chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHIEF COMPLAINT:   Per EMS, "syncopal epidsode during bathroom x 1 minute. +LOC. +N/V. denies hitting head. denies bloodthinners. Blood glucose 542. +Covid Saturday."   HISTORY OF PRESENT ILLNESS:     This is a 53-year-old female with a history of atrial fibrillation not on anticoagulation, insulin-dependent type 2 diabetes presenting for a syncopal episode.  Patient reports that she tested positive for COVID-19 5 days ago.  Since then, she has experienced generalized weakness, nausea, several episodes of vomiting.  This evening when the patient was attempting to use the bathroom, she reportedly fainted.  Per EMS, the patient reports a loss of consciousness for approximately 1 minute, unclear if she hit her head on the ground.  On arrival here, the patient reports generalized weakness and shortness of breath.  Denying chest pain.  Reports cough no fever.
excruciating pain in my right leg and couldn't walk any further; excruciating pain in my right leg and couldn't walk any further; extracted 20 cc's of liquid from right knee; This is a spontaneous report received from contactable reporter (other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2021 08:00 (Lot number: EN6200) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included CORTISONE; SIMVASTATIN; FOCUSFACTOR; CENTRUM SILVER +50. Vaccination history included Bnt162b2 (dose number=1, lot number=EN5318, administration time=11:00 AM, vaccine location=Left arm), administration date 28Jan2021, when the patient was 63 years old, for Covid-19 immunization, reaction of soreness in my right knee. The following information was reported PAIN IN EXTREMITY (non-serious), GAIT DISTURBANCE (non-serious) all with onset 27Feb2021, outcome recovering; ASPIRATION JOINT (non-serious) with onset 27Feb2021, outcome recovering. The events excruciating pain in my right leg and couldn't walk any further, excruciating pain in my right leg and couldn't walk any further, and extracted 20 cc's of liquid from right knee were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, gait disturbance, aspiration joint.  Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported that about 2 days following the first shot on 28Jan2021, he experienced a soreness in his right knee that progressively got to the point that he couldn't apply pressure on my right leg. He eventually saw my orthopedic surgeon for an assessment and they identified some water on the knee and gave me a cortisone shot. This was the same day that patient received his 2nd vaccination on 18Feb2021. On 27Feb2021, while walking about 1.5 miles, he experienced excruciating pain in his right leg, and couldn't walk any further. He was taken to the clinic where they extracted 20 cc's of liquid from his right knee, placed in a brace and crutches, and told to take 600 mg of NSAIDS 3 times a day. Pain was now subsiding.  No follow-up attempts are possible. No further information is expected.
Pt stated with 1st GARDASIL vaccine she passed out. Immediately after giving pt IM inj of GARDASIL. Pt leaned forward. Had pt sit up as she sat up. Pt started to have like tremor and straighten stiff administered ammonia inhalant to nasal passage and pt regained in matter of 1 minute sweating profusely.
Numbness in feet; Numbness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in feet) and HYPOAESTHESIA (Numbness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LOSARTAN, VENLAFAXINE and PHENTERMINE for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 30-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness in feet) and HYPOAESTHESIA (Numbness). At the time of the report, HYPOAESTHESIA (Numbness in feet) and HYPOAESTHESIA (Numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was not provided.
less than 3 weeks after my first covid shot i started to feel dizzy and faint.. Now, when i am over tired or stressed i start to feel faint and my equilibrium is off.. I was not like this prior to the Covid vaccine.. it usually happens when i am driving and i feel very unsafe when driving.
Fever; chills; headache; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 02Feb2021 at 01:30 PM at single dose for COVID-19 immunisation. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 12Jan2021 at 03:00 PM at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient did not take any other vaccine in four weeks. The patient was not pregnant at the time of vaccination. 05Jan2021, Patient was COVID tested after vaccination by nasal swab which revealed negative result. On 03Feb2021 at 01:00 AM, the patient experienced fever, chills and headache. No treatment was received. The outcome of the events was recovered.  Information on the batch/lot number has been requested.
Developed hives on face, neck, chest and upper back. Took Zyrtec within 20 minutes of onset of symptoms. Hives lasted approximately 2 hours. No lip swelling or breathing difficulty. I have never developed an adverse reaction with seasonal influenza vaccines previously.
27JAN93 pt recvd vax; 18FEB93 pos pregnancy test was performed; 16MAR93 an ELD&C was carried out due to blighted ovum;
Platelets really dropped; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (Platelets really dropped) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED (Platelets really dropped). At the time of the report, PLATELET COUNT DECREASED (Platelets really dropped) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  The treatment information was not provided.   Reporter did not allow further contact
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received from a mother regarding her 4 month old son who developed  a mild fever of 101 degrees Fahrenheit and swelling at the injection site, the size of a quarter. The pt received the 2nd dose on 10/13/2003. Event Details: Post Immunization, the pt developed a mild fever of 101 degrees Fahrenheit, and swelling  at the injection site the size of a quarter. Related Cases: See related cases: HQWYE173023DEC04, HQWYE279829DEC04, AND HQWYE280029DEC04.
Injection site red swollen and painful, fever TM 102.4, body aches. Headache.
12/5/19 client received Td - LA + Hep B - RA. 12/6/19 mother notified PHN that son had C/O chills during night; temp not taken at that time. Temp taken in 12/6/19 morning 101-102. Started giving Tylenol & alternating with Ibuphren. Denies C/O of pain, redness, swelling @ other injection sites. Instructed to contact private MD for confirmation of Adverse reaction. Go to E.R if Temps High. 12/6/19 PHN recommended that mother contact private provider & report vaccine adverse reaction for confirmation of reaction. PHN stated would need something in written that private provider believes safe to continue with vaccines for future. Client just started to received vaccines this year - had and Religious exemption before.
A spontaneous report was received from a pharmacist concerning a male patient of unspecified age, who received Moderna's COVID-19 vaccine, where more than half of patient's 1st dose of Moderna COVID19 vaccine was leaked from the syringe. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. The pharmacist reported that, during the administration of vaccine more than half of the dose was leaked from the syringe. No treatment information was provided. Action taken with mRNA-1273 in response to the event more than half of patient's 1st dose of Moderna COVID19 vaccine was leaked from the syringe was not reported. The outcome of the event more than half of patient's 1st dose of Moderna COVID19 vaccine was leaked from the syringe was resolved on an unspecified date. Reporter's Comments: This spontaneous report refers to a case of male patient who experienced non-serious event of more than half of patient's 1st dose of Moderna COVID19 vaccine leaked from the syringe, (Incomplete dose administered, syringe issue) for mRNA-1273 (lot # unknown), Exp. date-unknown). There were no reported AEs associated with the event of more than half of patient's 1st dose of Moderna COVID19 vaccine leaked from the syringe
mild/mod shooting pain in right breast/nipple area, it switched to left breast with the same sensation; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old, female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unspecified route of administration in the right arm on 17Mar2021 at 10:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included major depression, obsessive compulsive disorder (OCD), anxiety, hypothyroidism/hashimotos and Polycystic ovary syndrome (PCOS). Concomitant medication included sertraline hydrochloride (ZOLOFT), liothyronine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and methylphenidate hydrochloride (RITALIN) for an unknown indication and from an unknown date. The patient reported being intolerant to fructose. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 06:00, the patient experienced mild/moderate shooting pain in the right breast/nipple area, which was different from lymph node soreness and after one or two days she experienced same sensation in the left breast. The pain was reported to last for several minutes on and off but as she experienced it in both breast it was moderately painful and that she wanted to let someone know. Also, the pain was most concentrated by the nipple area both times. The patient reported that the pain was still occurring and that it lasted for a few seconds and she never had breast cancer/problems. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of event breast pain was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a healthcare worker concerning a male pt who on 10/26/05 was vaccinated in the arm with a dose of Pneumococcal 23v polysaccharide vaccine (lot 650329/0747P). On approx 10/26/05 the pt experienced numbness in arm, tightness in the chest, low grade fever, and hot red spots on his body. As of 10/28/05 th pt was improving. Additional information has been requested
Swollen Arm, pain at injection site, chills, fatigue, and body aches.  Symptoms for 48 hours
mom states noted pt felt warm, did not take temp; treated pt w/APAP; mom noted that w/in 1 hrs of vax APAP given; pt was having sz; pt taken to ER t105.7; mom states pt was placed on Amoxicillin, ER MD stated could not r/o OM;
Face and neck swelling, tightness in throat and chest, trouble breathing.  Lasted until the hospital gave him an epinephrine shot.
This spontaneous report was received from a physician (patient's mother) via field representative refers to a 13 year old male patient. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 21-AUG-2015 the patient was vaccinated with the first dose of GARDASIL. No concomitant medications were reported. Reporting physician stated that she observed severe hives all over the patient's body after he woke up on 22-AUG-2015. Hives were seen in the ears, nose and on his feet, everywhere on his body. The patient did not have any swelling of the mouth or throat. The patient did not require medical attention as his mother was the treating physician. She treated him with unspecified KENALOG. It was reported that it took approximately two weeks for the hives to resolve. The patient still had scars from the peeling skin as of the date of this report. Reporting physician did not assess the causality of the event with respect to vaccination with GARDASIL. Additional information is not expected as the reporter did not wish further contact.
Tinitus, Vertigo, Fatigue (headache sometimes of the day). And all these have been last for 3 weeks now (they started 1 week after the shot) I went to earing doctor, they said nothing wrong with my ears
Information has been received from a physician concerning a 14 or 15 year old female who on an unspecified date was vaccinated with a first dose of Gardasil (lot number unknown). On an unspecified date the patient was vaccinated with a second dose of Gardasil 0.5ml injection and passed-out on the elevator. Medical attention was sought. At the time of reporting it is unknown if the patient recovered. No additional information was provided. Additional information has been requested.
5/26 87y.o. female with history of vfib arrest presents with coughing and weakness
Dizziness same day starting around 3:50 until next day around 11:00 am then extrema dizziness, throwing up for about two hours then dizziness where I needed to be sitting until about 6 am the next day then the extreme dizziness came back for about 3 hours, after that a day and half dizziness. still weak but getting better each day
Fever; Joint pain; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the left arm on 12May2021 at 15:00 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8713 via an unspecified route of administration in the left arm on 21Apr2021 at 15:00 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On 13May2021 at 05:00, the patient experienced fever, joint pain and fatigue for two days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events fever, joint pain and fatigue and included treatment with unspecified non-steroidal anti-inflammatory drug (NSAID). The clinical outcome of the events fever, joint pain and fatigue were recovered on 14May2021.  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a 7 year old female who "sometime in January," in January 2007, was vaccinated with a second dose of 0.5mL injection of varicella virus vaccine live (Oka/Merck). In 2007, the patient developed a breakthrough case of chickenpox with less than 20 lesions after receiving the second dose. No further information was provided. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. Follow-up information was received from a registered nurse who reports that the patient, a female, was vaccinated subcutaneously into the right arm on 08 JAN 2007 at 11:00 with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 654132/1151F). Concomitant vaccines administered at 11:00, on the same day included a second intramuscular dose of hepatitis A virus vaccine inactivated (Lot # 656495/1209F) in the right arm. The patient came to the office on 04-MAY-2007 and was diagnosed with varicella, vaccine failure, and a rash appeared on the abdomen that morning. There was no fever. Chickenpox was going around school a few weeks prior to the onset. There were no complications. The patient was treat symptomatically. The outcome was unknown at the time of reporting. No further information is expected.
This spontaneous report as received from a nurse refers to unspecified amount of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date these unspecified amount of patients were vaccinated with ROTATEQ (lot#, dose not reported, default route: oral) that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported. Follow up information was received from the nurse on 03-SEP-2014, reporting the lot number of the ROTATEQ that underwent a temperature excursion. Lot number K001450 expiration date 18-NOV-2015. This is one of several reports received from the same reporter. Additional information has been requested.
w/in 1/2hr of vax pt broke out in hives over face & trunk;pt was given DPH & kept for 1/2hr observation;breathing OK;
Sore arm; Felt a little tired; Third Pfizer vaccine; This is a spontaneous report from a contactable consumer based on information received by Pfizer from regulatory authority (manufacturer control number: US-AMGEN-USASL2021137858). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number 3, single for covid-19 immunisation. Relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE ONE, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE TWO, SINGLE), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 04Nov2021, outcome "unknown", described as "Third Pfizer vaccine"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "Felt a little tired".  bnt162b2(BNT162B2) is under agreement with regulatory authority.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received a dose of undiluted Pfizer Pediatrics (0.3 ml) instead of Pfizer Adult dose.
Flu-vaccine given at 3:30 pm, at 8:30 pm suddenly became chilled, dizzy, sweating and had syncope - taken to urgent care, then hospital.
A spontaneous, non-serious report of rash was received from a nurse concerning a six-year-old female patient subsequent to FLUMIST administration. Medical history and concomitant medications were not reported. On 25-Nov-2009, the patient received FLUMIST. On 26-Nov-2009, the patient developed a rash around her neck, which presented as little tiny bumps that were very itchy. The rash spread from the lower portion of her neck down to her torso. The outcome of the event, rash, was not reported.
Headache, Fever, NauseaVomiting, RUNNY NOSE Narrative:
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 29-OCT-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K016966, expiration date 10-MAY-2017, dose and route not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 48 hours, the lowest recorded temperature was 34 Fahrenheit degree and the type of excursion was refrigerator (R). The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received SHINGRIX for prophylaxis. On 13th March 2019, the patient received SHINGRIX. On 14th March 2019, 1 days after receiving SHINGRIX, the patient experienced headache and general body pain. On an unknown date, the outcome of the headache and general body pain were not recovered/not resolved. It was unknown if the reporter considered the headache and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 13th March 2019 (the day before reporting date), the patient received SHINGRIX at the local pharmacy. On 14th March 2019, the patient had headache with body aches. The patient was a teacher and was working on the reporting day. The patient asked, was it okay to take TYLENOL or ADVIL for the reported adverse event.
experienced a change in menstrual cycle; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received an unknown dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration on 27Mar2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic kidney disease. The patient had allergy to contrast iodine dye. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On an unknown date in 2021,  following the vaccine, the patient experienced a change in menstrual cycle. It came 1.5 week earlier than planned in tracking device and with various different symptoms. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event of change in menstrual cycle was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
pt recv vax & lt arm became sore;devel fever p/this 101;spoke w/MD 6MAR97 in morning;states lt arm is sore & moving pain up to neck w/problems breathing;to ER;hosp r/o pneumonia;c/o sore throat;pt mad @ PMD secretary;