chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt with urticaria, swelling to face and itching to mouth that occurred within 10 minutes of administration. She was treated with benadryl 50 mg IM upon onset of symptoms. She did not have any stridor, hypoxia, or tachycardia or hypotension. She did have a change in pulse from 70s to 100 then back to 70s 10 minutes after administration of benadryl and stated she has a paradoxical reaction to benadryl.  She experienced pallor and livedo after administration of benadryl which resolved after 15 minutes. She experienced urticaria on 01/01/21 into 01/02/21 requiring continued antihistamines which did subsequently improve.
Six weeks later I tested positive 29May, Started 5 day Paxlovid series same day (second time Paxlovid) Today, 13 days later still testing positive; Six weeks later I tested positive 29May, Started 5 day Paxlovid series same day (second time Paxlovid) Today, 13 days later still testing positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), in Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 83 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: ENBREL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Six weeks later I tested positive 29May, Started 5 day Paxlovid series same day (second time Paxlovid) Today, 13 days later still testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (13Apr2022) negative; (29May2022) positive; (10Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. The vaccine Lot was unknown as it was not available/provided to reporter at the time of report completion. Patient received other medication in 2weeks: Enbrel and Paxlvoid. Patient was Home test positive. He started taking Paxlovid. On second day a hospital test was negative. I continued and finished 5 day series. Paxlovid was started on 12Apr2022 to 16Apr2022. Six weeks later he tested positive 29May at 12:00 AM, Started 5 day Paxlovid series same day (second time Paxlovid). Today, 13 days later still testing positive. Symptoms not problem for me that I know of.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Painful cramps in thigh and foot making walking impossible. Occurred around midnight lasting almost an hour.  Very rapid breathing lasting 6 hours starting at midnight through the next morning at 6:am.
20SEP98 diarrhea;28SEP98 rash from abd area to lack & face;fever;
found, pink but unresponsive, could not be revived-prev noc fed well;
Information has been received from a physician concerning a 12 year old male who on 24-OCT-1995 was vaccinated SC with a dose of Varivax. On 04-JUN-2006 the patient developed a breakthrough case of chickenpox. Unspecified medical attention was sought. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Vaccination site pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.  The patient did not had any problems after first two doses.   Reporter did not allow further contact
felt a little bit of soreness.; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A 73-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 13Feb2021 (at the age of 73-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. In Feb2021, he felt "a little bit of soreness" within 12 from receiving the Pfizer-BioNTech COVID-19 Vaccine. He is currently fine. He is scheduled on 26Feb2021 for a dental appointment to remove a temporary crown. He mentioned that he would be given a local anesthesia, and asked if this would have any interaction with the vaccine. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
This is a spontaneous report from a contactable pharmacist reported through a Pfizer sales representative. A 57-year-old female patient of an unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for pneumococcal disease. The patient medical history and  concomitant medications were not reported. The patient experienced developed a golf ball size swelling on arm after injection on an unspecified date with outcome of unknown.
Patient states got a fever day after receiving the immunization which happened for 2 days. Received Prednisone 20 mg take one tablet 2 times a day for 5 days on 1/14/2019 because of a sinus infection. 3 months later a bump has developed at the injection site. Patient states that they have not seen a doctor about their arm.
This spontaneous report as received from a pharmacist refers to a patient (id# 422) of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX23 on 24-AUG-2012. Lot# was reported as 0087AE, expiration date: 18-AUG-2013. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes. From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reported received from same source. 1209USA007525, 1209USA008597, 1209USA008598, 1209USA008599, 1209USA008600, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614. Additional information has been requested.
Systemic: Child does not feel well-Mild, Additional Details: Mother only described that the child is not feeling well today. Additional details not available.
fever; injection site tender; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and INJECTION SITE PAIN (injection site tender) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and INJECTION SITE PAIN (injection site tender). At the time of the report, PYREXIA (fever) and INJECTION SITE PAIN (injection site tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt recv vax & 5mo later pt exp a zoster-type rash (grouped vesicles on erythematous base) on lt hand & arm proximal on elbow;cult of lesion was unable to detect any virus;
Patient received 3 doses Dose 1: 03/10/21 Lot EN6205 Dose 2: 03/16/21 Lot 003A21A
Fatigue,   Vomiting  Fever  Chills  Mouth Ulcers 3-4 days later  Loss of appetite for 2 weeks
On 11/2/17 she ate poorly, fever of 100.4 during the day. Mother took her to Dr.'s office and Dr. said she thought it was a cold. Then on 11/2/17 around 8:30 pm., she developed 4 hives on left mid thigh which went away without Benadryl. No further rash or hives. Mother states child didn't seem to want to scratch area.
Patient described visual disturbances in left eye, with "orange" appearance. Re-evaluated patient with vital check; all within normal limits, provider did eye exam, no abnormalities noted on exam. Advised if continues, to schedule office visit with eye doctor. Follow-up via phone to parent the next afternoon; patient's visual disturbance had resolved and no other issues.
No addittional adverse events reported; she administered a dose of VARIVAX via the intramuscular route; This spontaneous report was received from a pharmacist referring to a patient of unreported age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 11-MAR-2022, the patient was vaccinated by the pharmacist with a 0.5 ml dose of varicella virus vaccine live (oka/merck)(VARIVAX) via the intramuscular route (incorrect route of product administration ) for prophylaxis (lot # T032317, expiration date: 22-SEP-2022; vaccination scheme frequency and anatomical location not reported). No additional adverse event (AE) reported (no adverse event ).
Pink papular dermatitis on outer arms shoulder to hand and anterior thigh and lower legs (B). Plan: No treatment advised. Follow up if not resolve in one week. May use BENADRYL 3-5ml if itchy. Call if worse.
May 8th 2021, 14:00h, first vaccination: May 9th: Severe pain in vaccinated arm Night form 9th to 10th of May: Cold chills, fever (38,5?C), continued pain in vaccinated arm, very severe muscle pain going beyond existing chronic myopathy, throughout neck, back, both arms, hips and legs. It felt like I had a severe flu.  May 10th: Fever dropping back to normal by the evening. Rest of symptoms remain. Severe myalgia. May 11th: symptoms remain. Myalgia. May 12th: slightly feeling better, but cold sore on both sides of mouth manifest May 13th: Doing much better May 14th: symptoms gone, except for cold sores that lasted an unusual 2 weeks  June 19th, 15:30h, 2nd vaccination: Sore throat starting in late evening Night form 19th to 20th of June: Cold chills, fever (38,5?C), continued pain in vaccinated arm, very severe muscle pain going beyond existing chronic myopathy, throughout neck, back, both arms, hips and legs. Throat infection with swollen lymphs. It feels like I have a severe flu.  June 20th: Fever dropping back to normal by afternoon. Rest of symptoms remain. Severe myalgia.
initially started with body aches at 11:00 am on 1/4/2021 and then developed a fever and chills at 4:00 and 5:00 severe body aches with difficulty moving/walking due to pain and also had slight sore throat - best description is I felt like I had been hit by a truck.  Napped from 5-6:30 and then to bed at 10:00.  Woke up on 1/5/2021 without body aches but continued with slight ichy throat and feeling like the roof of mouth and tongue were burnt.  Continuing to feel those symptoms on 1/6/2021
pain in the lymph nodes; The patient received her first dose (lot #027C21A) of Moderna COVID19 Vaccine on 26May2021; Body aches; Lymph node swollen; throat pain; pain in her navel area; loose stools; diarrhea that was quite severe, multiple episodes per day for 10 days; This spontaneous case was reported by a pharmacist and describes the occurrence of DIARRHEA (diarrhea that was quite severe, multiple episodes per day for 10 days), OROPHARYNGEAL PAIN (throat pain), ABDOMINAL PAIN (pain in her navel area), DIARRHEA (loose stools) and LYMPH NODE PAIN (pain in the lymph nodes) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced DIARRHEA (diarrhea that was quite severe, multiple episodes per day for 10 days). On 07-Jun-2021, the patient experienced DIARRHEA (loose stools). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (throat pain), ABDOMINAL PAIN (pain in her navel area) and LYMPH NODE PAIN (pain in the lymph nodes). On 07-Jun-2021, DIARRHEA (diarrhea that was quite severe, multiple episodes per day for 10 days) had resolved. At the time of the report, OROPHARYNGEAL PAIN (throat pain) had resolved and ABDOMINAL PAIN (pain in her navel area), DIARRHEA (loose stools) and LYMPH NODE PAIN (pain in the lymph nodes) 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.   Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
patient has new muscle pain the radiates up into the neck, also has "shocking" sensation on and off since Saturday. advised patient to follow up with md to ensure issue not from another unknown source
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 5-month-old patient who received KINRIX. Previously administered products included dtap/ipv (1st dose). On an unknown date, the patient received KINRIX at an unknown dose. On an unknown date, an unknown time after getting KINRIX, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.
Patient developed low grade fever, fatigue, aches 11/14/23.  Morning of 11/15/23 acutely confused, vomited multiple times.  Sent to ED 11/15/23: CT head, MRI brain negative, labs, UA, chest x-ray without abnormal finding. Viral pathogen testing negative.  Dx with delirium, improved with time.
swelling of her arm; Hurting of her arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling of her arm) and PAIN IN EXTREMITY (Hurting of her arm) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PERIPHERAL SWELLING (swelling of her arm) and PAIN IN EXTREMITY (Hurting of her arm). At the time of the report, PERIPHERAL SWELLING (swelling of her arm) and PAIN IN EXTREMITY (Hurting of her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. On 03Feb2021, her symptoms are back to what they were and are just as bad as originally.
Blood Clots in left leg; This is a spontaneous report from a contactable 74-year-old male consumer (patient) reported for himself that he received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8733) via an unspecified route of administration into the left arm on 07Apr2021 (at the age of 73-year-old) as single dose for COVID-19 immunisation. The patient medical history included blood pressure and blood disorder. Concomitant medications included lisinopril for blood pressure and baby aspirin to keep his blood thin. He started taking lisinopril 10-15 years ago. His blood pressure was under control with it. He stated he has been taking baby aspirin for years. Doctor advised him to quit taking it while he was taking Eliquis. He stopped taking it on 20Apr2021 when he was diagnosed with blood clots. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6205, Expiry date: unknown) via an unspecified route of administration into the left arm on 17Mar2021 as single dose for COVID-19 immunisation. He stated that on 07Apr2021 he received his second shot. On 20Apr2021, the patient reported of blood clots in left leg that showed up after the Pfizer Covid vaccine which was continuing. Never had a blood clot in his life until now. On 20Apr2021, he went to the doctor and was told he had blood clots in left leg. His doctor sent him to the emergency room for testing. The doctor told him he was on blood thinners until August and put him on Eliquis. On 20Apr2021, test results showed sonogram positive for blood clots in left leg. He was not admitted to the hospital as there were no beds available. They were full and kept him there for about 6-8 hours and sent him home. Report was not related to a study or programme. The patient took Pfizer Covid-19 Vaccine because of COVID-19. Investigation assessment done. Patient provided age at time of blood clot diagnosis as 74. No further information provided. No additional vaccines were administered on same date of the Pfizer suspect nor any prior vaccinations within four weeks. Outcome of the event was unknown.
rash at the injection site; itchy at the injection site; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash at the injection site), INJECTION SITE PRURITUS (itchy at the injection site) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included RIVAROXABAN (XARELTO), FUROSEMIDE, METFORMIN, LISINOPRIL and THYROID (ARMOUR THYROID) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced INJECTION SITE RASH (rash at the injection site), INJECTION SITE PRURITUS (itchy at the injection site) and NAUSEA (Nausea). At the time of the report, INJECTION SITE RASH (rash at the injection site), INJECTION SITE PRURITUS (itchy at the injection site) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient used dalcaecarm 240mg for unknown reasons.  Patient applied Something warm on arm  for the symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: No new information was provided.
Patient reported numbness on the face after 15 mins after the 1st dose of Pfizer and 5min after the 2nd dose of Pfizer.
Itchy skin, rashes, hives 1 1/2 hours after having Tdap and MENVEO.
Yeast infection in mouth, noticed 3 days after inject given lasted 2 1/2 wks. Only tx ate alot of yogurt & sx left on their own.
Information has been recvd from a registered nurse. On 11/2/00, pt developed redness, warmth and hives on the upper arm. The pt observed this, and on an unspecified date, the symptoms subsided. The pt was seen on 1/4/01 for a non-associated visit. Conflicting follow-up info recvd from the registered nurse reported that the pt was vaccinated on 11/2/00, and the pt stated that she "had a local irritation and generalized rash approximately one week later." The pt did not inform the MD's office of the adverse experienced until 1/4/01. It was reported that the pt recovered in 12/2000. No further info is expected.
pt claims to have pain in upper arm area and decreased arm motion due to vaccine. says he did not feel any effects day of vaccine, but felt severe pain and loss of motion the day after
Arm hurt so bad it went all the way up an around back of my neck; I had migraines; Lost weight; Real fatigued; Fever; Chills; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt so bad it went all the way up an around back of my neck), MIGRAINE (I had migraines), WEIGHT DECREASED (Lost weight), FATIGUE (Real fatigued) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 PAIN IN EXTREMITY (Arm hurt so bad it went all the way up an around back of my neck), MIGRAINE (I had migraines), WEIGHT DECREASED (Lost weight), FATIGUE (Real fatigued), PYREXIA (Fever), CHILLS (Chills) and VOMITING (Throwing up). At the time of the report, PAIN IN EXTREMITY (Arm hurt so bad it went all the way up an around back of my neck), MIGRAINE (I had migraines), WEIGHT DECREASED (Lost weight), FATIGUE (Real fatigued), PYREXIA (Fever), CHILLS (Chills) and VOMITING (Throwing up) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       All these symptoms went on for a week. No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2021-220850 (Patient Link).
rec'd on 2/12 and didn't have much of a reaction until 8 days later it felt like the shot was just received, arm began to sting and red and itchy and that's been since 2/12.
Idiosyncratic/probable reaction.  Patient noticed induration at injection site on 4/19/06; over the course of 5 days patient developed cellulitis from shoulder to elbow (swelling, pain, fever, leukocytis) & was admitted for IV antibiotics (cefazolin, vancomycin). Patient improved and was discharged on 4/27/06 with outpatient antibiotics.  12/22/06 Received medical records from hospital which reveal patient admitted 4/23/05-4/27/05 with RUE cellulitis s/p tetanus vax.  Improved on antibiotics & continued on oral antibiotics at home.   Final DX:  RUE cellulitis, improved.
Patient had severe swelling about the size of a baseball, redness, warm to the touch, and severe itching. Patient treated with BENADRYL tablets and Cortisone cream.
Urticarial wheal at injection site of varicella vaccine within 5 minutes of injection.