chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received one shot of pneumococcal 13-valent conjugate vaccine and had an allergic reaction; sensitivity to other allergens/she now has an allergy to nuts and fish; Arm Swelling; Asthma; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration in Mar2018 at a single dose in the arm for immunization. The patient's medical history and concomitant medications were not reported. The patient received one shot of pneumococcal 13-valent conjugate vaccine and had an allergic reaction on an unspecified date. The allergic reaction was clarified as arm swelling for one week. However, it was not specified which arm. She also had asthma for two months since Mar2018 to 2018, unable to confirm which month ended and had sensitivity to other allergens that started and continuing. Since getting the shot, she now has an allergy to nuts and fish since an unspecified date. Outcome of the events arm swelling and asthma was recovered, for event sensitivity to other allergens/she now has an allergy to nuts and fish was not recovered and unknown for other event.  Information on the lot/batch number has been requested.
Pt came in 2/1/23 to the pharmacy and reported having pain in her arm at the injection site ever since injection on 12/27/22.  I advised her this did not sound like a normal reaction and she should follow up with her doctor.
PRIOR TO RECEIVING THE BOOSTER VACCINE; Pain; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (054550).  A 39 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "PRIOR TO RECEIVING THE BOOSTER VACCINE"; PAIN (non-serious), outcome "unknown", described as "Pain". Therapeutic measures were taken as a result of pain.  Additional information: Pt stated she has been on leflunomide to help with pain. Pt delayed [xeljanz] dose due to md instructions prior to receiving the booster vaccine. Xeljanz start date not provided  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
He was immunized at the appropriate ages (12 months and 4 years) with Varivax vaccine.  No history of chicken pox disease.  Three days after he received Menactra vaccine on 8/20/2021, he developed Zoster (Shingles) in the same arm.  This was the same arm he had received second dose of Varivax  in 13 years prior.  I suspected vaccine strain Zoster, perhaps triggered by the stress of Menactra vaccination.   Menactra lot number U6951AA, PMC  given left deltoid 8/20/2021 Varivax lot number 0154X given left arm 9/2/08 Varivax lot number and site of administration unavailable given 8/29/2005
This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 16-SEP-2015, the patient were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336, the expiration date: 17-AUG-2017 (dose and route were not reported). The total cumulative hours out of range were 56 hours with 48 degrees C as the highest recorded temperature. On the other hand, the total cumulative hours out of range were 328 hours with 29 degrees C, 264 hours with 33 degrees C as the lowest recorded temperature. The storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint (PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
No adverse event but received the incorrect vaccine.  Should have received the Pfizer Bivalent Booster
Client came on 7//23/21 and received dose #1 of Moderna. Client returned on 8/17/21. Clerical staff registered client and wrote that she was due for Pfizer #2.  Client did not have vaccine card and was poor historian. Nurse did not confirm utilizing history.  Client received Pfizer on 8/17/21. Medical director notified and because CDC sees the 2 MRNA vaccines as essentially interchangeable, he was not concerned. VM left for client to discuss.
Information has been received from a consumer concerning his 18 week old son with no medical history and no drug allergies, who on 07-DEC-2007 was vaccinated with a second dose of PEDVAXHIB (OMPC).  Concomitant suspect vaccinations included ROTATEQ and pneumococcal vaccine (manufacturer unspecified).  Other concomitant vaccinations included poliovirus vaccine, and DtAP (unspecified).  On 08-DEC-2007 the patient experienced diarrhea, fever, was moaning, and was very lethargic.  It was reported that the patient's symptoms lasted for about thirty six hours, but the patient was still experiencing diarrhea.  The physician was contacted by phone.  No laboratory diagnostics were performed.  At the time of the report, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Within 10 hours of second dose of Moderna vaccine, I had chills, slight fever (99.5F), fatigue.  On the third day  post second dose, I began to experience mouth soreness with small intramural blisters, but also two larger blister-like lesions left to the philtrim area of my upper lip.  Either the same day or after, I began to notice sensitivity to light and what appeared to be conjunctivitis.
Immunization administered after expiration date of 9/30/22, however per the manufacturer the stability was good through 10/19/22. No adverse events, no treatment, patient is fine.
Initiallly decrease in hearing in left ear with feeling as if it was filled with water, then general head congestion. Followed by dizziness, feeling of unsteadiness, normal temp at 7 p.m., but temp at 11:30 p.m. 100.4 and generalized feeling of malaise. This persisted for approx 10 hrs. but symptoms gone upon awakening next morning.
FLU VACCINE GIVEN WAS INTENDED FOR CHILDREN ABOVE 3 YEARS OF AGE. PATIENT HAD NO REACTION TO VACCINE. NOTIFIED FAMILY OF MISHAP. NO NEED TO REVACCINATE.
Received vaccination at the workplace, and returned to his job in the kitchen. Approximately 5 minutes after he received the IZ, patient lost conciousness and fell on the heavy rubber floor mat of the kitchen. He was BP was 90/44 and faint radial pulse, slow to respond. EMT were called.
pt pale, hot, trembling, vomited;mini sz (legs, jerking) T102 fever,visited ER;
Metallic taste; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Mar2021 at 16:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and allergies to cillin based medications. 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 lansoprazole (PREVACID), pioglitazone (MANUFACTURER UNKNOWN) and unspecified birth control; all for an unknown indication from an unknown date and unknown if ongoing. On 09Mar2021 at 17:00, the patient experienced metallic taste. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event metallic taste was resolved on an unknown date in Mar2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient experienced severe nausea and vomiting, lethargy and weakness 5 minutes after receive dose of vaccine.  Patient went to the bathroom and was dry heaving and 911 was called and treated her.  Her bp was elevated and she was stll weak.  The paramedics treated her but she declined to go to the hospital and decided to go home and rest and if symptoms persisted she would go the hospital.
Patient broke out in rash on neck and arms, May 17th 2021, two days after 1st covid vaccine.  The rash lasted 2 days and went to the walk-in clinic on May 19th, The rash was diagnosed as allergic reaction and treated with oral steroids and an anti-histamine.  Patient had a liver transplant 2 years ago and still is a patient at facility.  She had a visit at Facility this past Monday, May 31st 2021.  They are aware of the rash and the reaction to the first vaccine but told patient she must get the 2nd dose (strongly recommended). I discussed with her and guardian signs and symptoms of allergic and when to seek immediate medical attention.  They understood the risks of an allergic reaction with 2nd covid dose and what to do.
General side effects after 1st and 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (General side effects after 1st and 2nd dose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, 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 (General side effects after 1st and 2nd dose). At the time of the report, VACCINATION COMPLICATION (General side effects after 1st and 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was provided. No treatment  was provided.   This case was linked to MOD-2022-439047, MOD-2022-439468 (Patient Link).
This spontaneous report was received from a healthcare worker concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. In approximately 2015, reported as "since 01-JUN-2015 on unspecified dates", unspecified patients were vaccinated with doses of PNEUMOVAX 23 (Lot # K020795 Expiration date: 19-MAR-2016, K020215 Expiration date: 15-MAY-2016 and K019386 Expiration date: 09-JUN-2016), which were exposed to temperatures outside of the recommended range (dose, route and anatomical location of administration were not reported). No adverse experience has been reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Pt recvd 1st dose of Hep B vax approx DEC91; approx 30 mins to an hr following vax devel hives; No further details were provided;
Headache, nausea, body aches, fever 103f, severe rigors unrelieved by Tylenol and Motrin for 6 hours the night of the injection. Continued low grade fevers (100.4-100.8) and malaise, nausea, headache for the next two days. And sore arm
Vaccination site pain; Itches a lot; Swollen; Red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE PRURITUS (Itches a lot), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itches a lot), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red). On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE PRURITUS (Itches a lot), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
R09.02 HYPOXIA 4/20/2021 ANOXIC ENCEPHALOPATHY R09.02 HYPOXIA 4/20/2021 SEPTIC SHOCK
Patient came into pharmacy to pick up a prescription and said that after she the Pfizer vaccine on 6/20/21 that her heart started beating very fast and she had flushing /heat around areas of her body close to her heart. She said she had this effect for up to a week after the vaccine but wasn't sure if the vaccine caused this or something else so she didn't mention it until today. She said she hasn't got her 2nd dose of the vaccine because she was afraid of having this effect again. I recommended that she discuss her adverse side effect with her physician.
Large cellulitis / exanthem, warm to touch at site of vaccination, Left arm pain, Numbness
The patient observed to be flushed, lightheaded, and nauseous 10 min after the vaccine. Denies, trouble breathing, chest discomfort, or difficulty swallowing, facial swelling, or notable rash. Did not eat breakfast that morning and was nervous about receiving the vaccine. Slightly tachycardic. Given cetirizine 10 mg with relief.
Chills, body aches, joint pain, loss of energy, head aches, Kidney pain, shortness of breath and coughing. Teeth hurt,  Point of injection sore ness
1 day after receiving vaccine began developing facial rash - unknown if related to vaccine?  Patient was seen in clinic for first time 6 days after vaccination for this mild facial rash.
RIGHT EYE CLEAR LIQUID SECRETION; RIGHT EYE WAS SWOLLEN SHUT; ARM SORENESS; REDNESS OF FACE; SWEATING; This spontaneous report received from a patient concerned a 45 year old female. 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 and batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced redness of face. On 10-APR-2021, the subject experienced sweating. On 10-APR-2021, the subject experienced arm soreness. On 12-APR-2021, the subject experienced right eye clear liquid secretion. On 12-APR-2021, the subject experienced right eye was swollen shut. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right eye clear liquid secretion, and right eye was swollen shut on 12-APR-2021, and redness of face, and sweating on 11-APR-2021, and was recovering from arm soreness. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Dose administered prepared on 7/2/2021 and administered on 7/5/2021.  Pt did report s/s following error.  Moderna study did not recommend re-vaccination.
gave the full dose in vial without diluting the pediatric covid vaccine  no symptoms or signs of adverse reaction at time or at 4hr mark
pain injection site; aches all over her body; felt like I was hit by a truck; heart rate was faster than normal; This spontaneous case was reported by a consumer and describes the occurrence of   in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020. Concomitant products included METOPROLOL for Heart rate increased.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pulsing in both ears still occuring; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and TINNITUS (Pulsing in both ears still occuring) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath). On 18-Mar-2021, the patient experienced TINNITUS (Pulsing in both ears still occuring). At the time of the report, DYSPNOEA (Shortness of breath) had resolved and TINNITUS (Pulsing in both ears still occuring) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Reporting per Pfizer that patient tested positive for COVID post-vaccination (1/21/2021) and was hospitalized (1/24/2021).  Patient received Bamlanivimab treatment 1/22/2021, 2nd dose will be deferred 90 days per PCP.  Patient admitted for hypoxia, improved SPO2 to >95% on room air, and was discharged back to ALF 1/25/2021.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/15/21 (en6201) Pfizer Dose 2 3/11/21 (EN6205) Pfizer Dose 3 12/2/21 (FH8027) COVID Positive 12/21/21  12/21/21: The patient complaining from generalized weakness and fatigue, decline fever or chills or cough or shortness of breath or abdominal pain or nausea or vomiting or diarrhea, no chest pain or palpitation. The patient is vaccinated for COVID-19. His labs show stable CKD, he does have pyuria, chest x-ray show possible pneumonia.  COVID-19 test is positive.  12/27/21: The patient admitted for worsening COVID symptoms and Aerococcus UTI s/p Ceftriaxone course  The patient is vaccinated for COVID-19.  Patient not requiring oxygen during hospitalization but had respiratory insufficiency while ambulating  He was managed with IV steroids. No remdesivir given because of kidney function  Patient's symptoms improved. He is hemodyanmiclly stable  Patient accepted at home and will be discharged today
Patient had received vaccination,   He was standing in front of "drop off" to get his appointment for the second immunization and fainted.  He went to the floor flat on  his back. The tech called my name and I went out the door to find him on the floor in a semi-conscious state.  When I knelt beside him, his eyes opened and I asked him several questions to  establish that he knew who he was and where he was at.  I asked him to remain on the floor until I could verify that he had no injuries to his head or limbs.  Once that was established, I helped him stand and provided a chair for him.  He stated that he didn't know why he fainted.  I asked if he had eaten .  He said he was fasting today.  I sent the tech to get him some orange juice and a roll, which he consumed. most of.  I kept him for another 20 minutes.  he said he felt good and would eat a meal at home.  I called him at his residence at  7:45pm this evening.  He stated that he felt good except for the sore arm where I administered his vaccination.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 01Apr2021 as dose 2, single (Lot number: ER8737), in left arm, on 31Aug2021 as dose 3 (booster), single (Lot number: FE3184), in right arm and on 09Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Ulcerative Colitis" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ, start date: 01Dec2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid Rebound. Two days after completing Paxlovid I developed a runny nose, congestion & cough with fatigue.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a licensed nurse practitioner refers to a patient of unknown age. On 18-JUN-2018, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # N026686, expiry date: 30-MAR-2019) (route: oral) (incorrect product storage). The vaccine was exposed to a temperature of 47 F to 77 F at a time frame of 8 hours, 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. This is one of the three reports received from the same reporter. Sender's Comments: US-009507513-1808USA001326: US-009507513-1808USA001701.
The first symptoms appeared on 2/23/98 which were fever, vomiting diarrhea, dehydration. These occurred immediately following; a loss of eye contact and interest in engagement with others, repetitive movements and speech, echoalic speech, insomnia, destructive behavior without remorse or understanding of what was done. FOLLOW UP information received on 08/02/02 states, "Autism-socially impaired, sensory integration dysfuntion, speech delay, self-regulatory dysfunction".
2 days after MMR/varicella/Dtap/flu vaccines, developed a measles-like rash that lasted about 2 weeks. 1 week after same, developed a varicella rash lasting a few days.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 09-NOV-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L018501, expiry date-22-JUN-2017) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Rash on her torso; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash on her torso.  The patient's medical history was not provided. Concomitant medications reported were gabapentin, trazadone, duloxetine for drug use for unknown indication.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 014M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the event(s) rash on her torso.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash on her torso was Not Recovered/Not Resolved.