chrisvoncsefalvay/vaers-outcomes huggingface dataset:
alopecia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), reporting the same event under the same product for 6 patients. This is one of 6 reports.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Single, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Single, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Single, unknown manufacturer), for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300179111 same reporter/product/event, different patient;
Was given at age 16/ at a college clinic, thinking all students were 18+, mother works at facility and signed child up
4:00a.m., next  morning,chills (couldn't get warm), fever ( temp 102.8) , difficult to stand, no appetite, very sleepy all day. Had to hold onto walls just to walk felt dizzy, weak, aching and confused.   Right shoulder swollen, not red. No desire to eat,and forced myself to take fluids. Lasted 4 days.
15 hours after injection, woke up in the night with myalgias @ 2 a.m. 9/3/21. Approximately 12 pm on 9/3/21 began coughing w/ SOB and hemoptysis started at 3 pm.
Adverse effects Tested positive for Covid 19  on 01/14/2022 Lingering side effects were continuous cough in upper chest, lingering malaise, blood pressure increased.  Went to Dr about continous cough - just give it time to get over cough - cough is subsiding after 4 months, but still occurs occasionally. Received a Z-Pak and steroid shot on 02/15/2022 More sensitive to allergens and airborne particles which results in the cough returning.  Dr's also increased blood pressure medication to keep it within acceptable limits.Covid19( vaccine Pfizer shots were received on 01/16/2021, 02/06/2021, the 1st Pfizer booster shot was given on 10/3/2021 at the pharmacy
Woke up this am with neck & shoulder pain, cries when attempted to massage. TYLENOL seems to help. No fever, cold sx, sore throat.
Contact  for injection site.  Completely avoided human contact, no buildings etc. since last year March 13,2020.  Vaccine appointment 03/03/2021 7:10am.  Adverse allergic reaction 03/05/2021 11:30pm.  Extreme swelling on upper Legs with rash.  The skin was extremely swollen, stiff, tight, and red but not itchy.  The skin was an enormous welt on Left leg, small hives on Right. Took Benadryl to relieve symptoms followed up withAllergy specialist  over TELEHealth appt.  Recommended notify vaccination site and CDC.  Taking Benadryl prior to 2nd shot and remain at vaccination site 45 min. The Dr. Provided Epi Pen and Nebulizer Meds for emergency use only and to seek immediate medical assistance if needed.
Nine days after the injection an itchy rash broke out on my left foot. I've been putting antifungal cream on it and it's improving now. I don't know if it has anything to do with the Modern vaccine;  I'm reporting it in the interest of your data collecting.
Modern COVID-19 Vaccine EUA  Developed rash at injection site.  Itchy bumps, but not bad overall, no need to see a doctor, just thought it?s odd that it developed 8 days after the shot!
This spontaneous report as received from a Registered Nurse refers to multiple unspecified patients of unknown age and gender. On an unspecified date the multiple unspecified patients were administered ROCOMBIVAX HB (Lot# unspecified) dose, frequency, route and location unspecified was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
After the initial dose of Benadryl wore off, my skin began to itch, as well as my throat and ears. My arm also swelled up to the size of a softball where the injection was. I developed some bumps on my body, but was not covered in a rash. I had no problems breathing. I was itchy all day Sunday and my arm seemed to go down a little, but on Monday, when I went to work and couldn't take the allergy meds, it swelled again to nearly the size of a baseball. I think I might be allergic to the acetic acid in it because that's part of the compound in Aspirin, but I'm not sure. It's Tuesday and I still feel yucky, my arm is still itchy and it's still feverish and swollen and red at the injection site. Please call me and let me know if I should take the second dose. My husband has heart failure and I am a teacher. I want to protect him, but I worry that I had that kind of reaction even after taking allergy medication just in case beforehand.
7 days post vax, the pt was presented with rash on abdomen, back, face and limbs with an elevated temp of 101. The pt denies cold symptoms.
pain in arm; diarrhoea; stomach pains; vomited; fever; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), DIARRHOEA (diarrhoea), ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomited) and PYREXIA (fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 07-Dec-2020. Concomitant products included ATORVASTATIN, FLUOXETINE and AMOXICILLIN TRIHYDRATE (AMOXISOL) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomited), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm) and DIARRHOEA (diarrhoea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Jan-2021, ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomited), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in arm) and DIARRHOEA (diarrhoea) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-133408 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Follow up information was received on 15-MAY-2021, Additional information included onset date of medical history, updated additional events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
No symptoms or adverse effects reported; Nurse reports 8 patients received unspecified dose of PROQUAD that was improperly stored; This spontaneous report was received from a registered nurse, referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided.  On 18-NOV-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number S012530 and expiration date 20-OCT-2020) as prophylaxis. The sterile diluent (manufacturer unknown) used was properly stored.  According to the reporter, the temperature excursion was -12.8 degrees Celsius for a time frame of two hours and 38 minutes on an unspecified date (product storage error), with multiple previous temperature excursion of, the worst temperature/ was -9.8 degrees Celsius for about 112 minutes; which was detected by a digital data logger.  This is one of eight reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA009891:
Within 2 minutes of receiving booster, began to feel nausea and light headed. she then passed out and proceeded to have seizure like activity. belle went stiff as a board with dilated pupils and contracted hands. she has no memory of the event which lasted approximately 30-45  seconds before regaining consciousness. she then had severe headache and ringing in her ears. 4 hours later, she had red burning blotches all over her face and body which were relieved with antihistamines.
ASYMPTOMATIC COVID INFECTION Narrative: pt receiving testing as part of pre-op assessment testing for upper endoscopy. Tested positive for COVID but exhibited no symptoms. Recovered without advanced care at home. Procedure was postponed. No reaction following vaccine, no recent hospitalizations
Urticarial rash secondary to DTAP preservative? L leg cool compresses, Benadryl.
Extremely sore arm (couldn?t move it), nausea, constant vomiting for 3 hours, diarrhea, headache, extremely weak, and the chills
A week later right arm starting itching at injection site- large red blotch- sore to touch & arm/welt area feels feverish No treatment - continue to take Zyrtec- reported to my physician
Client stated he was breaking out with hives and felt itchy. Given 2 Tabs 12.5 BENADRYL by mouth condition improved B/P 120/80 - 72 - 14.
Pain on lower back; Joint pain on her left hip; Joint pain on left knee; Joint pain on both shoulders; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Pain on lower back), ARTHRALGIA (Joint pain on her left hip), ARTHRALGIA (Joint pain on left knee), ARTHRALGIA (Joint pain on both shoulders) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for Antacid therapy.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced BACK PAIN (Pain on lower back), ARTHRALGIA (Joint pain on her left hip), ARTHRALGIA (Joint pain on left knee), ARTHRALGIA (Joint pain on both shoulders) and HEADACHE (Headache). At the time of the report, BACK PAIN (Pain on lower back), ARTHRALGIA (Joint pain on her left hip), ARTHRALGIA (Joint pain on left knee), ARTHRALGIA (Joint pain on both shoulders) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Information has been received from a pharmacy intern student concerning a patient who on 10-NOV-2006 was vaccinated intramuscularly in the deltoid muscle with a 1 inch needle close to the elbow with a dose of Pneumovax 23.  That same day the patient experienced a cellulitis-like reaction near the injection site that appeared red and swollen.  Unspecified medical attention was sought.  At the time of the report, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Patient was given Combivax containing IPV and also was given extra dose of IPV in separate injection at same time.  There was no adverse response.  Patient did fine.
This case meets vaccine breakthrough criteria . SXS BACK PAI, WEAKNESS, NAUSEA, CHRONIC COUGH
Hives reaction < 5 min post injection given (Synagis Hep B #2)-erythematous patches over B lower ext + head-2 min later presented on trunk (same rash but less no raised lesions) no wheezing per Dr upon auscultation-3/4tsp of Benadryl given-observed in office x 30 min-no wheeze or cough-rash resolved in 20 min-sent home-referred to allergist-to ER if cough/ wheeze.
Swelling in armpits; Swelling in armpits causing painful rash; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 10:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to gluten and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). Concomitant medications included duloxetine (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown dates and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 13:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient previously also received morphine (MANUFACTURER UNKNOWN), for unknown indication from an unknown date and experienced drug allergy. On 21Apr2021, the patient experienced swelling in armpits causing painful rash. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of reported events which included treatment with topical hydrocortisone (CORTISOL) cream. The clinical outcome of the events swelling in armpits causing painful rash was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
4/6/2021 approximately 10:30pm I started getting hot.  The back of my neck was very hot and stiff to move.  Overnight I had heavy sweating.  I took ibuprofen before going to sleep.   4/7/2021 approximately 7:00 am I noticed my arm was very hot and red at and around the injection site approximately 3 inches.  It was sore to touch.  Throughout the day the spot kept getting bigger and harder and now it is raised.   The mark is approximately 12 inches long and 4 inches wide.  (8:00 pm).  It does not appear to be getting better at all.
12cm erythematous and indurated set of concentric rings w/ warmth and pain.
started w/redness to rt arm 13NOV98;seen in clinic 17NOV for cellulitis to rt elbow;
Engorgement/Swelling of lower right extremity from hamstring to foot, significant discomfort in right calf weight bearing, flexion of right foot/ankle, and to touch (e.g., massage).
At the time of the booster , chills on and off, body aches, headache . I started with having high blood pressure issues visited Dr. to readjust medication . December completed routine bloodwork ; showed that my platelet count was extremely low.  Dr. to follow up in Jan. platelet count is lower then that last visit, Dr. prescribed prednisone 40mg. Diagnosed with ITP .Final outcome was dangerously low blood platelets. Dr. tried a different steroids. Currently on Prolacta.
3 pediatric patients (between the ages of 6 months - 5 years) could have received their first or 2nd dose from the Dark Pink cap instead of Blue cap at their facility, essentially receiving a lower than authorized dose.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (3 pediatric patients (between the ages of 6 months - 5 years) could have received their first or 2nd dose from the Dark Pink cap instead of Blue cap at their facility, essentially receiving a lower than authorized dose.) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and 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 INCORRECT DOSE ADMINISTERED (3 pediatric patients (between the ages of 6 months - 5 years) could have received their first or 2nd dose from the Dark Pink cap instead of Blue cap at their facility, essentially receiving a lower than authorized dose.) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (3 pediatric patients (between the ages of 6 months - 5 years) could have received their first or 2nd dose from the Dark Pink cap instead of Blue cap at their facility, essentially receiving a lower than authorized dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 INCORRECT DOSE ADMINISTERED (3 pediatric patients (between the ages of 6 months - 5 years) could have received their first or 2nd dose from the Dark Pink cap instead of Blue cap at their facility, essentially receiving a lower than authorized dose.).    Patient age was reported as between the ages of 6 months to 5 years. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information about 3rd patient out of 3.   This case was linked to US-MODERNATX, INC.-MOD-2023-736989 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736989:Master case (Patient 1)
Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. On unknown dates these patients were vaccinated with doses of improperly stored GARDASIL (dose, frequency and lot# were not reported). No adverse effects were reported. This is one of several cases reported by the same reporter. Additional information is not expected because the reporter would not like to be contacted.
3 yo male with Sickle Cell disease vaccinated as per AAP recommendations with PPSV23 (1st dose). Injected intramuscularly to left thigh, tolerated will in office and sent home ambulating and in no distress after 10 minutes. Mother called around 2pm reporting that school called to inform her that child was having left thigh pain and swelling, otherwise well with no fever or respiratory distress.
Received vaccine at 5:45 p.m.  I sat down to start my 15 minute wait and my heart started to race, was pounding, became jittery, felt pressure in my left jaw,  couldn't catch my breath with mask on.  I lifted my mask to be able to get air as I attempted to check my pulse rate, but it was too fast to count.  I quickly took my coat off.  I sat back down and was going to get help, but noticed my heart rate decreasing, jittering decreasing, and was able to breath with mask on.  Pulse was down to 80 bpm.  The skin on my face and neck felt like they were burning.  The tip of my tongue felt tingly.  All subsided until next day, felt fluish, temp 101.5.
patient presenting with left arm redness, swelling, warmth, tenderness at the reported site of the prevnar 13. symptoms reported by patient to have started right after the injection and have worsened. no drainage. no red streaks. area is firm to touch. was seen in office on 11/4/19, vaccines given in pharmacy on 10/29/19, records obtained from pharmacy, scanned into patient chart.
Several bumps that itched in her head and scalp; arm swelling; never received the second dose of Shingrix but she couldn't be certain; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included drug-drug pharmacodynamic interaction.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced itchy rash, swelling arm and incomplete course of vaccination. On an unknown date, the outcome of the itchy rash was recovered/resolved and the outcome of the swelling arm and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the itchy rash and swelling arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's Mother. The age at vaccination was not reported. The patient received the 1st dose of Shingrix several years ago and experienced several bumps that itched in her head and scalp itched and also had arm swelling. The reporter believed that the reactions started within 12 hours of receiving the 1st dose and she was uncertain when the side effects resolved. The reporter explained that the patient recently had a similar reaction to the Pfizer COVID vaccine so she was curious if her daughter could be allergic to an ingredient in both vaccines. The reporter believed that her daughter never received the 2nd dose of Shingrix but she could not be certain which led to incomplete course of vaccination. The reporter consented to follow up.
Noticed a rash (bright sun-burn red color) on both thighs. Client went to the emergency room where she received Benadryl. Rash began going away and was gone in an hour.
Generalized twitching without alteration in consciousness. Initial onset within 1 hour of receiving vaccine. At that time twitching involved upper and lower body. Since that time has gradually improved, now only involving upper body, right arm and left chest.
This spontaneous report was received from a pharmacist refers to an approximately 73 years old female patient with no drug reactions or allergies. On an unspecified date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # and route not reported). No concomitant medications were reported. On an unknown date, the patient experienced rash. No treatment information was reported. The outcome of rash was unknown. The patient experienced similar adverse events with ZOSTAVAX and AFLURIA 1210USA004391 and 1210USA004394. Additional information is not expected.
18JUL94 pt recvd vax & mom report pt had blotches on face & body which appeared approx 1-2 hrs p/vax; mom instructed to go to MD or ER immed;
Diagnosis from ER was muscle spacicity; pain radiating from injection site to back; pain radiating from injection site to back, suspected brachial plexus; forearm numbness; This case was reported by a physician via sales rep and described the occurrence of muscle spasticity in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number CF9K4, expiry date unknown) for prophylaxis.   On 9th July 2019, the patient received the 1st dose of Shingrix .5 ml. In July 2019, less than a week after receiving Shingrix, the patient experienced muscle spasticity, injection site pain, back pain and numbness of upper extremities. On an unknown date, the outcome of the muscle spasticity, injection site pain and back pain were recovered/resolved and the outcome of the numbness of upper extremities was not recovered/not resolved.   The reporter considered the muscle spasticity, injection site pain, back pain and numbness of upper extremities to be possibly related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the had forearm numbness after vaccination. The patient had pain radiating from injection site to back, suspected brachial plexus. The patient did seek medical help from emergency room for muscle spacicity.