chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US023855 is an initial spontaneous report received from a pharmacist on 26 Nov 2014, with a follow up received from pharmacist on 09 Jan 2015. This report refers to a 61 year old female patient. The patient's past medical history was none. Concomitant medications were not reported. The patient had tolerated the vaccines well in the past. On 25 Nov 2014, she was vaccinated with a partial dose of FLUCELVAX (batch number: 012022A, expiry date: Mar 2015) intramuscularly into the arm. During the vaccination, some of the vaccine came out of the injection site and trickled down her arm. The reporter noted that the patient was visually obese and her arm had more adipose tissue and wondered if the vaccine was injected into her muscle. It was reported that the patient was hospitalized (no further details provided). Follow up received from pharmacist on 09 Jan 2015: updated seriousness criteria (hospitalization) and other clinically relevant information in the narrative.
Chills, body ache, cough, severe fatigue; 12 hr duration; treated with Ibuprofen
Consumer forget about her second shot. She wants to make sure that whether she did get her second dose or not; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Consumer forget about her second shot. She wants to make sure that whether she did get her second dose or not) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Consumer forget about her second shot. She wants to make sure that whether she did get her second dose or not). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Consumer forget about her second shot. She wants to make sure that whether she did get her second dose or not) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant details were provided No treatment details were provided
The patient went to the hospital with a major asthma attack shortly after getting her flu shot. She has had the shot in the past without any issues.
Patient had developed difficulty breathing with 5 mins of receiving the vaccine. Patient had her own EPI-PEN and it was administered. She was transported by wheelchair to our treatment room and was administered Benadryl IM. Our provider on today called EMS and her transported to the nearest Emergency Room. After EPI-PEN and Benadryl were administered the patient stated she was feeling  much better and was able to breathe clearer.
Patient received 0.3 mL undiluted Pfizer vaccine x 1 injection.  Facility contacted Poison Control center for direction. Contacted Medical Director for further instructions. No adverse effect resulted from adverse event.
Pt reports fist like pain as soon as injection administered with progression of pain down the left arm to elbow. States pain is shooting pain of the elbow with movement; decreased ROM, weakness left arm only. Required office visit. Treated with NSAIDS and medrol dose pack. Will follow up in two days.
itching; hives; This case was reported by a pharmacist and described the occurrence of pruritus in a male patient who received Herpes zoster (Shingrix) (batch number 7434N, expiry date 24th April 2022) for prophylaxis.   On 4th September 2020, the patient received Shingrix (intramuscular). On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pruritus and hives. On an unknown date, the outcome of the pruritus and hives were recovered/resolved.   It was unknown if the reporter considered the pruritus and hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was updated from 74342 to 7434N, as per sales data sheet. The patient experienced event and it could be on same day or a week after was not sure.  The patient did not had hives or itching any more. The reporter did not consent to follow up. The reporter did not want to prove further details and did not agree to follow up and was not happy providing details.  The reporter did not want to provide address and no further information provided.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored VAQTA (lot # L015460, expiration date 20-JUL-2017, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
second dose at week 6; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at the vaccination was not reported. Patient was administered with second dose of Shingrix at week 6 from the first dose instead of 8 weeks apart, which was shorter than the recommended interval, leading to shortening of vaccination schedule. The reporter claimed that he had no information to provide about the vaccination schedule and or the patients. The reporter consented to follow up.
It was reported that an 82 year old female pt with a history of arthritis in shoulder was vaccinated with Fluzone SV '01-'02 in her left arm on 10/18/01 and Pnu-Imune on 10/24/01. On 10/25/01 the pt developed a swollen arm and was hospitalized with an infection of the left shoulder. Further info is requested. 9/16/02: During internal review of all files, it was deemed necessary to amend the report by upgrading this case to a 15 day alert report due to this case being SAE and unlabeled.
Redness, swelling, hot to the touch, raised whelp about 6 inches by 3 inches. Hard and moderately painful.
I had expected flu like symptoms the day after the second shot (chills, fatigue). After the first shot I had a couple hives scattered on face, arms, neck and body. After the second shot, the hives progressed. Many more showed up on face, neck, arms.  The number and frequency has worsened. I have been using antihistamines to mild improvement.
Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Revax unwanted
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A female patient received bnt162b2 (BNT162B2), administration date 23Aug2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset Aug2021, outcome "unknown", described as "got sick"; PYREXIA (non-serious) with onset Aug2021, outcome "unknown", described as "fever"; COUGH (non-serious) with onset Aug2021, outcome "unknown", described as "cough". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient's wife called asking what she should do. Her husband's arm was swelling, with some limited heat, but no redness in the area. She was instructed to have him take a Benadryl tablet, apply cold compresses to the area, and take him to either an urgent care or an emergency room. At around 10:15am when the patient checked-in with the immunizing pharmacist, there was no sign of reaction to the immunization. There were no reports from the patient or family members until 4:20pm.
A few hours after: mild stomach cramps Next day: more mild stomach cramps off and on Third day: woke up with severe 10/10, stabbing on and off pain all day, felt lower back numbness. Fourth day:  stomach felt on fire, numbness tingling throughout body, disoriented exited off wrong exit to work,  Felt constricted blood flow to chest, couldn?t breath for 20-30 seconds off and on for a min or two, had a panick attack as a result, called ambulance, full body shaking /chills. Fifth day: severe 10/10 headaches.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no other medication in 2weeks. The patient has taken Paxlovid antiviral for the treatment of COVID-19 from 10Oct2022 to 15Oct2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Spreading purpuric rash, initially at abdomen but spread to axilla, groin and upper thighs. Arthralgias and swellling of hands, knees and feet. Decreased oral intake.
I was supposed to get the new bivalent booster shot, but was incorrectly given an initial dose shot instead.
I received this vaccine and shortly after I used moni-stat 7 day treatment in 2019 because I thought I had a BV and shortly after I've noticed it looks like I may have a prolapse . I have three visible holes in my vagina doctors continue to tell me nothing is wrong. There's foul smelling odor when I use the restroom and I can hardly poop. I want to note that this was my third HPV shot.  However my previous shots were back in 2015 and they of the hpv 4 variant.  I am unknown if that matters. I have a high sensation now for wanting to be sexually active resulting in relief only if I orgasm or this will sound odd and weird but if I cry I seem to find relief.
Redness, swelling of the left deltoid. Grandmother was instructed to put a cold washcloth on the area to take out the heat.  Shown VIS which shows it takes 1 - 7 days to resolve
Mild dose of chickenpox - rash on belly - chest - back - top of arms and butt. Some have pus in the center and itch. It's still there and some new ones. "BENADRYL" for itch.
Lowback pain; BODY ACHES; ARM PAIN; FEVER; FELT TIRED; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lowback pain), MYALGIA (BODY ACHES), PAIN IN EXTREMITY (ARM PAIN), PYREXIA (FEVER) and FATIGUE (FELT TIRED) in a 46-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 Rheumatoid arthritis.    The patient's past medical history included Overmedication (3 years) from 01-Sep-2017 to 01-Mar-2021, Skin rash from 2017 to 01-Jan-2022 and COVID-19 (7 days) from 25-Mar-2021 to 01-Apr-2021. Concurrent medical conditions included Sulfonamide allergy (Sulfur allergy) and Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS).   On 01-Sep-2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced MYALGIA (BODY ACHES), PAIN IN EXTREMITY (ARM PAIN), PYREXIA (FEVER) and FATIGUE (FELT TIRED). On an unknown date, the patient experienced BACK PAIN (Lowback pain). On 01-Jan-2022, MYALGIA (BODY ACHES), PAIN IN EXTREMITY (ARM PAIN), PYREXIA (FEVER) and FATIGUE (FELT TIRED) had resolved. At the time of the report, BACK PAIN (Lowback pain) outcome was unknown.            No concomitant medication information was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  The reporter's causality for the events of FELT TIRED, FEVER, BODY ACHES and ARM PAIN with HUMIRA(ADALIMUMAB) was not related whereas not reported with low back pain.   This case was linked to MOD-2022-642694 (Patient Link).
High temperatures; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Bexsero and high temperatures occurred after Bexsero vaccination. No other information was available.
Small red area on right thigh at 2 injection site. Fever since pm 3/8/07. 4/3/07 Received medical records from hospital which reveal patient experienced fever 102.7 at home w/sneezing.  Seen by PCP earlier same day & sent to ER for direct admit for overnight observation.  Progressed well & d/c to home next day.   FINAL DX: probable viral illness.
Rash, erythennous macula in right deltoid area. With heaviness to depomedrol.
popping sound in ears/popping is like when you're in an airplane; ringing in ears; dry cough; hoarse at times; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (popping sound in ears/popping is like when you're in an airplane), TINNITUS (ringing in ears), COUGH (dry cough) and DYSPHONIA (hoarse at times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR DISCOMFORT (popping sound in ears/popping is like when you're in an airplane), TINNITUS (ringing in ears), COUGH (dry cough) and DYSPHONIA (hoarse at times). At the time of the report, EAR DISCOMFORT (popping sound in ears/popping is like when you're in an airplane), TINNITUS (ringing in ears), COUGH (dry cough) and DYSPHONIA (hoarse at times) had not resolved.      No relevant concomitant medications were provided. No treatment information was provided.   Reporter did not allow further contact
I had the vaccine and after 10 minutes after my throat and esophagus were itching but it didn't close up, they gave me water and I was able to drink it but someone told me I was flushing and my heart rate increased and they had EpiPen's ready but they wanted to do liquid Benadryl first and it calm everything down. The next day about noon time my face turn bright red and my right side was swollen and I did more liquid Benadryl and that was fine. 2 days after the shot my arm was itchy and the next day my arms were fine but the next day my legs were itchy and I took more liquid Benadryl and then I was fine after that. My doctor told me to not take the 2nd vaccine because of my allergic reaction.
We discovered the product was not stored according to the labeling and was kept in the refrigerator longer than the manufacturer requires.
19 yr old patient was administered an adult dose of  Hep B vaccine on 4/5/2021. No reports of any injury or reactions.
BODY ACHE; VOMITING; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 45 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 drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced body ache. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, vomiting, and nausea on 09-APR-2021, and was recovering from fever. This report was non-serious.
4 days after shingrix shot patient blood sugar was elevated to 350 an took about 2 weeks until it stabilized
On day 1, post vax, the pts arm was sore. On day 2, she had a stiff neck X 1 day. On day 5, she had swelling of the face with hives on face and neck X 1 day. Also on day 5, she had itching of her face X 2 days. Then on day 5, she had night sweats X 1 day.
This case was reported by a lawyer and described the occurrence of vision loss in a 42 year old female patient who received Lyme disease vaccine recombinant injection for prophylaxis. A physician or other healthcare professional has not verified this report. On an unspecified date, the patient received LYMErix. At an unknown time after receiving LYMErix, the patient experienced severe neurologic symptoms, vision loss, sensitivity to heat and noise, numbness, tingling, lightheadedness, and muscular symptoms: SPECT (single photon emission computerized tomography) scan shows moderate to severe global hypo-perfusion with heterogeneity (demyelination on brain SPECT scan). Time to onset, treatment, and outcome were not reported. Comment: Vision loss, hypo-perfusion, and demyelination were considered medically serious (OMIC). Per follow up report received on 03/21/2005:  Legal case, follow up unavailable. Missing data report from GlaxoSmithKline (October 1, 2004 to October 21, 2004). Legal case no follow-up available.
Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Diarrhea-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Additional Details: Pt had convulsive chills that lasted 45 minutes, jaw hurt, nausea, diarrhea, couldn't raise arm for 1 hour. Symptoms lasted 10 hours
Patient presented to the ED and was subsequently hospitalized on 2/18/21, within 6 weeks of receiving COVID vaccination. He also presented to the ED on 3/30/21
I had a rash and about the rash was on buttock.; I started with shingles/It look like shingles that hurt.; This is a spontaneous report from a contactable consumer or other non hcp.   A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: 30155BA), dose 3 via an unspecified route of administration, administered in Arm Left on 18Oct2021 (at the age of 68 years) as dose 3 (booster), single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included denosumab (PROLIA). The patient previously took bnt162b2 for covid-19 immunization as dose 1, bnt162b2 for covid-19 immunization as dose 2, shingrix, omeprazole for neoplasm malignant. On 18Oct2021 the patient experienced a rash on buttock and started with shingles/it look like shingles that hurt. Patient went to the doctor yesterday and they said patient started with shingles that patient got the Pfizer the 3rd booster, that got it on Monday and on that evening she had this rash so she didn't know whether the rash was from the vaccine because she had read somewhere where you can get a rash from it or what was that number now I have 3 of the vaccine for shingles before (Further not clarified) and so anyway are they see nurse practitioner says that it look like shingles that hurt so I just (Sentence Incomplete). Patient have put some Polysporin on the rash and it was going to get better and you know what made it feels like sick in that and everything and then doctor gave me. It was a pill Val acyclovir and all its Valacyclovir 1 mg tablet, one tablet every eight hours for seven days and then they ordered me something to put on the rash when she went out there after several hours its done already they have to call the doctor and then doctor had to call them back. Probably 2 weeks before she had an injection in the left arm she had Prolia injection in her side arm so she give me some medicines an omeprazole to take and that is supposed to treat me from having the cancer again hopefully. Clinical outcome of the events was reported as unknown.  Follow-Up (27Oct2021): Follow-up attempts are completed. No further information is expected.
High fever (105) with seizure of approx 20 minutes. Required Ativan X 3. Left with left hemiparesis and developmental regression. Most Sn/Sx have resolved. Now with mild-moderate speech delays. 60 day Follow-up Information: She probarly have minimal developmental delays of speech/fine motor - she had regression of her development and has recovered and catching up and is close to normal for age. Therapy and formal evaluation is not accepted by parents at the present time.
Nurse noted patient tolerated injection within normal limits. No adverse reaction noted by the nurse after the vaccinations were administered. At home and four hours after the vaccinations, patient's mother noticed hives and a rash over both of patient's legs. He began to run a temperature of 101.80 F and started to shake uncontrollably. Patient would scream when he tried to walk. The vaccination area appeared red and bruised. Mother stated that she then called the doctor's office. The next day patient's temperature raised to 103 F. He became lethargic and began vomiting. The rash had continued to spread to his arms and back. Mother took him to the hospital. He was admitted and released the next day. Mother reported that patient returned to health soon after he was released from the hospital. The hospital treated patient for dehydration. According to mother, the doctor does not want patient to receive this years 2nd flu vaccine. Patient receiving the next years flu vaccine has not been determined, according to mother.
Provider submitted order for MenQuadfi and HPV,  MA administered both MenQuadfi and HPV. Provider then realized patient did not require MenQuadfi booster since patient had already received a dose on 02/14/2022. Provider notified parent and patient of error. Attempted to call Sanofi Pasteur to receive guidance but closed due to holiday. No adverse reaction at the time of discharge.
On 3/23/16 pt received a PNEUMOVAX from her PCP (11:40 am) 7 hour later, pt. presented to urgent care Dept. c/o chest pain and sob with redness and pain on injection arm site. Pt was given BENADRYL and SOLU-MEDROL IV and was transferred to hospital ED.