chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt came in with mother on 09/07/2007 and received a varicella vaccine subq into RPUA without pain or incident.  On Monday 09/10/2007 mom reported to school nurse child went hunting with dady on Saturday (09/08/2007) and Sunday (09/09/2007) am and on Saturday afternoon c/o arm being sore and again on Sunday afternoon but mom did not look at arm till Sunday afternoon then saw about orange size area of reddnes, sl swollen and tender, and red rash to belly.  She put ice to area and gave child Tylenol. On Monday morning area was less red, less sore, but rash was on belly and back. School nurse checked rash and reported it to be sl grandular feeling.  Child never had fever. No drainage noted from site.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unknown doses of GARDASIL 9 (lot # L020015 with expiry date 16-AUG-2014, lot # L011846 with expiry date 16-JUN-2017 and lot # reported as L040459 with expiry date 06-APR-2014), which were exposed to the temperature of 1.5 degree Celsius for 265 hours and 19 minutes. There was no previous temperature excursion. No adverse effects were reported. Lot number L040459 is an invalid lot number for GARDASIL 9. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 19-FEB-2014, the patient was vaccinated with expired PNEUMOVAX 23, lot # 1947AA, expiry date 20-OCT-2013, dose (unknown) and route of administration (unknown), for unknown indication. No concomitant medications were reported. Pharmacist mentioned PNEUMOVAX 23 did not have any previous temperature excursions. No adverse symptoms reported. No product quality complaint was involved. The outcome of events was unknown. No further information provided. Additional information has been requested.
04/18/2021  Typical symptoms... Fever 102-103, headache, nausea, fatigue...  NonTypical symptoms.... left side of face by mouth felt numb (like getting numbing at dentist); Slept all day but kept waking up because left arm, right arm, left leg fell asleep or numb.    04/19/2021 Today  Fever Broke and just feel fatigued.  Numbness and limbs falling asleep seems to have gone away.
3 days after vaccination, patient developed diffuse rash and intermittent unexplained fevers.
feels like it's burning at night; couldn't stand up straight; sciatica acting up but it has never lasted that long; more achy than sore; aches and pains down left side, down her back to left leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (aches and pains down left side, down her back to left leg), BURNING SENSATION (feels like it's burning at night), DYSSTASIA (couldn't stand up straight), SCIATICA (sciatica acting up but it has never lasted that long) and MYALGIA (more achy than sore) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (aches and pains down left side, down her back to left leg). On an unknown date, the patient experienced BURNING SENSATION (feels like it's burning at night), DYSSTASIA (couldn't stand up straight), SCIATICA (sciatica acting up but it has never lasted that long) and MYALGIA (more achy than sore). The patient was treated with NAPROXEN SODIUM (ALEVE) for Sciatica, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (aches and pains down left side, down her back to left leg), BURNING SENSATION (feels like it's burning at night), DYSSTASIA (couldn't stand up straight), SCIATICA (sciatica acting up but it has never lasted that long) and MYALGIA (more achy than sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Patient provided consent for safety to Follow-up.
2 1/2 hours after the shot, I felt pressure building in my head, my eyes felt bulging, my throat felt tight, and I started having an asthma attack
This is a spontaneous report received from a contactable reporter(s) (Other HCP). A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Test positive again after 2 negative test; Negative, notes: Test positive again after 2 negative test; Negative, notes: Test positive again after 2 negative test. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Anti-viral details: product: COVID-19 Treatment, treatment start date: 13May2022 and stop date: 18May2022, indication is used for treatment of COVID-19, administrator route=Oral Adverse event: Test positive again after 2 negative test. If patient received treatment is Unknown. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s): US-PFIZER INC-202200787479 Same patient, different product and event.
Pfizer-BioNTech COVID-19 Vaccine EUA  Pain at injection site   Fatigue Felt ?feverish?
Striking induration of right deltoid area with surrounding ill-defined erythema of upper half of arm. Rx: PO Keflex in ER. Complete resolution with in 2 weeks.
vasovagal rxn following inj, brief syncope X4 sec. monitored X39 mins, orthostatic VSS, given ginger ale and crackers with improvement. MD evaluated pt, ED eval not recommended. No s/s anaphylaxis.   advised to return to  ED if feeling worse today.
Chills and low grade fever within 24 hours followed by red and tender left posterior cervical or supraclavicular node along with mild redness and tenderness left shoulder.
Pt adm 1st dose of vax ID experienced numbness in his wrist; Rec'd 2nd does & experienced a more pronounced wrist & arm numbness which persisted for seven days; Seen by MD dx paresthesia, acute radiculoneuropathy & peripheral neuropathy;
c/o watery eyes, coughing, trouble breathing, p120 of good quality; tachycardia present;
Hot Red Spot Sore Started the Size of a Dime now 10 days later size  of baseball redness traveling to  under my are near my muscle .
some discomfort in arm; It was due to the way the pharmacist gave the shot; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (some discomfort in arm) and ADMINISTRATION RELATED REACTION (It was due to the way the pharmacist gave the shot) 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 06-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced LIMB DISCOMFORT (some discomfort in arm) and ADMINISTRATION RELATED REACTION (It was due to the way the pharmacist gave the shot). On 06-Oct-2021, ADMINISTRATION RELATED REACTION (It was due to the way the pharmacist gave the shot) had resolved. At the time of the report, LIMB DISCOMFORT (some discomfort in arm) outcome was unknown.            No concomitant medication were reported.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Persistent ringing in the ears (tinnitus) high pitch, pulsating.  Ear pain.
pins and needles in the feet, toes, bottom of the feet; it's just uncomfortable and the bottom of my feet; My wife says it can be Psoriasis; This is a spontaneous report from a contactable consumer (patient). A 84-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After vaccination, the patient park the car and all of a sudden he started to get like pins and needles they used to call in old days in his feet, in his toes. Last time he had this something like this years ago, he sat in the car too long. So, he loosen up his snickers and all and sat there, everything else was all right, a lady came over 15 minutes later and she said okay they can go. So the patient said he got some pins and needles in his feet, before he said the lady said "huh, are you having trouble breathing or anything", the patient said no he felt fine. So let they go home, and then the patient went home it's at night when he was laying down he didn't get much reaction and all. So he went up to the doctor she looked at up a few things and opened few things and the patient didn't think the doctor really had an answer for it. It was scheduled to go Monday again for the second it was still there. The patient didn't know it was probably kind of nerve reaction and all and his wife said it could be psoriasis, he never had this, it was not aggravating it's only when he walked he forgot he even had it . It's just uncomfortable and the bottom of his feet. He never had any reaction to any shot whether it was shingles or pneumonia, flu shots or whatever. The outcome of events was unknown.    Information on the batch number/lot number  has been requested
Sudden hearing loss in left ear; worsened tinnitus; hearing had decreased by 20 percent; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7533), dose 1 via an unspecified route of administration, administered in Arm Right on 31Mar2021 14:15 (at the age of 67years) as single dose for Covid-19 immunization. Medical history included eosinophilic esophagitis, degenerative disc disease, and food and environmental allergies, and as reported " previously lost hearing in my right ear and partial in my left ear"; all from an unknown date and unknown if ongoing. Concomitant medications included meloxicam, omeprazole, azelastine, and triamcinolone acetonide (NASACORT); all taken for an unspecified indication, start and stop date were not reported. The patient previously took Codeine, Cipro (ciprofloxacin), and Percocet and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient experienced sudden hearing loss in left ear beginning within a week of taking vaccine. Inability to recognize words and sounds was most apparent, in addition to worsened tinnitus. The patient stated, "I previously lost hearing in my right ear and partial in my left ear in earlier sudden hearing losses, so I was aware of what was happening and scheduled an ENT visit. The patient had a hearing test on an unspecified date, and it showed that hearing had decreased by 20 percent. The ENT started her on the injectable steroid treatment in her left ear. The start date of adverse events was 03Apr2021 (as reported). The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was treated with interaural steroid injections. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.
Within approximately 8hrs of the shot, I began to have a headache which lasted nearly 24hrs.  I had pain in my upper left arm.  I ran a temperature throughout the first night between 102 and 104 degrees with profuse sweating and violent shaking.  I had trouble sleeping.  I had a bout of diarrhea and a persistent cough with slight congestion.   The second day/night the cough remained, headache remained and I ran a low grade fever overnight and trouble sleeping.  My cough remains persistent and my headache comes and goes.
Blood pressure 194/100; Losing 3 days of work; Arm all swollen at injection site; Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure 194/100) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure 194/100) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Losing 3 days of work), PYREXIA (Fever) and CHILLS (Chills). 27-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Arm all swollen at injection site). On 29-Apr-2021, BLOOD PRESSURE INCREASED (Blood pressure 194/100), PYREXIA (Fever) and CHILLS (Chills) had resolved, VACCINATION SITE SWELLING (Arm all swollen at injection site) outcome was unknown. On 30-Apr-2021, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Losing 3 days of work) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Blood pressure measurement: 194/100 (abnormal) 194/100. On 27-Apr-2021, Body temperature: >102 (abnormal) abnormal.         Concomitant medications was not reported/ unknown.  Treatment was not reported/ unknown.  Action taken with mRNA-1273 in response to the event was not provided/unknown.   This case was linked to MOD-2021-062775 (Patient Link).; 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.
On February 7, 2021, I awoke about 9:00 a.m. with a  reddish small rash at the injection site (L. arm).  It did not itch, was not painful, did not ooze.  It started out about the size of a quarter, and has since spread slightly to size of a silver dollar the next day.  It is still there, as of 2/9/2021.
Pt vaccinated with MMR experienced Opthamoplegia, double vision, vertigo.
Vaccine exposure via breast milk; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) in a patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jul-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk). At the time of the report, EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Patient mother received the COVID-19 moderna vaccine on July 15th and august 12th, currently breast feeding was wondering if there was a clinical trial she could volunteer for.
RENAL ARTERY THROMBOSIS; KIDNEY INFARCTION; LEFT FLANK PAIN; RED CELLS IN URINE; ELEVATED SEDIMENTATION RATE AND C-REACTIVE PROTEINS; FLU LIKE SYMPTOMS; FEVER; This spontaneous report received from a physician concerned a 38 year old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included patient had no trauma, no illegal drug use, no predisposing medical conditions with no evidence of infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-MAR-2021, the patient experienced fever and flu like symptoms. On 24-APR-2021, the patient experienced elevated sedimentation rate and C-reactive protein, acute onset of steady left flank pain. He went to emergency room (ER) and discovered red cells in urine. In ER did a Computerized tomography (CT) scan and ruled out kidney stones. Found infarctions of the lower half of the left kidney and thrombosis of the ventral inferior distal renal artery branch that supplied the lower pole of the left kidney. Echocardiogram was normal. On 28-APR-2021, Laboratory data showed C-reactive protein was 172 mg/L, sedimentation rate was 110 mm/h and Fibrinogen (NR: not provided) 677 mg/dL.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and fever on 08-MAR-2021, was recovering from left flank pain, and had not recovered from renal artery thrombosis, kidney infarction, red cells in urine, and elevated sedimentation rate and c-reactive proteins. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210500068-COVID-19 VACCINE AD26.COV2.S-1.RENAL ARTERY THROMBOSIS,KIDNEY INFARCTION,LEFT FLANK PAIN , RED CELLS IN URINE, ELEVATED SEDIMENTATION RATE AND C-REACTIVE PROTEINS- These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
2 grand mal seizures; This is a spontaneous report from a contactable consumer reported for herself. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 86-years-old, via an unspecified route of administration, administered in Arm Left on 04Mar2021 10:00 (Batch/Lot Number: EN6200) as dose 1, single for COVID-19 immunization. The patient was not pregnant. Medical history included heart attack, pacemaker, stroke, non epileptic episodes. Concomitant medications included metoprolol succinate; escitalopram; and omeprazole; all taken for an unspecified indication, start and stop date were not reported. The patient previously took Codeine and experienced allergies. The patient experienced 2 grand mal seizures on 06Mar2021 13:00 (within 5 days after). The events resulted in emergency room/department or urgent care visit, and no treatment received. The patient had no prior vaccination and did not test post vaccination. The outcome of the events was recovered with sequelae.   Follow-up attempts are completed. No further information is expected.
Site: Itching at Injection Site-Mild, Systemic: Fainting/Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Patient reported to me he had issues with injections and blood draws  before the vaccination. He said it is likely for him to feel clumsy and faint. He was monitored for 30 minutes. He was doing fine and left the building. He was not alone. He had someone with him during the whole process.
Information has been received from a registered nurse concerning a female child who was vaccinated PO with a first 2 mL dose RotaTeq vaccine after 12 weeks of age. No adverse affects. No other information. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been sought. This is one report of several from the same source.
dizziness; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VOMITING (vomiting) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced DIZZINESS (dizziness), VOMITING (vomiting) and NAUSEA (nausea). At the time of the report, DIZZINESS (dizziness), VOMITING (vomiting) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Drugs and treatment was reported.
1. (R) arm swelling- 25 inch- Raised wheel  2. Chest tightness MDP, Albuterol
Chills, fever 101 for about 12 hours, muscle aches, fatigue
This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a female patient who received SHINGRIX (batch number T73K2, expiry date 9th June 2021) and (batch number ZT25S, expiry date 6th July 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nausea, tiredness, cold sweat, blister and feeling abnormal. On an unknown date, the outcome of the nausea, tiredness, cold sweat, blister and feeling abnormal were not reported. It was unknown if the reporter considered the nausea, tiredness, cold sweat, blister and feeling abnormal to be related to SHINGRIX. Additional information were reported as follows: The batch number ZT25S, expiry date 6th July 2021, reported for SHINGRIX adjuvant. The patient received SHINGRIX in the left deltoid. The patient had experienced nausea, extremely tired, cold sweats, blister on opposite arm of injection site and stomach. The patient stated she felt like she had been beat up. The pharmacist asked how long does the side effects last after receiving SHINGRIX injection.
PT C/O BODY ACHES, LEFT ARM SWELLING, REDNESS AND WARM TO TOUCH. PT'S SWELLING DEVELOPED IN THE EARLY EVENING ON THE DAY OF VACCINATION.