chrisvoncsefalvay/vaers-outcomes huggingface dataset:
in case of bacterial pneumonia; fever for 14 days; This spontaneous case was reported by a physician and describes the occurrence of PNEUMONIA BACTERIAL (in case of bacterial pneumonia) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A, 010A21A and 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-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 PNEUMONIA BACTERIAL (in case of bacterial pneumonia) (seriousness criterion medically significant) and PYREXIA (fever for 14 days). The patient was treated with AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) for Bacterial pneumonia, unspecified, at a dose of UNK dosage form and PREDNISONE for Bacterial pneumonia, unspecified, at a dose of UNK dosage form. At the time of the report, PNEUMONIA BACTERIAL (in case of bacterial pneumonia) outcome was unknown and PYREXIA (fever for 14 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood culture: negative (Negative) Negative. On an unknown date, C-reactive protein: negative (Negative) Negative. On an unknown date, Chest X-ray: negative (Negative) Negative. On an unknown date, Electrocardiogram: negative (Negative) Negative. On an unknown date, Laboratory test: negative (Negative) Negative. On an unknown date, Red blood cell sedimentation rate: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Patient had Augmentin for 7 days started taking on day 11 of fever and Prednisone for 5 days states today is last day of prednisone. "in case of bacterial pneumonia".  Patient had the Moderna booster dose and has had a fever for 14 days; Sender's Comments: This case concerns a 81-year-old, male patient with no relevant medical history, who experienced the unexpected event of Pneumonia bacterial and the expected event of Pyrexia. The events occurred on an unknown date after the third dose of mRNA-1273 Vaccine. The patient was treated with Augmentin and Prednisone and the lab tests done ( blood culture, chest x-ray, labs, EKG, ESR, CRP) all came back negative. The events had an outcome of unknown. The rechallenge was unknown since no information about the events of the earlier dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Headache, bone chilling chills, nauseas, fever, muscle joint pain, including eyesockets  jaw and cheek bones.  Skin on body sensitive to touch in places.  Nerves in left leg firing sharp pains.  Arm injection site bruised and painful.
Received Anthrax vaccine on 11 Apr 11, had itching around the vacc. site, noticed redness around the area 12 Apr 11, which has spread since yesterday. Pt came today for eval. I marked the erythematic area & referred him to his PCM for further eval.
A burning pain in "my" shoulder after 2 weeks; "My" arm was sore after shot. Still sore arm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 15:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and known allergies to peanuts and strawberry. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), potassium (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); all for an unknown indication from an unknown date and unknown if ongoing. On 31Mar2021 at 20:00 the patient's arm was sore after shot. Still sore arm at injection site. On an unknown date in Apr2021 the patient experienced a burning pain in her shoulder after 2 weeks. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. The patient also reported she was going to doctor that week. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm was sore after shot, still sore arm at injection site and burning pain in shoulder after 2 weeks was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster.
Redness & swelling @ inject site, soreness w/mobility of deltoid muscles x 3 days;
Chest Pain, Pleurisy diagnosis (Naproxen treatment), approximately 4 weeks of recovery time.
Tingling sensation on right side of face immediately after vaccine lasting around 15 seconds. Redness on right side of face lasting around 3 minutes and subsided gradually. Feeling heavy and hot for around 15 seconds and improvement over the course of 15 minutes. Rapid heart rate for around 5 minutes but returned to normal.
pt was given 1st dose of vax & 8FEB94; devel severe urticaria rash all over the body on the same evening;
Had pain in arm , shoulder, wrist and hand right away. The burning pain went away in about 2 weeks however I still have constant pain in my shoulder upper arm six months later. The pain has not gone away.
Pt's birth was normal. After 11 1/2 months pt was spelling. Say words correctly then approx. 1/2 month later, pt became a mute baby. He was then non-responsive. He now attends therapy PT, SP, OT.  MR received from PCP from 1/9/2003-5/30/2008. (Record is somewhat illegible). Seen 7/22/2003 for runny nose and cough x 5 days. Vax given. Occasional sick visits. 12 mon shots given 4/21/04. Parent expressed concerns re: developmental delays 4/25/06. Speech tx noted 7/31/06. 4yr check 7/02/07. PE WNL.  Dx Speech Delay 2/7/2008.
Pt developed fever 102-103, extreme irritability 3 hrs; Taken to ER; dx: rxn to DTP advised to use cold compresses for extreme swelling RL was unable to keep fever down w/APAP; MD advised to use DT & no further HIB;
Client reported waking up around midnight on 1/8/2021, that she had a Temp of 100 degrees, chills, whole body ached, felt really bad, this lasted about 24 hours.
Felt nauseous - BP 161/84, HR 76, O2 Sat 90% , went to emergency room
(R) deltoid with 9cm x 10cm area of erythema, warmth, slight swelling and discomfort to palpation. No streaking.
Information has been received from a physician concerning a 11 year old female who on 13-SEP-1999 was vaccinated with the first dose of MMR II (route, site, dose and lot number not reported), and on 02-JUL-2002 received the second dose of MMR II (route, site, dose and lot number not reported). On 06-DEC-2009 the patient experienced mumps (thought the date diagnosed was reported as 12-NOV-2009). The patient was afebrile. The labs showed serum mumps immunoglobulin M antibody test negative, serum mumps immunoglobulin G antibody test 1.2 and serum amylase test 39. Follow up information has been received concerning the 11 year old female patient who on 13-SEP-1999 and on 02-JUL-2002 was vaccinated with the first and second dose of MMR II (route and lot # unknown), respectively. On 09-JAN-2010, the patient experienced mumps (she was diagnosed on 13-JAN-2010). The patient had R parotitis. It was reported that there was unspecified exposure to others with mumps. At the time of the report the patient's outcome was unknown. No further information is available.
Numb, swollen  and tingling tongue and mouth (lasted for about a week) Headache, severe dizziness
Local site reaction (arm turned red) and fever of 101-102 degrees for 4 days starting about 6 hours after receiving the vaccine.  She also had joint pain once the fever started that has continued a day since the fever broke.
Rashes all over the body causing itching comes up every 2 days and goes away with Allegra. It has been almost 3 weeks now and they keep on coming.
Right upper arm, just below the injection site became warm, red, firm and itchy.  Size 3 inch x 2 inch.  Resembles an allergic hive.  No other effects noted. No treatment needed.  Continues for 30 hours after initial indication.
No additional AE details are available; a dose of MMR II which expired on 5/30/2021 was administered to a patient on 6/17/2021; This spontaneous report was received from a medical assistant and refers to a 11-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was not provided.  On 17-JUN-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, dose: 0.5 milliliter, lot # S016676, expiration date: 30-MAY-2021 (dose number, route of administration and anatomical location were not reported) for an unknown indication established as prophylaxis. The expired dose of vaccine had no temperature excursions. No additional adverse events were reported.
Developed Covid  Cough Fatigue Shortness of breath Been on antibiotics for 1 1/2 months
rash, bumps all over arms & chest;no blisters broke out, occurred w/in 4hr p/dose given, no allergies known;as far as knows pt isn't taking any med;
Severe splitting headache, nausea and vomiting, loss of appetite, aches in joints
I still have outbreaks/ suspected vaccination failure; Still have outbreaks, aren't as severe as they used to be; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 75-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (off and on since the patient was 35).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I still have outbreaks/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Still have outbreaks, aren't as severe as they used to be). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by patient via interactive digital media. The patient took the 1st shot when they first came out.  Then when 2nd shot came out the patient took it also. The patient still had outbreaks but they are not as severe as they used to be. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
COVID 19 Treatment/ Paxlovid Rebound; COVID 19 Treatment/ Paxlovid Rebound; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 01Apr2021 as dose 2, single (Lot number: ER8727), in right arm and on 23Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment/ Paxlovid Rebound". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (COVID-19 treatment).
Every morning I spray my nose with nasal spray and it burned my nose one day and that when I knew something was wrong. I set up an appointment to get tested and tested positive for COVID-19. I really didn't have any symptoms.  The second week after I had COVID-19 I started having chest pains. I went to the hospital and they used a camera to look at my heart. They found inflammation in my muscles around my heart due to COVID-19. My sugar went up while I was in the hospital and they kept me for 3 days until it went down.
This spontaneous report as received from a consumer of unknown age and refers to himself. No medical history was reported. The patient stated that he was not sure if he ever received ZOSTAVAX. In May 2015 (reported as 'over the weekend"), the patient visited a urgent care clinic and was told that he had shingles. Since there was a possibility patient might have received ZOSTAVAX (lot number, dose, frequency and route of administration not reported) on unspecified previoous date. No concomitant medications were reported. The patient sought for the medical attention and visited the clinic on unspecified date. The outocme of herpes zoster was unknown. The causality was not reported. The patient did not want to give further information. No product quality complaint (PQC) was filed. Additional information has been requesteed.
Major hot flashes all day long with sweat dripping and really bad when i'm on my period.
finger joints swollen stiff; finger joints swollen stiff; joint painful; This is a spontaneous report from a contactable other-HCP for herself (non pregnant). A 59 year old female patient received first dose BNT162B2 (Solution for injection, lot_number:EL3246) via an left hand of arm on 15Jan2021, at single dose for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After vaccination Patient experienced finger joints swollen stiff and painful on 18Jan2021. Facility most recent COVID-19 vaccine was administered at Hospital. Due to event doctor or other healthcare professional to visit the clinic. There was no treatment for the events. The event outcome was not recovered.  Information on Lot/Batch has been requested.
Patient experienced a lingering headache that increased in the days leading up to an ischemic stroke that occurred 16 days after receiving the second dose. Emergency Department CT confirmed an occlusion  of the midline cranial artery. TpA (clot buster) was administered on 3/3/21. Subsequent TEE confirmed a patent foramen ovale (PFO), which was closed with a surgical procedure on 3/30/21.
After injection a nodule formed at the injection site immediately. The nodule became the size of a marble and was firm. The patient did not feel different in any way and was not in pain. Massaged the area and monitored patient. After 3 minutes (11:33am), rechecked nodule and it was not growing, no redness, nodule was less firm than 3 min prior. Continued to monitor patient- no other signs/symptoms of allergic reaction were recognized. Checked nodule after 5 more min (11:38am) and it had dissipated but was not completely gone. I was able to massage the nodule and it was not firm in the center. Patient did not feel any signs/symptoms of allergic reaction or pain. Advised patient to monitor the nodule and call with any questions or concerns.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 at 17:30 as dose 5 (booster), single (Lot number: GJ3274) at the age of 49 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Lot number: EM9810), as dose 2, single (Lot number: EN6204), as dose 3 (booster), single (Lot number: FC3181) and on 08Jul2022 as dose 4 (booster), single (Lot number: FJ4991) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Migraines" (unspecified if ongoing), notes: Migraines; "Epilepsy" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. Past drug history included: Tegretol, reaction(s): "Allergy_Tegretol"; Cephalasporin, reaction(s): "Allergy_Cephalasporin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
I experienced the following symptoms after my booster shot: Hives Breakout (Primarily - abdomen, chest, back, both arms, and leg), and chest tightness.  I took some anti allergy medication for treatment but it did not work or did not do much so I decided to visit a doctor for consultation and he diagnosed me with  unspecified carinaria and was prescribed with Hydroxyzine Hydrochloride (25mg) . As of today 03/07/2022 I still experience some hives breakout on my chest, back and abdomen.
Breakthrough case admission after 2 vaccines Pfizer 2/9/21 Lot# EL9267;  Pfizer 3/3/21 Lot# EL6202
This spontaneous report was received from a nurse practitioner regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On 17-SEP-2016 and 20-SEP-2016, the patients were vaccinated with improperly stored (wistar ra 27-3) M-M-R II lot # L036851/expiration date- 23-SEP-2019, subcutaneous (incorrect product storage). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information is not expected as reporter does not wants to get contacted.
Extremely puffy face/neck/ears 3 days, then slowly subsided but skin flaked off massively over next 5-6 days, very dry.
Approx 1 wk following injection developed rash on chest progressing up neck to face, eyes, forehead. Intense burning in throat, nose, eyes. Pt did not seek help until around Christmas. Saw eye doctor rx for betamethasone. Which worsened reaction. Referred to dermatologist. Patch test shows allergy to thimerosal. Treatment with steroids, pt reported allergy to pharmacist on 02/03/2005.
Patient received vaccine on 3/10/21, she states that she did not have any redness or swelling. Today (3/24/2021) she developed a 2 inch red circle at the injection site with slight tenderness
NO ADVERSE REACTION. Child was behind on vaccines and came for a 9month visit at 11 months old. Had only received 1 other set of vaccines in their life. Vaccines were ordered correctly in the room for pt to receive Pediarix, Hib, and pcv15. The lab tech also administered a second dose of Rota. Vaccine was ordered after the mistake was made and documented. Parent was notified of all info including the risks
Expected redness/soreness roughly 24 hours after injection, not at site but medial to site. However, in early AM on January 1st, significant itching occurred along red area (medial aspect of L arm above biceps).
Information has been received from a pharmacist concerning a 78 year old female who on 24-MAY-2010 was vaccinated with ZOSTAVAX (Merck) (route and injection site not reported). The patient has had an injection site rash since it was given on 24-MAY-210. The patient did not seek medical attention. At the time of reporting, the patient's injection site rash persisted. Additional information has been requested.
Very loud tinnitus in both ears. I had mild tinnitus in my left ear before that didn't really interfere with my life. This is much louder than I've experienced previously and is impossible to ignore or sleep with. Also have body aches and sore arm.
Arm soreness around 3:00pm. Light headed and dizzy around 9:00 pm the day of the shot.  Light headed ness continued the next day along with a mental fog feeling. Chills began at 8:30 am until 1:00pm. General feeling of being unwell and body aching most of day..
Uncontrollable crying for about 4 hours.  Vomiting & spitting up phlegm and choking on it, pounding on his head with his hands.
This spontaneous report was received from a registered nurse via company representative regarding three patients of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. Improperly stored ROTATEQ with Lot# L029617 and Expiry date:19-MAY-2017 were administered to three different patient on 07-JUL-2016, 12-JUL-2016 and on 21-JUL-2016 (dose and route of administration information was not reported). No adverse effects were reported. Temperature and time frame: 8.6 C for 3 hours and 41 minutes; -10.1 C for 1 hour and 10 minutes and 9.8 C for 4 hours and 5 minutes. Previous temperature excursion: 8.8 C for 43 minutes; -0.1 for 3 hours and 18 minutes. The temperature was adjusted back to range. The call was because of data logger. No product quality complaint was reported. This is one of the two reports (Same reporter link : WAES1608USA10262). Additional information has been requested.
reaction; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction). At the time of the report, VACCINATION COMPLICATION (reaction) outcome was unknown.        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 relevant concomitant medications were reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-068997, US-MODERNATX, INC.-MOD-2021-069012 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-069012: US-MODERNATX, INC.-MOD-2021-068997: