient recovered. EMS did not take patient.
Numbness (not pins and needles) developed in left middle finger immediately, then developed on left side of nose, left upper gums, left ear within 30-45 minutes. Tightness in head , sight headache and sticky eyes which dissipated quickly. The numbness subsided in about 2 -3 hrs. Slightly elevated temp in the evening which abated by bedtime. All better next day.
I tested positive for COVID-19. I had low-grade fever, bad headache, sinus congestion, extreme fatigue; running nose, and. because of my addison's disease my blood pressure dropped. I had to increase my medication. I talked to my doctor through telehealth and she prescribed me the lower dose of Paxlovid. I felt better on day 6 and took another test and tested negative. The next morning I starting coughing and tested positive again. I had the same symptoms but not the headache and symptoms were milder than the first time. This lasted for another 5 to 6 days. It took 6 weeks for the fatigue to go away.
Pt recvd 3 doses of Engerix-B titer checked 7 months p/3rd dose; titer result was neg;
Started breaking out (red hives) on breast and spread to torso and legs, then on back over a couple of hours after getting vaccine. I took Benadryl 25mg when I got home and then 25mg 5 hrs later. I used hydrocortisone ointment on the rash.
Horrible horrible horrible rash covering head to toe of my one year olds body. We are on day four and the rash continues to get worse. Two trips to the dr and a trip to the ER and it has been said to be the MMR vaccine given at her one year old appt. she is non stop scratching and is just unsettled. Looks like hives covering her little body. I am pro vaccines but there has to be a different way to keep her safe.
c/o very painful shot site, T- 100.8-103 /win 24 hrs, vomited next day, + s/s Gr A strep-next wk, *sib started /w vomiting 3 days later
The morning after getting the vaccine, I passed out while sitting. I had no warning, I just woke up on the floor.  This has never happened to me before.
7/28  about 1am - onset of flu-like symptoms (headache, muscle aches, chills, fevers, nausea) primarily grade 2, symptoms were almost neglible on 7/29; however, 7/29 about 2pm shingles type rash on left wrist and upper left arm.
This case was reported by a physician via call center representative and described the occurrence of vomiting in a 31-year-old male patient who received FLUARIX quadrivalent (batch number 2SN22, expiry date 30th June 2016). In 2015, the patient received FLUARIX quadrivalent. In 2015, 4 hrs after receiving FLUARIX quadrivalent, the patient experienced vomiting, fever and diarrhea. On an unknown date, the outcome of the vomiting, fever and diarrhea were unknown. It was unknown if the reporter considered the vomiting, fever and diarrhea to be related to FLUARIX quadrivalent. Additional details provided were as follows: The patient experienced fever greater than 101 degree F.
No additional AE/no PQC; HCP called to report PROQUAD was administered to a 17 yo patient.; This spontaneous report was received from a medical assistant and refers to a 17-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-OCT-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, (lot#, strength, expiry date, route of administration and anatomical location were not provided) for prophylaxis (product administered to patient of inappropriate age). No signs, symptoms or adverse effects have been reported from the administration of vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 as dose 2, single (Lot number: 301458A) at the age of 47 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received anti-viral (Brand=Pfizer) for COVID 19 treatment from 16Jun2022 to 20Jun2022. The patient received Enbrel (brand=Amgen) within two weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
On 12/29/20 at approx. 21:00, I felt lightheaded, pressure in my chest and left arm pain at the injection site. I stood up and walked towards bedroom and started feeling weak in my legs.  I fell to my knees and woke up, on my knees with my head on the floor. I was unconscious for about 30 seconds (unsure exactly) and felt like I was shaking. I stood up slowly and walked to the bedroom. I laid down and called for my husband.  He took my blood pressure and heart rate, and both were very low (BP 65/43 and 40 heart rate). I continued to lay down while left arm was throbbing, feeling wiped out, pale and weak.  My eyes were very heavy with pressure behind my eyes. I tried to sit up slowly about 5 minutes later and I felt lightheaded again.  So, I laid back down.  Then, about 10 minutes later, I sat up slowly and felt ok, walked to restroom with family help. Went to lay back down and my blood pressure was coming back up.  I went to sleep for the night and didn't feel any other side effects, except very tired and left arm pain.
Injection went into subcutaneous tissue; Redness; Headache; Fatigue; A spontaneous report was received from a consumer, concerning herself, a 65-year-old, female patient, who received Moderna's COVID-19 vaccine and injection went into subcutaneous tissue, experienced redness, headache and fatigue.  The patient's medical history reported included hypertension and sleep apnea (CPAP machine). Concomitant medications reported included metformin, pravastatin and fluticasone propionate, salmeterol xinafoate.  On 28-Jan-2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number 004M20A) subcutaneously in her right arm for COVID-19 infection prophylaxis.  On 28-Jan-2021, the patient reported that the injection went into her subcutaneous tissue and developed redness, headache and fatigue. Treatment information was not provided  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the event, injection went into subcutaneous tissue was considered to be resolved on 28-Jan-2021. The outcome of the event, headache was considered to be resolved on 29-Jan-2021. The outcome of the event, redness and fatigue was considered unknown.; Reporter's Comments: This case concerns a 65-year-old, female subject with medical history of Hypertension and Sleep apnea, who experienced nonserious expected events of Erythema, Headache, and Fatigue. The events occurred after the first dose of the mRNA-1273 administration on the same day.   Based on the current available information and temporal association between the use of the product and the start date of the events of Erythema, Headache, and Fatigue a causal relationship cannot be excluded.
developed arthralgia, mialgia, low grade temperature, had enlarged lymp nodes in arm pit of arm given injection, tachycardia, hypertension.
administered expired vaccine to patients, after the manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacturer date of expiration) in a 77-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The dose was administered to the patient after 30-day use by date or after manufacturer date of expiry.  The date on which the vial was initially stored in the refrigerator was unknown.  Number of doses/vials that were administered from that lot was reported as 173 doses.  The vial did not undergo any temperature excursion.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up received contain non-significant information
06/03/02-DTaP & HIB - history of urticaria, )7/29/02- DTaP, HIB, Prevnar, IPV -Urticaria, Confirmed 08/01 -Benadryl
This spontaneous report as received from a pharmacist via a company representative refers to an unknown number of diabetic patients of unknown age. The pharmacist stated that during a first aid class, an "emergency medical technician (EMT" stated that an unknown number of diabetic patients had experienced loss of glycemic control after receipt of ZOSTAVAX (dose, route and lot # unspecified). It was unknown if the patients sought medical attention or not. The outcome of loss of glycemic control was unknown. Additional information is not expected.
Came to appointment for 2nd Men B vaccine on 4/28/22 and  reported that 2 hours after receiving vaccines listed in section 17 on 3/24/22 pain, redness, and swelling occurred in bilateral arms down to about the mid bicep. Symptoms lasted about 36 hours and was treated with Tylenol and rest. Denied rash, hives, or itching. History obtained per mother and patient and are reporting a full recovery.
patient experienced excessive bleeding at injection site. estimated at 1-2ml. the patient also had swelling at the injection site under the skin
Stomach upset (gas, cramping, heartburn), chest pains (central, across top of collar bones), burning sensation above armpits on the front of shoulders, sinus congestion, post nasal drip, fatigue
Reports rash over entire body about 3 days after administration of vaccines. Went to ED .Was given 5 day course of Prednisone. Rash subsided. Stated on 12-7-05 that rash recurred 2-3 days ago.She has already consulted her personal physician.
Pt states immediately after vaccine fatigue , headache , and nausea. Now has irregular menses since vaccine .
arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013m208 and 0276208) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.            Patient DOB was 1949. No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2022-455763 (Patient Link).
2 WEEKS OF DIARRHEA (5 TIMES DAILY), VERY ODOROUS
no adverse effects reported; unspecified 14 year old male was inadvertently administered an expired dose of GARDASIL 9; Lot Number N021571 is NOT valid for GARDASIL 9, it is valid for GARDASIL; This spontaneous report was received from a licensed practical nurse referring to a 14 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.    On 19-MAY-2020, the patient was inadvertently vaccinated with an expired dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot #N021571 (verified to be a valid lot number), expiration date reported and stablished as 29-APR-2020. No adverse effects were reported.  (It was reported hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with lot #N021571 which was not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). However, lot# N021571 is valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)).
pt received severe swelling and redness, pt went to physician and was told to take Benadryl and ice, swelling subsided after 4 days
Patient received Moderna on 3/4/21 (lot 030A21A), and 4/1/21 (lot 031B21A.) Patient was admitted to the hospital on 8/11/21 with COVID pneumonia.
Headache and chills for two hours. Fallowed by sleepiness,. Slept 20 hours.
Within 20-24 hrs after receiving VARICELLA #1 LA.S.O. localized redness, warm, elevated red 30 x 20 mm appeared at vaccine site. Patient/client concerned reaction-encouraged comfort. Next 24 hours-has done nothing so far-Benadryl q 6 hours; Advil, Motrin, q 4-6 hours-Ice to vaccine reddened site-client also stated she felt tired after getting all 4 vaccines. 1/27/10 review of vaccine site 40 x 35 mm. Less induration-larger reddened area but not tender-not sore or bothersome today-ice-Motrin-Benadryl q 4-6 hours last 24 hours-improvement. 1/28/10 arm redness improved.
No Adverse Effect; administered PROQUAD & VARIVAX concomitantly; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 03-SEP-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, frequency, site and route of administration, lot# and expiration date were not reported for both), concomitantly for prophylaxis. No adverse effects were reported.
Within five minutes after my second dose in my left arm, midway between my elbow and my shoulder I have a lump that has not gone away. I also now have PVCs - heart racing at the time of the vaccine. This lasted for about 20 minutes but the tech said I could leave. I wasn't feeling well and just took it easy. My heart now, on and off again, regardless of physical effort, my heart will race. Premature ventricular contractions.
tenderness and redness on injected arm; tenderness and redness on injected arm; This case was reported by a consumer via call center representative and described the occurrence of tenderness in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced tenderness and erythema of extremities. On an unknown date, the outcome of the tenderness and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the tenderness and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's boyfriend. The lot and expiry date were unknown. The patient experienced tenderness and redness on injected arm for 1 day after getting Shingrix. The reporter did not consent to follow-up. This case has been linked with US2021029245, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021029245:same reporter