chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient became inconsolably fussy about 2 hours after vaccinations were administered. No fever, no apparent redness, swelling at the admin sites.
Pt started developing a droopy right upper eyelid on Friday night (01/29/21) and by the time he woke up on Saturday, his right upper eyelid was completely shut and he couldn't open at all unless he physically used his finger to open the lid. Pt also experienced double vision when opening the eye. Pt went to the Emergency Dept and was given an MRI and CT to r/o stroke and everything came out normal. He was diagnosed with a partial 3rd nerve palsy and was referred to Optometry where we saw him on Monday (today). Pt does indeed have a partial right 3rd nerve palsy which can happen after vaccinations.
Generalized papular erythematous rash with low grade fever starting 11 days after immunization with multiple vaccines including MMR.
Injection approx. 3:30 pm 2/15/13. On 2/17/13 pt. returned approx 11:30 AM to show arm with redness, whole arm soreness, lump under skin, complained of warm feeling in area, and 2 dots of rash. Area of redness observed approx. one inch x 1.25 inch. Inquired about treatment / seeing physician - This is a Sunday - Pt. went to walk-in clinic - later.
Headache, nausea, dizzy/foggy feeling, unfocused, sore throat, upper back/shoulder pain and burning feeling, randome pinch like feeling in different places on body from legs, abdomen, arm, short of breath at different times all  between 9/14/21 to present day
12 days after the injection of her first COVID-19 vaccination, the patient developed a large warm erythematous circular rash at the injection site that resolved without medical treatment over the next 4-5 days
The vaccines were created in a substrate of raw egg embryos.  The shots created a life-long IgG allergy to eggs--egg whites, yolks, ovalbumin and ovalmuccoid.  The allergy expresses as atopic dermatitis in the creases of my arms, legs, ears and eyes whenever I eat anything with eggs.  The rash first appeared after the first two vccinations for DpTDT and Polio at age 2 months (1966) and 6 months (1967).  I broke out in that rash the first time my mother introduced eggs into my diet.  She called the doctor and he said it was normal but she should remove eggs for a year to see if I "outgrew" the allergy.  In 2007 and 2016 I was tested for IgG allergies and discovered that I am 100% allergic to eggs.
Pt  stated the vaccine hurt while administering and when needle was pulled out.  She said she almost immediately had a funny feeling in her chest. A numbness type of feeling. Not pain or tightness.  She said it was really hard to describe otherwise. I took her BP. BP was 119/79 and pulse was 74.  I asked  her if I should call 911 to be on the safe side and she said "no". I gave her some water to drink while she sat. Over the next 15 minutes I continued to ask how she was feeling and there was no change . She called her husband to come pick her up. He arrived about 15 minutes later. I explained to situation. Pt said she started to feel better and the two left. I called her house an hour later adn she said she was eating and felt better
Patient received a dose of Pfizer COVID-19 Vaccine Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial  was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL ,  0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.
Splitting headache; Extreme fatigue; Hot flashing; Felt nausea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: PAA16596S/06/2022), via an unspecified route of administration in the left arm on 15Mar2021 at 11:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Meniere's disease. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC), multivitamin (MANUFACTURER UNKNOWN), ubidecarenone (COQ10) and vitamin D not otherwise specified (NOS) (MANUFACTURER UNKNOWN) all since an unknown date for an unknown indication. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021 at 11:05, within 5 minutes of vaccination, the patient felt nausea and had nausea all day for 48 hours. Four hours after the shot, at 15:00, extreme fatigue had kicked in and experienced hot flashing. On 16Mar2021, the morning the patient woke up with a splitting headache that lasted for 24 hours. On 17Mar2021, the patient felt great and free of symptoms. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events felt nausea, extreme fatigue, hot flashing, and splitting headache were recovered on 17Mar2021.   No follow-up attempts are needed. No further information is expected.
No additional AE reported; a 49 year old male patient received his second dose of GARDASIL 9 on 12JUL2021; This spontaneous report was received from a pharmacist, via company representative, referring to a 49-year-old male patient.  The patient's pertinent medical history, concurrent conditions, concomitant medication and drug reactions or allergies were not reported.  On 12-JUL-2021, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, vaccination scheme, lot number and expiration date were unknown by the reporter; route of administration and anatomical location of administration were not reported) as prophylaxis (product administered to patient of inappropriate age). The date of administration of the first dose was unknown. No additional adverse events were reported.
Numbness of injection site 3 weeks and 3 days later. Tingling needle like numbness around injection site.
Received injection 10/12/21.  Started having congestion and pain in Right armpit on 10/17/21.  Pain increased and numbness started due to swelling. Pain into R side of neck, R breast, and shoulder blade area. Took aspirin and IBU for pain and inflammation. Had some relief. Warm compress to armpit for 10 minutes up to 10 times a day.  Saw provider 10/20/21, lymphedema  confirmed. If no improvement in 1 week ultrasound will be ordered.     Pain is effecting some daily activities and may have ulnar nerve involvement due to swelling.  Grip decline on Right side. Numbness and pain constant at this time.
Initial unsolicited report received from a pharmacist on 04-Oct-2017. This case involves a 68-year-old female patient who was vaccinated with a 0.5 ml single dose of FLUZONE HIGH-DOSE (batch number, expiry date and site of administration were not reported) via intramuscular route on 19-Sep-2017. The patient's medical history and concomitant medications were not reported. On 20-Sep-2017, one day following the vaccination, the patient developed fever chills and malaise she slept about 20 hours. On 21-Sep-2017, two day following the vaccination, the patient experienced nausea and vomited. The patient's laboratory data and corrective treatment were not reported. On an unknown date, the patient was recovered from the events. (It took a full week to feel better). List of documents held by sender: none.
Heart started fluttering; his asthma has been worse; headache or migraine; headache or migraine; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient's wife) reported that a male patient of unspecified age received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot/batch number, expiry date and NDC number: not provided) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history includes ongoing asthma. Concomitant medications were not reported. Reporter stated that since her husband received the covid vaccine, his asthma has been worse, and his heart started fluttering and also has had a headache or migraine on an unspecified date. Reporter and her husband both received the Pfizer covid vaccine on an unspecified date. Reporter does not know right now if patient's symptoms are related to the covid vaccine. Reporter does not know all the details about patient's symptoms to report about them. Outcome of the events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
No additional AE; improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 03-MAY-2023, the patient was vaccinated with Hepatitis A Vaccine, inactivated (VAQTA) intramuscular injection (0.5 ml/once, lot#: x004813, expiration date: 28-JUL-2024; route of administration, and anatomical location were not reported) for prophylaxis. The vaccine administered was improperly stored at 46.74F for 2 minutes (product storage error). No additional adverse events (AEs) were reported (no adverse event).
stiffness soreness across both shoulders, shoulder blades and base of neck - started about six hours after injection but worsened in bed overnight. Began to ease off after 26 hours. Awakened 20 hours after shot with sense of lassitude, sluggish thinking  - like the drowsiness an antihistamine may cause.  Just felt strange almost not really present in the moment sensation.  This is still still ongoing after 30 hours but easing off significantly.  no fevers, chills, myalgias or flu feeling. no local swelling or redness at injection site. This odd feeling did not interfere with daily 10000 step walk.  Feel much improved after exercise.
Increased heart rate, chest tightness, shortness of breath, increased blood pressure. Abdominal cramping   Visited with primary health care physician and placed on blood pressure medicine. Next appointment is with cardiologist
3 days after PREVNAR injection patient developed red swelling a few inches from the injection site - red, swollen, warm to touch. Pt. saw MD today 1-31-2017 and determined infection likely due to vaccine. Treated with cephalexin. Vaccine given at Pharmacy - pt. followed up with PCP regarding arm.
Presented 9/24/09, 2:22, eyes bloodshot, red. Hasn't eaten since yesterday. HA started after vaccine and nausea, bloodshot eyes start couple of hours after. Eyes were burning initially and arm itching a little. Had it before last year the flu and pneumonia and previous years.
Patient tested positive for COVID-19 by PCR on 4/16/21; >2 weeks after 2nd dose in vaccine series. Symptoms of congestion/rhinorrhea.
Chills,night sweats, difficult breathing,stomach pain,severe gas, headache, muscle aches,fast heartbeat.
tingling in neck; soreness; Can't move arm with throbbing; Couldn't sleep; Couldn't sleep; Tingling in the right arm, tingling in the neck; Constant pain in the right arm, throbbing; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in the right arm, tingling in the neck), PAIN IN EXTREMITY (Constant pain in the right arm, throbbing ), INJECTED LIMB MOBILITY DECREASED (Can't move arm with throbbing), the second episode of INSOMNIA (Couldn't sleep) and the first episode of INSOMNIA (Couldn't sleep) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 09-Feb-2021 at 3:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PARAESTHESIA (Tingling in the right arm, tingling in the neck), PAIN IN EXTREMITY (Constant pain in the right arm, throbbing ) and the first episode of INSOMNIA (Couldn't sleep). On 24-Feb-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Can't move arm with throbbing), the second episode of INSOMNIA (Couldn't sleep) and PAIN IN EXTREMITY (soreness). On 25-Feb-2021, the patient experienced PARAESTHESIA (tingling in neck). At the time of the report, PARAESTHESIA (Tingling in the right arm, tingling in the neck), PAIN IN EXTREMITY (Constant pain in the right arm, throbbing ), INJECTED LIMB MOBILITY DECREASED (Can't move arm with throbbing), the last episode of INSOMNIA (Couldn't sleep), PARAESTHESIA (tingling in neck) and PAIN IN EXTREMITY (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Tylenol.
Patient received smallpox vaccine which has spread around site of admission. Patient has developed a low grade fever and fatigue.
chest tightness; slight wheezing; total head/body aches; total head/body aches; skin very sensitive/tender; skin very sensitive/tender; chills; Injection site extremely tender for 5-7 days; rash all over body; This is a spontaneous report from a contactable Nurse (patient). A 53-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171), intramuscular, administered in left arm on 11May2021 at 10:00 (at the age of 53-years-old) as dose 2, single for COVID-19 immunisation. The patient previously received first dose of bnt162b2 (lot number EL9263) on 20Apr2021 and experienced total head/body aches, skin very sensitive/tender, chills and injection site extremely tender. Medical history included high blood pressure (BP), depression, high cholesterol and COVID (Prior to vaccination). Concomitant medications included metoprolol succinate, candesartan, vilazodone hydrochloride (VIIBRYD), estradiol, amlodipine besylate, bupropion, hctz, atorvastatin, amylase/ascorbic acid/cellulase/folic acid/lipase/protease nos (JUICE PLUS), cyanocobalamin (B12), fish oil (OMEGA 3) and apoaequorin/colecalciferol (PREVAGEN) taken. On 11May2021 at 16:00 the patient experienced total head/body aches, skin very sensitive/tender, chills, injection site extremely tender for 5-7 days, rash all over body, and slight wheezing. On 13May2021 the patient experienced chest tightness. The events resulted in Doctor or other healthcare professional office/clinic visit. The events were treated with Benedryl and anti itch cream. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was recovering.; Sender's Comments: Based on the closet temporal relationship and known drug safety profile, the association between the reported events with BNT162b2 cannot be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an adult female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD21-053585, MOD21-053559, MOD21-053712, MOD21-053725 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up information received updated event outcome and patient age group.; Sender's Comments:  MOD21-053585:Cross linked NO with Patient MOD21-053559:Cross linked NO with Patient MOD21-053712:Cross linked NO with Patient MOD21-053725:Cross linked NO with Patient
Patient received a Pfizer Monovalent booster instead of a Bivalent booster. She requested this instead of waiting for the arrival of the Bivalent booster which had not yet arrived in our clinic.
Pt recvd vax & exp GBS; sx started 27OCT93 w/sore arm; GBS started 21FEB94 had flu sx last wk s/diarrhea & fever of 101.8; when given vax felt like fire was going up arm & walked in daze p/recvd vax;
Patient complained of feeling flush in face and having tightness in throat.  EMS was called and vitals taken.   at 13:51 BP 138/88, Pulse 135, Resp 20, O2 Sat 98. Patient was breathing and talking without visible distress.  At 13:56 BP 135/84, Pulse 110, O2 Sat 98 and patient breathing and talking without visible distress.  EMS arrived at 14:00 and care was handed over to them.
Patient was in usual happy, content state when he received his 4 month vaccines 02/02/07. Since that evening he has been crying, fussy. Parents are unable to put him down. No bowel movement for 3days(also unusual). Just very irritable. Parents claim baby has only slept 3-4 hours over the last 4 days. Patient was seen at the clinic,02-06-07 and found to have a normal exam.
injection site pain; sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 (Lot number: ER8732) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FENOFIBRATE; MULTIVITAMINS [VITAMINS NOS]. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "injection site pain"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Multi-vitamin and fenofibrate was medications that patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. Patient did not visit the emergency room and physician office visit for the events.  No follow-up attempts are possible. No further information is expected.
still feeling very sluggish; no energy during the day\ I've lost so much energy; night sweats/, gets up and is soaked; it is a little strange/has been bugging him; no appetite; at night feverish; This spontaneous case was reported by a patient and describes the occurrence of SLUGGISHNESS (still feeling very sluggish), ASTHENIA (no energy during the day\ I've lost so much energy), NIGHT SWEATS (night sweats/, gets up and is soaked), FEELING ABNORMAL (it is a little strange/has been bugging him) and DECREASED APPETITE (no appetite) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LORAZEPAM.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (still feeling very sluggish), ASTHENIA (no energy during the day\ I've lost so much energy), NIGHT SWEATS (night sweats/, gets up and is soaked), FEELING ABNORMAL (it is a little strange/has been bugging him), DECREASED APPETITE (no appetite) and PYREXIA (at night feverish). The patient was treated with VITAMIN B COMPLEX (B-COMPLEX [VITAMIN B COMPLEX]) at an unspecified dose and frequency. At the time of the report, SLUGGISHNESS (still feeling very sluggish), ASTHENIA (no energy during the day\ I've lost so much energy), NIGHT SWEATS (night sweats/, gets up and is soaked), FEELING ABNORMAL (it is a little strange/has been bugging him), DECREASED APPETITE (no appetite) and PYREXIA (at night feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-239185 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received to safety on 29-Jun-2021 as Consent denied to follow up and no other information was added.
Drug ineffective; We both came down with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, 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) with onset 15May2023, outcome "unknown"; SUSPECTED COVID-19 (medically significant) with onset 15May2023, outcome "unknown", described as "We both came down with Covid". Clinical course: Her husband had all their vaccines and boosters except the last one out now. He came down with Covid, 15May2023. It was mild-4 days and no worse the a cold or bad allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300104610 same reporter/product/event, different patient;
Small indurated palpable lesion with a pustule - needle aspiration did not yield any fluid; area around induration was a bumpy texture with 2-3 small visible vessicular lesions.
Received his second Covid-19 vaccination on 2/8/2021, then tested positive for Covid-19 on 2/17/2021
I had chest tightness on the 27th. I have that a few times. I got an EKG done on the 28th. It said that I have an incomplete right bunch bundle block. I saw a cardiologist and had another EKG and she said the same thing. I am getting an Ultrasound next week. No treatment. I am still chest tightness at random times. Note: I was pregnant when I had my first dose of the vaccination. I had a scheduled C-section exactly a week after receiving the first dose of Moderna vaccine.
Sore arm within hours. Slight fever of the course of the next day. On morning of 22 May, woke up with high fever, swelling in face and what appeared to be hives all over body. Taken to ER immediately and attending doctor diagnosed with Erythema Multiforme minor.