chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I've had frozen shoulder and nerve tingling that has continued. Also, my first period after the vaccine went on for 9 days. The second period was 6 days-regular for me- however, there was a huge clot the span of 5 quarters that was about 3/4 an inch thick.
Hives, Itching, Accelerated Heart Rate, Rash on arms, and feeling faint.
Light headedness, 15 to 30 minutes post vaccination, EMS called and took her to the ED.  Time spent in ED: 2.5 hours.
Patient went pale, blacked out for ~20 seconds, but did not fall. He said he felt terrible and threw up.  EMS was called; however, patient recovered and decided to not go to the hospital. Then the proceeded to go home.
pharmacist used the diluent from a Shingrix vaccine to reconstitute an MMR vaccine (Merck product) and administered to a patient; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 5XP9M, expiry date 15th October 2022) for prophylaxis.   On 27th May 2021, the patient received Shingrix. On 27th May 2021, unknown after receiving Shingrix, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were provided as follows: The reporter was pharmacist manager. The pharmacist used the diluent from a Shingrix vaccine to reconstitute an MMR vaccine (Merck product) and administered to the patient, which led to wrong vaccine administered. The reporter consented to follow up.
pt recv vax 21MAY97 & pt seen w/ local severe swelling, erythema @ inj site measuring 8x4" w/o necrosis;pain radiating to neck/back;seen by MD 23MAY97;
Immediate numbness to left face and arm, lasting 4 days. Nerves all over body have been firing & crawling and are still uncontrollable today- 9/23/21. Systemic inflammation- onset of dry cough, shortness of breath w/activity, chest pain about 5 days after vaccination. at 1 month after vaccination, due to unresolved respiratory distress, MD ordered angiogram because my D-Dimer was elevated to about 800. Angio neg for blood clot. tested for Covid-19 on 9/20/21 resulted negative. had to be prescribed albuterol inhaler for ongoing respiratory distress, still present today- 9/23/21. Hx of allergic reactions to Flu vaccine was ignored by government state mandate and i was forced to still take covid vaccine against my will or be fired from my RN, BSN job. I have very sensitive Hashimoto's disease and was still denied a waiver. This Covid vaccine reaction has caused severe respiratory distress and has forced me to miss 5 days of work.
This case was reported by a physician via sales rep and described the occurrence of herpes zoster in a 75-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received in November 2007). On 30th May 2018, the patient received the 1st dose of SHINGRIX. On 6th June 2018, 7 days after receiving SHINGRIX, the patient experienced herpes zoster. On an unknown date, the outcome of the herpes zoster was unknown. It was unknown if the reporter considered the herpes zoster to be related to SHINGRIX. Additional details were reported as follows: Seven days later was seen by the physician and was diagnosed with a confirmed case of zoster. The patient was not immunosuppressed. The physician granted permission for GlaxoSmithKline to follow up. No further details known by representative.
Information has been received from a physician concerning a 2-month-old male who in January 2007, was vaccinated PO with the first 2.0 ml dose of Rotateq. Concomitant vaccinations administered on the same day included a dose of Pediarix. The physician reported that on 08 Jan-2007, the patient developed a rash. Unspecified medical attention was sought, but no laboratory/diagnostic tests were performed. At the time of this report, the patient's rash persisted. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 2/13/2007.  Information has been received from a physician concerning a 8-week-old Hispanic male with no medical history who on 08-JAN-2007, at 10:00, (previously reported as January 2007), was vaccinated PO with the first 2.0 mL dose of ROTATEQ (Lot #654970/0777F).  Concomitant vaccinations administered on that same day and time included the first IM dose in the right leg of PEDIARIX (Lot #AC21B079AA), the first IM dose in the left leg of ACTHIB and the first IM dose in the left leg of PREVNAR (Lot #B08675C).  There was no illness at the time of vaccination.  The physician reported that on 09-JAN-2007, at 11:00, (previously reported as 08-JAN-2007), the patient developed an erythematous papular rash all over his body.  The patient was seen by the physician, but no laboratory/diagnostic tests were performed.  On 19-JAN-2007, the patient's rash resolved.  Additional information is not expected.
Pharmacist administered vaccine to patient , readjusted seating and needle then grazed the inside of thumb. Both source individual and pharmacist went for blood testing. Will hear back in 1-5 business days.
No adverse effects were reported.; The nurse reported the patient was administered an improperly stored dose of V ARIV AX (S002874 1/29/2021) on 10/7/2019; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 07-OCT-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # S002874 and expiry date 29-JAN-2021; route of administration, injection site and exact dose were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot # N030413 and expiry date 05-JUL-2020). The vaccine was exposed to the temperature of 7.64 degrees Fahrenheit (F) for 20 minutes. There was previous temperature excursion, when the vaccine was exposed to 19.34 F for 34 minutes. The digital data logger was involved. No adverse effects were reported.
Patient took Dose 1 (19-MAY-2021 ,and Dose 2- 16-NOV-2021); This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Dose 1 (19-MAY-2021 ,and Dose 2- 16-NOV-2021)) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A and 023C219) for COVID-19 prophylaxis.     It was unknown if the patient had ever been diagnosed with or tested positive for COVID-19.  It was unknown if the patient had acute illness at the time of vaccination and up to one month before. It was unknown if the patient had any chronic or long standing health conditions.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Dose 1 (19-MAY-2021 ,and Dose 2- 16-NOV-2021)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Dose 1 (19-MAY-2021 ,and Dose 2- 16-NOV-2021)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies had been taken by the patient at the time of vaccination and/or at the time of the adverse event.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-581743 (Patient Link).
Caller states she had left arm pain with her first Covid vaccine, but not as bad as now; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Caller states she had left arm pain with her first Covid vaccine, but not as bad as now". Additional Information: Caller did not have product information on her vaccine card. Patient took Covid 19 vaccine, adult because mandated for employment. Other products were not provided. No investigation assessment. Healthcare provider info was as provided by Caller. Additional vaccines were not administered on same date of the Pfizer suspect. There was no requirement of emergency room visit and physician office for AE's. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Family medical history relevant to ae(s) was not provided. No relevant tests.   Follow-up activities closed, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101823595 Same patient and drug, different event separated in time
Before leaving the clinic, the pt fainted and collapsed, falling backwards onto the floor. The pt was lying on the floor with symptoms of a seizure. Trembling and twitching were occurring of the hands and neck. The pt's face was rigid and both eyes were open. The duration of this episode was approximately 1 minute. Subsequently, the pt became  combative (kept trying to get up), belligerent, and displayed disorientation as she did not recall getting vaccinations or where she was. Blood pressure was 130/80, pulse 100 and regular, pupils equal, and skin was warm and dry. Pt had a complaint of a headache. The pt was detained for approximately 15 minutes until symptoms improved. The pt left will all symptoms gone except the belligerent attitude. The parent was compliant with referral to the hospital emergency room so the pt may be examined by a physician. Following the exam the pt was sent home.  The pt was doing well until about 10:00 PM when she started vomiting and had a complaint of a headache. She was taken back to the ER assessed and transported to a hospital in another city. It was reported she had surgery to relieve inter-cranial pressure. On 1/25/00, the pts father reported she was doing "OK" since the surgery.
11:30 AM WOKE WITH BOTH EYES SWOLLEN NEARLY SHUT, RASH ON CHEST SHOWED UP ON 1/2/2022, SPREAD THROUGHOUT ENTIRE BODY OVER THE NEXT TWO DAYS, AWOKE DURING THE EVENINGS WITH SEVERE ITCHING ON BODY/EARS. IN AUGUST 2021, I CONTRACTED COVID AND WAS GIVEN A DOSE OF REGEN-COV AND WITHIN 2 MINS HAD A SEVERE REACTION (HEART RATE AND BLOOD PRESSURE DROPPED AND CHEST COMPRESSIONS WERE GIVEN).  THE DOSAGE WAS STOPPED. IT WAS LISTED AS AN ADVERSE REACTION TO THE ANTIBODY TREATMENT
Initial case was received on 23 September 2010 from a healthcare professional. A 69 year old female patient received on 20 September 2010 a right deltoid intramuscular injection of FLUZONE HIGH-DOSE (lot number U3617AA). A few hours after the vaccination the patient experienced a "headache, dry heaves, pain in jaw and slight fever." The patient had no illness at the time of the vaccination. Her pre-existing medical conditions included asthma. She had no known allergies. Her concomitant medications included "PULMACORT" and other unspecified medications. She had received "FLUZONE" on an unspecified date "in the past"." The patient's recovery status was unknown. Follow-up information was received from a health care professional on 18 October 2010. The patient had no reported adverse events following prior vaccinations. The patient was reported to be "50%" better in 12 hours and recovered in 48 hours. This case is linked to 2010-05340 by the reporter. Documents held by sender: None.
Large indurated redness 1" at injection site on 6/17. 5x5 cm redness on 6/19/14. Lower back pain x2 days 6/20. Rash-hives with pruritus 6/23/14. No pain in area. Delayed and prolong reaction (used BENADRYL 1x once).
Chest tightness w/ mild difficulty breathing, erythema, swelling > 24 hours after immunization.
Redness & swelling size - began 50 cent size - painful, itching enlarged - redness area warm to touch about 2 days - decreased grade fever aching - hard lump size of 50 cent
I took Johnson and Johnson shot after I  was informed by medical it was not needed. Because I was considered I was fully vaccinated after taking one Moderna and one Pfizer
Scabs forming at the injection site; Covid 19; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE SCAB (Scabs forming at the injection site) and COVID-19 (Covid 19) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020. Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Influenza vaccine. Concurrent medical conditions included Penicillin allergy, Seasonal allergy and Drug allergy (Decongestants).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced COVID-19 (Covid 19). In March 2022, the patient experienced INJECTION SITE SCAB (Scabs forming at the injection site). At the time of the report, INJECTION SITE SCAB (Scabs forming at the injection site) and COVID-19 (Covid 19) had not resolved.            No concomitant medication was reported.  Scabs occurred every 5-6 months, where the scabs form and within 7-10 days, heal themselves. Patient said that it's very prominent at the injection sites and that he can see the 3 injection sites when the scabs start to form, as that is where they start to form. The issue has been ongoing since MAR2022 and occurred every 5-6 months. The most recent one started happening in AUG-2023 and was lasting the longest, for about 6 weeks now. It has occurred at 4-5 times since the booster shot. He stated that he has pictures that he can share where the scabs forming at the injection sites.  No treatment information was reported.
Chest pains, nausea, headache and low grade fever. He vomited once and stayed home from school. Also body aches.
BOWEL MOVEMENT PROBLEMS; STYE EYE , INFECTION IN EYE; CLOUDY VISION; SHADOWS, PARTICLES ,LIGHTNING IN VISION/IMPAIRED VISION; TIGHTNESS IN LEGS; COUGH; SCRATCHY THROAT; MUSCLE CRAMPS IN THE LEG; LEG AND ARM SHAKING; URINATING PROBLEMS/URINE WAS REALLY THICK DARK BROWN LIKE BLOOD COMING OUT LIKE MUD; DOUBLE VISION; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart attack, and concurrent conditions included stent in heart, and other pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 05-AUG-2021) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced double vision. On 17-JUN-2021, the subject experienced urinating problems/urine was really thick dark brown like blood coming out like mud. On 18-JUN-2021, the subject experienced muscle cramps in the leg. On 18-JUN-2021, the subject experienced leg and arm shaking. On 18-JUN-2021, the subject experienced scratchy throat. On 18-JUN-2021, the subject experienced tightness in legs. On 18-JUN-2021, the subject experienced cough. On 23-JUN-2021, the subject experienced shadows, particles, lightning in vision/impaired vision. On 04-JUL-2021, the subject experienced stye eye, infection in eye. On 04-JUL-2021, the subject experienced cloudy vision. On 05-JUL-2021, the subject experienced bowel movement problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from urinating problems/urine was really thick dark brown like blood coming out like mud on 20-JUN-2021, and bowel movement problems on 11-JUL-2021, was recovering from scratchy throat, shadows, particles ,lightning in vision/impaired vision, and cough, had not recovered from muscle cramps in the leg, leg and arm shaking, stye eye , infection in eye, cloudy vision, and tightness in legs, and the outcome of double vision was not reported. This report was non-serious.
Pfizer-BioNTECH COVID-19 Vaccine EUA Patient received Pfizer COVID Vaccines on 3/09/2021 and 4/06/2021. Patient presented to ED on 7/17/2021 with 2 week history of increasing shortness of breath and cough with associated chills, weakness and unsteadiness on her feet.Admit diagnosis acute hypoxic respiratory failure due to COVID-19. Upon admission, CTA showed a nonocclusive segmental PE and ground-glass opacities. Patient was treated with IVF, Rocephin, Zithromax, Decadron 6mg (10 days), a heparin drip, and remdesvir (5 days). Patient expired on 7/28/2021.
5/20/04: Temp 97F. Several erythematous macules and vesicles on trunk and legs. No lesions of face. 1 scab. Developed 2 days prior to visit.
Patient newly diagnosed with myasthenia gravis.    Then subsequently had respiratory distress and required intubation, and later required a Tracheostomy and PEG feeding tube.  Patient has been hospitalized for 27 days so far.
Patient had redness and soreness at injection site, which is to be expected but patient reported today (8 days later) that the redness flares up after showering, the exposure to warm water causes the redness to come back also had red marks that look like "capillaries are broken under the skin ".
Fainted; Bad stomach pain; Feeling Light headed; Chills; Nausea; A spontaneous report was received from a Consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea, chills, bad stomach pain/abdominal pain, feeling lightheaded/dizziness and fainted/syncope.  The patient's medical history was not provided. Concomitant products used by the reporter were lansoprazole, simvastatin and famotidine.  The patient received the first dose of two planned doses of mRNA-1273 (batch no: 023M20A) for prophylaxis of COVID-19 infection on an unknown date.  On 16-Mar-2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (batch no: 006B21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Mar 2021, same day of vaccination, the patient experienced nausea, chills, bad stomach pain, felt lightheadedness and fainted (medically significant).  Laboratory details were not provided.  The treatment medication included acetaminophen for the events  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events fainted, nausea, chills, stomach pain, feeling lightheaded were considered as not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Presented with CP, cough, body aches; + covid in ED Labs: D dimer 1.15; CRP 24.48 Ferritin 4553 CXR: Diffuse bil infiltrates consistent with Covid PNA Tx: Rocephin, Remdesivir, Decadron, Merrem, singulair, zinc;  initially 6 LPM NC; back to room air by d/c
Janssen COVID-19 Vaccine EUA Extreme pain in injection site.  Immobilizing muscle pain.  Headache/migraine that has effected eye sight.   Fever.  Chills.  Nausea
Tingling and numbness started in left leg and then in both legs, lasted for 2 hours and then went away.  There was a rash on my left upper leg several days later.   Both hands are very achy, joint pain.  Sleep has been very restless since 8/12/21, tossing and turning all night - heavy legs.
The child was given Tdap and Hep A in left deltoid as he is sitting on the exam bed, after vaccines are given he stood up and walked to his mother as he is leaning against a table he starts to turn pale and begins to lean to the left. The nurse grabs him and lays him on the floor the child is very pale and sweaty he is still able to talk while the nurse has him on the floor. The child is moved to the exam bed where he continues to be pale and profusely sweating.
Instant muscle tightening on scalp.  Same night, pain in between shoulder blades on back.  That pain is still there.  Dizziness still present as well as weakness/fatigue.  All symptoms still present one month later.
Pt recvd vax & devel GBS, an autoimmune problem & a neurological disorder; pt was hospitalized @ end of APR94 w/ a fever of undertermined origin;
no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to an 8-month-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 03-OCT-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541 with expiration date: 11-JUL-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Bruising, pain, redness, and swelling to left arm (injection site). Flushed, aches, and fatigue. Was seen in clinic, per physician assistant to take cefaclor 500mg only if symptoms worsen.
About 10 min later, I got up to use the bathroom and I was stumbling b/c I was so dizzy. I was sent back to work and eventually sent home for sever dizziness. I was also sent home Sunday and then severe chills along with dizziness and severe fatigue. I literally laid in bed for days after the shot b/c I felt like I was about to throw up when I moved. I ended up being diagnosed with Bell's Palsy. The side of my face was drooping. My doctor is saying that I ended up with positive Hep C results, which he thinks if false and due to the Bell's Palsy from the vaccine. I am still having issues. I still have days where the right side of my face will numb and droop. I was told it could take up to 6 months to heal or it could be permanent.
I had a strong reaction to the second dose (fever over 101 after taking Ibuprophen that lasted 2 days).  Then I had abnormal uterine bleeding that prompted me to contact my doctor who ordered a pelvic ultrasound.  The ultrasound showed what looked like possibly a clot or a cyst in the uterus.  I then had a hysteroscope to further examine it and it was no longer there so it has been a clot that subsequently passed. Since then, my periods have returned to a normal timing pattern, but remain heavier than before.
I was to administer an adult dose of Pfizer COVID-19 vaccine for a second dose, and administered a Pediatric Pfizer COVID-19 dose by mistake. Patient stayed for the 15 min wait after getting the vaccine and did not have any type of reaction.