chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I went to a concert, a day and a half later I had a really bad sinus headache. I was bed ridden, I had a slight fever and head cold. I used a home COVID-19 test that came back positive, I went into an Urgent Care the next day. I was given a rapid COVID-19 test that came back positive and prescribed Paxlovid. I started taking it immediately and it took a week and a half before I started feeling normal.
At 1045 pt c/o she is "very hot", upon assessment the pt's skin is cold and diaphoretic. The pt is also not very verbal at this time.  At 1048 the pt's vitals are: HR 50 bpm (per monitor), O2  98%RA (per monitor), and BP was unable to be determined per monitor x3.  At 1053 the pt's vitals are: BP 78/46 (pre monitor), HR 88, Resp 16, & O2 99%RA, per monitor. At 1103, the pt's vitals are: BP 97/65 (per monitor), HR 76, Resp 20, & O2 100%RA per monitor.  At 1108, the  pt's vitals are: BP 91/61 (per monitor), HR 78, Resp 20, & O2 100%RA per monitor.  At 1110 Northstar arrived, pt transported to DCH RMC ED at this time. Pt in stable condition upon departure.
Loss of consciousness (syncope) following Tdap vaccine administration. Pt experienced contractures and tremors increased heart rate, rapid respirations, pallor. Due to history of food allergies, pt given 5 ml Benadryl (wt= around 90 #) fluids po (around 16 oz) and 2L oxygen by facial mask over around 30 minutes. Discharged home oriented x 3, ambulating well.
Arm pain, redness, swelling. Shortness of breath, generalized weakness, myalgia. Tachycardia and kidney pain. All began within hours of vaccines.
Within an hour after returning home from my vaccine my arm began to feel extremely sore and I felt very tired. I also experienced throbbing pain where I assume my kidneys would be in my back and this all lasted for around 3 days.
The day following the vaccine, the above noted patient had a suspected seizure, the first one of her life. Upon investigation at the hospital, there are no signs of any other causation?s of this occurrence. Therefore considering the close proximity of the vaccination, we believe it may be an adverse event that should be reported.
A nurse reported that a 2 month old female received a 1st dose of Prevnar and Infanrix on 01/10/2002. Immediately post immunization, the infant developed hives on her face and turned pale. She was treated with dihenhydramine and observed in the physician's office for one hour. She recovered. No additional info was available at the date of this report. F/U 7/2/02: Information received on 3/19/02, from LPN; included pts name and address, lot numbers of the vaccines and the county of vaccine administration.
This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX. On 20th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site induration. On 20th April 2018, the patient experienced injection site pain and hives. On 21st April 2018, the patient experienced joint pain and influenza-like symptoms. The patient was treated with TYLENOL #3 WITH CODEINE. On 23rd April 2018, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the injection site pain and injection site induration were not recovered/not resolved and the outcome of the hives and joint pain were unknown. It was unknown if the reporter considered the injection site pain, injection site induration, hives, joint pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 65 year or older. According to the reporter she did not think the patient received any other vaccines concomitantly. The patient received 1 dose of SHINGRIX at a pharmacy, this past Friday. She developed what looked like non-elevated hives. She woke up in the middle of the night (Saturday morning) with joint pain. She had flu like symptoms on Saturday. The flu like symptoms had resolved by Monday morning and she went to work. However, her arm was still sore at the injection site. Her skin was still hard around the injection site. The patient took 2 TYLENOL 3 WITH CODEINE for pain over the weekend. The reporter did think the adverse events were due to the vaccine.
Debilitating migraine headaches that last 2-3 days on a weekly basis from February 2021-July 2021. I had to take prescribed Migraine medication to treat my headaches. I don't normally take medication and this vaccine caused me to have a medical problem that required treatment.
Mild reaction right upper arm 2 - PNEUMOVAX  RX: TYLENOL as needed ice to area as needed
Pt came to the office with concern for a red rash to his face - right side - and his right upper arm. Pt was advised of symptomatic measures and advised isolation precautions.
Rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart beat) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Rapid heart beat). At the time of the report, HEART RATE INCREASED (Rapid heart beat) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: rapid heart beat (High) rapid heart beat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
fever of 99.6°F; pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 99.6°F) and VACCINATION SITE PAIN (pain in the injection site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (10 days in the hospital) in April 2020. Previously administered products included for an unreported indication: SHINGRIX (Shingles shot) in January 2021. Concurrent medical conditions included Back pain (fall from horse). Concomitant products included OXYCODONE for Back pain.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PYREXIA (fever of 99.6°F) and VACCINATION SITE PAIN (pain in the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Vaccination site pain, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever of 99.6°F) and VACCINATION SITE PAIN (pain in the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Body temperature: 108 DF (High) fever of 99.6 DF.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
On 06/25/2022 I tested positive for COVID with the home Covid test. I received my last booster on 05/16/2022. Have COVID now. Breakthrough test.
Pt received lst does of Engerix-B on 8-JUN-90 & was hospitalized on 11-JUN-90 w/significant swelling of both hands also experienced itching of hands, rash on arms & hands club like fingers
Arm soreness for two days with headache and swollen lymph nodes day of. One week later gastrointestinal issues with severe nausea, bloating and pain for a whole week. Second week brain fog, vertigo, extreme fatigue swollen lymph nodes breathing difficulty with inflammation in the chest.
Pt vaccinated with Recombivax HB developed multiple sclerosis following vaccination. Additional info being requested.
This spontaneous prospective pregnancy report was received from a registered nurse, for pregnancy registry GARDASIL, refers to a 22 years old female patient. The patient's history of previous pregnancies and live births was not known. It was reported the patient was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL lot # (671994/1628AA) on 18-APR-2012. Concomitant medications included buprenorphine hydrochloride, SUBOXONE, methadone hydrochloride and Alprazolam. The patient might have been pregnant at the time of the vaccination, about 4 weeks gestation (it was also reported that as of 02-AUG-2012 gestation was of 19 weeks). LPM was calculated as on approximately 18-MAR-2012 and EDD as 23-DEC-2012. The patient sought unspecified medical attention. No treatment was given for adverse event. At the time of the report patient's status was not recovered. Nurse also reported that patient experienced elevated blood pressure and shaking with CELEXA. Additional information has been requested.
Moderna COVID-19 Vaccine EUA  Delayed redness around injection site, approximately 3" wide by 4" long. First noticed a week after vaccine was received. Has yet to go away.
Patient stated he experienced hand tremors and unsteadiness for 4 days. Stated he was walking like he was "drunk."
This 35 year old reported receipt of Tdap (ac52b094ba SK), YF (uh287aa SP), FLUMIST (AH2193 Medimmune), and Typhoid Vi (g1541 SP) on 9/10/2012 at 10:00 am. Approximately 1 hour later after eating lunch he began to sneeze and had a runny nose. Lunch consisted of 2 slices of pizza bought day before from a family owned pizzeria which had red sauce, ground beef, oil, green peppers, onions and olives. He also advised eating hard boiled eggs with protein shake for breakfast 4 hours before getting vaccinations with no adverse reaction (eats frequently). Approximately 1 hour after eating but 2 hours since vaccinations, he complained of swelling, itching to face, lips, eyes, ears and itching to bilateral arms, difficulty speaking with tingling to mouth, lips and surrounding facial tissue and oral cavity (especially gums, but no tongue swelling), his throat felt tight and full "as if closing off", had difficulty swallowing water and he could only speak in whispers, he had a dull midsternal chest ache-tightness worse with breathing in/out. He denied any use or contact with new detergents, soaps, deodorants, shaving cream, clothing, etc. He took daily Lisinopril, but his was not a new prescription or new bottle. He returned to medical at 1431 hours (4 hours since vaccinated) with chest tightness, wheezing and throat swelling. He was treated for an anaphylactic reaction with IM BENADRYL, Albuterol neb, and EPIPEN with resolution of symptoms about 30 min later. He was released with MEDROL dose pak x 6 day, CLARITIN and ZANTAC with prn BENADRYL. Patient advised he completed all medications (MEDROL/CLARITIN/ZANTAX but no BENADRYL) without difficulty. he reported it took 2 days before he felt "normal" and remains asymptomatic since completion of medication on 9/16/12. He experienced a similar reaction in 2006 after eating falafel - Middle Eastern dish with chickpea's, parsley, tomatoes, and other ingredients: had hives with redness and swelling to hands/feet with some SOB but not as severe as 9/10/2012 event. He advised he routinely eats/uses oil, vinegar, mayo, mustard, ketchup, parsley, basil, regular peas, pita bread, etc with no adverse reaction. He has not eaten chick peas since 2006. He presented to the clinic on 9/19/2012 with no symptoms.
Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a seven- years old patient (gender was not reported) who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (lot: UJ034AB in the left deltoid) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to vaccine underdose and exposure via skin contact. There was not any cracks in the syringe. It was unsure if the patient received a complete dose because it looked like most of it was on the patient's arm..No adverse events reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
body aches, fatigue Narrative: Took OTC Tylenol  Other Relevant History:
Patient presented to ED on 6/8/2021 with sub-sternal chest pain 9/10 with mild radiation down his left arm which was worse with breathing nd moving.  Per patient he had 2 less severe episodes of chest pain on 6/7 which were short in duration and resolved on their own.  ED evaluation was significant for mildly elevated troponin at 1.88, EKG with diffuse ST elevation, elevated CRP of 1.9, mild hyperglycemia. He had a normal chest xray.   Echocardiogram demonstrated normal biventricular function with no obvious pericarditis. ***
Left thigh with 1 cm area of erythema and induration at site of immunization. No warmth. Full ROM. Rx: BENADRYL as needed.
On the afternoon of 4/1/2021 soreness started on the injection site. Is ongoing. Only felt when moving the arm.  On the morning of 4/2/2021 a mild nausea -and  dizziness.
numbness in legs in legs arms hands back face; Burning in legs arms hands back face; tingling in legs arms hands back face; This is a spontaneous report from a contactable Consumer (patient).  A 58-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6202), via an unspecified route of administration, in Left Arm on 02Feb2021 at 16:00 (at 58 years) at single dose for covid-19 immunisation . Medical history included allergy to Salmon and react to codeine. Concomitant medication included ibuprophen and vitamins.  Previously on 31Jan2021 at 09:00 (at 58 years) patient took the first dose of the vaccine (lot EL0142) in Right arm for covid-19 immunisation. On 25Feb2021 at 08:00 the patient experienced "burning tingling numbness in legs arms hands back face". No treatment given. The outcome of the events was unknown.No follow-up attempts are possible. No further information is expected.
Post herpetic neuralgia; Mental and emotional distress; This initial spontaneous report was received from a lawyer on 01-JUN-2020, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or around 12-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving the vaccination), the patient suffered post herpetic neuralgia. As a direct and proximate result vaccination, the patient's symptoms have resulted in physical limitations not present prior to vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of vaccination, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.
Shingles type rash center of low back and upper right buttocks. Rash occurred approx. 5 months after the Varicella vacine was given.  Dx. by family medical caregiver at Physicians office.  Treated with Acyclovir.  Rash occured about 2 weeks ago.  Mother reporting it today.
Breast pain on left side; Feels like ink is being injected into my body; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Breast pain on left side) and FEELING ABNORMAL (Feels like ink is being injected into my body) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (Breast pain on left side) and FEELING ABNORMAL (Feels like ink is being injected into my body). At the time of the report, BREAST PAIN (Breast pain on left side) and FEELING ABNORMAL (Feels like ink is being injected into my body) outcome was unknown.      Concomitant medication was not provided.  Treatment information was not provided.
A 65 year old woman received an intramuscular injection of Td (Lot #A084A) in her right arm as a routine booster at a Pharmacy on June 20, 2016. She received no other vaccinations that day or within the preceding 4 weeks. She was taking her routine medications at the time of the immunization: Lisinopril (40 mg/day), Atorvastatin (20 mg/day), Amlodipine (5 mg/day), and Levothyroxine (100 micrograms/day). On June 21, 2016 (1 day post-immunization) she developed numbness in her right arm extending to her finger tips, swelling of her right 2nd and 3rd fingers, stiffness of her right hand, and a rash on the inside of her right wrist. The patient did not seek immediate medical advice for her symptoms but reported them to her physician after taking Ciprofloxacin on June 23, 2016 to determine relatedness of the event. The patient later contacted the pharmacy where she received the Td vaccine and the pharmacist reported the adverse event to MassBiologics. Reporter's Comments: The primary reporter mentioned that the patient is allergic to Penicillin. Sender's Comments: All of the adverse events presented in this case were assessed as non-serious. Musculoskeletal stiffness and rash are labeled reactions described in the package insert. Swelling is also a labeled reaction that can occur at the injection site; while the reported swelling is distal to the injection site, it did occur in the limb injected and may have been most noticeable in dependent areas, particularly at the fingers. The development of numbness is unexpected, as it is not described in the package insert. It is possible that the patient's symptoms of numbness, swelling, and stiffness are all related to a local inflammatory response to the vaccine administration as they are localized in the injected arm. All of the patient's symptoms fully resolved after 1 week, before the AE was reported. Therefore, no patient follow-up by MassBiologics was performed or is planned.
QUEASY STOMACH; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced queasy stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of queasy stomach was not reported. This report was non-serious.
In June I ended up having to go to the doctor multiple times to tell them I was very fatigued and tired. On 07/31/2021 I started experiencing a lot of stomach pain and I was really fatigued. On 07/31/2021 I started bleeding like menstruating. I ended up going to the ER on August, and they said I was pregnant and I was very surprised. I found out on 09/08/2021 I was internally bleeding. On 09/09/2021 they did surgery and claim it was an atopic pregnancy. I was hospitalized for 3 days. On 11/21/2021 I ended up going to the hospital again for stomach pains and ended up having my gallbladder removed. I was hospitalized for 3 days. They have done a lot of MRIs, CT scans, and ultrasounds. I still have to go back to the doctor because now they want to do something with a GI doctor because I am still experiencing stomach pains. That appointment is on 01/31/2022. They only gave me pain killers for 2 days but nothing else.
Left deltoid: Erythema/ T T palp/warmth (oval 8 cm x 10 cm patch). Cellulitis vs Drug rx. No abscess. BENADRYL 1 1/2 tsp PO QID. SEPTRA 2 tsp po BID x 14 day. MOTRIN.
Headache, Arthralgia, UrticariaPruritus, ITCHING; 9/9/2021 BODY ACHES, HEADACHE  Narrative:
Immediately after administration, her left deltoid had a little blood spot, after wiping off the injection site, it became swollen and red. The Left deltoid was noticeably swollen, tender, and red.
Redness under arm and little swelling around and below injection site. She only noticed it this morning when removing Band-Aid. She has had reaction before with other vaccinations.
Patient received SHINGRIX vaccine on March 26, 2018. He called his primary care provider's office on April 3, 2018 complaining of soreness in his right arm/shoulder area that started approximately 2 days after the injection. Icing the area, acetaminophen, and ibuprofen were ineffective to alleviate the pain. Patient made an appointment to see his provider on April 5, 2018 to have the injection site evaluated. The provider noted no swelling, reddening or tenderness of the injection site area. On April 13, 2018, patient went to ER due to worsening right and left shoulder pain radiating towards his neck. On May 22, 2018, patient called his primary care provider again to tell him the pain had not subsided. He had a cortisone shot which did not alleviate the pain. Patient is currently awaiting an MRI to see if there is any damage to the injection site area.
12 days after his second Moderna COVID vaccine, my father developed Shingles. His left eyelid is incredibly swollen and his right eyelid began to swell today. That is his only symptom. He?s on an antiviral and gabapentin. He had received both doses of his shingles vaccines about 3 years prior. We have no idea if related to COVID vaccine but wanted to make you all aware.
she is a little hard of hearing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: HYPOACUSIS (non-serious), outcome "unknown", described as "she is a little hard of hearing". Additional information:A caller said she wants to go and get her Pfizer COVID booster, but most of the pharmacies in her area only have Moderna. She keeps asking when they are going to have Pfizer and if they will get it, and they're telling her it's not approved. She wants to know when it will be approved, why it's not, and whether Moderna and Pfizer boosters are interchangeable. She mentioned all of her shots have been Pfizer shots to date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.