chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1. 27 Sep, ~0830.  I was driving by myself in town.  I had nothing but water to drink that day.  I went to a coffee shop to get a cup of coffee.  I got in the car and the inside of my lip started feeling odd.  Like there was something on the inside of it.  I realized about 15 minutes later that my lip was actually swelling.  It was very swollen, very obvious to others.  As if I had gotten in a fight.  it subsided around 1100.  The swelling was almost completely gone by early afternoon. 2. 3 Oct, ~1800.  I was standing in the kitchen.  I had poured a glass of wine.  I was doing the dishes and prepping for the next morning, kid lunches, etc.  I noticed my upper lip was swelling.  It wasn?t as bad as it was the first time, but it was noticeable.  My wife could clearly see it was swollen.  It subsided completely within an hour or two. 3. 5 Oct, ~1530.  I dropped the kids off at the gym.  They were changing and I was talking to the owner.  I noticed the left side of my face felt odd.  My face was swelling.  I even made a comment to employee, who I was talking to.  I went in to the bathroom to look in the mirror.  I couldn?t tell that it was swollen like the other times, but it was clearly not normal as I felt it internally.  Then the left side of my face started to go numb.  It was numb for approximately 2-3 hours.  I felt really off the rest of the day, just not normal. 4. 14 Oct. 1000. Lower lip started swelling.  Not as bad as previously but noticeable. My mom noticed it too. Remained in a swollen state for approximately 3 hours. Then subsided.  5. 16 Oct. 1000. Got coffee. Went to play soccer. Lower lip started feeling weird.  Swelling and numbness on the left side of my lower lip and a little bit into the facial area. Small red dots noticed around the lower lip area that night.  6. 17 Oct. 1750. At home. Center upper lip swelling. Just the center portion. Numb. Feels like I got hit in the mouth.  Or, More accurately, like I just got a novocaine shot in my lip.  Began returning to normal around 830pm. Some red dots on lower left lip still noticeable.
Hives started 22 hours, still having an occasional breakout and scratchy throat into the 48 hours. Started benadryl every 4 hours at the time of hives and still taking 2 days later.
Within the first three weeks, the pt experienced pain and weakness in the right wrist, within one month, the pt experienced tendonitis type pain, next the pain developed in the left elbow and knee. The pt then experienced intermittent pain in the groin area.  Several mornings the pt awoke with a numb or tingling sensation in one or both arms. Within the 1st  two months, the pt experienced back pain, stomach discomfort, nausea and severe cramping, loss of appetite. The pt also experienced severe chest pain, depression, or loss of balance and mental clarity.  The sensation that the skin was burning or stinging. These symptoms have subsided, but remain in a lessened degree.
C/o itching, tiny bumps - denies redness or fluid or temp. C/o sore throat and fatigue. "Rash" covers ears, lips, hands, and "all over body." States history of eczema. Follow-up call with PT's mother on 2/7/03 states unable to get to MD. Rash self resolved, as well as other reported Sx's, only has "remaining after rash on skin" - with clarification mom agreed - discoloration of skin after rash resolved. Also reported new since last contact "Psoriasis rough skin on elbows."
COLD CHILLS, POUNDING HEADACHE, FEVER 101.5, BODY ACHES, LASTING 36 HOURS BODY ACHES, HEADACHE MILDER AFTER 36 HOURS
I felt achy all over after receiving the vaccine for a day. In November 2022, I began feeling dizzy and lightheaded. I went to the emergency room for observation and then admitted. I was diagnosed with vertigo. I tested positive for COVID-19 07/02/2022. I am on medication for vertigo which is helping but I continue to be very tired.
Patient called within 24 hours stating that her arm was very swollen at the site of injection and the rest of her arm was swollen too. Pt stated she was applying ice and took NORCO that she has for pain. Pt stated the swelling was down 24 hours later.
Rash on chest starting next day p/vax given on 3JUN91 itching still continues on 3JUL91; has hx of skin rashes, but never  has been on chest a/;
FAINTED; LETHARGY; PAIN; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a female patient of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, 1 total administered on 02-APR-2021 or 03-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  It was reported that on 02-APR-2021 the patient fainted 12 hours post COVID-19 vaccine as well as fever, lethargy and pain. She woke up about a minute after. The following day (03-APR-2021), she experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted on 02-APR-2021, and lethargy, and pain, and the outcome of flu like symptoms was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210745222-covid-19 vaccine ad26.cov2.s-Fainting . These events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
After not menstruating  for almost seven years with mirena iud in place, patient began to menstruate every 28 days for five months, with serious hormonal symptoms accompanying menstruation, none of which had occurred since the placement of the first iud 7 years prior.
pt recv vax 11AM & just p/12noon pt devel blotchy rash-purplish in color-pt was listless, limp, sleepy & by 230PM temp was 104;rash & temp remained for about 15hr;
Unconsolable crying continuously for 7 hours. Parents did not report this until visit today when asked if any problems with previous shots.
The whole upper arm swell. The swelling went down toward the inner elbow, it is red and painful.
15 mo given MMR, DTAP, HEP A on 5/16/06 hrs later 106.3 A temp. Twitching, no seizure activity. In ER temp 40.7 PO exam. WNL.
Patient was arrived for a nurse visit. Patient was brought back and identified. Pulled immunization and did not get a second look. Administered the Tdap instead of the patient's second hepatitis B.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted approximately 5 minutes after vaccine administration and fell on the floor - experienced no physical trauma/injuries and became responsive right after. EMT arrived 5 minutes after. Patient was sent home 20 minutes after the event.
Flu s/s (extreme fatigue, lt diarrhea) 24 hrs p/flu shot; lasted 1 wk chest tightness, dry cough, SOB progression worsened; MD never ordered BC recvd Keflex x 10 days; pt seen by cardiologist stated heart pumping capacity 30% due to vax;
she cannot walk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 4434308.  A 47 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS. The following information was reported: GAIT INABILITY (non-serious), outcome "unknown", described as "she cannot walk".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness, induration and pain at site of injection (left arm); muscle aches, headache lasted approximately 1 week. As of 06/01/2010 still have slight tenderness on palpation at site of injection and stiffness of left side of neck and pain in axillary muscles on the left.
Near Vasovagal syncope within approximately 2-3 minutes of receiving the vaccine; Hives on the neck, fast heartbeat, dizziness, weakness, tingling of the entire body, slight difficulty breathing; This lasted about 20 minutes; Hives subsided; Taken to the ER via EMS; Secondary episode 11/21/2018, ER visit with the same symptoms; Hives on the neck, fast heartbeat, dizziness, weakness, tingling of the entire body, slight difficulty breathing.
Patient was given the FLUMIST Nasal Spray versus the injection.  This is not recommended for children under 2.  Was given in error.  Patient is a healthy 19month old.   I was looking at the wrong VIS sheet recommendations.
Redness in left eye with tearing and discomfort. Cornea damage appeared 4 - 5 days after redness.
Spikevax 133% Full dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Spikevax 133% Full dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: comirnaty, comirnaty and comirnaty. Past adverse reactions to the above products included No adverse event with comirnaty, comirnaty and comirnaty. Concurrent medical conditions included Primary immunodeficiency syndrome.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Spikevax 133% Full dose). At the time of the report, ACCIDENTAL OVERDOSE (Spikevax 133% Full dose) outcome was unknown.            No concomitant medication was reported. It was reported that patient took 3 Comirnaty (BioNtech), 2 Spikevax (Moderna 100 percent and 133 percent full dose). Patient also reported that every booster resulted in broader AB answer (yet with very low titers due to PID). No treatment medication was reported.
This spontaneous report was received from a Medical Assistant, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 01-MAY-2018, the patient inadvertently received an expired dose of GARDASIL 9, intramuscular injection, lot # M009378 and expiration date on 23-APR-2018, for prophylaxis. There were no adverse effects reported.
Patient reported itchiness at injection site that spread moving down left arm. No swelling noted redness noted down left arm to hand. Pt continued to report itchiness. Pt treated with BENADRYL 50mg/ml IM right deltoid at 10:56 am by PHN.
took the vaccine currently have the shingles / suspected Vaccination failure; shingles; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, took the shingles vaccine, it was 2 shots, 8 weeks apart and currently now had the shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
This spontaneous report as received from a pharmacist refers to a 71 year old female patient with no drug reactions or allergies. On 08-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # H019035, expiry date was 17-JAN-2014), 0.65 milliliter (ml), subcutaneously. Concomitant therapies included vitamins (unspecified). On 10-MAR-2013(reported as 2-3 days later) the patient developed swelling at the injection site. The patient reported that is had grown in size over the past week and was 2-3 inches across. The patient reported no pain with swelling but only slight periodic itching since an unknown date in March 2013. Laboratory test performed was none. The patient sought medical attention (visited pharmacy) and no treatment was given. The outcome of all the reported events was unknown. Additional information is not expected.
covid; covid; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, 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: "CAD" (unspecified if ongoing), notes: other medical history: CAD. The patient had no known allergies. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19 Positive antigen test again; (31May2022) Positive, notes: Positive antigen test again on 31May2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. From 17May2022 to 22May2022, the patient was treated with Paxlovid. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Approximately 32 hours after receiving my booster, I passed out and my pulse went down to 40. I had gotten up in the middle of the night (2am) to use the bathroom and felt light headed while sitting down. I then passed out for about 15 seconds, experienced extreme sweats and cramps in my intestines. About 30 minutes after the incident I felt completely fine and my pulse had returned back to normal.
Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092507, 2015SA092508, 2015SA092509, 2015SA092510, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092722, 2015SA092723, 2015SA092724, 2015SA092725 (same vaccine). Abstracts: OBJECTIVE: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. METHODS: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. RESULTS: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). CONCLUSION: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of Tdap (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. This is a case for 2 neonate patients (gender: unknown). The patients were exposed to Tdap vaccine in utero. The patients died on an unspecified date. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was fatal. Documents held by sender: none.
Nausea and vomiting for two hours; chills; muscle aches; joint pain; headache; fatigue for about 30 hours. Felt like a horrible flu.
20 minutes after receiving moderna vaccine, pt developed generalized shaking, felt "cold". Reported no shortness of breath, chest pain, fever. b/p  156/93. HR 118
Pt. arm went numb after dose #1 and when received dose #2, arm went numb as well - Lasted 1-2d. Vaccines given in opposite arm and fully recovered.
15 year old male had COVID-19 PCR positive test on 1/11/2021.  Received COVID-19 vaccine on 8/4/2021 (Pfizer-BioNTech Ew0198 IM left deltoid) and 8/25/2021 (Pfizer-BioNTech Fc3182 IM left deltoid). Sister with whom he lives had illness consisting of rash, abdominal pain, fever ~9/7/2021.  Patient developed chest pain and was evaluated in ER on 9/21/2021, found to have pericarditis by electrocardiogram and elevated troponin to 15.5 ng/mL (normal <0.03) on 9/21 at 12:32.  Admitted to PICU.  No arrhythmias on telemetry.  Normal systolic function on echocardiogram, no pericardial effusion (9/21/21 on presentation and again on 9/22/2021).  Started colchicine and ibuprofen.  Troponin 19.47 ng/mL on 9/21/2021 at 18:06, then 10.6 ng/mL on 9/22/2021 at 05:15.
Swelling around site; erythema. Induration 10x15cm area. No fever; no anaphylaxis, no LOM on left arm at DTaP site.
pt recvd vax 16NOV92 AM & by early afternoon site was size of quarter; 17NOV92 AM became size of fifty cent piece; 19NOV92 AM approx size of inflammation area 4x4" red, hot, tender; referred to MD;
stroke; This is a spontaneous report received from a contactable reporter (consumer) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), administration date 02Sep2021 (lot number unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 21Sep2021, outcome "unknown", described as "stroke".  The lot number for bnt162b2 was not provided and will be requested during follow-up.
Sore left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Sore left arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm). At the time of the report, VACCINATION SITE PAIN (Sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   This case was linked to MOD-2022-644138, MOD-2022-644145 (Patient Link).
Patient states that after receiving the 2nd dose of Pfizer 01/28/2022, started experiencing symptoms that evening of fever, chills, muscle aches, fatigue, and congestion. Primary communications with recommendations of hydration, antibiotics, and Tylenol.
I have a psoriatic arthritis flare start on September 30 and October 16 it finally started coming down. All my joints swelled up.   I was unable to close my fingers on both hands my right shoulder left hip left knee and left ankle were swollen to the point I was wheelchair-bound. My lower back SI joints were also inflamed that I was prescribed oxycodone/acetaminophen for pain.  No I was able to see my rheumatologist on October 17 and he confirmed the flare was a result of a vaccine. It?s supposed to create an immune response and that?s exactly what it did.
Patient calling stating that she was not feeling well after lunch and thought it was possibly due to having been vaccinated so she laid down to take a nap.  When she awoke, she states that she felt like she had to urinate "really bad" so she went into the bathroom but she was not able to void.  She states that she then had extreme pain over the bladder area.  She states she was eventually able to void and now the pain over her bladder area is more mild but she is wondering if this might be a reaction to one of the vaccines she received today.
Patient stated headache and stomach pains were present soon after getting the shot. Patient had had stomach pains for >1 year but are now worse. No reports of trouble breathing. Advised to follow up with PCP.
Received the Moderna COVID19 Vaccine at Walgreens on 5/7/2021 3pm. My upper right arm is tight like a raised knot at the injection site. Also, I have experienced numbness in my fingers, on and off, primarily in the arm that received injection. Numbness/Tingling sensation began Monday after injection and continues throughout the day and evening.
This case was reported by a pharmacist via sales rep and described the occurrence of fever in a 50-year-old female patient who received SHINGRIX for prophylaxis. On 24th December 2018, the patient received the 1st dose of SHINGRIX. On 25th December 2018, 1 days after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The patient ran a temperature of 104 degree F on next day of vaccination. The patient was following up with her primary care physician.
patient sent to emergency room by PCP for chest xray showing pneumonia. patient states SOB has been going on for 1 week. patients admitted and given dexamethasone. patient discharged to home with home healthcare on 11/1/21