chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 1350 Patient received Janssen vaccine. Three minutes after administering vaccine patient complained of feeling dizzy. Witnessed patient becoming pale and clammy. Ice pack placed behind patient's neck and raised patient legs. Vitals stable. B/P 120/80 resting HR-88. Pulse Ox 98%. Patient appeared to be fainting.  Immediately called 911 and ambulance in route. Patient never lost full consciousness. Patient was able to respond to day/month. Patient told paramedic upon arrival developed onset of headache/ dizzy and lightheaded. Patient reports has a fear of needles and has fainted after blood draws. After work up with paramedics, patient refused to go to the hospital. After 30 minutes of monitoring patient was released by paramedics to follow up with family care and for urgent symptoms /side effects follow up with emergency department.
Rash, UrticariaPruritus,redness, swelling burning Narrative: developed injection site reaction on 12/31/2020- tenderness, swelling, itching, and erythema which resolved on 1/4/2021. On 1/12/2021 arm began hurting, burning, itching and a rash (8cmx 7 cm) developed at the injection site and is still present. Will have the site looked at today.
Information was received from a medical assistant referring to a male adult patient. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On 03-AUG-2016 the patient received two doses of RECOMBIVAX HB (lot # K021581, expired on 24-OCT-2016; lot # L042846, expired on 15-SEP-2017)(dose and route unknown)(product use issue). The reporter was not aware of nay adverse effects or side effects related to the event. Additional information is not expected as there is no consent for follow up.
Rash neck, scalp, upper back, chest pain, short of breath, head dizzy, "foggy" thinking. Assoc. with steroid shot wk before. Took 4 day to clear with rest, no activity, TV, comptr other medic: INDOCIN, steroid shot wk before.
Skin sensitivity that feels like a sunburn from elbow to middle of back (covering the shoulder blade on the side where the vaccine was injected). Painful sunburn sensation for the first day or two after presentation, but has lessened to more of an irritation 11 days later. Definitely still present though. No visible rash or marks.
Malaise; Body ache; Arthralgia; Fever; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), MYALGIA (Body ache), ARTHRALGIA (Arthralgia), FATIGUE (Fatigue) and CHILLS (Chills) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced FATIGUE (Fatigue) and CHILLS (Chills). On 25-Jan-2021, the patient experienced MALAISE (Malaise), MYALGIA (Body ache), ARTHRALGIA (Arthralgia) and PYREXIA (Fever). On 26-Jan-2021, PYREXIA (Fever) had resolved. At the time of the report, MALAISE (Malaise), MYALGIA (Body ache), ARTHRALGIA (Arthralgia), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: Negative.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  Treatment details included Tylenol.   Reporter did not allow further contact; 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.
This spontaneous report was received from a pharmacist and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were mistakenly vaccinated with the second dose of ZOSTAVAX (lot #, expiration date, exact dose and route of administration were not reported). This was outside the recommendations per the ZOSTAVAX prescribing information. No adverse effects were reported. Additional information has been requested.
Moderna COVID- 19 Vaccine EUA: patient presents to urgent care reporting lower lip swelling for three hours one day after receiving vaccination. Patient also reports tongue feeling tight, tingly, and with pressure. Patient has been taking diphenhydramine. Vital signs all within normal ranges. No vomiting, diarrhea, drooling, rashes, shortness of breath, cough, chest pain, or nausea. Patient able to speak in full sentences and take full breaths. Patient presribed Epi-pen to use as needed, advised to manage with antihistamines, and discharged to home stable.
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 56-year-old, adult female patient. The patient had no relevant medical history and did not receive any concomitant medications. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019). No adverse events reported after administration of the vaccine. This case 201804689 was cross-linked with the original case 201804657 due to the same reporter. Significant case amendment (19-Oct-2018): The lower level term of the event (received 1.5 ml dose instead of 0.5 ml) was corrected from extra dose administered to overdose in the event tab. The narrative and case comment were amended accordingly.
tiredness; Dizziness/ lightheaded; fever; headache; chills; soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 at 16:45 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for covid-19 immunization; Covid-19 vaccine (Dose 3, MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 11Nov2022 at 03:00, outcome "recovered", described as "Dizziness/ lightheaded"; CHILLS (non-serious) with onset 11Nov2022 at 03:00, outcome "recovered"; PYREXIA (non-serious) with onset 11Nov2022 at 03:00, outcome "recovered", described as "fever"; HEADACHE (non-serious) with onset 11Nov2022 at 03:00, outcome "recovered"; PAIN (non-serious) with onset 11Nov2022 at 03:00, outcome "recovered", described as "soreness"; FATIGUE (non-serious) with onset 11Nov2022 at 03:00, outcome "recovered", described as "tiredness". Therapeutic measures were not taken as a result of fatigue, dizziness, pyrexia, headache, chills, pain.  Additional information: Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Intense upper abdominal cramps that began 20 minutes after injection, and intensified over the course of the next 4 hours. This is the point at which I'm completing this form.
I ache all over, have no energy my chest hurts, bloody nose, sweating, fever and chills.... in general I feel like I have been poisoned.
Irregular heartbeat, shortness of breadth, palpitations.   Treatment:  Vascular dilator--just started treatment
Cellulitis of left arm extending 3/4 of the distance to elbow. Failed oral antibiotics with worsening cellulitis. Required IV antibiotics and hospitalization.
Flushed, nauseous,  serious headache and extremely tired within first hour after receiving the injection.  took 2 Ibuprofen and laid down. Ate supper with the family, headache still really bad. Stepped outside for a few minutes and my heart began to race wildly.  Called hospital after I couldn't get it to calm down with breathing technique after trying for 40 minutes. Too many bpm for me to count myself.
Felt very dizzy.  Had difficulty walking.  Felt as if I was going to fall sideways.  Had to hold on to furniture to be able to walk.  Had difficulty focusing my vision.  Eye movement from side to side as if scanning, but couldn't stop it.
I was achy all over, injection site was hot, swollen, red and hard.  I had a fever of 101.3.  Because I was so miserable, I took two tylenol and hours later my fever broke and the achiness is better.  Injection site is still hot, swollen, red and hard.
MALAISE; CHILLS; INJECTION SITE SORENESS; LOW GRADE FEVER; RECEIVED TWO DOSES OF JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 30-MAR-2021, and dose was not reported, administered on 11-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-SEP-2021, the patient experienced received two doses of janssen covid-19 vaccine. On 11-SEP-2021, the patient experienced off label use. On an unspecified date, the patient experienced malaise, chills, injection site soreness, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever, malaise, chills, and injection site soreness, and the outcome of received two doses of janssen covid-19 vaccine and off label use was not reported. This report was non-serious.
ACUTE NON ST ELEVATION MI 4/12/2023 NON-ST ELEVATION MYOCARDIAL INFARCTION ACUTE MI 4/19/2023 NON-ST ELEVATION MYOCARDIAL INFARCTION
Chest cold symptoms; Missed period X5 days (still awaiting cycle as of date); extreme muscle pain (every muscle in body hurt for 1 day approximately 1 week after 2nd dose); This is a spontaneous report from a contactable consumer (patient). This 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Aug2021 at 10:0 AM, at the age of 38 years, as the second single dose, in right arm, for COVID-19 immunisation. No other vaccine was administered in 4 weeks. Medical history included breast cancer, allergy to taxol chemo drug, dairy and bee venom. The patient received the first dose of BNT162B2 vaccine on 13Jul2021 at 10:00 AM, at the age of 38 years, in right arm. The patient did not have COVID prior vaccination. Concomitant medications were none. On an unspecified date in Aug2021, after the second dose, the patient experienced chest cold symptoms for 3 weeks, missed period for 5 days (still awaiting cycle as of date), extreme muscle pain (every muscle in body hurt for 1 day approximately 1 week after 2nd dose). The events required treatment with OTC pain medications. Events outcome was unknown. COVID was not tested after vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I was freezing cold, had a high fever, and had a bad cough. I was coughing up a lot of stuff, so I contacted my doctor, and he prescribed doxycycline for 6 days. My fever and all other symptoms went away but I was still coughing a lot, so I called my doctor again and he prescribed prednisone. I am still coughing and have Asthmatic Bronchitis, so he is going to prescribe more prednisone.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, itchy rash, pustular rash and scab. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the injection site erythema, injection site swelling, itchy rash, pustular rash and scab were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, itchy rash, pustular rash and scab to be related to SHINGRIX. Additional information received as follows: On 17th or 18th October 2018, in morning, the patient had the shot of SHINGRIX. The patient was not sure of the exact date. In afternoon, the patient experienced redness, soreness and swelling at the injection site after receiving the shot in the morning. Eight to ten days later she noticed a few bumps behind her knee that looked like 3-4 bug bites. They were itchy. They appeared on her stomach too. After a day or 2 they produced little puss heads and then they scabbed over. A few recently appeared on the back of her arms, on front and back of her neck and on her right foot. She stated that they come and go. The reporter gave consented to follow up.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
Received the first vaccine 1/10/21 and had no side affects.   Received the second vaccine 2/7/21 @ 0830. At 1500, had a 101.0 fever, full body aches, chills, and all over body shaking. Concentrated, Dark, malodorous urine. Lasted on and off until 0700  2/9. Extreme Fatigue following on 2/9. At 2100 on 2/9, noticed bilateral hand swelling and discoloration (Purple and blue hands, with visible veins, ) BP taken on home BP cuff 159/95, HR 80 (no history of HTN).
Vaccinated 12/23/2020.  On 01/01/2021 developed fever, sweating, ache, cough, and congestion.
irritable for several hrs later that day; next morning pt was fine, smiling, acted nl w/good eating, etc; then put down for a nap & 15-20 mins later-no response;
Notified on 09/01/22 at 2:50 pm that we are to no longer administer monovalent vaccines.
A few pts recvd 2 doses of Engerix-B & following the 2nd dose devel local reactions, irritation, redness, fatigue; tx unk;
Moderate persistent headache- present every day- still present 2/14. Fatigue- can?t stay awake through day.
Left shoulder pain, chest pressure. Went to ER and had tests for heart related event and given pain medications. Pain continued for several days. Patient reports unsure if was caused by vaccine and was not told by ER staff what the pain was caused from.
Patient claims to feel light headed , shaking, and body feels hot. Patient mentioned she hasn't ate or drank anything since last night. Vitals where taken see below. Patient declined transport to hospital.
Rash at injection site spreading to chest well, self-limited. No anaphylactic reaction. Diphenhydramine 50 mg PRN.
Hives began appearing on February 5, 2022. The itching was intense and the hives were dispersed throughout my body (from my scalp to the soles of my feet and all over in-between). Visited with a general practitioner on February 7, 2022. Doctor was able to recognize hives but could not determine origin of hives. He prescribed a 10 day taper of Prednisone along with Benadryl and/or Allegra. After 3 days there was no improvement. I called the doctor's office and the doctor suggested, in addition to what I was already taking, to begin taking 40mg of Pepcid and increase Allegra. This alleviated my itchiness but the hives were still present. While taking these medications I felt my chest tighten and I also felt my throat closing. I had the feeling of a "lump in my throat" and went to the E.R. on February 10, 2022. I was treated with epinephrine at the hospital. This calmed my hives, itchiness, and my throat felt better. I returned to the same primary care physician I saw prior, on February 15, 2022 for a follow-up. I continued with hives. He suggested I add Singulair to my list of medications and also recommended I see a dermatologist. I began Singulair and took it for a few days but it seemed to cause headaches. I still have hives and now struggle with random heart palpitations, chest pain on many days, feelings of a lack of oxygen, numbness and tingling in my hands almost daily, and some insomnia.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 25-JUN-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23 0.5 ml, which had a lot # of L003188 and an expiration date of 06-JUL-2016 (route and anatomical location of administration were not reported). The sum of hours in excursion was 8 hours and the lowest recorded temperature reported was 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Mysterious rash appeared under both arms, down sides and on lower back and somewhat on lower abdomen  Being treated with Mometasone Furoate Cream 01%
Incorrect diluent volume was mixed (the vial contents were diluted with a diluent volume of 0.8 mL instead of 1.8 mL), but 0.3 mL dose was still administered. We have already talked to Pfizer-BioNtech. They told us that if the dose given in error is the first dose, a second dose should be administered at the recommended interval of 21 days. If the dose given in error is the second dose, the series is complete, and no additional doses are needed. We have already informed the patients of the potential of local and systemic adverse events.
two doses, one day apart; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number FA95N, expiry date unknown) for prophylaxis.   Concurrent medical conditions included diabetes (Patient is diabetic). Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 21st October 2022, the patient received the 2nd dose of Shingrix. On 21st October 2022, 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 Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comment: The reporter called to ask for information about the administration of two doses of Shingrix to a patient one day apart.  The reporter asked for safety information and how to proceed with patient vaccination.  The reporter consented to follow up. Additional Supportive Information: The patient received the 2nd dose of Shingrix earlier than the recommended schedule, which led to drug dose administration interval too short.
This is a spontaneous report from two contactable nurses reporting on behalf of a nurse practitioner. A 16 years old female patient of unspecified ethnicity received the first dose of TRUMENBA (lot J29203, NDC number: 0005010010, expiry date: 01Jun2016) intramuscular in left arm on 09May2016 at 15:58 at 0.5 ml single dose. Medical history was not reported. Concomitant vaccine included the second dose of MENACTRA; (Manufacturer Sanofi, lot U5244AA) intramuscular in left arm on 09May2016 for immunization. The patient experienced hives on 11May2016. The patient was visited at doctor office. The patient was not admitted to hospital. PCP suggested skin testing at allergist with the following dose. The event resolved on 12May2016. The reporter considered that the vaccine had a causal effect to the adverse event. Follow up (01Jun2016): New information from a contactable nurse includes: patient age, vaccination time, concomitant vaccination, event onset date, details and outcome reporter causality assessment. Follow-up attempts completed. No further information expected.
Patient reported Syncope/Fainting on site EMS was required. SBP 118, Oximetry 98, EMS/on site physician decided No treatment was needed transported to local hospital.
The Patient requested a COVID Vaccine, first dose, Moderna was listed as preferred. The patient presented with parent to the vaccination room, where the version of Vaccine was questioned. It was confirmed it was the vaccination of choice. Neither FNP, nor pharmacist on duty caught the age discrepancy for recommended first dose administration (Pfizer being preferred ). On November 8, 2021, the error was discovered, reported, and instructions received for follow-up.  Patient parent contacted by this clinic on 11-09-21, and parent denies any adverse reaction. Patient is reported as doing well. Patient mother instructed to contact clinic for any reactions or symptoms. Patient mother verbalized understanding and had no further questions at this time.
Stomach ache and loss of appetite for 5 days after injection. Last 2 days of stomach ache and loss of appetite also had chalky stools, which returned to normal after the 2 days.
As soon as I got the shot the left side of my body felt tingly my face and neck got bright red I was extremely hot and my throat hurt and my tongue felt fat but I was able to breathe OK I got a rash on my neck that went to my face and that happened within two minutes of the shot the symptoms got worse over the weekend and on Monday the 29th I went to my doctor to get steroids to calm down the reaction my head was itchy my ears were hot . I also had to take benedryl the entire weekend before doc appointment. It?s been over 6 months and still having the same issues and have been on steroids 3x to try and help it calm down
Extreme tinnitus in left ear one week after second dose and continuing to present; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 08Feb2021 09:00 (Batch/Lot Number: EM9809) (at the age of 48-years-old) as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. Concomitant medications included pantoprazole and atorvastatin; both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks of COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in right arm (Batch/Lot Number: EI32u7) (at the age of 48-years-old) on 18Jan2021 COVID-19 immunisation. The patient experienced extreme tinnitus in left ear one week after second dose and continuing to present on 15Feb2021. The patient was treated with Acupuncture for the event. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of event was not recovered.   No follow-up attempts are possible. No further information is expected.
Pt. received 2nd Pfizer on 3/5 and went to ER at facility on 4/7 with blood clots in right lower leg. Attending physician advised him to let us know as he received vaccine with his. Unclear if clots are related to vaccine.