chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bells Palsy on right side of face; Severe rash on hands, trunk, neck; large blister like bumps on hands, trunk and head: itching; itching; facial swelling/ swelling in face; hand swelling/ swelling in hands; tingling in lips; some mild difficulty swallowing; throat swelling; mild difficulty breathing; numbness; swelling in mouth; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 06Apr2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose on 05Feb2021 15:00 (lot: EN6201) and second dose on 25Feb2021 15:00 (lot: EN6205); both via an unspecified route of administration in left arm (at the age of 45-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a public health department. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient have not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2. Medical history included known allergies Sulfa, bee stings, shellfish and Ceclor. Concomitant medications included armodafinil; clonazepam; vortioxetine hydrobromide (TRINTELLIX), also Tooo Max and an unspecified vit. The patient experienced Bells Palsy on right side of face; throat swelling; itching; mild difficulty breathing; severe rash on hands, trunk, neck; numbness; swelling in mouth; large blister like bumps on hands, trunk and head: itching; facial swelling/ swelling in face; hand swelling/swelling in hands; tingling in lips; some mild difficulty swallowing on 02Mar2021 at 15:00. The patient considered the case as non-serious, did not result in death, non-life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and non-congenital anomaly/birth defect. The events resulted doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received prednisone, cetirizine hydrochloride (ZYRTEC), omeprazole (PRILOSEC), methylprednisolone sodium succinate (SOLU-MEDRO) IV at ER as treatment. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt previously vaccinated with Moderna COVID 19 vaccine 08/11/2021. No reactions. Pt returned to clinic for second injection. Received Pfizer COVID 19 vaccine in error. Vaccine documented as given. No reactions noted. Pt made aware of error. Vaccine not repeated. No further action taken at that time. Pt instructed to call to report any adverse events. No call from pt at time of this report.
Patient had just received the flu shot, a couple minutes later started complaining of dizziness, sweating, headaches, and shakiness. His pallor changed. These symptoms continued for a good 30 minutes before the patient started to feel better. No treatment was given.
Left arm pain reported on 11-18-09 with no known injury + received Flu shot 6 wks prior. Took MOTRIN 600mg TID x 6 wks. Pain still persisting at left deltoid. No swelling fever + pain with ROM. Left shoulder/humerus. MOTRIN D/C, Treatment: Naprosyn 500mg 20# BID/Phys therapy, U.S., iontophoresis with dexamethasone.
Patient woke up Saturday morning with a rash on her right thigh near the injection site.  As the day went on it turned into a large (basically her entire right thigh) red ring around the site.  By Saturday night it was a bright red circle.  It stayed this way all Sunday.  On Monday it was much lighter but still noticable for several days.  It never bothered her but was warm to the touch.
Seizure activity, tx with ativan IM and sent to local ED. Febrile to 102.9, status epilepticus, given Fentanyl, Versed, and Keppra. RSI and intubation performed. Intubated and transferred for neurology care. History of similar events; had similar event when infected with COVID-19.  Was extubated uneventfully and is recovering well. Currently on azithromycin and augmentin for aspiration PNA>
Fever, dizziness / light headedness, servere muscle aches,  vomiting,  diarrhea,  sore throat, like I got a servere flu
I mistakenly administered dose of 1cc instead of the usual 0.5 cc. Patient was observed 15-20 min without any symptoms.  Later that afternoon, I realized my error and the chief medical officer phoned patient to check on him. Left message and no response.
Initial and follow up information has been received from a physician concerning a 70 year old retired male (previously reported as a female patient (age not specified)) with chronic myelodysplasia and a history of an allergic reaction possibly to vidaza injections. On 9/29/05 (previously reported as 10/18/05), in the AM, the patient was vaccinated with PNEUMOVAX 23 (lot # 649694/0386P) in the left deltoid. The patient was reported to have chronic myelodysplasia at the time of vaccination. On 9/29/05, in the PM, the patient developed redness and swelling at the site of injection spreading down to elbow, a warmth sensation and cellulitis. It was previously reported that on approximately 10/18/05, 6 hours after the vaccination the patient developed cellulitis in the affected arm. It was reported as raised rash and warm to touch. The patient was treated with cephalexin and diphenhydramine hydrochloride. It was reported that the patient had forgotten to tell the physician that she had been vaccinated the previous year with PNEUMOVAX 23. The patient sought unspecified medical attention. In follow up it was reported that the male patient developed an acute allergic reaction IMK which revealed local cellulitis. The patient was given a Medrol dose pack to use as directed. At the time of this report, the outcome of the events were unknown. The reporting physician considered the events to be other important medical events. No further information is available.
Within 12 hours of receiving the booster, I developed a fever of 100.4-101.0, severe body aches, night sweats, chills, exhaustion, nausea and bad headache. These acute symptoms lasted for 72 hours and then resolved. Approximately on 12/13, I developed a chronic headache/migraine at times (with some nausea) that has yet to resolve. It has been minimally responsive to OTC meds, chronic, and varying in degree from mild to severe. On 12/21, I went to my primary care doctor complaining of this same headache and nausea. He did a neurological workup and suggested bloodwork, prescribed antibiotics, offered RX pain meds (which I declined that day) and a return visit if it worsens. Two days later, 12/24, my headache began waking me up at night and increased in severity. I went to the ER where they performed a CT scan, bloodwork and prescribed migraine medication. On 12/26, symptoms exacerbated and in addition to the intense headache, the symptoms from my booster shot returned: body aches, chills, elevated temperature (99.7), nausea, and some additional pains including more muscle soreness, especially in my legs at night. I took an at home Covid-19 test and it was negative. I went to my primary care doctor again on 12/28 and he prescribed prednisone and urged I get bloodwork the following day. Today, 12/29, I met with a naturopathic doctor to discuss supplements to support my immune system and detox from the vaccine side effects.
Child had red swelling at site of injection  Started out @ 2 1/2 on then to over 6 1/2 cm round on 04/24/2002. Fever over 102 degrees F for 1 day Range of motion was fine and B/P was fine.
Chills, high temperature (102-104), fatigue, headache.  Treatment: Ibuprofen (initially),  switched to Aspirin; beginning 1 every four hours,  after two doses switched to 2 every four to 6 hours.  Outcome:  temperature subsided by morning of 1-31.  Headache continued but handled with Aspirin.
I got the COVID-19 vaccine on Saturday (janssen). I just wanted to let you know that I experience mid back pain after the covid vaccine was administer on my left arm. it felt like a sharp pain but only in my mid back area. by the evening i got chills and also a fever which i took tylenol, i felt nauseous, my head felt like it was not attached to my body, i havent sleep anything in 2 days. I had a severe migraine and also vomiting but most of all is the spinning of y head like when people have vertigo. I havent been able to eat food because it comes out both ways, either i vomit or constant diarrhea. i made a call to my doctor waiting for her response. this symptos started around 6pm on 03/06/21 and still until today 03/08/21
Minutes after shot felt pain in back of left knee. Left arm felt "heavy". That night left arm felt "asleep" (numb/tingling). The following days the sensation travelled throughout left side of body. Muscle twitches occured spontaneously all over body. Left calf became tight. The pins and needles sensation has persisted for two weeks since. Also, first night woke up every 2 hours with vivid dreams and feeling hot. Every night since has been similar. Vision now seems slightly blurry.
02/17-soreness and weakness of right, upper arm two hours after injection that lasted 48 hours. 02/17-four & one-half hours following injection, extreme tiredness & sleepiness that lasted 36 hours. 02/17-that evening, swelling and redness around injection site. Unable to sleep on right side as I normally do, because of soreness in upper arm 02/18-area about the size of a baseball at injection site  was red, swollen, hard, and hot to the touch. It stayed that way for about 36 hours. Then it began to shrink in size. 02/20-injection site turned a red/purple color about the size of a half-dollar, only slightly warmer than rest of arm. 02/21-upper arm began itching around injection site. When I looked in the mirror, there was a red rash covering most of my upper arm. It continued until 02/24. Went away for almost 24 hours, but returned. I continue to have itching, but only around the injection site. It is not as severe now as it had been. Applying ice pack to numb the itching helps.
pt in w/mom 8MAR96 w/prescription noted form PMD;mom said on this visit 8MAR96 pt had high pitched scream form 8PM 5JAN96 until 12MN then rested off & on 12MN to saturday AM 6JAN;seen by MD 6JAN96;given APAP x 48hrs;t100-101 by mom's report
chest congestion; My lymph nodes were swollen; my throat hurt; can't swallow; It affects the asthma; can't breathe; This is a spontaneous case received from a non-contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included asthma. Concomitant medications were not reported. The patient asked for information on the side effects with the vaccine for people with asthma because she had asthma and got sick from it. Her lymph nodes were swollen, throat hurt, she couldn't swallow and had chest congestion. It affected the asthma and she couldn't breathe. She was wondering if it was from the shot or not. She will have her second shot on Thursday. Outcome of the events was unknown.   No follow-up attempts are possible; information about batch number cannot be obtained.
Left arm became painful because shot given up "too high." Trapezius muscle spasms, unable to sleep for 2 weeks. No numbness. Lot of pain in the shoulder, wakes patient up at night.
A general myalgia began in the morning, about 10 AM, in addition to the standard injection site pain Headache began about an hour later, accompanied by fatigue.   Early in the afternoon I had shivering with a fever that reached 100.6. About 9 PM or so I had an episode of diarrhea, followed by another episode of diarrhea the next morning.
Patient felt dizzy, then threw up and sweating. She rested for 20 minutes then requested some water. I gave her a bottle water. She got better then left.
Patient just felt sore arm after each injection; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Patient just felt sore arm after each injection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 021A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 2 diabetes mellitus and Seasonal allergy. Concomitant products included METFORMINA [METFORMIN] for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient just felt sore arm after each injection). At the time of the report, PAIN IN EXTREMITY (Patient just felt sore arm after each injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was under a lot of medications, but she only remembered Metformin. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment details was not reported by the reporter.   This case was linked to MOD-2023-723800 (Patient Link).
Mom states pt had 2 episodes of "blacking out-fainting" p/leaving  clinic; Taken to ER seen by MD reportedly had URI & dec BP; MD uncertain about cause; 5DEC91 pt shook all over;
This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. 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: NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "I know two patients of mine that reported neurological issues". Additional information: Caller stated "nothings updated on there. Even the vaers was not 100% accurate because they know two patients that reported neurological issues and one a blood clot. And they filled it out. It was never even reported on there.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
rash near injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash near injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included DENOSUMAB (PROLIA), LISINOPRIL, BETAHISTINE HYDROCHLORIDE (VERTEX [BETAHISTINE HYDROCHLORIDE]), FAMOTIDINE (PEPCID AC) and ESTRIOL for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced INJECTION SITE RASH (rash near injection site). At the time of the report, INJECTION SITE RASH (rash near injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash is consistent with the product known safety profile.
She was diagnosed with Guillain-Barre and hospitalized; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization, medically significant), outcome "unknown", described as "Guillain-Barre". The patient was hospitalized for guillain-barre syndrome (start date: 05Sep2021).  Reported verbatim: The reporter wanted to find out whether reporter's daughter had a reaction to the Pfizer vaccine shot. She was diagnosed with Guillain-Barre and hospitalized. It was in the fall, so she was not hospitalized now but she was hospitalized. Discharge date was reported as 08Sep (year not clarified). Reason of hospitalization: Guillain-Barre.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient states that the afternoon after receiving vaccines her right arm began to hurt as she was counseled would occur and has continued to hurt ever since and that it is still hurting and she has limited movement in her right arm.
Patient return after 5 days and had a local reaction resembling shingles. About 3 x 3 area.
Local symptoms- soreness in both arms. General symptoms-tinkling in the back of the throat. jittery, itching, tingling i palms of bottom of feet.  Narrative:
Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.
This spontaneous report was received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX (lot # M023383, expiry date 11-MAY-2018, dose, strength, dose number, vaccination site, route not provided). No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. Additional information has been requested.
pt exp fever; was hosp on 3dec97 because of fever, diarrhea and thrombocytopenia purpura; also kept crying for almost 4 hours; PAR noticed stool had blood; pt tx w/ meds;
Client passed out while seated in observation falling to the right side of the chair and onto the ground Client landed face down on the floor and was turned over onto his side first before being flipped onto his back  Client?s head did hit the ground Client reportedly appeared to be having a seizure when he was turned over Multiple people were present to assist client including nurse and EMT  At12:09, LVN called 911 and relayed information to the dispatch While on the phone, nurse went to get an Ambu-bag because staff present reported that the Client stopped breathing but had a pulse   Upon bringing the Ambu-bag, the Client had already regained normal  breathing pattern and no longer needed assistance breathing .   Ambu-bag was present but was not used Client was assisted into a wheelchair and taken to the private recovery area. Physician, nurse, and EMT were present  Client was alert enough to answer questions Client began to vomit / dry-heave for a short moment Client asked EMT about transport billing and was informed that he might possibly get a bill  but that he had the option to choose not to pay it  At 12:20, Vitals taken BP 155/112, Pulse 64  Client informed of the need to be further evaluated at the hospital Client verbalized multiple times that he did not want to be transported even after speaking with the physician  Physician suspected that the client had some underlining reason that he did not want to disclose regarding his refusal to be transported At 12:25,  Vitals taken BP 135/83, Pulse 58, O Sat 97% Blood sugar reading 104 Client reports no pain in the head, no nausea Client reports that he did not eat anything prior to coming At 12:31, Ambulance arrives  EMT briefs paramedic regarding the incident and the client?s history Paramedics questioned client  Client signed  form and verbalized that he did not want to be transported and felt well enough to leave Client called his brother to drive him home At 12:41 Client was wheeled in the wheelchair to the car Client informed of selfcare and instructed to go to the hospital / ER if symptoms worsen or headaches develop Client informed to let further vaccine administrators know that he passed out in the past and needs to have the injection lying down Client verbalized understanding Client?s brother drove him home
11 days after my booster shot, I developed a rash on my arms, chest, and scalp. Treated with Benadryl. On November 5th my eyes started to swell shut and itch severely so I presented to urgent care. Received oral prednisone course and treated with Benadryl. Swelling subsided however full body hives continued. Was administered prednisone shots in my arm which appeared to help for several days but hives returned. Hives are not localized and appear all over body. This report is being submitted on 2/16/22 while I am still experiencing full body hives and itchiness all over body. Benadryl has helped with treating itchiness however is only temporary. Best relief has been by taking 50mg Famotidine HCL every evening before bed. After 3 months of famotidine, the hives still present after running out of medication. We have been under assumption that something in my environment (exposure to dirty boxes @ a charity event) was causing the allergic reaction. As more extensive cases of uticaria following mRNA boosters have been reported, it is becoming a larger known issue which matches my symptoms and timeline. I am not anti-vax, I?m glad I got my three doses and am protected from COVID. I just need help finding out how to cure these hives and get my life back to normal. I cannot keep treating with Benadryl and being in a constant state of drowsiness or hives. Please help me!