chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Menactra R deltoid and Boostrix L deltoid. R eye later became swollen. The eye is only uncomfortable if she touches the lower lid where it is swollen.
injection site has been discolored since receiving vaccine,  Narrative: Injection site discoloration since receiving vaccine.
I developed chest pain and shortness of breath which started 3 hours after getting the vaccine.  I almost passed out walking back to my car. The symptoms persisted, so I went to urgent care 24 hours later and was diagnosed with bilateral pulmonary embolism.  I received oxygen via nasal cannula, oral aspirin, and am now on Lovenox.  I will be transitioned to oral medication (Pradaxa) in 5 days.  I was discharged from an overnight stay after less than 24 hours.  My chest pain and shortness of breath are slowly improving.  I have a follow up appointment next week.
Sore all over the body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore all over the body) 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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced MYALGIA (Sore all over the body). At the time of the report, MYALGIA (Sore all over the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.   Reporter did not allow further contact
Racing heart; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EL3249), via an unspecified route of administration in the left arm on 21Jan2021 at 11:00 (at the age of 72-years-old) as a single dose for COVID-19 immunization.  Medical history included hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications included atenolol, bio-identical hormones and deplane (information presented as reported). The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  On 22Jan2021 at 15:45, the patient experienced racing heart. The patient reported that when walking she had to sit down to get heart back in rhythm, the patient was still experiencing the event, even when not walking. The patient stated it was a bit un-nerving and that the patient is a strong walker. The patient did not receive any treatment for the event. The clinical outcome of the racing heart was recovered with sequalae (reported as "Recovered with lasting effects") on an unknown date.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
at time of injection, burning (painful) feeling of arm.  No redness or warmth to touch.  Nurses on duty reassured that it may be a nicked nerve ending.  Burning sensation stopped  ~40 minutes after shot. Next 7 days: tiredness, joint pain. Day 7 from shot: soreness around injection site.  Muscle of injection site (left bicep) is warmer to the touch and noticeably inflamed.  There is redness around the injection site that was not there before.  When arm is lifted laterally, the muscle feels tense, as if cramping slightly.
pt recv vax in OCT94 & allegedly devel shingles some time later;this report was recv as part of legal proceedings involving the MD;
Treatment of COVID-19; Treatment of COVID-19; Dose 4:Moderna; Dose 1, 2 and 3: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: ER8729), in left arm, on 11May2021 as dose 2, single (Lot number: EW0176), in left arm and on 10Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 37 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 26Oct2022 as dose 4 (booster), single (Lot number: 061F22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Bactrim/sulfas" (unspecified if ongoing), notes: Known allergies: Bactrim/sulfas. The patient took concomitant medications (Multivitamins). Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim", notes: Known allergies: Bactrim/sulfas. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Oct2022, outcome "unknown", described as "Dose 4:Moderna; Dose 1, 2 and 3: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jun2023) Negative, notes: Positive test day 12 after previously testing negative in days 8 and 10; (18Jun2023) Negative, notes: Positive test day 12 after previously testing negative in days 8 and 10; (20Jun2023) Positive, notes: Positive test day 12 after previously testing negative in days 8 and 10. Therapeutic measures were taken as a result of drug ineffective, covid-19.
DEVELOPE TRANSINT TOPICAL REDNESS OF FACE FEW MINUTES AFTER RECEIVING ABOVE VACCINE. SHE WAS DISTRESSED AND SHOCKED NOT TALKING. PARENT REPORTED SHE SEEMED CONGESTED, SPIT UP CLEAR MUCUS BUT NOT ITCHY AND HAD NO RASH WITHIN FEW MINUTES SEEMED TIRED, NOT RESPONDING BUT VITALS STABLE, EMS CALLED LUNGS WERE COARSE O2 AND ALBUTEROL SVN GIVEN AND WAS TAKEN TO ER BY EMS
Tingling then swelling of the tongue, swelling of the throat, jaw clenching, difficulty breathing.   Took 75mg Benadryl, and 40 mg of famotidine   As of today, my tongue still feels swollen and my throat feels tight
Information has been received on 16-APR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 21-MAR-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles. In 2016, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of injection site muscle pain in a 69-year-old male patient who received SHINGRIX (batch number CH2X7, expiry date unknown). Concomitant products included Calcium, LIPITOR, Metformin, ZETIA, Aspirin, ALDACTAZIDE, ALIGN, COZAAR, PRILOSEC and TOPROL. On 8th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, several hours after receiving SHINGRIX, the patient experienced injection site muscle pain, injected limb mobility decreased and swelling. On an unknown date, the outcome of the injection site muscle pain, injected limb mobility decreased and swelling were recovered/resolved. The reporter considered the injection site muscle pain, injected limb mobility decreased and swelling to be probably related to SHINGRIX. Additional details were provided as follows: This case was reported by the nurse practitioner. The patient's concomitant medication included Multivitamin. The patient received the vaccine at a pharmacy. The patient experienced exaggerated muscle pain in the area of the SHINGRIX injection with the inability to move their arm. In May 2018, injection site muscle pain, injected limb mobility decreased and swelling were resolved.
within minutes of vaccine feeling of vertigo started.  Later in the day was normal pain in arm, headache, fatigue, but also pain in left side of neck. Day 5 started tinnitus, pain in left side of back, leg and buttock. Pain, tingling, and numbness in arms, hands, feet. Burning feeling in back. Day  7 feeling of tilting to the left and continuation of all of above. Continued fatigue. Called physician  I called my doctor who prescribed a 5 day course of Prednisone 10mg. which did help relieve the symptoms but not eliminate. He also ordered an MRI which indicated swelling or aneurysms not seen in previous studies. An MRA was ordered later and consistent with lessening symptoms was normal. As of today I am having occasional headaches with brain fog, and continued tinnitus but other symptoms have gone.
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster) , single (Batch/Lot number: unknown) at the age of 56 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "graves disease" (unspecified if ongoing); "arrythmia" (unspecified if ongoing); "allergic to apple and peach skins" (unspecified if ongoing). There were no concomitant medications. Patient had no other medications in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 01May2022, outcome "not recovered", described as "tested positive for COVID"; COVID-19 (medically significant) with onset 01May2022, outcome "not recovered", described as "tested positive for COVID ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Negative; (01May2022) Positive; (15May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient started to feel sick on 28Apr2022 and tested negative for COVID on 29Apr2022. On 01May2022, she tested positive for COVID and took Paxlovid for 5 full days. She began Paxlovid on the evening of 01May2022 and finished the treatment on the morning of 06May2022. She started to feel better about one or two days after finishing the treatment. Then, about a week later (on Friday, 13May2022), she started to feel sick again with very similar symptoms (sore throat, congestion, mucous, sneezing, etc.). She took a COVID test this morning on 15May2022 (it was now 2.5 weeks from the initial onset of her COVID symptoms) and it was positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Since the vaccine, I've been waking up at 2-3 AM every night for the past week, with creepy crawly symptoms. Feels like RLS and unless I take something I cannot go back to sleep, now it seems the feeling is starting to persist during the day time. Nothing else has changed in diet or medication since the vaccine so thinking this could be vaccine related.
No Adverse event; Extra dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Extra dose administered).    No concomitant medications were reported.  Pharmacist called to report that the patient received a 2nd Bivalent booster on 16-Dec-2022, 2 months after the first Bivalent booster. All vials thawed on 16-Dec-2022.   No treatment drugs were reported.  This case contains the information of 8th out of 13 elderly patient who received the vaccine as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-688372 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-688372:
Per clinical pharmacist internal report:   Adverse Drug Reaction Vaccine: COVID vaccine (unclear if 1st or 2nd and which manufacturer) Reaction: Unclear if associated with vaccine but wanted to report in case it is  Patient presented to hospital via EMS with a CC of dizziness and nausea. She was found to have increase O2 demands (4L O2, 3L O2 at home) but was ready for discharge when she developed aphasia, bilateral grip weakness, and staring into space. Oxygen was increased to 10L and a Code Stroke was called. Subsequent workup was negative for a stroke (MRI, CT). The following day, another episode occurred and MRI did show an acute left frontal stroke determined to be embolic in nature per neurology in a patient with a below goal INR and atrial fibrillation.  The patient has a past medical history of atrial fibrillation (CHADS VASC 5 prior to CVA this admission) and is on warfarin at home. INR at admission was 1.79 (previously stable with home regimen per hospital ACC notes, no missed doses were noted PTA). Due to NPO status, the patient was soon placed on full-dose enoxaparin at 0346 on 3/11 when admitted. This was continued and no doses were missed prior to CVA being diagnosed. The patient's husband states that she was in normal health until her COVID vaccine the morning of admission.  Unclear if COVID vaccine could have decreased INR or put patient at a higher clot risk. Of note she was found to have Ulceration and infection of left 2nd toe however systemically she was not exhibiting signs of infection.  Pfizer COVID-19 Vaccine - lot number: EN6199  Given at hospital on 03/10/2021
Patient developed and inject site rxn of redness, swelling & pain, and unable to lift arm. This is 1 of 2 patients from this facility to develop an injection site rxn following vax.
01/06/22 presents to ED for "Shortness of Breath". PMHx of "SLE, Pulmonary Hypertension, HTN and diabetes"
bumps feel hot an itchy like a mosquito bite; he noticed bumps in his legs; itchy like a mosquito bite; This is a spontaneous report from a contactable consumer. This is the 2nd case out of 2 cases. A 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3180, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 20Aug2021 (age at vaccination 46 years) as dose 1, single for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. On 21Aug2021 the patient experienced bumps feel hot an itchy like a mosquito bite, he noticed bumps in his legs, itchy like a mosquito bite. Reporter stated, noticed 6 bumps on his legs, wrist and it started itching more, bumps feel hot and itchy like a mosquito bite. Reporters husband (consumer) received his Pfizer Covid-19 vaccine first shot yesterday around the same time and his side effects were between 12:30 to 2:00 am last night, he noticed bumps in his legs when he went to the restaurant it started itching and when he went to bed, he started itching more and noticed 6 bumps on his legs and wrist, bumps feel hot an itchy like a mosquito bite. She gave answer to his questions. The patient did not receive any treatment for reported events. The outcome of event was not recovered.
Got an ear infection last week; This is a spontaneous report from a Pfizer sponsored program, . A contactable consumer (patient) reported a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#: unknown), via an unspecified route of administration and date at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported.  The patient received the first shot already on an unknown date. She got an ear infection last week (in 2021) and was inquiring if she can get a second shot while taking antibiotics for ear infection. Outcome of the event was not recovered.   Information on the LOT/Batch number has been requested
Fever/chills (6 hours) treated with Acetaminophen Body aches-especially low back (48 hours) Acetaminophen Headache (6 hours) treated with Acetaminophen Severe injection site pain (48 hours) treated with Acetaminophen  All symptoms resolved within 48 hours
Patient started to experience pain and soreness the evening of the vaccine date, 07/13/22. It progressed to soreness that injection site, pain on right shoulder around to the left upper back. Patient also experience joint stiffness, pain and discomfort that caused her not able to sleep.  She reported to have seen her doctor on 07/25/22 and prescribed Medrol dose pack and tramadol for pain and discomfort.
Mother called and reported child has 3x4 cm welts on left leg around injection sites. States child c/o pain at site. Mother states no fever, swelling or respiratory distress.
the left armpit was swollen- up to 5 cm swollen area, just the entire area is ballotable
Chills and overall ache for the whole day after 2nd vaccination.  The following day all was pretty normal.  Took Tyle ol a d Advil during g that day.
arm soreness/stiffness; fatigue/malaise Narrative:  Other Relevant History:
Little dizzy that day.  Next morning very dizzy & off balance.  Lost balance & fell into freezer door which badly bruised my right arm .I continued having trouble with dizziness & off balance.  On 4/27 when coming out of the store I got dizzy & lost balance while pushing my cart to car.  Lost my balance & fell onto concrete sidewalk.  I landed on my right side.  My hand up to my shoulder was sore & bruised.  On 4/29 I went to emergency room with swellling & pain.  Ive had 7 lympe nodes removed from that arm from previous breast cancer so trama of falling on that arm caused lymphodema.  It took until 4/30 before dizziness & off balance went away.
Had sinus congestion and bad sore throat. Tested positive for COVID-19. Treated with Paxlovid. Felt better after the Paxlovid but 3 days later got all congested again. Called personal doctor and was put on a Z-pack which got rid of the congestion. Never had fever during whole event.
Unconsoleable crying, blue skin under tongue, vomiting, lack of appetite, diarrhea, sleeping for extended periods of time (11 hours without eating and asleep without movement), difficult to wake during sleep, fever 99.8, pale skin and swollen eyes.
This spontaneous report as received from a registered nurse refers to a patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of (Oka/Merck) VARIVAX (doses and routes were not reported) lot # J008982, expiration date 19-JUL-2015, and lot # reported as K010442, expiration date 22-JUL-2016, that were exposed to temperatures outside of the recommended range. The registered nurse was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Arm was very sore and red warm and swollen.  Client called and had taken Tylenol and a Benadryl.  Had place cold pack and warm pack on her arm and it was still sore and swollen.  She came down for this nurse to evaluate it.  It is measuring 4 X 5 cm and is warm red and swollen, tender to touch. She had also received a Tdap 10/13/2008 and had soreness with a bump under it for a good long time after the shot was given.  It also was red warm and swollen after the shot for several days.  I spoke with her today (10/22/10) and she is still with red warm and swollen, sore arm and is taking Tylenol and Benadryl.  She is concerned about if she may have an allergy to some component of the vaccines?  And if she should take vaccines.  I told her that she would have to weigh the risks and benefits but that I would also be sending in a VAERS report on this reaction.
Patient fainted for a few seconds two times, gave water, juice, layed down for 30 min, vitals checked every 5 minutes.
A 17-year-old female patient, had received an intramuscular dose of FLUZONE (lot number: UH760AC, dose number was not reported) in left deltoid on 15 January 2013. The patient had no history of medical conditions, or concomitant medications and no illness at the time of vaccination. The patient's allergies were none known. it was reported that patient was not pregnant at the time of vaccination and was administered FLUZONE at post-partum visit. On 15 January 2013, 15 minutes after vaccination, the patient experienced severe chills, fever, and sores in mouth. Corrective treatment and laboratory details were not reported. On 25 January 2013, 15 minutes after vaccination, the patient experienced severe chills, fever, and sores in mouth. Corrective treatment and laboratory details were not reported. On 25 January 2013, the patient had recovered from events. Follow-up information received from a healthcare professional on 18 April 2013: The patient's concomitant medications included prenatal vitamins. The patient had received first dose of FLUZONE on 15 January 2013 at 09:00 AM. Documents held by sender: none