chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic reaction; severe lip/facial swelling on left side of face and top lip/swelling two days later on right bottom side of face and lip; severe lip/facial swelling on left side of face and top lip/swelling two days later on right bottom side of face and lip; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, first dose on 30Dec2020 at 09:00 (Lot number: EL0140) in the right arm and second dose on 20Jan2021 (Lot number: EL3246) in the left arm, both at the age of 48-years-old at a single dose for COVID-19 immunization. Medical history included low vitamin D, hypothyroid, Von Willebrand's, and idiopathic anaphylaxis (years ago, outgrew). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications within two weeks of vaccination. The patient previously received botulinum toxin type A (BOTOX) in the forehead years ago. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced severe lip/facial swelling on left side of face and top lip/swelling two days later on right bottom side of face and lip and allergic reaction on 31Dec2020. The events were reported as non-serious. The clinical course was reported as: The patient woke up with severe lip/facial swelling on left side of face and top lip. The patient went to doctor and they thought it was allergic reaction, but not sure if it was the vaccine. After the patient received the second dose, she had swelling two days later on right bottom side of face and lip. The patient had no lip/facial filler. The patient did not receive any treatment for the events. The clinical outcome of severe lip/facial swelling on left side of face and top lip/swelling two days later on right bottom side of face and lip and allergic reaction was recovered in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
10/20/05 PC from pt had broke out in whelps all over body; red and itching. Advised OTC Benadryl if got worse or symptoms of difficulty breathing, heart palpation and or with sweating see MD immediately. to call and let nurse know if worsens or have to see MD and or ER.  10/24/05 No problems further
TINGLY/NUMB HANDS; DIZZINESS; HIGH BLOOD PRESSURE; COUGHED UP 3 DARK GREEN CHUNKS THAT HAD SOME BLOOD; COVID-19 INFECTION; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hysterectomy, type 2 diabetes, and hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.8 F. On 06-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative.  On 12-APR-2021, the subject experienced covid-19 infection. On 12-APR-2021, the subject experienced coughed up 3 dark green chunks that had some blood. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 14-APR-2021, the subject experienced tingly/numb hands. On 14-APR-2021, the subject experienced dizziness. On 14-APR-2021, the subject experienced high blood pressure. Laboratory data included: Blood pressure (NR: not provided) 156/81. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 175/83. Treatment medications (dates unspecified) included: guaifenesin, and oxycodone hydrochloride/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, tingly/numb hands, and covid-19 infection, and the outcome of high blood pressure and coughed up 3 dark green chunks that had some blood was not reported. 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.
This spontaneous report as received from a registered nurse refers to multiple unspecified patient's. Between dates 02-AUG-2013 and 09-AUG-2013 the patients might have been administered expired M-M-R II  lot # 1251AA, expiry date 01-AUG-2013, dose and route not provided. No adverse effects were reported. Additional information has been requested.
Hives all over body for 3 days; parent did not bring to doctor for evaluation.
breakthrough covid infection; breakthrough covid infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: EP6955) at the age of 55 years as dose 2, single and administered in arm left, administration date 04Mar2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allery" (unspecified if ongoing). Concomitant medication(s) included: PREMARIN; RESTASIS. The following information was reported: VACCINATION FAILURE (medically significant) with onset 29Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 29Dec2021, outcome "recovering", and all described as "breakthrough covid infection". The event "breakthrough covid infection" and "breakthrough covid infection" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical Course: It was reported that facility where the most recent COVID-19 vaccine was administered was workplace clinic. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
vaccination reaction 7-14 days post; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed a reaction 7-14 days post vaccination.    The patient's medical history was not provided. Concomitant product use was not provided.   On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   The nurse reported the patient had a vaccination reaction 7-14 days post vaccination. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, developed a reaction 7-14 days post vaccination, was considered unknown.; Reporter's Comments: This case concerns a subject who experienced a non serious  unexpected event of Vaccination complication. The event occurred 7-14 days after first dose of the study medication administration.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.
Whole left arm got black and purple. Pt went to MD and doctor found out the INR level was high- Pt still have purple patches after 15 days of receiving shot.
Brain fog; blurry vision; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), VISION BLURRED (blurry vision), FATIGUE (Fatigue) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced FEELING ABNORMAL (Brain fog), VISION BLURRED (blurry vision), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Brain fog), VISION BLURRED (blurry vision), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Concomitant medications were not provided. Treatment information was not provided.
dull headache; left arm where she received her injection was sore; feeling of a little ache the day after the injection; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. In 2019, 1 day after receiving Shingrix, the patient experienced injection site pain and general body pain. On an unknown date, the patient experienced headache. On an unknown date, the outcome of the injection site pain, general body pain and headache were unknown.   It was unknown if the reporter considered the injection site pain, general body pain and headache to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient herself and she was an orthodontic employee. The age at vaccination was not reported. The patient was an orthodontic employee. The patient had the feeling of a little ache the day after the injection with a dull headache. The patient's left arm where she received her injection was sore. For drug tolerance of 2nd dose, refer case US2020AMR024903.
Narrative: Covid+, moderna #3, sore thorat, HA, cough, SOB, fever, chills, oxygen weaned, GI cocktail, d/c home
booster doses on 28Oct2021; very very sensitivity to touching of her fingertips and toes; severe headache; severe chills; feverish feeling; bruising; discoloration; swollen toes; She said she is very very tired; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot number was not reported, Expiry Date: Unknown, NDC and UPC number: Unknown), via an unspecified route of administration on 28Oct2021 (at the age of 68 years old) as dose 3 (booster), single for COVID-19 immunization. PQC was not present. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (COMIRNATY, solution for injection, Lot number was not reported), via an unspecified route of administration on Apr2021 as dose 1, Single and dose 2 via an unspecified route of administration on Apr2021 as dose 2, Single for COVID-19 immunisation and no side effects reported. The patient received booster dose on 28oct2021. On 28Oct2021, the patient experienced very very sensitivity to touching of her fingertips and toes, severe headache, severe chills, feverish feeling, bruising, discoloration, swollen toes, she said she was very very tired. The clinical outcome of the events was reported as unknown.  Follow-up attempts completed. Lot/batch number was not available despite the follow-up attempts made. No further information is expected.
Status epilepticus-resulting in extensive hospitalization; 4MAR94 began starring 5MAR94 active sz;
Zosters on torso,  prescribed valacyclovir 1g 3xday for 7 days, Prednisone taper
Patient began coughing on 12/6/2009 and was the diagnosed with pneumonia on 12/10/2009. She received the HINI flumist.
Patient turned pale, started sweating and felt dizzy; had severe headache on right side of the head and neck; felt weak in legs. Reaction started immediately as HPV (Gardasil 9) vaccine was administered. Patient was kept in the injection room for about 2 hours and given Juice to increase blood sugar level; cold towels were used to bring body temp down.
swelling of arm at injection site, fever (102 degrees), body aches, fatigue, headache.  Took Motrin for 5 days.  8 days later, arm is still sore.
Vial expired on 13-Jul-2022, stored in refrigerator on 15-Jul-2022 and administered on 15-Jul-2022; administered booster dose of the Moderna Covid19 Vaccine on 15Jul2022 from vial that expired on 13Jul2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered booster dose of the Moderna Covid19 Vaccine on 15Jul2022 from vial that expired on 13Jul2022) and PRODUCT STORAGE ERROR (Vial expired on 13-Jul-2022, stored in refrigerator on 15-Jul-2022 and administered on 15-Jul-2022) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered booster dose of the Moderna Covid19 Vaccine on 15Jul2022 from vial that expired on 13Jul2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 13-Jul-2022, stored in refrigerator on 15-Jul-2022 and administered on 15-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered booster dose of the Moderna Covid19 Vaccine on 15Jul2022 from vial that expired on 13Jul2022) and PRODUCT STORAGE ERROR (Vial expired on 13-Jul-2022, stored in refrigerator on 15-Jul-2022 and administered on 15-Jul-2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. It was reported that patient received booster dose. It was reported that 2 doses from 1 vial was initially stored in the refrigerator on 15-Jul-2022. The vial did not undergo any temperature excursion. Treatment medications were not provided.   This case was linked to MOD-2022-609202 (Patient Link).
Severe bruising at the injection site, numbness/weakness in left arm, severe leg cramps, dizziness, tightness of chest.
Approx. 45 min after injection, mother noted child was not acting correctly and returned to the office with him. He was noted to be having a seizure and was transported to the hospital where he suffered resp. failure and cardiac arrest. He is currently on life support. Died 10-30-07.  5/16/08 Autopsy report states COD as sudden unexplained child death associated w/acute pneumonia.  Autopsy findings include: hypoxic-ischemic encephalopathy; wide spread acute pneumonia; phenytoin & lorazepam; no trauma.  Patient had witnessed seizure followed by respiratory distress, intubation & subsequent cardiac arrest.  Short hospitalization & expired despite therapeutic intervention.  11/1/07 Received medical records from CDC which reveal patient experienced shaking & unresponsive behavior after being seen in pcp office for vax.  Returned to pcp & exam revealed patient having right sided seizure w/eyes deviated to right & right extremity twitching.  Taken to ER after seizing for approx 15-20 min.  Received 2 doses of ativan, intubated, received versed, paralytics, Pb, epi, bicarb, mannitol, lasix, solumedrol & atropine along w/IVF.  Transferred by flight to higher level of care.  11/2/07 Received hospital medical records from CDC which contain PICU Death Summary.  Reveals patient admitted s/p seizure & cardiac arrest.  Multiple episodes of ventricular fibrillation, lidocaine & defibrillation during transport from outlying ER.  Arrived at hospital hypotensive w/weak femoral pulses & quickly coded again for approx 5 min & pulse returned.  BP maintained on epi drip until brain death pronounced.  11/6/07 Reveiwed pcp medical records from CDC which confirm dose & lot # as reported.  Patient reported to be in usual state of health on day of vax but a little sleepy & cranky.  Returned to office approx 45 min s/p vax with patient having right sided seizure w/eyes deviated to right.  Office unable to obtain ativan, taken to ER, given O2 & IM ativan, then IV ativan when IV access obtained.  Seizure stopped w/n 4 min & patient became apneic & was intubated. Stable for aprox 30-40 min then O2 sat dropped, bradycardia & then asystole.  CPR started.  Remained asystolic for approx 1 hour & then regained pulse.  Developed ventricular fibrillation on the way to the helicopter & was converted back in ER. Then transported to higher level of care.
Mom states child covered w/rash; c/o itching had fever 101.6, severe joint pain, itching, bright red rash; could not bear wt on legs;
L nipple discharge bloody; L nipple discharge bloody; This is a spontaneous report from a contactable physician.   A 61-years-old female (non-pregnant) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EW0162), via intramuscular, administered in Left arm on 18Apr2021 11:00 (at the age of 61-year-old) as dose 2, single for covid-19 immunisation ( Health Clinic/ Administration facility). The patient's medical history was none. The patient had no known drug allergies. The patient's concomitant medications were not reported. The patient had no covid prior vaccination. The patient had not been tested for covid post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: ER8732), via intramuscular, administered in Left arm on 28Mar2021 11:00 (at the age of 61-year-old), as dose 1, single for covid-19 immunisation. On 27Apr2021, the patient had L nipple discharge bloody (breast discharge and nipple exudate bloody). The reporter assessed the case as non-serious. The patient underwent lab tests and procedures which included mammogram: mammogram, referral on an unspecified date. The events resulted in doctor or other health care professional office/clinic visit. The patient received treatment. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
I felt funny; I didn't feel nothing in my arm or anything; I got some pain in back of my neck and head; I got some pain in back of my neck and head; I got had a little sore on my lips; my lip it's all gone rash; I was catching my breath; I got another pimple like cold sore something; I got had a little sore on my lips; my lip it's all gone rash; This is a spontaneous report from a contactable consumer or other non hcp.     A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date after vaccination the patient felt funny on Sunday night, it was also reported that patient didn't felt nothing in arm or anything but then on Saturday night patient got the pain, Sunday night he/she got some pain in back of neck and head, so patient took two Advil and wanted to bed and he/she was fine and when patient got up he/she was having up like a sore, Sunday morning patient had a little sore on lips, so that measure fever and had no fever and then patient again and but it was not bad as Sunday. Patient was talking to 'dermatologist' that he/she was catching breath which didn't think he /she was, but they know they can hear me better and then this morning. Patient got up and found that lip it's all gone rash and now got another pimple like cold sore something, but it has been patient had that injection and patient checked fever this morning it was 96.1. So, patient did not know if means anything or not. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
Information was received on 19-APR-2017 from an attorney in the form of an initial legal complaint regarding a male patient (age not provided). Medical history, concurrent conditions and concomitant medications were not provided. On 30-NOV-2011 the patient was vaccinated at a local pharmacy with ZOSTAVAX  for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-MAY-2015 the patient was treated at an eye center for blistering on his face that was diagnosed as shingles. On or about 07-JUL-2016 he was treated for a painful rash that spread to his eyes and he was diagnosed as herpes zoster keratitis, or shingles in the eye. On or about 18-JUL-2016 the patient was treated again at a medical center for continued shingles outbreak. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review the event of herpes zoster keratitis was determined to be medically significant. Additional information has been requested.
Light headed, dizzy, headache, night sweats; Light headed, dizzy, headache, night sweats; Light headed, dizzy, headache, night sweats; This is a spontaneous report from a non-contactable nurse (patient). A 22-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration in left arm on 23Dec2020 15:45 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient experienced light headed, dizzy, headache, night sweats on 23Dec2020 19:30 with outcome of recovering. No treatment was received.   No follow-up attempts possible. No further information expected.
The J&J Covid Vaccine was administered in the late of April 3, 2021.  Approximately three days after the shot (which was administered in the dominant arm) was given red streaks were noticed in the lower left eye.  The streaks were first thought to be eye irritation from the outside elements (wind, pollen) because the vaccine unit was outside.  When the streaks did not clear in a day or so an appointment was made with a local in ophthalmologist for Monday April 12th.  Upon examination a diagnosis of retina detachment was concluded.  Was seen by Dr. on April 13th (appt was not available for the afternoon of the 12th) and surgery for retina detachment was scheduled for Thursday April 15th.  Due to scar tissue a second retina detachment was diagnosed in late May/early June back home.
Following the administration of the second dose patient sat down to wait for 15 minutes. A couple minutes after sitting down patient began to feel "odd" and had a syncope event. Patient hit his head when falling and had some minor bleeding. We immediately attended the patient and called 911 so that he could be checked on. After some time patient felt ok, paramedics attended his wound and checked vitals. Patient's family came to the pharmacy to pick him up, aside from the wound patient felt ok.