chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Presented to the smallpox immunization clinic 27 July to assess her smallpox vaccine site. She is a primary vaccinee who was vaccinated on 18 May. No contraindications to receipt of vaccine. No hx of skin issues or immune suppression. She denied any major problems with the vaccine site, that it progressed normally and developed a large pustule and scab development. She is here today because the scab has not fallen off and remains attached to her arm. She is keeping the area covered with Tegaderm, but is allowing it to air dry in the evenings. Other than a recent viral illness she is feeling well. There is no drainage, no pain, and no swelling. Has been keeping the site dry, no swimming, saunas or hot tubs. Vaccine site contains approx. 6mm circular scab with surrounding pink skin. Scab is dried, and shiny. No drainage or surrounding erythema. Scab fell off on 16 Aug. No complications.
This case was reported by a consumer via call center representative and described the occurrence of sickness in a 79-year-old female patient who received SHINGRIX (batch number EREC/ASO1B ?, expiry date unknown) for prophylaxis. The patient's past medical history included cataract extraction (in February 2018). Previously administered products included ZOSTAVAX (received 10 years before the day of reporting). On 17th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. The reporter considered the sickness to be related to SHINGRIX. Additional details were reported as follows: The patient received the vaccine on arm. The patient had a severe reaction that couldn't get out of bed for 3 days due to being sick. She reported this to her doctor and her pharmacist. The doctor advised her not to get the second shot of the series. She was requesting reimbursement (lot number might be wrong but that was reported she was looking at her receipt trying to find it). The contact details of the physician was reported. The reported lot number EREC/ASO1B did not exist in sales database and was updated to EREC/ASO1B ?
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccine on 1/14/2021 and 2/12/2021. Presented to ED on 8/18/21. Family was concerned about patient's increasing confusion and generalized weakness, urinary frequency, incontinence, and fever. In the ED, the patient was found to have WBC count 16.9,  Cr 1.38, urine is hazy with amorphous crystals, blood pos 1+, trace protein, CRP 11.3,  Cr 1.38 which was up from 0.8 from July 2021, CT chest shows ground glass opacities in bilateral lungs. Patient was experiencing respiratory failure and was placed on Airvo at 80%. He experienced low saturations in low 80s and was tachypneic in 40s. Patient voiced he did not want to be intubated. Patient received Solumedrol, Ceftriaxone, Doxycycline, Remdesivir. Pt removed his oxygen and restated he did not want it. The patient expired on 8/28/21.
dry cough; slept quite a bit; had a slight cold; low-grade fever; nagging headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (dry cough), HYPERSOMNIA (slept quite a bit), NASOPHARYNGITIS (had a slight cold), PYREXIA (low-grade fever) and HEADACHE (nagging headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (to sulfa drugs). Concomitant products included MULTIVITAMIN [VITAMINS NOS], CURCUMIN (TURMERIC MERIVA) and CALCIUM CITRATE (CALCITRATE) for an unknown indication.    On 19-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced COUGH (dry cough) and PYREXIA (low-grade fever). 24-Jan-2021, the patient experienced HYPERSOMNIA (slept quite a bit), NASOPHARYNGITIS (had a slight cold) and HEADACHE (nagging headache). On 28-Jan-2021, COUGH (dry cough), HYPERSOMNIA (slept quite a bit), NASOPHARYNGITIS (had a slight cold), PYREXIA (low-grade fever) and HEADACHE (nagging headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: negative (Negative) negative. On 22-Jan-2021, Body temperature: 100.4 degree F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       Patient reports "We have a former exchange student, who comes to stay with us periodically for work. He came in on January 11th. We waited 5 days and then my husband and I were tested on January 15th and our visitor was tested on January 16th. We did this as a precautionary measure. They both tested positive but were asymptomatic. I tested negative." On 02Feb2021 patient received a monoclonal antibody infusion. She has not yet received the second planned vaccine dose because she was told to wait 90 days after the infusion.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow-up information received 15-Apr-2021 processed with initial report. Updates included added event details and lab test., added patient allergy and treatment recived.
3rd dose MODERNA, 1st and 2nd dose PFIZER; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose MODERNA, 1st and 2nd dose PFIZER) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Immunocompromised.   On 24-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) Dose 1 and dose 2. On 24-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose MODERNA, 1st and 2nd dose PFIZER). On 24-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose MODERNA, 1st and 2nd dose PFIZER) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
Information has been received from a physician concerning a 1-year-old female who, "recently", in approximately 2005, was vaccinated with a dose of varicella virus vaccine live. Three weeks post vaccination", in approximately 2005, the patient experienced shingles that appeared on her arm and torso. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
A 39-year-old female reported that she received a dose of influenza virus vaccine (2002-2003 formula) (manufacturer unknown) in 2002, and experienced soreness, bruising and swelling on her left arm for 2 weeks. Medical History: The patient's concurrent illness includes hypothyroidism. Product Details: Indication for the the influenza virus vaccine (2002-2003 formula was immunisation. Product was administered in 2002. Dose regimen was 1 dose. Concomitant Therapy: Concomitant therapy included Synthroid (levothyroxine sodium). Event Details: The patient received an unknown brand of flu vaccine in 2002 in her left arm. Her arm became black and blue, and swollen for 2 weeks. Related Case(s): See related case: HQWYE376721 (adverse event, non-expedited). No additional information was available at the time of this report.
After being vaccinated, my daughter started having a headache, then around 10:30pm that night, she started bleeding from her nose. Then the next day, she had a headache and started bleeding from her nose again. Yesterday, 6.6.22 she started bleeding again like 3 times yesterday along with a headache. She keep saying tired yesterday.  Her eye was so red.
Was given Pfizer BioNtech vaccine 81 minutes after expiration time.    When called states she did not feel well for 1-2 days after vaccine administration.
Sudden onset body aches, shaking chills, temperature 103.5 P.O. Tachypnea tachycardia. Referred to emergency room.
Around 10 days after the vaccine my daughter developed welts (hives) that we treated with antihistamines around the clock. The welts would disappear and than reappear in another spot. This continued for 48-72 hours. She also was on amoxicillin and was around day 8 of course.
swelling at injection site right side; itching at injection site right side; swelling of face right side; swelling of throat right side; swelling of underarm right side; swelling of breast right side; migraine type headaches; dizziness; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0151) via an unspecified route of administration in the right arm on 13Apr2021 at 16:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, hormone replacement therapy and COVID-19. The patient was allergic to sulfur. Concomitant medications included amlodipine besilate (AMLODIPINE BESYLATE) and estradiol (MANUFACTURER UNKNOWN); taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 16:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021, the patient experienced adverse events all on right side which included swelling and itching at injection site, swelling of face, swelling of throat, swelling of underarm, swelling of breast. The patient had side effects which include migraine type headaches, dizziness and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events swelling and itching at injection site, swelling of face, swelling of throat, swelling of underarm, swelling of breast and included treatment with prednisone (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling at injection site right side, itching at injection site right side, swelling of face right side, swelling of throat right side, swelling of underarm right side, swelling of breast right side, migraine type headaches, dizziness and fatigue were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fever; Chills; Body aches; Fatigue; Headaches; Night sweats; This is a spontaneous report from a contactable nurse(patient). A 32-years-old female patient received second dose BNT162B2( lot number Eh9899), Intramuscular at Arm Left on 12Jan2021 11:00 at 32 years old at single dose for COVID-19 immunization. The medical history included Penicillin allergy. The concomitant medication was propranolol. The patient previously took Clindamycin and experienced drug allergy. The Historical Vaccine was first doe BNT162B2 on 23Dec2020 09:00 at 32 years old for COVID-19 immunization. On 12Jan2021 21:30 the patient experienced Fever, chills, body aches, fatigue, headaches, night sweats. All the events resulted in Physician Office Visit. There was no treatment received for all the events. There was no other vaccine in four weeks. There was no COVID prior vaccination. There was no COVID tested post vaccination. The outcome of the events was recovering.
Woke at 6am the day after the 2nd covid dose, headache, numbness jow-neck-head pain, lathargic, nauseated, back pain, RHR 90, painful at injection site, stiff hands.  Around 10 am ate 1/2 bagel, 1/2 banana and had been drinking water even though just rolling over in bed was a challenge.  1pm got up and walked 20 feet, stood and talked to daughter for a bit, began to sweat profusely, walked towards bathroom because thought to vomit and passed out and hit my head.  Tried to rest back in bed and the head and neck pain was to bad and PCP recomended to go to ER.  Temp 99 degree at ED.
Caller stated that after vaccine about 12 in the afternoon she felt nausea, fatigue and a headache.  Caller took the Zofran and slept for 20 hours and felt better.
Neuralgia on neck; 2 weeks after injection RUL pneumonia; still had neuralgia that's lowered her QOL.
Generalized tonic - clonic seizure X 1 minute with temp 103.  Arms flex hands and elbows, eyes rolled up & postitetal, no rash.  When to ER for flu then OV her scheduled 2/13/2010.
A non-serious spontaneous report of administration to pregnant female was received from a nurse concerning an adult female. On 10-Nov-2009, the patient received FLUMIST. The patient's obstetrical history included that she was in her second trimester. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
no adverse reaction but pt got covid vaccine dose 2 too soon. First dose was given on 3.4.21 and then second dose was given 3.16.21
Patient had FLUVIRIN and ZOSTAVAX shots same day on same arm. She complained of her toes hurting really bad, lower back and neck hurting. She had a quarter size red area where ZOSTAVAX was administered. Patient's symptoms all resolved within 4 days.
Date and time adverse event started: 2 weeks ago; Patient took Tylenol which helped alleviate symptoms
I did not have an adverse reaction to the vaccine. On 04/19/2022 I started not feeling well with a severe cough with mucus production. I thought it was due to my asthma condition. I tested positive for COVID-19 on 04/20/2022 with severe cough with mucus production and extreme fatigue. I contacted my doctor but was not prescribed additional medication. I used my asthma medication and rested for ten days. I believe in the vaccinations and that my case of COVID-19 was mild and more to do with my asthma.
Pt. presented with macules, papules, eczematous rash on bilateral lower legs that started on 1/24-1/25 that got worse by 1/29. The rash originally looked like dry skin, but by 1/29 mom reported it was  rough, red, and scabby in appearance.  She originally began to apply breastmilk, aloe vera, and active skin repair (spray and hydrogel) as well as a diaper rash salve. She has not had fever, she has been eating ok, and she consolable. She has continued to have good wet diapers and stooling. She went to NRT to test her rash which tested for fungal over growth and food sensitivities.  Other Treatment: Infant- dermal colonizer topically, zymex, Ther probiotic, HVS, Vitamin D3K2, breast milk or oatmilk baths. Maternal- Prenatal with Omega 3 DHA, black radish, calcium lactate, probiotic
I had no issues other than short term injection site pain and fatigue with first 4 shots. After my bivalent shot, I was exhausted for the next week and it has continued fairly unabated. I almost cancelled a visit to my daughter on Oct 4, twelve days after, because of it. I have not seen a doctor yet but am concerned because I am overly tired and my heart seems to race after modest exertion.
Maladministration of AS01B Adjuvant of Shingrix (without the Lyophilized Antigen Component); Maladministration of AS01B Adjuvant of Shingrix (without the Lyophilized Antigen Component); This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number X2E93, expiry date 6th May 2023) for prophylaxis.   On 25th April 2022, the patient received the 1st dose of Shingrix. On 25th April 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's Comment: The reporter reported that, he accidentally administer only the adjuvant portion of Shingrix as a didn't reconstitute the vaccine. The patient called this afternoon to inquire about Shingrix. She did not provide any other details on the adverse event case but did state to this agent the location of the pharmacy. The patient confirmed her birthdate and initials as documented in the adverse event. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, he accidentally administered only the adjuvant portion of Shingrix as a didn't reconstitute the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
I have been extremely nauseous, had extreme aches, extreme dizziness and light headedness, and headache. Heart races.
Sudden onset Insomnia, erratic behavior, psychosis, delirium, period of somnolence, cognitive decline.
Adverse side effects included low-grade fever, muscle aches, pain at the injection site and severe shakes. The primary adverse reaction was the shaking. It felt almost like a compulsion and I was unable to stop it. I added an extra blanket to the bed and turned up the heat in the house to 72ºF. I shook from about 10 pm to 3 am that night. The fever continued into the morning when I took one tablet of ibuprofen. Tenderness at the injection site lasted for 48 hours after the first onset of the symptoms (around 9 pm on 11/23/2021).
Severe Chills, Sever Muscle cramps (leg), Joint Pain, Body ache, Headache,
Headache, Sedation, Myalgia, Arthralgia, fatigue and chills. pain at the injection site.
Significant  feeling of nauseousness /loss of any appetite for approximately 24 hours, headache, fatigue, and body feelings of hot and cold.
Failure to thrive at 1 year; weighs only 15 pounds. Repetitive and severe tightening of body now. Chronic diarrhea after vaccine administered.
This spontaneous report was received from a patient of unknown age and gender regarding himself/herself. Medical history and concomitant medications were not reported. On an unknown date the patient went to physician's office for a tetanus shot(tetanus toxoid). But the nurse wrongly administered a fourth dose of GARDASIL, intramuscularly. The patient did not have any adverse effects at that time. Additional information has been requested.
This spontaneous report was received from a nurse licensed practical refers to a 69 years old female patient. The patient's concurrent conditions included hyperlipidaemia, irritable bowel syndrome (IBS), cystitis interstitial, osteopenia of lower leg, chronic sinusitis and oestrogen deficiency, the drug reactions (allergy) included: SEPTRA, MACRODANTIN, azithromycin, CRESTOR, BUSPAR, FLAGYL, cefrozil and levofloxacin. The patient's historical conditions and concomitant medications were not reported. On 06-DEC-2018 the patient was administered with PNEUMOVAX 23 lot # R007722, intramuscular for as routine vaccination (dose was not reported). On 07-DEC-2018, experienced redness and edema at the injection site down to the elbow, the patient visited an unspecified emergency room in which she was diagnosed with cellulitis and treated with intravenous antibiotic and was discharged from the emergency room at the same day with a prescription for an antibiotic. Blood Urea Nitrogen and Creatinine tests were conducted, however, the results were not provided. At the time of reporting, the patient was recovering from the event. The causality relationship between the event and PNEUMOVAX 23 therapy was not reported. Upon internal review, cellulitis was determined to be medically significant. The reporter also considered the event as life threatening.
No adverse reaction known thus far, patient received the pediatric dose for 11 and under when he is indeed 12. Attempting to get him the correct dose as soon as possible awaiting return call from parent.
Approximately 2 hrs after flu vaccine given developed persistent cough, then myalgias, nausea, diaphoretic. Eyes developed discharge, lid swelling and conjunctival infection. Cough resolved in approximately 2 hrs, VSS, symptoms gone in approximately 24 hrs.
began to get dizzy & sweaty, warm skin, immediately upon receiving vax; assisted to lie down VS BP 76/54, P100, T97.4; c/o mild h/a;
a patient received their 2nd dose of Havrix one month after the first dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 34-year-old male patient who received HAV (Havrix 1440) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX 1440).   On 30-OCT-2023, the patient received the 2nd dose of Havrix 1440. On 30-OCT-2023, an unknown time after receiving Havrix 1440, the patient experienced drug dose administration interval too short (Verbatim: a patient received their 2nd dose of Havrix one month after the first dose.). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-OCT-2023 The pharmacist called stating a patient received their 2nd dose of Havrix one month after the first dose. The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccinations schedule. (Drug dose administration interval too short) minus 4 days. The reporter consented to follow up.
Pt recvd 3 doses of Engerix-B vax & was determined to be a non-responder; pt recvd 4th dose of 4OCT91;
Sunday, the day of the shot, I was quite dizzy a couple of hours after the injection and my arm at the vaccination site was itchy, but no other significant reactions. The following morning I awoke to a very swollen, hot,  red, and rashy-looking upper left arm at the site of the injection. Had a bit of diarrhea twice in the morning. My temperature 100.4 which is 3° higher than normal for me.  Later that afternoon, I got dizzy again so I took my blood pressure and it was 90/59 which is low for me.   I had been eating normally even though I had a feeling of unease.  The most concerning thing was the discomfort in my upper arm and the swelling.  It was very localized and looked as if my arm had swallowed a tennis ball.  Itchy, red, hot, and very tender.  Today is Day 4 and the swelling has subsided but still not entirely gone and it is still quite warm.  I've been applying cold compresses and taking some Tylenol.
This spontaneous report as received from a healthcare worker (Medical Assistant) refers to an unspecified number of patients (age and gender unknown). The healthcare worker stated that improperly stored M-M-R II (administration/dosage details unspecified) had been possibly administered to these patients between 17-DEC-2014 and 05-JAN-2015. Concomitant medications were not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient already had the 3 pfizer serie vaccine and the PCP gave her the 4th one Moderna. Babies can only have 3 and she got 4.