chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 5 year old patient with no pertinent medical history and no drug reactions/allergies who on 16-AUG-2005 and on 29-AUG-2008 was vaccinated with the first and the second doses of VARIVAX (Merck) (lot number and expiration date not provided). The second dose was received at another office. There was no concomitant medication. On 19-MAY-2010 the patient came into the office with 5 to 10 varicella like bumps on the buttocks area and also an another region of the body it was itchy. The nurse reported that the patient was diagnosed as varicella. No laboratory tests were performed. At the time of the report, the patient was recovering. In follow-up, the nurse indicated that on 16-AUG-2005 the female patient received the first dose of VARIVAX (Merck) (lot number 660331/0485X) into the left arm/left thigh. On 29-AUG-2008 the patient received the second dose of VARIVAX (Merck) (lot number not reported) subcutaneously. On 10-MAY-2010 the patient was seen in the office and was diagnosed with chickenpox with 10 papules peri area and no fever. On 18-MAY-2010 the patient's mother stated that "all spots gone per phone". On 18-MAY-2010 the patient recovered from chickenpox. Additional information is not expected.
Dizziness, Flu symptoms, nausea, couldn?t walk. Have never felt right since the injection
Patient can't lift the arm more than few inches. Started experiencing this within few hours of vaccine administration.
Two hours after having booster vx she came down with a 101 fever and felt really itcy. 3 days later she called her Dr's nurse at the medical center and was told to try to take benedryl. She took it for two days and her arm started really swelling up, stayed swollen for 1 week, then finally went back down to normal.
Swelling in ankle / Swelling in knee; discomfort / discomfort in leg; discomfort / discomfort in knee; arthritic reaction; headache; disorientation /he wasn't as aware or sharp in his mind; fever; decreased strength; This case was reported by a consumer via call center representative and described the occurrence of headache in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than 4 months after receiving Shingrix, the patient experienced strength loss of. On 24th July 2019, the patient experienced disorientation and fever. On 25th July 2019, the patient experienced headache. On 27th July 2019, the patient experienced leg discomfort, discomfort in joints and arthritis. On 4th November 2019, the patient experienced ankle swelling. The patient was treated with analgesic, nos (Pain Reliever (Drug Name Unknown)). On 25th July 2019, the outcome of the fever was recovered/resolved. On 27th July 2019, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the disorientation and strength loss of were recovered/resolved and the outcome of the leg discomfort and discomfort in joints were not recovered/not resolved and the outcome of the arthritis and ankle swelling were unknown.   It was unknown if the reporter considered the headache, disorientation, fever, strength loss of, leg discomfort, discomfort in joints, arthritis and ankle swelling to be related to Shingrix.  Additional case details were reported as follows: The patient had his first dose of Shingrix in July.  Initially right after the vaccine he noted his was disoriented, meaning he wasn't as aware or sharp in his mind. It stated the day after the vaccine but resolved within a day. The patient had a fever the same day but that resolved the next day of vaccination. Headache that started the day after the vaccination but resolved two days later. The patient noted an all over decreased body strength but that resolved quickly as well. On 27th July 2019, 3 days after vaccination noted discomfort in his right knee and leg, he called it an arthritic reaction.  The patient continued to have those issues, and also noted on November 4th he experienced swelling in his ankle and believed he also had experienced knee swelling. The patient saw his physician for the issues on September 10th, but didn't let the physician knew he felt like they were related to the vaccine. The physician prescribed a pain reliever. The emergency room visit was required. The reporter consent to follow up.
Pain, induration, erythema, tenderness beginning 1 day after vaccination and continues 5 days later, though improved. Pt was taking azithromycin for other diagnosis during this time.
About 4:30 Lt arm sore. By 5 difficulty raising arm. 6PM could not move arm from shoulder to elbow; arm extremely painful to the touch and warm. Started taking Tylenol 500mg max.dose. Have had gastric bypass so no NSAIDS. Warm wet compress & heating pad. Could not lie on Lt side. Arm painful to the touch. These symptoms lasted 48 hrs. Wed about 5 pm i could move my arm 4-5 inches from my body. By 9 pm i could l lift over head with pain and much effort. Continued with Tylenol reduced dose for 3 more days. Arm sore until Monday 7 days after injection. I was in contact with my PCP and my daughter is an NP so did not go in to be seen I'm an RN, PHN, retired after 42+ years and have never had a reaction to any vaccine like this.
The morning after the vaccine I experienced extreme nausea, diarrhea, aches, pains, scalp tingling. Was not able to keep food down for 9 hours.
Red, swollen right deltoid, warm to touch, not hot.  Patient denies any pain/discomfort at site of injection.
Sore all over neck, arms, thighs; Sore all over neck, arms, thighs; Walks like a 100 year old man; Wants to go to bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), 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: NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Sore all over neck, arms, thighs"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Walks like a 100 year old man"; SOMNOLENCE (non-serious), outcome "unknown", described as "Wants to go to bed".  Additional information: The patient was asking if it was a normal response to experience soreness as described all over neck, arms, thighs and having issues with walking after receiving the booster. The patient felt like he was run over by a truck or beat up with a baseball bat. Patient was walking like a 100-year-old man and wanted to go to bed. The patient had same symptoms last time, he had a COVID vaccine, unspecified. Patient would never get a COVID vaccine again, after the last time. The caller stated that he was going to take ibuprofen.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201348905 same patient, event and reporter, different dose;
Fever, chills, migraine, increased heart rate for an extended period of time, body aches
This spontaneous report as received from a registered nurse refers two patients of unknown ages and genders. On 12-NOV-2012, the patient was vaccinated with PNEUMOVAX23 (exp: 11-NOV-2012) (dose, route and lot # not provided). No concomitant medications were reported. The nurse stated that on 12-NOV-2012, two patients were administered a PNEUMOVAX23 were administered one day after expiration date. No adverse effect reported. Additional information has been requested.
Breakthrough COVID-19 case. Pt received Moderna on 2/6/21 and 3/6/21
I have them now; I have them now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media The patient had the Vax and he/ she had them now (at the time of reporting). All over right side of his/ her face, on chin in her/ his mouth and in ear.  The reporter stated that it was miserable. The reporter stated that thank goodness not in his/ her eye. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
pain at injection site, burning on entry.   6 hours later: fever, chills, pounding headache, severe body aches (especially in the back, kidneys, & legs), nausea.  Took tylenol Q8 hr 3x  symptoms lasted for 48 hours
PERISHED APPROX 9 WEEKS POST INJECTION OF YOUR PRODUCT; This spontaneous report received from a company representative via social media and concerned a male patient of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported, expiry not reported frequency one total, dose, therapy start date were not reported administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient perished approximately 9 weeks (2021) post injection and cause of death was unknown. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210713544-covid-19 vaccine ad26.cov2.s -Perished approx. 9 weeks post injection of your product. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
10/03/2009 Mild Other Redness and swelling at site measuring 80x55MM.
has not been feeling well; has been laying around with no energy; This is a spontaneous report from a contactable consumer (patient).   A 68-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date, at the age of 68-years-old, (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient stated that she had the first Pfizer shot has not been feeling well, that she has been laying around with had no energy. The patient wanted to know if she can get the Johnson shot, if it is okay to switch or if she has to get the second Pfizer shot. Stated that she has an appointment for her second shot next week. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
About 12 hours after receiving my 3rd dose. I started having neck pain. I woke with chills and fever around midnight. I felt the same the next day, but with fatigue. This lasted for a week. My left arm didn't hurt at first, but then I couldn't lift it hardly at all. My back pain went across my shoulders and down around my buttocks, right leg and to my heel. Along with this, I started getting a rash that started on my fingers and toes. I noticed there was a little on my chest, but not much. Then the migraines came. It was awful. I started having issues with my breathing and with stomach pain. The pain was starting around my esophagus to my left side. I have been only able to sleep for about 10-15 minutes per night for the past few weeks. I did get 3 hours last night. I went to two ER hospitals, and they gave me morphine (which I'm allergic to) and that added welts to my rash and pain I already had. I kept myself from eating and drinking anything for a while. I had ice chips and started to become nauseous and vomit a bit, but it wasn't much because all I consumed were ice chips. I've noticed, for about a week now, I've been belching a lot. The migraine, chills and fever have subsided, but everything else remains. I was told that I need to have an endoscopy because the pains are not going away. I'm trying to schedule an appointment. I have been in complete exhaustion.
Chest pain on the left to middle portion of chest. Pain is mild but comes on suddenly and is unexpectant.
Lightheaded, flushing. Evaluated by EMS (refusal to transport) Cleared
Redness, warmth, pain at site of injection-beginning day after-no Rx.
1 giant hive at vaccination site- itchy for about 1 week; 1 giant hive at vaccination site- itchy for about 1 week; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 14Feb2021 13:15 (Lot Number: EN6201) as 0.3 mL, single for COVID-19 immunisation. Medical history Thyroid Nodules, Mild macular degeneration, postmenopausal syndrome, HBP, total hysterectomy w/ oophorectomy, gall bladder removal, appendectomy, penicillin allergies, adhesives allergies, HOH allergies, allergies: contrast dye. Concomitant medications included valsartan (DIOVAN); estrogens conjugated (PREMARIN); levothyroxine sodium (SYNTHROID); pravastatin; colecalciferol (VIT D3); famotidine (FAMO). The patient previously took nitrofurantoin (MACRODANTIN) and experienced allergies, claritine (CLARITIN) and experienced allergies. The patient experienced 21Feb2021- 1 giant hive at vaccination site - itchy for about 1 week, started 2 days after injection (16Feb2021) - very mild - arm was not sore at all. Treatment received for the events which included self medicated with benadryl & Aleve. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovering.
DELAYED REACTION-ON 2/4 RECEIVED VACCINE, DEVELOPED SORE, RED, HARD ITCHY PATCH NEAR INJECTIONS SITE ON 2/9/21
No adverse event; an 08-year-old patient received 0.5 ml Bivalent Moderna COVID-19 vaccine instead of 2nd primary dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (an 08-year-old patient received 0.5 ml Bivalent Moderna COVID-19 vaccine instead of 2nd primary dose) and NO ADVERSE EVENT (No adverse event) in an 8-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (Dose 1) on 03-Jan-2023. Past adverse reactions to the above products included No adverse reaction with COVID-19 VACCINE.    On 01-Feb-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 01-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (an 08-year-old patient received 0.5 ml Bivalent Moderna COVID-19 vaccine instead of 2nd primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (an 08-year-old patient received 0.5 ml Bivalent Moderna COVID-19 vaccine instead of 2nd primary dose) 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 WRONG PRODUCT ADMINISTERED (an 08-year-old patient received 0.5 ml Bivalent Moderna COVID-19 vaccine instead of 2nd primary dose).    No concomitant product reported by the reporter. It was reported that multiple errors may had occurred. The 2nd primary dose was Bivalent vaccine, and they administered 0.5ml instead of 0.25 ml of Bivalent shot. No treatment medication reported by the reporter.
BLOOD CLOT; STROKE; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, 1 total administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-May-2021, the patient begun to experiencing confusion and could not think straight. On 23-MAY-2021, the symptoms progressed when the patient went to the hospital. The patient was diagnosed with blood clot and had stroke. The patient was hospitalized on 23-MAY-2021 and was discharged on 26-MAY-2021. The patient was hospitalized for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot and stroke was not reported. This report was serious (Hospitalization Caused/Prolonged).; Sender's Comments: V0: 20210554839-covid-19 vaccine ad26.cov2.s-blood clot and stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Was administered 2nd dose of Covid vaccine was Pfizer the 1st dose received was Moderna.  Pt complaint of tongue tingling, heart racing and not feeling good.  Vital signs were taken 3:30 BP 130/80 p 76 and regular, R 16 pulse ox 98-99.  had not eaten much that day.  Was given a 8 oz coke and a pack of crackers with cheese she ate those, was communicating with others and laughing.  3:19 still complaint of tongue tingling 25 mg of benadryl given.  3:20 vital signs 124/76, p 67 and regular r 16 pulse ox 100.  She sat for 10 minutes and returned to work on her own choice.  stated she was feeling better
Chills, fever (101.5), aches - until 12:00 or so. I have had these same symptoms the last to times I have had a flu shot, the next day I feel drained but have no chills, aches, etc.
pt with vasovagal response post vaccination c/b orthostatic hypotension supine pulse 75 blood pressure 105/51 standing pulse 80 but blood pressure dropped to 81/61 pt better after hydration . advised mother to followup orthorstatic hypotension without compensatory tachycardia r/o dysautonomia
fast heart rate 115 b/m, headache, uncontralible shivering, nausea, outbreak of shingles on my stomach.
One hour after vaccines, child returns to clinic c/o extremely stuffy and congested nose, and flushed face.  No chest pain, no wheezing, no edema.  Vital signs - within normal limits.  Gave Benadryl, observation.  Mother requested ER, mother frantic, so 911 was called.  Child was given Prednisone in ER, and discharged home.
Severe Lt upper arm and shoulder and Lt neck pain; Severe Lt upper arm and shoulder and Lt neck pain; Severe Lt upper arm and shoulder and Lt neck pain; This is a spontaneous report from a contactable Nurse. A 70-year-old female non-pregnant patient (Nurse) received first dose BNT162B2 (Solution for injection, lot number: EN5318, COVID 19, brand: Pfizer) via an unspecified route of administration in left arm on 01Feb2021 at 12: 30 at single dose for COVID-19 immunisation. Patient medical history included Htn (Hypertension), Depression, Asthma, Ulcer (bleeding ulcers hx), known allergies: Sulfa. Concomitant medications included paroxetine hydrochloride (PAXIL), primidone, gabapentin, lisinopril, trazodone. Patient previously took Wellbutrin and had Known allergies. On 02Feb2021 at 12:30 PM, patient had severe Leftt upper arm and shoulder and Left neck pain since. Not relieved with Voltarin Cream and Tylenol Unable to take NSAIDs due to bleeding ulcers HX. No covid prior vaccination, no covid tested post vaccination. Outcome of events was not recovered.
Feverish feeling in face, slightly dizzy , felt like nodes under left side of chin were getting tighter, i.e., labored breath slightly, felt like heart was racing for a few seconds.   Sat down and waited for 10 minutes. Feelings subsided.  Did not report this to the pharmacist.
Besides normal side effects that are well known, I got blood blisters in the gums of my mouth. I have very good oral hygiene and have never had a cavity in my life, and no recent changes to any medications or anything. One of them popped, and it was filled with blood.
Pt complain of fast heart beat  feeling hot then cold.  Patient was taken by ambulance to ER
Severe abdominal pain, like a very painful gastritis; Gas pains; Severe diarrhea, running to the bathroom all night; Sore arm at injection site after second shot; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Severe abdominal pain, like a very painful gastritis), FLATULENCE (Gas pains), DIARRHOEA (Severe diarrhea, running to the bathroom all night) and VACCINATION SITE PAIN (Sore arm at injection site after second shot) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included VITAMINS NOS (ONE A DAY ESSENTIAL [VITAMINS NOS]) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 14-Apr-2021 at 2:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at injection site after second shot). On 14-Apr-2021 at 11:30 PM, the patient experienced ABDOMINAL PAIN (Severe abdominal pain, like a very painful gastritis), FLATULENCE (Gas pains) and DIARRHOEA (Severe diarrhea, running to the bathroom all night). On 15-Apr-2021 at 6:00 AM, ABDOMINAL PAIN (Severe abdominal pain, like a very painful gastritis), FLATULENCE (Gas pains) and DIARRHOEA (Severe diarrhea, running to the bathroom all night) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm at injection site after second shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-077629 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077629:1st dose
On 12/29: lightheadedness, flushed, felt like I was going to pass out, numbness/tingling down arms and hands, chest tightness, clammy hands and feet.