chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 43 year old female who has completed a 45-minute observation period with the following signs and symptoms of an adverse reaction: other - Chest tightness and skin redness. Per patient, she had a "bad" reaction to flu vaccine and had to be sent to ED. Patient c/o feeling warm, appears flushed. Given cold pack. Lung sounds, clear. No audible wheezing. No visible rash or hives noted. Denies SOB, No tongue or lip swelling noted, no difficulty swallowing. Patient speaks in full sentences.  Allergies Allergen Reactions ? Erythromycin Base Skin Rash and/or Hives and Asthma and/or Shortness of Breath ? Pcn Class [Penicillins Class] Skin Rash and/or Hives and Asthma and/or Shortness of Breath     Anaphylaxis   ? Trazodone And Phenylpiperazines       Palpitations with 50 mg at bedtime       Pfizer-BioNTech COVID-19 vaccine # 1 in series administered.  o Action(s) taken: Another drug administered - benadryl 25mg PO and Recommended transfer to higher level of care, risk and benefits explained to patient, patient declined o Allergy to COVID-19 vaccine documented in Allergies activity: No, will discuss with clinician o Patient advised to discuss second dose considerations with a clinician o sent home stable. Refused to go to ED or urgent care   Vitals:   07/28/21 1642 07/28/21 1700 07/28/21 1715 BP: (!) 164/80 (!) 148/68 134/76 Pulse: 80 78 72 Resp: 18 18 18 SpO2: 100% 100% 100%
Received #1 rabies vaccine in AM worked out in the heat (high heat index) all day. Woke up in the night with nausea, abdominal cramps in ER, c/o SOB; problems swallowing. ER MD stated it was vaccine Rx. over the weekend he was back out in the heat, back to ER with cramping of arms, legs, abdomen. Dx severe dehydration. Back to work 7/19 with c/o cramping, ill feeling. Health Director states it is not vaccine reaction.
This case was reported by a healthcare professional and described the occurrence of a local reaction at injection site in a 54-year-old female subject who was vaccinated with Flulaval, GlaxoSmithKline. On 2 October 2007 the subject received 1st dose of Flulaval at 0.5 ml in the left arm. On 2 October 2007, at an unspecified time after vaccination with Flulaval, the subject experienced a local reaction at injection site and her arm became sore. On 3 October 2007, the subject's arm became red, swollen and tender. On 5 October 2007, the subject was examined by the reporter who stated that the subject's symptoms had gotten progressively worse. The redness moved down her arm. The healthcare professional considered the events were disabling. The nurse prescribed Benadryl, Tylenol and Motrin for the subject. The healthcare professional considered the events were probably related to vaccination with Flulaval.
A couple of hours after receiving Tdap and PPSV23 in his right upper arm shoulder area developed pain around injection site. The next morning had increased pain, redness, swelling at injection site with redness, swelling and pain radiating out from the injection site to the arm pit and  chest area. Developed 102. 2 temp for most of the day even with use of Ibuprofen. Contacted pharmacist who administered vaccines who recommended for him to see his doctor. The client went to urgent care and was told he had a bacteria infection and was prescribed antibiotics. Instructed to return if the symptoms didn't get better. Today the fever has resolved with a reduction in redness, swelling chest area. However, the redness, pain and swelling in the upper arm shoulder area and arm pit has gotten worse. The client plans to return to the urgent care if not better by 4-5pm this afternoon. Client advised to go urgent care sooner if symptoms get worse. Call 911 if facial swelling, or difficulty in breathing occurs.
Pt reported a "hard lump" at injection site the day after administrations with an approximately 2" of swelling around the site, some mild pruritis, and erythema, plus HA x 2 days. denies rash. Total area of redness was 2" wide by 6" long. 3 days later reports redness and itching have decreased significantly, but lump remains the same.
Had an upset stomach for a little over a wk. His BP fell. He usually takes 3 BP meds. He stopped the Amlodipine which he takes 2 times a day. He had trouble with diarrhea for a couple of wks.
Fever (100.4), severe joint and muscle pain, severe headache,  tremors, teeth ache, inability to sleep, fatigue  Symptoms stated at 7p with aches and tremors, fever started at 10p, fever broke at 3:30a
14 hours after the shot, I got a chill to end all chills. I shook uncontrollably for 45 minutes, My arms shook violently. My entire body shook. I was in bed at the time and added an extra blanket and put on a sweatshirt. They provided some relief but it didn't seem like anything could stop the shakes. Finally, after about 45 minutes, the chills and shakes stopped. I did not sleep well after that. I woke up every hour, but was able to get back to sleep without trouble. I think at the end of the night I may have taken some acetaminophen (2 tablets 500mg each), perhaps around 4 or 5 AM. I slept better after that.  I slept a half hour longer than normal (I turned the alarm off and went back to sleep) and felt reasonably good when I got out of bed. There were no reoccurrence of the chills and shakes all day. I feel much better now, about 24 hours after the onset of the chills.
I received my Moderna updated Covid booster at approximately 3:30pm on Friday November 11th, 2022. I woke up on Saturday the 12th and could not hear out of my left ear (the same side I received my vaccine). It lasted all day until I woke up Sunday morning (the 13th) and could hear normally. I did not have any congestion or cold symptoms, I just couldn?t hear out if that ear. I also have very swollen lymph nodes in my left armpit and left collarbone area.  I will mention that I have had the swollen lymph nodes before but never the hearing loss. I would also like to mention that this was my first Moderna Covid vaccine. All my other doses were Pfizer.
fever 103, headache. joint pain, red and swollen arm site of injection took extra strength tylon andbed rest better two days
arm below the injection site was swollen, red and hot; it was about 2 inches down below injection site; arm below the injection site was swollen, red and hot; it was about 2 inches down below injection site; arm below the injection site was swollen, red and hot; it was about 2 inches down below injection site; nauseous/nauseated; This is a spontaneous report from a contactable consumer.  An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, via an unspecified route of administration, on 13Jan2021 at SINGLE DOSE for COVID-19 immunization.  Medical history included COPD (chronic obstructive pulmonary disease) and diabetes and cancer surgery. The patient has unspecified concomitant medications ("she takes many"). The patient experienced being nauseous/nauseated when she got up this morning (25Jan2021). And her arm below the injection site was swollen, red and hot; it was about 2 inches down below injection site. The patient underwent unspecified lab tests and procedures on Dec2020, results were also unknown. Patient took Tylenol as treatment to the events. Outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Narrative:  Patient presented to PCP appointment to establish care. Reported history of anaphylaxis to "Influenza (Swine Live)". Also reported receiving influenza vaccine from a different PCP 11/29/2020. No documentation as to if this was the vaccine that caused reaction. Description and timing of the event not documented. No influenza vaccine ever given by this clinic.
Pt. complained of feeling as if his heart was racing. This went on for about an hour, and then he began vomiting uncontrollably. He couldn?t get up off of the floor and was heaving even with nothing left in his stomach.
Late-onset localized reaction at the site of the injection characterized by redness, increased warmth, and swelling. Reaction area is ovular in shape and was initially approximately 3 inches in length and 1.5 inches in diameter, but increased in size slightly over the course of 12 hours. As of 04:45AM on March 12, 2021, localized reaction has decreased in redness and swelling, but is not yet fully resolved. Area of the local reaction is equal in size to previous day.  Patient (self) has taken Zyrtec and Allegra over-the-counter medications for allergies daily, with no effect on the localized reaction. Patient has not taken any anti-inflammatory medications or medications other than those described above prior to or following onset of the localized reaction. No other symptoms have been observed at this time.
Within the week of receiving the vaccine, the baby developed mucousy bowel movements which contunued and then progressed.  About three weeks later the child presented to the office with mucousy stools and 'screaming fits' which prompted an ER evaluation for intussusception.  From there she was discharged and seen by a pediatric GI specialist who called it 'gastroenteritis' with no change in intake or treatment.  The symptoms gradually spontaneously resolved. No second rotovirus vaccine was given at the four month check up.
Patient felt "tired' getting up from chair. Patient was seated and evaluated. Past medical history of DM on metformin - did not take metformin today, and did not eat anything. Anxious about getting vaccine. Patient felt better after sitting, and able to get up without problems. Felt well enough to return hoe.
Right arm large (13x9 cm) red, hot, painful area. No fever. Tx: Keflex 250/5ml 1 tsp PO 96 hours x 7 days, Benadryl 12.5/5ml 1/2 tsp PO q4-6 PRN itching PRN ice/ Tylenol. Follow-up 4-5 days.
Initial unsolicited report received from nurse on 09 November 2016. This case involves a 5-year-old patient (gender not reported) who was vaccinated with a dose of FLUZONE Quadrivalent (batch number, dose, expiration date, site and route of administration was not reported) on an unspecified date. (Reported as 05th or 6th October) The patient's medical history and concomitant medication were not reported. On 11 August 2016, following vaccination patient diagnosed with Influenza B. On an unspecified date following vaccination (had been month since immunization) patient had temperature of 103 degree Celsius. It was a case of vaccination failure. Lab data and corrective treatment were not reported. Outcome of event temperature of 103 degrees Celsius was not recovered and outcome of other event was not reported. Upon internal review the case was considered as serious because of important medical event: Influenza B and vaccination failure. List of documents held by sender: none. Sender's Comments: As with any other vaccine, INFLUENZA QUADRIVAL A-B VACCINE vaccination may not protect 100% of susceptible individuals. Aspects such as patient's immune status at the time of vaccination might interfere with the immune response to the vaccine. However patient's immune status, medical history, concomitant medication etc. is require to further assess this case.
Urticaria all over body. DECADRON 4 mg given IM. Rx for prednisone and BENADRYL elix.
On or about the day of vax, the pt experienced an injection site nodule that has persisted for a month. Unspecified medical attention was sought. Follow up information reported that the nodule was approximately 1 cm in size and that as of 05/23/2000 is smaller and minimal.  Additional information has been requested. Follow-up info from a physician reported that the nodule resolved 2-3 months later. No further info is available.
After about 15 to 16 days, patient reported hives/rash that are round in shape with sharp clear borders. Initially light red in color, turned red then dark red, then faded with border becoming more diffuse. Rash occurs on right thigh and back of right arm. The rash feels hot, a feeling of heat, like she was touching a hot burner. Vaccine was administered on right deltoid. Severe insomnia, could not sleep at all. Headaches. Today 6/9/2021 the rash appears to have subsided, became more diffuse and lighter but still there.
Collapse of lung; Diarrhea; very weak; lost his appetite; This is a spontaneous report from a contactable consumer.  A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered on right arm on 03Mar2021 (Batch/Lot Number: EL9261) at single dose (at the age of 78 years old) for COVID-19 immunisation.  The patient medical history included had vascular problems in his legs, and his legs were very clogged. The doctors couldn't do anything and tried to do a catheterization. Thyroid was not okay, and now his doctor increased his thyroid medication. The reporter blamed the hospital for doing something wrong when her husband was there the last time. She said the hospital made a mistake and gave her husband the wrong medication. She said the first time her husband was at the hospital, the hospital didn't give her husband his thyroid medicine. She said the second time, the hospital gave her husband the wrong dose of medication. Concomitant medications were not reported. The patient previously took BNT162B2 (lot number: EN9581) dose 1 on 10Feb2021 for COVID-19 immunisation. The patient previously took flu vaccines in Sep2020. On Mar2021, the reporter's husband was okay at first. She said now her husband had diarrhea and pooped in his clothes. She said her husband was very weak and lost his appetite. She clarified her husband's symptoms started probably 2 weeks ago, and her husband was worse, and like a different person now. She said her husband used to eat at the table, and now he just sits in his chair, and after 5:00PM he wants to go to bed. She said she was not sure if her husband's symptoms were related to the COVID-19 Vaccine. She said her husband was supposed to have heart bypass surgery on Monday (22Mar2021), and his surgeon called on Saturday night (20Mar2021) and called off her husband's surgery. She said the surgeon said her husband had a collapsed lung. She said her husband had a chest x-ray in late Feb2021 and his lungs were clear. She said everything that happened to her husband, happened after he had his second dose of the COVID-19 Vaccine. She said she was not sure if her husband's collapsed lung (19Mar2021) was related to his second COVID-19 Vaccine. She said before getting the COVID-19 Vaccine, her husband did not have a problem with his lungs. She said her husband's surgeon can't figure out why her husband's lung collapsed. She said she can't prove his collapsed lung was a side effect of the COVID-19 Vaccine, but her husband never had sick lungs in his life. She said she knows her husband doesn't have the COVID-19 Virus because he had to be tested on Saturday (20Mar2021) for the COVID-19 Virus before he could have his surgery on Monday (22Mar2021). She said her husband's COVID-19 Virus test was negative Saturday, but he has all these problems. The patient's wife was afraid to give her husband Pepto Bismol, so she didn't give her husband anything. She said her husband has an appointment on Thursday (25Mar2021) with his primary care doctor to talk about his symptoms. The outcome of collapsed lung was unknown and other events were not recovered.
hives, short of breath, nausea, vomiting, headache- given epinephrine , Benadryl, solumedrol, iv fluids
Patient admitted for 2-day history of nausea and vomiting, found to be in DKA. Patient also tested positive for COVID-19 on admission.
Immediately following injection, pt. became dizzy and lightheaded.  Placed in Trendelenburg position and given sips of water. Was flushed and diaphoretic.  She reports having similar issues with other immunizations.  After about 30 minutes she recovered and returned to class.  Teacher and school nurse involved in decision to release her.
FELT LIKE WAS GETTING FLU; CHILLS; JOINT PAIN; LOW GRADE FEVER; FELT TIRED; This spontaneous report received from a patient concerned a 78 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced felt like was getting flu. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced joint pain. On 24-MAR-2021, the subject experienced low grade fever. On 24-MAR-2021, the subject experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, joint pain, low grade fever, and felt tired on 25-MAR-2021, and the outcome of felt like was getting flu was not reported. This report was non-serious.
Patient was given vaccine that was beyond "use by" date of 8/16/22. Patient did not report any signs or symptoms.
Black and blue bruising; swelling and redness in the Left elbow; swelling and redness in the Left elbow; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swelling and redness in the Left elbow), ERYTHEMA (swelling and redness in the Left elbow) and CONTUSION (Black and blue bruising) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced JOINT SWELLING (swelling and redness in the Left elbow) and ERYTHEMA (swelling and redness in the Left elbow). On 14-Mar-2021, the patient experienced CONTUSION (Black and blue bruising). At the time of the report, JOINT SWELLING (swelling and redness in the Left elbow) and ERYTHEMA (swelling and redness in the Left elbow) was resolving and CONTUSION (Black and blue bruising) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient did not receive any treatment medications.
No adverse event; Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose) and NO ADVERSE EVENT (No adverse event) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced ACCIDENTAL UNDERDOSE (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose).    No concomitant medications information was reported.  Vaccination date: between 22-Jul-2022 and 28-Jul-2022 It was unknown if patient experienced any symptoms after getting the vaccine.  No treatment medications were provided.
:hills, Systemic: Headache, Systemic: Hypertensive, tachycardic, tremors, severe anxiety
Approximately 1.5 hours after injection, patient began having right arm pain and headache over the next few hours. Patient began having 102 fever, nausea, aching, and headache became worse. Patient was unable to get out of bed for 4 days. 6 days after injection, patient still had a headache. By the 7th day, headache went away. Patient also complained of nausea, diarrhea, and abdominal cramping for 5 days.
Fever of 103, feeling chills & freezing, severe pounding headache & rash covered the entire back of the arm. Patient visited doctor & got an injection (not sure which one) & felt better.
Didn´t received / second dose / first dose was given 8 months ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 8 month ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consent to follow up.
CHild received 3 vaccines as a rising 7th grader, Tdap, Meningoccal , and HPV#1. He started passing out and came to. He insisted he was alright however when he stood up pass out again. Hew was placed on floor with knees up. He was then assisted by 2 public health staff   to the school nurse office for observation and parents to be called.
Fever - 103 deg five days after shots! Day after vaccine 30 sec episode of non blinking/non responsive. 2 days after vaccine - 20 episodes of same, 1 lasting 5 min. Rest were 30-60 seconds.
Severe case of Gout right big toe. Rendered patient immobile for several days . Pain on a scale of one to 10 was 17.  Excessive amounts of water and tart cherry juice have been consumed plus magnesium and tart cherry supplements. Ibuprofen dosage has averaged 2,400 mg per day for the last 5 days  Patient is healthy (5?9 height, 175lbs weight) and lifts weights 5 times a week and runs ~8 miles a week.
Patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received dose from vials beyond 30-day use by date) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received dose from vials beyond 30-day use by date). On 14-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The date of refrigeration was on 06-Aug-2021. No concomitant medications are provided. No treatment medications are provided   This case was linked to MOD-2021-363756 (Patient Link).
Fever of 100 F, chills, headache, nausea, severe muscular pain in the arm injected needed to keep arm in a sling to immobilize, swelling at injection site along with rash which was very painful to touch; severe pain in sinus cavities radiating into upper jaw, pain with chewing food. After several days, the pain subsided; however, the rash lasted well over one week.