chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Malaise; Injection site soreness; Patch of pox-like lesions on my abdomen that were raised and red; it did indeed look like shingles; raised Rash / lesion; This case was reported by a consumer and described the occurrence of malaise in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox as a child).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced malaise, injection site pain, red rash, vesicular rash and raised rash. On an unknown date, the outcome of the malaise and injection site pain were unknown and the outcome of the red rash, vesicular rash and raised rash were recovered/resolved.   It was unknown if the reporter considered the malaise, injection site pain, red rash, vesicular rash and raised rash to be related to Shingrix.  Additional details were provided as follows: The patient had chicken pox as a child and was exposed to it when, the patient's children also had chicken pox. The patient never had shingles previously. The patient had no evidence of severe allergic reaction after vaccination. Less than 2 years after vaccination with dose of Shingrix, the patient experienced red rash, vesicular rash and raised rash . Few days after, the patient had patch of pox like lesions on my abdomen that were raised and red, unlike any type of rash or bug bite. The patient contacted to doctor, who asked to sent a picture of the rash confirmed that it did indeed look like shingles, even though theoretically it should not occur with a non live virus vaccine. The patient stated that, rash resolved in 10 days.
fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical condition was reported.).   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.   This case was linked to MOD21-036714 (Patient Link).
Hospitalized with a fall, intracranial bleed, COVID + on admit. Remdesivir  x 3 days. Required intubation and vent for resp failure 6/2/2022, subdural hematoma increased in size, 6/7/2022 progressed to comfort care due to no hope of meaningful recovery from intracranial bleed.
Pt felt palpitations, panic feeling and blurred vision within 10 minutes of receiving influenza (seasonal) vaccination. Continued to have high BP 160/90, 184/90, 200/? after supine. Began shaking, tearful. Pale initially then flushed. Taken to ED for further evaluation.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX for prophylaxis.  On an unknown date the patient experienced incorrect product storage and poor quality drug administered.  The outcome of poor quality drug administered is unknown. The reporter considered incorrect product storage and poor quality drug administered to be not related to VARIVAX.; Sender's Comments: US-009507513-1707USA001045: US-009507513-1707USA001046: US-009507513-1706USA007156:
At 09:20, shots given; client fainted; BP low-80/40; client clammy; client laid on floor with feet up; BP increased; client back up to chair; at 09:47 client reports he's OK; BP-110/68. Left Health Dept with mother.
Patient received Moderna Covid vaccine to left arm at approximately 11:55AM.    Afterwards, patient sat in the observation area, accompanied by female companion, presumably his wife.   As soon as patient sat down, medical assistant witnessed the patient shake, lose color and roll his eyes back.   Medical assistant called out to observation nurses for assistance.   Nurses approached the patient immediately.   Patient went limp and was assisted to floor.   Wife was questioned about patient's history, which she reported were cardiac related; CABG.   Patient was lethargic but oriented x4.  Manual pulse taken revealed a weak pulse of 60.  O2 Sats on room air showed 90% on pulse oximeter.  Patient was clammy and pale.   When questioned about his current symptoms, patient responded that he felt "heartburn" and tingling to this left arm.   An AED was placed on patient's chest and 911 was called.   No shock was delivered. Patient remained conscious but lethargic and nauseous.   Paramedics arrived  at approximately 12:00noon and patient was taken to nearest hospital.  No additional information regarding patient?s condition is known at this time.
VERTIGO; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination.  The Batch number was not reported and has been requested. Concomitant medications were reported. On 10-MAY-2021, the subject experienced vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vertigo was not reported. This report was non-serious.
within on half hour of administration hand, feet were red and swollen  lasted several hours  School nurse cooroborated, patient not seen in office by about 6 hours symptoms were gone
Patient came  in yesterday (9/7/19) and talked about and showed that the injection site from her flu shot from 9/5/19 was red and slightly raised. It was about 2 inches in diameter around the injection site. It did not hurt, was not painful, hot to the touch, or itchy, just appeared/there. I advised the patient to monitor the area. Also advised if she wanted to apply a little topical hydrocortisone or benadryl to the area that that would be ok. I told her if it doesn't get better in a few days, then to seek medical attention and when she is in next to let us know how it is doing (she's coming later this week).
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 04-APR-2018, the patient was vaccinated with improperly stored PROQUAD (dose, units and frequency not reported) (lot # N020616 and expiration date: 22-JAN-2019) subcutaneously, at a temperature of 28.2 Fahrenheit (F) for 4 hours 57 minutes. No adverse effects were reported. It was reported that there was no previous temperature excursion. Data logger was involved. No product quality complaint was involved.
Inflammation and tenderness at site of injection (left deltoid);  advised ice to decrease inflammation and Benadryl.
p/vax pt devel SOB, bronchitis approx 5wk p/vax;rapid antigen test for influenza A positive when adm to hosp;significantother devel some s/s but wa snot hosp;
28JUN91 devel generalized maculo papular rash & urticaria on evening of 27JUN91; recvd vax PM 26JUN91; Seen on ER 28JUN & treated for allergic rxn, poss response to vax the MD told mother;
This case was reported by a physician via sales rep and described the occurrence of shingles in a 73-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 42 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported but it could be in between 72 to 73 year. In 2018, 6 to 7 weeks after receiving SHINGRIX dose, the patent experienced possible Shingles rash and secondary rash on arm. The reporter agreed to follow up contact.
mild nausea (1 hour);  moderate fever and chills (24 hours); moderate aches 48 hours; headache 24 hours
Information has been received from a licensed practical nurse concerning a female pt who was vaccinated with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot649695/0512P) and within 72 hrs she developed cellulitis at the injection site. The pt sought medical attention and was treated with antibiotics. The pt recovered. There was no product quality complaint reported. The reporter considered cellulitis at injection site to be an other important medical event (OMIC) and disabling. Additional information has been requested.
pt states that arm became red & swollen @ site of vax; also states that had pain & swelling of rt armpit; pt was seen @ ER on 15MAY93; pt states that ER mD gave a sling for rt arm to use for 5 days; burning of rt neck & shoulder area;
Pt developed red unraised rash immediately after vaccine was given on her left deltoid. Rash completely resolved after 10 min. No reaction after first dose. Tested other arm for sensitivity to alcohol without reaction.
Received booster dose before 6 months after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster dose before 6 months after the second dose) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 054C21A and 033B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster dose before 6 months after the second dose). On 28-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster dose before 6 months after the second dose) had resolved.            The patient received booster dose before 6 months after the second dose.  No Concomitant product use was reported. No treatment information was provided.
Initial unsolicited report received from a consumer on 07 Dec 2016. This case involves a 67 years old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, and dose in series were unknown) via intramuscular route in left deltoid on 25 Nov 2016. Illness at time of vaccination was reported as no and Pre-existing physician diagnosed allergies, birth defects, medical conditions were allergies to strawberries and codeine. Any other vaccinations within 4 weeks of vaccination was not reported. The patient concomitant medications were not reported. On 25 Nov 2016, on the same day by evening following vaccination, the patient experienced soreness at the injection site, the next day his left arm became sore. Over the next few days, the soreness traveled up to his shoulder, to the back of his neck, to the top of his head. The patient had a dizzy feeling that would come and go and this lasted for 3-4 days. On 05 Dec 2016, after riding his bicycle, the patient fell to the ground, his left eye started twitching, left side of his face drooped, his face felt numb, he had a bad taste in his mouth, and could barely talk. The patient also suffered from headache, which was not usual for him. Laboratory investigations were not reported. The patient required ER doctor visit, where it was diagnosed as Bell's Palsy. The patient corrective treatment were reported as steroids and antivirals. The outcome of the events was not recovered. Upon internal review, the company decided to consider the event serious because of important medical event Bell's Palsy. List of documents held by sender: none. Sender's Comments: Bell's Palsy is listed with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This is poorly documented case. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant product use was not provided.
ACHY; SLEEPING ALL DAY; COLD CHILLS; TIRED; SLIGHT FEVER; This spontaneous report received from a patient 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) dose, start therapy date were not reported 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 subject experienced achy, sleeping all day, cold chills, tired, and slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, sleeping all day, cold chills, tired, and slight fever. This report was non-serious.
experienced seizures for the first time in my life two nights after the second vaccination. Conducted several neurology tests/studies (MRIs,etc.) and they could not locate anything that would allude to epilepsy.
Intermittent asthma; Vaccine availability issue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Intermittent asthma) and PRODUCT AVAILABILITY ISSUE (Vaccine availability issue) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced ASTHMA (Intermittent asthma) and PRODUCT AVAILABILITY ISSUE (Vaccine availability issue). At the time of the report, ASTHMA (Intermittent asthma) and PRODUCT AVAILABILITY ISSUE (Vaccine availability issue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided. The reporter stated that that she had intermittent asthma, did not clarified if it before or after receiving the vaccine. Treatment details were not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment  Very little information was received for this case. The patient declined follow-up so no new information is expected. Based on current available information it is unclear if the patient actually received the vaccine and if the event was an ongoing, pre-existing condition.   Reporter did not allow further contact; Sender's Comments: Very little information was received for this case. The patient declined follow-up so no new information is expected. Based on current available information it is unclear if the patient actually received the vaccine and if the event was an ongoing, pre-existing condition.
Feb after vaccine 10/22, I developed a trigeminal Neuralgia on right side of face and scalp lasted 2 weeks then went away, but still had skin pain on both shoulders and arms. feels like sunburn  to the touch. this condition is constant.  I caught  Covid  in  March of 23 Mild symptoms.  Late Aug/23 facial pain returned on right side of face then subsided after 2 weeks.  Skin pain sensitivity on arms remains constant. On 1800 mg Gabapentin no effect on pain. On 10/07/23 Took Moderna Spike Vaccine. On 10/16 facial pain returned on right side of face.
pt states had redness about 6" from inj site to elbow & 4" wide tenderness;advised via phone to apply ice, compress & apply hydrocortisone cream if available & see provider soon;
Headache, body ache, particularly lower back ache. Increased heart rate up to 106 BPM. B/P 128/70 fever with temp 103 degrees. Patient was seen at her campus health clinic. She took 2 Advil (200mg) at 12:00 am & 1 200mg Advil at 1:00 am. She stated that her fever was "normal" at 6:00 am this morning and has remained "normal". She states that she "feels fine" now.
tested positive for covid; tested positive for covid; fully vaccinated was exposed to a family member with Covid and came down with symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid"; EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "fully vaccinated was exposed to a family member with Covid and came down with symptoms". It was reported that "the patient was fully vaccinated and was exposed to a family member with Covid and came down with symptoms and tested positive for Covid." The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The lot number for bnt162b2 was not provided and will be requested during follow up.
Pain in my entire left side. Left ovary aching, chest pain. Low grade fever, headaches,  violent chills and sweats for 2 days
Vaccinated  12/21/2020 & 1/11/2021. Ended up contracting Covid and tested positive on 5/6/2021.
high pitched cry from 1PM to 8PM on 3AUG95 & t100.5-102.8 2x w/APAP; slept all noc w/o problems; TC to PMD in AM; no ofc visit necessary
Vaccine breakthrough case - hospitalized for preventative monoclonal antibody treatment.  CDRSS Case ID: 3354208  Case began experiencing symptoms on 9/14/21 and tested positive the next day. Case was experiencing the following symptoms: Myalgia, Runny nose/Congestion, Sore Throat, Loss of Smell/Taste, Headache, Fatigue, Dyspnea & Loss of Appetite. At the time of Health Dept interview (9/20/21), the case was still experiencing the following symptoms: Congestion, Loss of Smell/Taste, and Loss of Appetite.  The case was hospitalized (Preventative) Admitted: 9/16. Discharged: 9/16. The case did not develop pneumonia, ARDS, and was not admitted into the ICU.
Noticed difficulty breathing- laborious respiration which resolved with medical attention after which client noticed developing of mouth, face on one side. Not able to drink out of straw, drooling. Notice when tries to smile.
On January 19, 2021 (4 days after the vaccine injection) I developed severe itching in the palms of my hands.  By the next day, January 20, 2021, I had developed severe hives bilaterally from my groin areas down to almost my knees, as well as on my buttox.  I also had severe hives in both armpits.   Both hands (palms) and wrists had become swollen and fire-engine red and the itching was maddening.  I saw a Physician who gave me an injection of Depo Medrol and a 7 day prescription of Dexamethasone, 4mg ,  take twice a day and a prescription of  Hydroxyzine HCL 25 mg, 4 times a day as needed.      The hives began to fade after 18 hours of medication and got fainter and fainter each day, along with relief from itching.   Hives were completely gone by the time I completed the 7 day cycle of Dexamethasone.   I have not had a recurrence.
30NOV93 @ 345PM pt recvd vax & began feeling nauseated & exp cold chills by 9PM; began vomiting & ached all over; vomiting subsided @ 4AM 1DEC93;
HR and BP shot up, red face, chest and arms, dizziness, tightness in chest, SOB, and metallic taste in mouth.
10-12 cm area of redness and warmth on R thigh at site of DTaP injection started 24 hrs after immunization.
Initially just mild fatigue and "brain fog" but by the next day the fatigue  "brain fog"/malaise/disorientation was so intense I could barely stay awake and could not function at my desk job.  This continued at that intensity for about a week.  I couldn't do ANYTHING...was previously running 7 miles/day but in the past month since vaccine I have only had the energy to walk around the block one time.  The cognitive impairment has been debilitating at work where I can not concentrate or process complex topics.  I'm an IT executive so this is part of my daily job and was no problem prior to the vaccine.  By the second week I was starting to make very tiny progress each day.  I would be OK for an hour or 2 after waking up but then the fatigue and malaise would return and I wouldn't be able to work.  This is often accompanied by headache.  Generally the duration of symptoms has been  getting shorter each day but very slowly. On may 9 my impairment was so great I couldn't even drive (was like being a bit drunk).  Finally, Monday May 10, the intensity of the symptoms was light enough that I was able to work a full day despite the mild headache and fog.  The same continued on May 11, so I hope I am close to being over this.
Pt. has a 2 cm red welt at the site of injection. No complaints of itchiness, or pain. Per mom, "Doesn't seem to bother her". Advised cool compresses. Follow up if not resolved or condition worsens.
Pt received vaccine. Patient moved to waiting area. After a few minutes, pt reported dizziness, vision changes, and feeling faint. VS were taken: BP46/31. EMS called at 12:25. Patient moved to cot and laid supine with legs raised on chair. VS taken two more times: 96/60 and 110/90. EMS Arrived at 12:35. Patient reported improvement in symptoms. Patient refused EMS Transport and chose not to go to ED.
Pt reports feeling "whoozy" after receiving vaccine. Denies LOC. Pt had heart loop recorder implant placed in hospital yesterday following stress test. Pt confirms she ate late breakfast, but not lunch PTA. Reports she took her scheduled/prescribed medications PTA. Pt spouse at bedside. VS at 1455: BP 175/79, HR 68, RR 18, O2 sat 97% on RA. VS at 1505: BP 171/84, HR 71, RR 18, O2 sat 98% on RA. VS at 1510: BP 169/81, HR 65, RR 18, O2 sat 97% on RA. VSS at time of d/c to home. Pt escorted to restroom via wheelchair, but refused w/c to exit, stating she preferred to walk the rest of the way. No s/s of distress noted.