chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient had no immediate adverse effects. The patient started to feel light-headed slightly before lunch and started to feel bad. She did not feel like she could drive herself home so she had someone come pick her up. Once at home, she changed and noticed that there was a red, slightly painful, and raised knot where she had got her shot the day before. She did not notice the knot this morning in the shower and felt fine going in to work. Once at home, she used a heating pad to loosen up the knot. She was advised to keep doing this and to take ibuprofen of Tylenol, whichever she can tolerate. If symptoms still persisted after a couple of days, she should go see the doctor.
Pt recvd 3 doses of Hep B vax 17APR90, 15AUG90 & 11DEC90 & on 18JUL91 it was determined that the titer was neg; reporter indicated that pt refuses to come bac for booster;
Pt developed induration and redness 11x8cm at site of injection of DTAP and MMR at about 48 hours after dosing.
On 1-13-15 around 6pm left arm at injection site became sore, red and hot about size of 50 cent piece. The next day size got 3x larger, fever was at 99.3. This lasted one week. Today 1-27-15 site has a faint red color - no other symptoms.
Horrible chemical smell started about 3 days after my 2nd shot; It is ongoing and is driving me crazy; Nothing tastes or smells as it should.; Nothing tastes or smells as it should; I've also had headaches which is not normal for me at all.; had a normal reaction the day after each shot - fever, chills, headache; had a normal reaction the day after each shot - fever, chills, headache; This is a spontaneous report from a contactable consumer (patient). An elderly non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0178, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 19May2021 as dose 2, single; and the patient previously received first dose of bnt162b2 (Lot Number: EW0164), via an unspecified route of administration, administered in right arm on 26Apr2021 as dose 1, single; both for COVID-19 immunisation in pharmacy or drug store. Prior to vaccination, patient did not receive any other vaccines within 4 weeks. Since the vaccination, the patient has not been tested for covid. Medical history included known allergy to Penicillin, and patient was diagnosed with COVID-19 in Nov2020. The patient's concomitant medications were not reported. It was reported patient experienced a normal reaction the day after each shot - fever, chills, headache. On 20May2021, the day after second vaccination patient experienced headaches which was not normal for her at all, and had a normal reaction of fever and chills.   Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.
Pt said she has/having pain on her left arm, and its painful to lift up her arm, especially from the shoulder to elbow. Analgesics and patches helped a little, but still has the same intensity of pain as before. She got the flu vaccine on 10/10/07.
Information has been received from a healthcare professional concerning a 14 month old female patient with no known allergies and no past medical history who on 04/04/00 was vaccinated SC in the left arm with a 1st dose of Measles virus live. Concomitant therapy included Hib conjugate vaccine (HibTiter). On 04/18/00, the patient experienced a fever of 103.8 F and had a seizure that lasted for 5-10 minutes. The patient's seizure is considered to be an Other Medical Event. The patient was seen in the ER and treated with Tylenol and Motrin for the fever. It was noted that urine and blood cultures were Neg. On 04/19/00 the patient's fever was 101 to 102 F. The patient did not have a rash. Follow-up information from a physician reported that the patient experienced a febrile seizure. ON 04/19/00, the patient recovered from her experience. Additionally, on 04/19/00 the patient was diagnosed with a right ear infection.
Patient received 2nd dose of Moderna COVID vaccine (lot 004M21A exp 7/13/22) at approximately 1500. Patient was instructed to wait in clinic 30 mins after vaccine due to a previous reaction to iodine and PO demerol. Pt had reported before the vaccine that her throat swelled with both iodine and demerol. COVID vaccine was completed, and pt sat down in front lobby to wait. At approximately 1508, Pt walked up to front window and stated her throat was swelling now, and she went back to her seat. RN brought the emergency cart  to front lobby. Pt was given oxygen via face mask 5L, Epinephrine Auto-Injector 0.3 mg IM L outer thigh at 1511 and Benadryl 50 mg IM R outer thigh at 1513. EMS arrived at 1515 and report was given. Vitals- BP 161/92, HR 62, O2 saturation 100%. Pt was evaluated by EMS but refused to be transported and refused further care. Pt ambulated to care and left health department.
The pt experienced pallor, hypotension, unresponsiveness, petechiae to the lower extremities.
body aches; headache; nausea; a low-grade fever; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) via an unspecified route of administration on 16Feb2021 12:30 at single dose on left arm for covid-19 immunisation. The medical history was none. Historical Vaccine included first dose of of bnt162b2 (lot number: EL3247) on 26Jan2021 12:30 at single dose on left arm for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamin D, and ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE). The patient experienced body aches, headache, nausea and a low-grade fever on 17Feb2021. About 12 hours after the second dose, the patient started to have body aches, a headache, and nausea. This lasted for about 18 hours. At about 24 hours post-shot, she took her temperature and had a low-grade fever. She took 400 mg of ibuprofen at about 24 hours post-shot and that helped ease the side effects. By 30 hours post-shot, she was able to return to normal activies. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered on 17Feb2021.
Reaction to Guillain-Barre Syndrome; This is a spontaneous report from a non-contactable consumer (the patient) from a Pfizer-sponsored program. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot/batch number and Expiration date were not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported reaction to Guillain-Barre Syndrome (no other details provided). The clinical outcome of reaction to Guillain-Barre Syndrome was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient information corrected.  Follow-up (16Mar2021): This is a follow-up report to notify that case 2021157553 and case 2021285669 are duplicates. All subsequent follow-up information will be reported under Manufacturer report number 2021285669.
I experienced a breakthrough case of COVID-19 which consisted of these symptoms: fever, body aches, coughing, runny nose and tiredness.
Sore throat. I went to the Doctor and I was given prescription Flonase.  That medication made my throat hurt all the more and that was in January and today my throat still hurts, it feels raw and it feels like something is caught on it.
hips are not working; She can't use them; If she tries to get up and stand up, she can't stand up; She is mad because the side effects are so terrible; she fell onto a shelter and she peed; hips are not working; She can't use them; If she tries to get up and stand up, she can't stand up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSSTASIA (non-serious), ARTHROPATHY (non-serious), outcome "unknown" and all described as "hips are not working; She can't use them; If she tries to get up and stand up, she can't stand up"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "She is mad because the side effects are so terrible"; FALL (non-serious), outcome "unknown", described as "she fell onto a shelter and she urinated".  Additional Information: Reporter stated that she was trying to get to someone. The reason she was reporting is because she had the problems, and she was reporting about side effects. She said that she was reporting about the bad things that have happened to her from having the-she stops her sentence here and says, why aren't you answering me? What are you doing? She was having side effects from the second COVID vaccine. She said, let her try to be nicer. She is mad because the side effects are so terrible. This was probably a strange, strange side effect and she is very smart, and she looks at all the side effects. Why would her hips not work? She can't use them. If she tries to get up and stand up, she can't stand up. Because the day she did the shot she was 100% normal, then she went to sleep and woke up at 11:00 PM at night and couldn't get her hips out to go pee and she could barely get there. She thinks there was no other difference in her life other than when they did the shot. She like scrambled across the end of the bed and then she fell onto a shelter, and she peed and then she had to walk back to the bedroom, and she couldn't even hardly roll over to get into the bed. Why else would somebody else make her body do that? There was nothing that she wanted other than she wanted to be able to roll over and go to the bathroom. Reporter seriousness for the events were unspecified.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
muscle soreness - within 24 hours and still remains after 4 days, knot at injection site- within 24 hours & still remains after 4 days, headache - within 3 hours -& lasting for 3 days , neck pain - within  24 hours & lasting for 3 days , fatigue - within 24 hours & lasting 3 days, nausea - within 24 hours & lasted 1 day, itching - began on day 3 and remains on day 4.
Vaccine DT given to left deltoid on 7/24/01 at 13:30 and felt light-headed. She went to eat. At 16:30 she had a seizure Grand Mal and went by EMS to the ER. Her temperature was 100.2F. In the hospital, over the next 4 days, she had 7 seizures, was lethargic, decreased appetite, and weight loss. She had localized swelling, redness, a lump and site was hot to touch. Still sleepy with decreased appetite and don't feel well. She was given IV fluids. She had DT Pediatric instead of Adult TD.
Received phone call, 4 hours after vaccination, from patient complaining of swelling at site of injection of PNEUMOVAX. Patient has put ice on site of injection and taken BENADRYL. Patient calling Dr. in morning.
Swelling of neck glands or salivary gland - enlarged over 5 cm.
Patient received booster of Moderna on 10/25/21. According to moderna website specific lot number has an exp of of 10/24/21.
Patient stated that on day 3 after the administration of the vaccine he started to experience low back pain without a known cause.  He has been treating the pain with ibuprofen which helps some but the pain does not seem to be improving.
SHE SAID HER TONGUE AND THROAT WAS TINGELING, SHE SAID IN PAST WHEN SHE RECEIVED VACCINES SHE WOULD GET THE SAME ADVERSE REACTION. SHE SAID IN PAST SHE WOULD TAKE 2  BENADRYL'S 25MG AND IT WOULD GO AWAY. I THEN GOT HER 2 BENADRYLS FROM THE OTC SECTION AND SHE TOOK 2 OF THEM. AFTER ABOUT 10 MINUTES SHE FELT BETTER AND WENT HOME. SHE DECLINED USE CALLING FOR HER TO HAVE SOME COME AND PICK HER UP.
One hour later my left arm started swelling- painful to move and lift. Four hours later I had flu like symptoms- total body aches, sweating. Rashes and hives began developing on the left arm and through the night, spread throughout the body. I remained bedridden with body aches and hives for 4 days.  Saturday Dr. told me to take Benedryl. Tuesday I was given prednisone to take. Hives continued so I was reissued prednisone 2/15/21.  I saw another Dr.  on 2/19/21 who prescribed Montelukast 10mg. and Zyrtec. As long as I took the meds the hives subsided. When meds wore off, the hives returned.  I saw and allergist Dr.  on 2/22/21 who told me to take a double of Zyrtec and Allegra.  Today is 2/25/21 and the hive are still returning when the meds wear off.
The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.; No adverse event; doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event) in an adult 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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 28 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case, Patient 1 out of 50 (Lot AS7143C was administered on 5-JUN-2023)
(L) upper arm with generalized erythema, warmth, firmness and tenderness extending entire length of upper arm and cirmferentially - worsened over 24 hours; TX'd w/Clinda (PCN allergy). R/O cellulitis.
Patient received an Engerix-B expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 25-year-old female patient who received HBV (Engerix B) (batch number K2L79, expiry date 12th August 2022) for prophylaxis.   On 17th August 2022, the patient received the 3rd dose of Engerix B. On 17th August 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date- 18-Aug-2022 Reporter's comment: Licensed practical nurses (LPN) reported that a patient received an expired dose of Engerix-B. This was patient's third dose of Engerix-B. The reporter did not consented to follow up. Additional Supportive Information: The patient was administered an expired dose of Engerix-B, which led to expired vaccine used.
Hospitalized worsening dyspnea on exertion and worsening chest tightness known covid (Positive PCR 1/19/2022) being remotely monitored.   Booster 10/13/2021 Pfizer Lot FC3183 IM LD
pt recv vax 16OCT97 & removed bandaid 17OCT noticed 3/4"W scratch & redness;18OCT put a new bandaid w/triple ATB;21OCT noticed gob of pus;also noted 22OCt & 23OCT;24OCT to MD no pus noted shot given in shoulder per pt felt achy 1-2 days;
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since 11-MAY-2016, the patients were vaccinated with the improperly stored doses of VARIVAX (lot #, expiration date, dose and route were not reported). No adverse effects were reported. VARIVAX was supported until the labeled expiry. This is one of several reports received from the same reporter. Additional information has been requested.
A report has been received from a Health Professional concerning a 10 month old, Male subject. It was reported that the patient accidentally received FLUMIST QUADRIVALENT (intranasal), 0.2 Millilitres, (which was usually indicated for 2-40 years) intranasally, on 22-Dec-2015. The outcome of the event of accidentally received medication and underage-medication error is unknown. The report was considered to be non-serious.
Patient states that he awoke on 10/12/14 with his right arm "Frozen" and that he felt "achy and tired". As of 10/13/14, his arm was "still sore" and still felt tired. He took one dose of Aleve. As of 10/14/14 he states his arm is "all better".
Swelling in the arm got worse over a period of a week. There is now a hot rash at the injection site.
Migraines, chronic fatigue, dizziness, muscle and joint pain, night sweats, short term memory loss unexplained skin rashes or infections, vision problems, seeing spots, and extreme tingling or numbing in all limbs.
Noticed swelling/ soft tissue mass on left arm developing over the last week. Denies any trauma and only significant event to the affected area was the flu shot administered on 10/27/14.
patient reported a 104 fever that lasted three hours after the vaccination with nausea.  He notes that they he developed a headache that has lasted seven days and a vesicular rash with blurred vision/photophobia that is slowly starting to improve today
Patient has been experiencing a red arm from her hand to her elbow as well as itching in the vaccinated arm.  The itching has improved on 11.1.20, but there is still some redness on the arm.
within 24 hours of injection, intense body aches, mild fever 2nd day, swelling at injection site. redness, itchy and hot to the touch 3rd day, swelling went down, subtle pinkness, hot to the touch and tender to touch
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088O21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had not resolved.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.  About 4-5 hours after getting vaccinated, the patient developed diarrhea with no gas pain/stomach pain. He mentioned that it just flowed. It was still on going at the time report.
Into clinic 10-15-09 for FLUZONE vaccine. Mother reported no allergies, had received flu shot last year. FLUZONE 0.5 ml administered IM R deltoid without problem. Child talking-no signs of distress, walked to waiting room with mother and told her he felt "dizzy". Mother had child sit down and called for nurse. Nurse arrived and had child lower head between knees. Child responded verbally to commands but kept c/o dizziness. Child lowered to floor and feet elevated. VSS=BP 130/70, P 100 reg, R 20 unlabored and even. Walked out of office with mother without assistance. PHN called mother later. Mother was concerned-took child to ER after left clinic. CT scan done, bloodwork. Impression new onset seizure and follow up with pediatrician on 10-16-09. Seen by pediatrician 10-16-09. VS MD office: BP 98/56, P 57, R 16, T 96. Pediatrician feels new onset seizure. Referred to neurologist for sleep deprived EEG and cannot rule out caused by FLUZONE.
Patient is complaining of shoulder pain from the shot. It was first reported to the pharmacy on 10/24/17 and we advised her to seek care with her primary care physician.
pt recv vax;approx 2 wk later,devel one vesicle on back;
On 12-8 I started having soreness in my lower body and I was fatigue. I also had lots of congestion and I felt horrible. The next day I had the same symptoms, and I was out of sorts. I was with my son doing a project and I went home as soon as we finished. My son called me to check on me because I was acting weird. My wife then contacted my doctor, but they weren't able to talk to me, so I received a call from another doctor which prescribed PAXLOVID. A few hours later I took a self-COVID-19 test, and I was positive for COVID-19. The next day everything had away but I still had a sore throat. This only lasted another 24 hours. That Sunday I had a slight sore throat but not as bad as before.
Information has been received from a nurse practitioner who is also the patient and is a 28 year old female with no known drug reactions or allergies and no pertinent medical history reporting that on 29-JUL-2010, she accidentally got a small amount of ZOSTAVAX (Merck) (Lot # 664670/0151Z) that is part of the Varicella Pregnancy Registry in her left eye while she was pushing an air bubble out of syringe. Concomitant medications included prenatal vitamins. The nurse reported that her left eye was irritated but she felt it was from the flushing of her eye with water. She was pregnant. At the time of the report the patient was not recovered. The patient sought unspecified medical attention. Additional information has been requested.
* Pain at the injection site & on the evening of 3/30/21, which eventually spread throughout the upper arm.  * Pain/tenderness felt in my armpit on the morning of 4/1/21. * Tenderness on the left side of my collarbone, near the shoulder,  on the evening of 4/1/21. *The upper arm pain still present.
pt recvd vax & devel red spots on neck; same rxn w/ 2nd dose of vax;