chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt stated she felt extremely nauseous, was dizzy, had a headache, started shivering, was shaeky and was coughin and hacking.  It lasted 45 minutes.  She said she had a headache with a black dot in her sight.  She said she felt nauseous for longer than the 45 minutes.
This spontaneous report as received from a pharmacist refers to her husband of unknown age. The patient was vaccinated with PNEUMOVAX 23 (dose, route and lot # not reported) in 2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced local reaction and flu-like symptoms after receiving a dose of PNEUMOVAX 23 in 2007. It was unknown if the patient sought medical attention. The outcome of flu-like symptoms and local reaction was unknown. Additional information has been requested.
pt recv vax 1992 & exp a very serious bacterial pneumonia & was hosp;
Around 4/16, the pt noticed a fine rash on face, also noted sore throat, and low-grade fever. She called work on 4/18 and stated she had rash over her arms, legs, and some on abdomen. Still had complained sore throat with fever and achy joints. Recommended she see physician to rule out rubella vs strep. Went to her own clinic and was seen by 3 different physicians and tested positive for rubella.
Numbing on right side of body; Pins and needles sensation; Nerve pain all over body; This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 30-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0171; Expiration Date: unknown), via an unspecified route of administration in Arm Left on 21-APR-2021 16:00 (age at the time of vaccination 30-years-old), as a single dose for COVID-19 immunization. The patient's medical history includes birth control pill. The concomitant medication included BALCOLTRA (ETHINYLESTRADIOL, FERROUS BISGLYCINATE, LEVONORGESTREL) for Oral contraception. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies. On 22Apr2021 21:30, the patient experienced Numbing on right side of body, Pins and needles sensation, and Nerve pain all over body. The patient visited to the emergency room for adverse events. No treatment received for the adverse events. Upon follow-up (21May2021), Company aware date: 21May2021, no new event coded, lot number of first dose, History, and Concomitant Products. Caller stated, she had terrible adverse effects from the COVID vaccine. The outcome for all the events was not recovered.  Follow-up (PRD 21May2021): This is a Follow up spontaneous report received from a contactable consumer. This 30-year-old female consumer (patient) reported for herself that included: Company aware date: 21May2021, no new event coded, lot number of first dose, History, and Concomitant Products, she had terrible adverse effects from the COVID vaccine, case reference number of 245, there is no product complaint to report and there is medical information request.  Information on Lot/Batch number was available. Additional information has been requested
mom called 5PM states baby wont stop crying & leg is red & swollen from knee to thigh referred to MD;
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medication was reported. No treatment medication was reported. It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration. This case contains information for the 33rd of 190 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE
This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal pain), MUSCLE SPASMS (cramping), FLATULENCE (gas) and ABDOMINAL PAIN UPPER (stomach ache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010821A) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced ABDOMINAL PAIN (abdominal pain), MUSCLE SPASMS (cramping), FLATULENCE (gas) and ABDOMINAL PAIN UPPER (stomach ache). At the time of the report, ABDOMINAL PAIN (abdominal pain), MUSCLE SPASMS (cramping), FLATULENCE (gas) and ABDOMINAL PAIN UPPER (stomach ache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2021-116440.
10 min post/vax, pt had raised bumps on both lips. MD on call, advised to hold epinephrine and monitor pt. Bumps on lips resolved within 30 min & pt sent home. Go to ER if symptoms worsen.
I started feeling feverish around 2:00 am the day after I received the second dose, and I also had a swollen lymph node in the left side of my neck which caused a lot of throat pain and difficulty swallowing. The fever symptoms went away around 24 hours after I received the shot, but my throat continued to hurt until about 72 hours after.
Difficulty swallowing. Elevated blood pressure in a setting of known hypertension. Patient advised transport to the ER.
Bruising, swell at injection; shot may have been given S.C. vs IM.
pt recv 2nd dose of vax 24MAY96 & 13AUG96 lab eval revealed that VZV-IGG was negative & pt failed to seroconvert;
pt recvd vax;exp induration,redness,itching at inject site; tx: hydrocortisone;
72 hr after vaccine: myalgia, joint pain - hip and neck, low grade fever, night sweats. 10-26-16 rash progressed from thighs to calves and top of feet. 10-29-16 joint/tissue swelling in bilat ankles. TX: ALEVE 440 bid, or MOTRIN 400 mg tid, Triamcinolone for rash.
Information has been received from a registered nurse concerning a female, five years of age, who on 02-FEB-2004 was vaccinated with Varivax (Lot # 646535/0575N). In 2007 the patient experienced breakthrough chickenpox. No further information was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. 02/11/2010 Information has been received from a registered nurse concerning a 4 year old female with no pre exisitng allergies, medical conditions or present illness, who on 02-FEB-2004, at 6pm, was vaccinated with the first doses of both VRIVAX (lot # 646535/0575X) and MMR II (Lot # 645909/0622N). The patient was seen on 2 JAN 2007 with a history of an itchy rash which began the previous day 01 JAN 2007 at 11:05AM. The patient presented with multiple erythematous papules all over her trunk, greater on the right side than the left. Most lseions were excoratied. Two lesions on the back were vesicular. The patient was prescribed ecyclovic 200 mg PO A5, for five days, and isolation until all lesions were crusted. The patient was recovered on 09 JAN 2007. There was no product quality complaint. There were no lab diagnositic studies performed. No further information is expected.
12/08/10 shingles vaccine given 12/10/10 CT scan with dye 12/15/10 PM started with red raised rash over entire body, burning & itching. No SOB or respiratory sx at all.
Hives noted on chin, cheeks and forehead , swelling noted on areas , tingling sensed  on lips and flushing expressed by the patient . Patient was slightly hypertensive and tachycardia. No SOB  noted , patient denied chest pain .
2 am - tried to get up, felt sharp burning pain in left chest from lower sternum to left side, strongest of the pain was at sternum.
pt recvd vax 1230PM on 12OCT95 c/o immed numbness & pain in rt wrist p/vax;seen 3 hrs later & felt achy, feverish & had hot flashes;had cont numbness to rt upper arm;
SHORTLY AFTER VACCINATIONS, PATIENT BEGAN TO FEEL DIZZY--WAS FIRST PLACED ON STOOL, THEN BACK ON CHAIR. SHE WAS PALE AND THEN HER HEAD FELL BACK AS SHE PASSED OUT.  SHE WAS LOWERED TO THE FLOOR TO REST AND REGAINED CONSCIOUSNESS.  SHE WAS GIVING ORANGE JUICE AND ENCOURAGED TO GET UP SLOWLY WHEN READY.  SEEMED FINE WHEN LEAVING.
Flu-like symptoms +: Achy, fever, diarrhea, nausea
As reported in the first dose: Symptoms appeared three days after second dose. I mainly have hissing perceived in my right ear, sometimes left ear, and sometimes in the middle of my head. The tone sometimes changes from hissing to a slight hum in both ears (like a faraway vacuum sound). After the second dose, I notice the humming sound is more prominent in my right ear, especially when I wear ear buds without accompanying music (such as wearing them when engaging in a phone conversation with someone).  Similar to the first dose, I get sudden spikes of my tinnitus that come out of nowhere but subside within a few seconds. The tinnitus is more prominent when in a silent room (such as sleeping at night), climbing the stairs, running, and after taking a shower. It sometimes gets worse if I am around loud noise.  I visited my primary care doctor for a routine physical exam on 5/7/21 and she didn't seem too concerned. She said there are many reasons for tinnitus and sometimes we don't know why it begins and I might not likely find a reason. She said she will refer me to an ENT if symptoms get worse or if I notice accompanying hearing loss.  I also do want to note I noticed hyperacusis (sensitivity to loud noise) approximately a week after my frst dose. That does seemed to have resolved itself just before the second dose (so it lasted about 2 weeks). I have not noticed hyperacusis after my second dose.
Heartburn; This case was reported by a pharmacist via call center representative and described the occurrence of heartburn in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th June 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 24th June 2019, 6 hrs after receiving Shingrix, the patient experienced heartburn. The patient was treated with omeprazole. On an unknown date, the outcome of the heartburn was unknown.   It was unknown if the reporter considered the heartburn to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine on right deltoid. The patient had to take omeprazole to treat the heart burn. The reporter was unsure if the symptoms resolved. The reporter consented to follow up.
Menstrual period, which had been regular at 29-30 days for 4.5 years, arrived 17 days early following this 3rd (booster) dose of Covid-19 Vaccine.   A second event occurred 6 weeks later, on 1/14/22.    I began having mild balance and coordination deficits, along with severe vision dysfunction.    My vision became blurry and diplopic or double vision, as I was seeing 2 images when looking with both eyes.    After assessment by optometrist, who diagnosed CN4 Palsy, a brain MRI presented with multiple active lesions in multiple areas of the brain, ultimately leading to Diagnosis of Multiple Sclerosis.
I contracted Covid19 on 04/28/2022 with symptoms of fever, sore throat, congestion, cough. I was prescribed Paxlovid 05/02/2022 and took 3 doses, but I experienced a metallic taste from the medication, and began vomiting from an adverse reaction to the medication so quit taking it. I was ill for 5 to 7 days. I am fully recovered with no lingering symptoms.
Presented with right lower abdominal pain 8 days after vaccine. Nausea and constipation overnight. Went to ER next morning. CT scan performed. Diagnosed with Appendicitis. Surgery to remove appendix.
BUMP IN THE LEFT ARM; HARD BUMP IN LEFT ARM; SORE ARM; HEADACHE; TIREDNESS; 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 pre-existing medical conditions included the patient had no known medical history and no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 15-MAY-2021, the subject experienced sore arm. On 15-MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced tiredness. On 17-MAY-2021, the subject experienced bump in the left arm. On 17-MAY-2021, the subject experienced hard bump in left arm. The action taken with covid-19 vaccine  was not applicable. The patient recovered from headache, and tiredness, and had not recovered from bump in the left arm, sore arm, and hard bump in left arm. This report was non-serious.
Pt seen in office with hx of bloody stool. Abdominal pain noted: pt lethargic, dehydrated (on 9-5-07). Referred to hospital by ambulance. Dx intussusception.  9/24/2007 Call placed to vaccine provider for verification per CDC request. Per vaccine provider, pt has not received any doses of Rotateq on that date or at any time. 9/25/07 Reviewed hospital medical records which reveal patient experienced unconsolable crying, abdominal pain, emesis & bloody stool x 1 day. Admitted 9/6-9/7/2007.  Enema initially reduced IS but recurred & taken to OR for laparoscopic reduction of ileocecal IS.  Did well postoperatively & d/c to home next day.  FINAL DX: Intussusception, surgically reduced.
Breakthrough case admission after third dose Moderna 3/16/21 Lot# 045A21A Moderna 4/13/21 Lot# 044B21A Moderna 10/27/21 Lot# 933906
raised rash, like hives redness and swelling lasting about 4-5 days.
Twinrix was administered to patient as Hep A and Hep B vaccines on 11/17/06 and 12/27/06. No signs or symptoms.  This was not identified until patient returned for third dose on 6/1/07.  Nurse who noted error contacted the manufacturer and CDC and was advised that Twinrix doses should be considered invalid and patient should receive age appropriate doses of Hep A and Hep B vaccines.
Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: Approx 5 min after injection pt complained of lightheadedness and nausea. Pt was visibly sweating with slightly labored breathing. Pt's partner began to fan him and water was given by pharmacy staff. After an additional 5 min pt was visibly improved. Couple remained in the store under then care of pharmacy team until pt felt ok to leave. Upon exit pt seemed to be back at baseline.
Was given a Pfizer vaccine and he reported that he had had the Johnson and Johnson vaccine in March 2021.
I was waiting 15 minutes after the injection and around that time I had a feeling like I was going to pass out and vomit. I also had a bitter taste in my mouth. My face and tongue also became tingly. It passed within 1 minute. I then had 3 waves of nausea and face tingling over the next 20 minutes, each lasted a few seconds. They were far less intense then the first episode and became less with each wave. After that, I developed a mild headache. Next day, no recurrent episodes of nausea and face tingling. Mild headache continues. Also have injection site pain.
Patient developed redness and extensive swelling around the injection site. He was treated with ice, acetaminophen, and an oral steroid (methyllprednisolone).
Patient came in to clinic for #2 Moderna Covid vaccine, immediately after receiving vaccine @ 1554 patient felt heart palpitations, but symptoms not reported until patient left after 15 minute monitoring and came back to clinic after feeling very foggy, "light", weak while walking & palpitations continued. Reports no other adverse reactions to vaccines in the past.   pt's vitals 156/83, HR 95 & O2 Sat 100%, denies any other symptoms at this time Reports her BP much higher than normal and her heart feels like it's racing Patient rested & monitored for additional 15 minutes, Vitals 143/80 HR 93 & O2 sat 100% After 15 minutes patient still feels "foggy & sluggish", but feels ok to go finish her shift & denies palpitations and will follow up w/ PCP as needed
Pt recvd vax 18NOV92 & 1/2 to 45 mins following inject, pt became warm, flushed, sweaty, devel swollen glands, was hoarse, exp h/a; pt described self as being fatigued;
Narrative:  COVID infection following COVID vaccine series 01/15, Pfizer, dose #1 02/05, Pfizer, dose #2 09/24 , Pfizer, dose #3 08/16 BinaxNOW COVID-19 Ag: NOT DETECTED 08/17 CT CHEST W/O IMPRESSION: Continued stability of multiple tree-in-bud opacities and nodular consolidations in the left upper and lower lobes. No new suspicious findings. 09/13 BinaxNOW COVID-19 Ag: NOT DETECTED 09/16 BinaxNOW COVID-19 Ag: NOT DETECTED  09/23 BinaxNOW COVID-19 Ag: NOT DETECTED 09/27 BinaxNOW COVID-19 Ag: NOT DETECTED 09/30 BinaxNOW COVID-19 Ag: NOT DETECTED 10/04 BinaxNOW COVID-19 Ag: NOT DETECTED 10/07 BinaxNOW COVID-19 Ag: NOT DETECTED 10/12 BinaxNOW COVID-19 Ag: NOT DETECTED 10/27 PT/INR: 12.2/1.09 10/27 COVID swab, result: detected 10/27 pt cc: exposure: unknown
Pt reports to have to turned black and blue at injection site immediately after vaccine administration. Pt feels sore and achy since the vaccine has been administered. She will be calling her doctor.
Numbness of injection arm and hand. Nausea, dizziness, headache.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TAMOXIFEN, start date: 02Feb2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Product: COVID 19 Treatment Brand was Paxlovid. Treatment start date was 06Sep2022. Indication was Treatment of COVID-19. Patient received other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Malaise; Clammy Skin; Cold to touch; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), HYPERHIDROSIS (Clammy Skin), PERIPHERAL COLDNESS (Cold to touch) and FATIGUE (Fatigue) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced MALAISE (Malaise), HYPERHIDROSIS (Clammy Skin), PERIPHERAL COLDNESS (Cold to touch) and FATIGUE (Fatigue). At the time of the report, MALAISE (Malaise), HYPERHIDROSIS (Clammy Skin), PERIPHERAL COLDNESS (Cold to touch) and FATIGUE (Fatigue) outcome was unknown.            No Concomitant product details were provided by the reporter. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Added Reporter Address and E-mail id - Considered as Non significant follow-Up
Pt on 04/21/05- woke from nap with heavy breathing and a red, raised area to injection site to right thigh. Mom took pt to MD immediately who RX'd Tylenol and Benadrly. No congestion nonted. Better by 04/22/05. Pt breathing improved prior to arriving to MD office.
C/O headache, lightheaded near fainting. Headache persisted till next day.
Hives- every morning and every night: legs, hips, arms, hands, feet.
pain during injection; skin breakout; This spontaneous case was reported by a physician and describes the occurrence of RASH (skin breakout) and VACCINATION SITE PAIN (pain during injection) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In February 2021, the patient experienced RASH (skin breakout). On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain during injection). On 09-Mar-2021, VACCINATION SITE PAIN (pain during injection) had resolved. At the time of the report, RASH (skin breakout) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication and Treatment information were reported.
Parent had called and said the child had a 2 pencil eraser sized blisters under both eyelids.
The same day I got the vaccine I had a fever, migraine, and started having stomach problems. I saw my doctor on 11/19/2021 and he suggested gas medication and said I had gastritis and prescribed me to medication (unsure on the name). After two weeks my stomach problems got much better but this is still a on going issue.
SORENESS IN LEFT SHOULDER NEXT DAY, RED DOTS ON NECK APPEARED NEXT DAY
Sever Shortness of Breathe,  swelling of arm, rash across torso. Used albuterol nebs and hand held inhaler, benadryl PO, hydrocortisone cream for rash. SOB lasted day and 1/2, rash took a week to go away. On Prednisone daily and had epi pen available.