chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 day p/vax pt presented to ER/urgent care clinic w/rash described as local rxn, lt upper extremity;tx w/pred & DPH
adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (adverse reaction). At the time of the report, ADVERSE REACTION (adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Narrative:  Patient contacted telephone triage nurse today requesting advice. Patient states he received 2 vaccines yesterday at clinic, "I got a flu vaccine and a shingles vaccine." Patient states when he got home, he developed body aches, "horrible abdominal pain", flushing, cough, wheezing. States he is worse today, "my teeth hurt today, my cheeks are swollen, and I am having some difficulty breathing, and I'm very weak." Recommended he call EMS, patient declined (see AMA disclaimer, below), "I'm only a mile away from the hospital, I will have a friend drive me to ER now."
vaccine was diluted with 0.8ml of diluent instead of 1.8ml of diluent and administered 0.3ml dose of concentrated reconstituted vaccine
Copied from comment received on 12/12/2018: I went to the Pharmacy on Saturday, October 27, 2018 to receive a flu shot. It was administered by the Pharmacist on-duty (unfortunately, I can't read her signature on my sheet). When she administered the shot, she injected it into my arm. She took no other steps except to just inject the shot into my arm. I noticed pain almost immediately, but per the guidelines on the take-home sheet and my previous experience, I know that vaccine sites can be sore for a few days. What was different this time was that the pain never went away; in fact, it got progressively worse. Two weeks after I was given the vaccine, I was at my physical therapist's office, and mentioned the severe, constant pain in my left arm/shoulder area. I mentioned that the pain's onset coincided with when I received the flu vaccine. He asked me how the shot was administered, and then specifically asked if the pharmacist had pinched my shoulder muscles when administering it. I answered honestly that she had not. My physical therapist then concluded based on my symptoms and description of how the shot was administered that my pain was due to the fact that the vaccine had been improperly administered. He said that the needle had gone through the deltoid muscle, and rather than depositing the vaccine into the muscle, it overshot the muscle and went into the shoulder capsule itself, which is what has caused me so much pain. It's been 6.5 weeks since I had this vaccine, and I still have constant, daily shoulder pain. I have had to go to PT specifically for this issue three times now. I wanted to let you know about this so you could re-educate your staff on how to properly administer vaccines. It's slightly frustrating on my end (to say the least) that all of this could have been avoided with a simple pinch of my arm muscle by your pharmacist. I know you have a high standard for your employees and your brand, and I am sure that you will take appropriate actions so more of your customers don't become injured due to your staff's lack of knowledge.
The side effects after the first of the two vaccinations (01/23/21) resulted in the side effects starting same night and resolving by 01/25/21 of headache, fatigue and localized soreness at vaccine injection site.  The side effects from tge 2nd vaccination administered on 02/13/21 resulted in the side effects beginning later the same night of  moderate site soreness, severe fatigue, headache, feeling hot and cold, loss of appetite and pain in muscles. All of the side effects resolved by 02/18/21 except the fever and chills which has happened every night since the second vaccination and had not been experienced prior to tge vaccination.
shortness of breath; A fib; Had water in my lungs; This is a spontaneous report from a contactable consumer (patient self). A 70-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, LOT number and expiration date: unknown) via an unspecified route of administration (location: left arm) on 29Jan2021 at age of 70-year-old at single dose for COVID-19 immunisation. Medical history included high blood pressure, diabetes. She had known allergies: Penicillin. The patient had a history of atrial Fib (Atrial fibrillation) but had been in sinus rhythm for a long time. No COVID prior vaccination. Concomitant medication included dabigatran etexilate mesilate (PRADAXA). On 30Jan2021 09:00 AM, after first dose of BNT162B2, she went to the emergency room (ER) with shortness of breath and in A fib (Atrial fibrillation), she also had water in her lungs. The events were resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient stayed for 5 days in hospital. She received unspecified medications as treatment. COVID tested post vaccination (Nasal Swab) on 22Feb2021 resulted negative. The outcome of events was recovering.  Information about lot/batch number has been requested.
no reactions or events.  I'm filing this because the patient was under 18 when booster was administered
45min p/vax pt became unresponsive @ home;returned to hlth dept stated eyes rolled back & body limped;VS taken except temp;02 started taken to ER;
i got the shot on Friday,03/26/ at 01:30 in the afternoon. i felt ok and went to bed about 11: that night. when i woke up the next morning i saw black dots and then black zigzag lines floating around. then black webs and specks about the size of a large ant moving around. i took Tylenol and it helped for a while. the same thing happened the next day and went a way that night.i Kept taking Tylenol every six or eight hours and it seems to help a little..
BODY ACHES, FEVER,ARM PAIN, HEADACHE,FATIGUE Narrative:
Parents both present for immunizations for child on 2/20/07. Spanish speaking only, with young girl along to translate. She states Pablo received his second flu shot on 12/12/06 and was admitted the next day to the hospital with a very high fever. He has had no previous reactions with any of his other immunizations, including the 1st flu shot on 11/14/06. 03/01/07-records received from facility for DOS ER visit 12/12/06 day of vaccine, Temp 102.3. ER visit  12/13/06 Febrile seizure, bilateral otitis media. ER visit 12/14/06 DX febrile illness bilateral otitis media.
Approx 2 weeks after receiving vaccines, pt woke up with severe headache and blurred vision and constant headache since then worse in left eye. Also began with fine pinpoint rash on upper chest, right shoulder and left lower arm just above wrist. Pt has been seen by an opthalmologist and also specialist. Pt had CAT scan recently and is scheduled for a MRI next week. Rash previously mentioned has almost faded. Advised pt to get permission from doctor re receiving next 2 doses of vaccine (Hep B #2 and MMR #2).
Had some swelling at injection at initial shot, but generalized urticaria after booster. Generalized hives. No arthralgia. No abd pain.
Heart racing (4 hours on and off evening of), eyes bugging feeling, fever. All resolved 24 hours.
Information has been received from a physician concerning a 24 year old female with a history of depression who, on an unspecified date, was vaccinated with a 0.5 mL, second dose of Gardasil (Lot# 658219/0755U).  The physician reported that the patient experienced intense burning sensation, slight redness and pain at the injection site.  She started crying during injection.  The patient complained that the first dose hurt a little but was tolerable.  The physician also reported that the patient recovered 3-5 minutes after onset.  Additional information has been requested.
PC vaccine -large area of bruising and swelling at area of vaccine. Dry eczema patch under eye, persisting low grade fever (99-102).
Headache, Myalgia, Arthralgia, pain at injection site Narrative:
Took shot early that morning and by 9:30-9:45pm the same day, very tired , exhausted. Went to bed and fell asleep . Woke up in 1/2hr with:  Fever , chills , hot /cold, body aches , head aches
left forearm started itching with rash/followed by my right arm itching with rash/escalated starting to spread to both sides of my front torso; left forearm started itching with rash/followed by my right arm itching with rash/escalated starting to spread to both sides of my front torso; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 06Oct2021 11:45 (Lot number: 30155BA) at the age of 80 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE. Past drug history included: Poly-ethylene glycol, reaction(s): "Known allergies: Poly-ethylene glycol". Vaccination history included: BNT162B2 (lot number: ER8731,, vaccine location: Right arm,, dose number: 2), administration date: 27Apr2021, when the patient was 79 years old, for COVID-19 immunisation; BNT162B2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right), administration date: 05Feb2021, when the patient was 79 years old, for COVID-19 immunisation, reaction(s): "Shingles on the right upper side". The following information was reported: IMMUNISATION (non-serious) with onset 06Oct2021 11:45, outcome "unknown", described as "booster"; PRURITUS (non-serious), RASH (non-serious) all with onset 06Oct2021 17:00, outcome "not recovered" and all described as "left forearm started itching with rash/followed by my right arm itching with rash/escalated starting to spread to both sides of my front torso". The event "left forearm started itching with rash/followed by my right arm itching with rash/escalated starting to spread to both sides of my front torso" and "left forearm started itching with rash/followed by my right arm itching with rash/escalated starting to spread to both sides of my front torso" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pruritus, rash.  Additional information: This report was received via COVAES. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested with COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient's concomitant medication LEVOTHYROXINE was taken for an unspecified, start and stop dates were not reported. The vaccine was administered in Public Health Clinic/and local facility. The course of the event was as follows: within 6 hours following the booster patient's left forearm started itching with rash, followed by her right arm itching with rash. Symptoms escalated starting to spread to both sides of her front torso. Patient saw a physician on Monday, 11Oct2021. The events were reported as not serious. The patient received steroids as treatment for the events.    No follow-up attempts are possible. No further information is expected.
Occlusive deep vein thrombosis in lower left leg. Pain began 12 hours after vaccination. Thrombosis confirmed via imaging. Prescribed 5mg Eliquis 2X/day. Visited Emergency dept 1/11/22 for treatment.
sore 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 62-year-old male patient received BNT162b2 (BNT162B2), on 09Jul2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single), administration date: 11Jun2021, for COVID-19 Immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".   Additional information: Caller states when he received his 4 vaccines "the only thing I ended up with was a sore arm.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
she started to feel weird things; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation. The following information was reported: FEELING ABNORMAL (non-serious) with onset 11Mar2021, outcome "unknown", described as "she started to feel weird things".  Additional information: There is no unaddressed medical questions referred or forwarded to Medical Information.  No follow-up attempts are possible. No further information is expected.
3/27/2022- Presents to ED, c/o allergic reaction and tremors. Pt states she has been having tremors, body stiffness, insomnia, suicidal ideas and decreased appetite since 3/25. VSS. Was released from Medical Center on 3/25 after a psychiatric admission from 3/8-3/25/2022 HX of previous ECT treatment. Had two previous suicide attempts and was admitted to Hospital for a drug overdose on 1/9/2022 and at Medical Center for acetaminophen overdose on 1/25/2022.  Admit psychiatric admission for safety, stabilization and medication management. 3/31/2022- Covid + test. T: 100.6 other VS stable. Pt denies suicidal ideation. 4/7/2022- Pt remains in good behavioral control. VSS. 4/8/2022- Initial ECT treatment today. Tolerated well. 4/11/2022- ECT treatment performed and tolerated well.  4/12/2022- Pt stable and improving with anxiety and depressive feelings. VSS and Covid asymptomatic. 4/15/2022- ECT treatment performed and tolerated well.  Discharged to home. Improved.
While exercising, suddenly collapsed and found without pulse. CPR initiated. Resuscitation attempts unsuccessful. "Long history of hypercholesterolemia and hypertension for which taking medication." Had prior episodes of chest pain related to exercise. Autopsy revealed severe 3-vessel coronary occlusion, remote healed myocardial infarct, left ventricular hypertrophy. No myocarditis noted. "Died of arteriosclerotic coronary vascular disease." Will fax autopsy report.
a bad skin reaction after that like Stevens-Johnson syndrome (SJS) only less severe; a bad skin reaction after that like Stevens-Johnson syndrome (SJS) only less severe; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 18Dec2019 (Batch/Lot number was not reported) as a single dose for immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced: a bad skin reaction after that like Stevens-Johnson Syndrome (SJS) only less severe (medically significant). On 18Dec2019, the patient received the pneumococcal 13-val conj vac (dipht crm197 protein) vaccine. The patient had a bad skin reaction after that, which was like Stevens-Johnson syndrome (SJS) only less severe. The patient still had some skin problems left. "The second exposure to a similar medication would cause a more severe reaction" (as reported). The patient stated, "I wonder if I should worry about receiving the second dose of the Pfizer vaccine. The first vaccination by Pfizer vaccine went uneventful. The composition of Prevnar13 is well known, the composition of Pfizer vaccine is known only to you and your scientists. Can they compare the vaccines and let me know if I am at a higher risk? " The clinical outcome of the events was not recovered.  The batch/lot numbers for the vaccine, pneumococcal 13-val conj vac (dipht crm197 protein), were not provided and will be requested during follow up.
patient had significant bruising in her arm (5+ inches) in size even 1 week after the vaccine. She is still having pain a week later as well.
I began to have am intense headache, and a strange acute pain in my gut. It hurt a lot, I became extremely achy and feverish. I had a fever of about 103°. There wasn't much pain in my arm, only a little. Everything felt so so achy. By the next day at noon my symptoms were gone.
I got the vaccine roughly at 6:10pm on 3/15. I was fine when I went to bed around 10pm. I woke up around 1am on 3/16 with fever/chills/body ache/headaches. Fever was around 103 degrees F at it's peak and stayed at or above 100 degrees from about 1am until about 5 or 6pm on 3/15. I took tylonel during this time. I also experienced diarrhea and loss of appetite during the day; random periods of feeling nauseous. I seemed to be dehydrated but drank a normal amount of water the day before. It felt like I had the flu, but I don't think I've felt this sick since I was a kid. It was terrible. I felt incredibly tired on Tuesday but couldn't fall asleep. 3/17--woke up today feeling mostly fine minus a bit of lingering soreness and feeling very tired still.
Itching, rash, swelling, received H1N1 shot 10/23 with FLUZONE shot in other arm.
1/27/22 pt admitted from nursing home for SOB; O2 sats in 70s% on RA; given O2 supplementation; positive COVID test; first positive COVID test on 1/3/22; CXR showed bilateral infiltrates; CTA chest showed bilateral PE; pt had respiratory distress and became pulseless, ACLS performed with ROSC achieved; intubated; transferred to ICU, experienced 2 other cardiac arrests; after the 3rd cardiac arrest and multiple rounds of CPR done, ROSC was not achieved; family decided to make pt a DNR and he passed away in the hospital; DC and medical records sent per VAERS request
4 menstrual cycles within 3 months after only having 3-4 a year because of my IUD
he had side effect like arm pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). This consumer reported for a male patient (husband). A male patient received bnt162b2 (BNT162B2), administration date 12Nov2021 (Lot number: FG3527) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "he had side effect like arm pain".  Additional information (Narrative case summary and further information): Batch/lot number, number, number and Expiry Date of COVID-19 Vaccine were Unknown. Reporter stated, "Oh, I am calling this in behalf of my husband. Yes, he have a vaccine the first one, he have a vaccine on 12Nov2021, he had side effect like arm pain, you have somebody speak to me." Reporter was informed about the role of the Pfizer drug safety. Reporter stated, "I actually, I don't want to say what you say I do but he had a vaccine on my husband you want my husband name first." Patient initials: Reporter stated, "the last name, First name. "(not alphabetically spelled hence patient initial captured as Unknown). Name: Reporter stated, "My name (not alphabetically spelled hence not captured in tab), I have got the vaccine the third one the number Pfizer but I am okay, my husband not okay." LOT# of Pfizer covid-19 vaccine: Reporter stated, "The LOT number the Pfizer number you mean, Pfizer FG3527."(not appropriately clarified). Permission to probe further questions: Reporter stated, "You speak so fast. I cannot understand, can you get someone else speak with me please, I will call back." Further probing could not be done as Reporter hung up the call abruptly. Hence,limited information was available over the call.  No follow-up attempts are possible. No further information was expected.
OUT OF SPECIFICATION PRODUCT USE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2022) dose was not reported, administered on 21-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2021, the patient experienced incorrect product storage. On 21-OCT-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine  was not applicable. The outcome of the out of specification product use and incorrect product storage was not reported. This report was non-serious.
Face/neck/chest were red. I I felt warm. Took my temperature, twice, and it wasn't even 98.6. I have had, in the past, very fine rashes, that, before, were usually contact dermatitis.   It eventually resolved on it's own.
fever >100 x 2 days w/full body rash-raised, red +itching;
Pain in her neck; Pain in her back; Having Hard time to move; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in her neck), BACK PAIN (Pain in her back) and MOBILITY DECREASED (Having Hard time to move) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced NECK PAIN (Pain in her neck), BACK PAIN (Pain in her back) and MOBILITY DECREASED (Having Hard time to move). At the time of the report, NECK PAIN (Pain in her neck), BACK PAIN (Pain in her back) and MOBILITY DECREASED (Having Hard time to move) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included inhaler. Treatment information provided included no medication. The patient has been to chiropractor
Patient complained of dizziness and fainted about 2 hours after vaccine was administered.  Patient was taken to ER.  Blood work showed low potassium.  Patient was prescribed potassium supplement.