chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 38-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 08-Jan-2021 and the estimated date of delivery was 08-Oct-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no treatment medication was provided
irritability (woke up screaming), legs aching, felt that she was very hot (no thermometer at home), nausea
Information has been received from a licensed practical nurse concerning a patient who was vaccinated with a dose of Varivax. Subsequently, the patient developed shingles. It was unknown if VZV analysis was done. No details about the child or the timeframe was known. No further information was available. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
9/5/21 PMH COPD, OSA, Afib on apixaban, CKD stage 5, HTN, HLD, and breast CA who presented to the hospital with dyspnea
Redness, induration at injection site, 8cm, Left upper arm, localized site inflammation, possible infection vs. allergic reaction.
Patient received first dose of Moderna COVID-19 vaccine on 4/7/2021. After vaccine was given, patient complained of lightheadedness, numbness in hands, light sensitivity, and nausea. Doctors and an RN evaluated patient. BP 96/64, not tachycardic. Mother was driving vehicle. No meds given but patient sent with EMS to ED.
Within 8 minutes of vaccination, the patient began to experience tachycardia with heart rate 130s.  This steadily improved over 5 minutes.  About 10 minutes later, patient  reported unilateral paresthesias.  Taken to ED for observation.   No shortness of breath.  Noted with a patchy rash to right shoulder extending to right side of neck and face.  Given Benadryl 25 mg IV, famotidine 20 mg IV and solumedrol 125 mg IV.  Rash resolved.
Reported pain, redness and swelling, feverish, body aches and headaches; Rx Alvelox; Administrator of vaccine notified of reaction on 3-6-08. Issue completely resolved at that time.
pt recvd vax; pt exp migraine headache which persisted for 3 days;
Developed group of carbuncles (7 locations) on upper back and back of neck approximately 3-5 days after receiving flu vaccine at local pharmacy. Carbuncle lasted for approximately 2 weeks with several breaking surface and becoming painful.  Carbuncles were treated at home and did not require medical attention. Carbuncles were monitored daily by myself for infection and improvement. I have no prior history of carbuncles nor had any since this occurrence. Was active and in good health at time of flu shot, and only received vaccine in anticipation of upcoming business travel and schedule for late December 2015. I do have a photo of carbuncles outbreak that I would like to make part of my adverse report. My history of obtaining the flu shot has been to get a flu shot every 1-3 years and dependent on CDC flu forecast and winter travel plans.
Entered ER for wholebody rash 12 days post 2nd vaccine with throbbing headaches, chronic lumbar pain and acute, left and right  shoulder aches and elevated resting heartrate >100bpm.  Admitted into hospital for further observation for bacterial infection, pneumonia based upon labwork and chest xray. Further tests pending results from CT scanfor the headaches and lumbar puncture to rule out meningitis. Tests ordered for labwork for liver enzymes and ultrasound. Root causes for all symptoms are still in investigation.
pt recv 1JUL98 & 7JUL98 noted a hot to touch swollen area in gen vicinity that shot was given;states exp a fever of 102 & diarrhea;also noted fell broke digit on 3JUL98;given naprosyn when took 2 doses prior to stopping;
swollen lymph nodes largely cervical; intense intractable right lower extremity pain; severe chills and so called constipation rather inability to pass HUGE amount of faecal matter ( limb pain excruciating at attempts ) to point of dire and extreme situation, pain, sweats....      still with issues mainly about hip area
Redness that spread to the size of a Jelly Jar Lid or the size of a magsafe charger. Patient noticed it when she took off bandaid and it has been three days; patient states that it was also sore, but it is not as sore today. Still is sore to the touch.
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Additional Details: Mom called saying patient was experiencing chills and body aches. She was not experiencing a fever but was given tylenol. Mom will take her to an urgent care if she doesnt feel better.
This spontaneous report as received from a medical assistant refers to a 14 years old female patient with a medical history of acne and no known drug reactions and allergies. On 10-SEP-2012, the patient was vaccinated with, 0.5 ml GARDASIL Lot # 0518AE Exp: 21-NOV-2014. Concomitant medications included: clindamycin. The medical assistant stated that on 10-SEP-2012, the patient experienced nausea, vomiting and tongue swelling after being given a first dose of GARDASIL Lot # 0518AE on 10-SEP-2012 at 3:30 pm. She noted that the patient developed tongue swelling a few hours later at 8 pm and was put on treatment with BENADRYL. Laboratory and diagnostics were not performed. The patient sought medical attention. The medical assistant stated that the patient's symptoms subsided and patient was recovered by the next day on 11-SEP-2012. Additional information has been requested.
12:29PM/Janssen vaccine 0.5ml administered to L deltoid 12:36PM/patient reported while in observation area he "was feeling dizzy, like he was about to pass out" 12:36PM/patient was assisted to the ground with 2 EMT's , patient feet elevated Patient vitals 111/68, 58,22,96%02 SAT. patient diaphoretic, able to answer questions, NO LDC, patient reports left pinky finger numb which resolved quickly (approx 2 minutes) 12:39PM/cool water bottle placed under patient head, alcohol pad waved under patient nose, patient alert and oriented x 4. Decreased disphoresis, increase in patient color, patient reports feeling much better vitals 109/77, 71, 24, 95%O2 SAT. Cap refill 3 seconds. patient declined 9-1-1 or beevaluated by paramedics. pupils equla and reactive  12:45PM/ patient reports history of fainting with pain, patient reports mother also does this 12:48PM/patient assisted to sitting position on the ground. Vitals: 129/102, 86, 20, 95% 12:52pm/patient able to get up and sit in chair with standby assist if needed. patient able to perform independently vitals: 136/92, 78, 18, 96% O2 At 12:58PM/patient reports feeling good, continues to drink water. Patient agrees to stay another 10 minutes to assure he feels ok to drive 13:05PM/Vitals: 115/60, 55, 18, 96% Patient reports feeling good and reports he is fine to drive. Encouraged patient to contact PCP or go to Urgent Care if he develops further symptoms that are concerning. Discussed SOA, chest discomfort. If he develops these to seek emergency care. patient verbalized  understanding and agrees with plan patient departed immediately after discussion.
Mom states pt started w/local rxn to rt leg (redness, & swelling w/red streaks) on 9MAR92; t102.2 & body was flushed, reddish looking; took pt to clinic; MD stated probably rxn from DTP instructed to give DT only per MD;
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after first dose) and EXPOSURE DURING PREGNANCY (COVID-19 vaccination during pregnancy) in a 39-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031M20A) for COVID-19 vaccination. The patient's past medical history included Pregnancy (Patient delivered on 16-AUG-2018 by live, full-term birth.) on 16-Aug-2018. On 11-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 28-Aug-2021. On 11-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPOSURE DURING PREGNANCY (COVID-19 vaccination during pregnancy). On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm after first dose). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 08-Apr-2021, EXPOSURE DURING PREGNANCY (COVID-19 vaccination during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm after first dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided by the reporter. Treatment information was not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Internal review conducted on 20-JUL-2021, resulted in updates to the pregnancy details, relevant history and pregnancy event onset date.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 014M20A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Cholesterol, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-042718 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up appended- added  reporter's address, date of birth, date of administration and batch number of first dose, second dose details.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 08-APR-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J011828 and expiry date: 26-DEC-2014, reported as 16-DEC-2014) which was improperly stored. Primary reporter was reporting exclusion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
My arm was very sore after the injection. Then I started feeling bad with no appetite and my stomach was in pain and nausea so I could not eat anything. I went to the doctor and they gave me medication for acid reflux omeprazole. He told me to take that along with PEPTO BISMOL. The symptoms improved after a few weeks. I am not sure if I have recovered as I still have the acid reflux really bad.
Horrible worsening of depressive symptoms after 1st dose and even more severe after 2nd
Migraine started 8 hrs after vaccine, flashes of lights (migraine auras?), with nausea and fatigue, no appetite. 26 hrs after vaccine started a fever of 102° with psychosis, visual hallucinations and distortions, fever and chills, extreme fatigue, pelopsia, teleopsia AIWS. 38 hrs after vaccine fever fell to 100° with only remaining symptoms being fatigue, nausea and swollen on arm, underarm on side of injection, dizziness, confusion, sore eyes.
p/vax pt exp 7''x3'' area of redness and soreness at inj site; no itching
Patient had T 101.9 and leg pain hours after vaccination. Received PCV 13 right thigh and Flu left thigh. Next day had right knee swelling + redness and was admitted to hospital. W/U - neg
36 hours after vaccine swollen lymph nodes on neck, over left clavicle front of should to left arm pit- lasted about 14 days; Migraine within 12 hours, brain fog and migraine lasted about 10days,; Brain fog; Lymph nodes still sore; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the arm left on 12Apr2021 at 12:30 (at the age of 17-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the arm left on 03May2021 at 12:30 (at the age of 17-year-old); as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 13Apr2021 at 00:30, within 12 hours the patient experienced migraine, brain fog and migraine lasted about 10days, didn't response to meds. On14Apr2021 at 00:30, 36 hours after vaccine the patient had swollen lymph nodes on neck, over left clavicle front of should to left arm pit- lasted about 14 days. Lymph nodes still sore but not enlarged, did second round and within hours all symptoms returned. Lymph nodes still enlarged 8 days after. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraine, brain fog and migraine lasted about 10days, didn't response to meds, swollen lymph nodes on neck, over left clavicle front of should to left arm pit- lasted about 14 days, lymph nodes still sore but not enlarged was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Cried almost continuously for at least 3 hrs. No fever (was on Tylenol), no local reaction. The irritability happened the day 12/19/2001 he received the vaccine.
One week after vaccines developed shingles rash..diagnosed by Dr.. treatment ordered is Valacyclovir 1 Gm TID for 7 days
This spontaneous report as received from a medical assistant, regarding a 22 year old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On 23-AUG-2017 the patient was vaccinated with the first dose of GARDASIL 9 which had a lot # N021571 with expiration date on 29-APR-2020 (dose, route and site of administration were not reported) for prophylaxis. On 24-OCT-2017, she received the second dose, and subsequently on 22-DEC-2017 the patient was vaccinated with the third dose of GARDASIL 9. However, no adverse effects were reported.
Information has been received from a medical assistant concerning a 62 year old male patient who on 01-DEC-2008 was vaccinated intramuscularly with a dose of PNEUMOVAX (Lot # 661577/1161X).  On the same day, the patient was "achy all over".  On 02-DEC-2008 the patient had a "red swollen area below the injection site and underneath the arm".  The patient sought medical attention and was placed on CIPRO on 03-DEC-2008.  At the time of reporting, the patient was recovering.  This is one of several cases received from the same source.  Additional information has been requested.
pt recv vax;devel high fever which required er visit;RN questioned whether there was a problem w/ the particular lot;
Redness at injection site at 24 hours after immunization. Redness, swelling, itching, tenderness and induration at injection site at 48 hours after immunization. Pain extended throughout entire left arm. Subject felt jittery and experienced episodes of heart racing. Subject was seen by a physician and prescribed Loratadine 10 mg daily and Topicort LP cream to site. Symptoms resolved completely as of 7/21/08, 6 days after immunization.
Pt recvd 1st dose of Engerix-B on 29APR91; w/in 12 hrs of 1st dose pt exp trunk covered w/hives & raised, itching skin lesions; outpatient tx required to treat events; Resolved in 24 hrs;
soreness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (soreness) and HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 07-Mar-2021, PAIN (soreness) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-044142, MOD-2021-044135 (Patient Link).
patient complained of feeling light-headed, dizzy, short of breath, chills and numbness in her chest.
Major stiffness and swelling of neck on left side, lack of mobility turning head in any ratio, over 36 hours now.  Throbbing pain at times, and cannot lean over with major throbbing pain.
patient received 2 different manufactured covid19 vacine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (patient received 2 different manufactured covid19 vacine) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication.    No Medical History information was reported.   In 2021, the patient received dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient received 2 different manufactured covid19 vacine). On 04-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (patient received 2 different manufactured covid19 vacine) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The pharmacist reported that the patient administered 1 dose of the moderna vaccine to three patients. Pharmacist reports that all three patients received a dose of the astrazeneca vaccine last month overseas  No concomitant medication was reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow-up information included race and ethnicity was added
Vertigo.  It is very serious in the morning when I get out of bed and eases somewhat during the day.  I have attempted the Eppley maneuver at home and my Primary Care Provider did a similar maneuver in her office recently
12 to 24 hours post vaccination patient had rash around injection site and the arm was swollen. No treatment was necessary.
Swelling arm; Itching; Hardness; Which feels like she was getting a cold; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm), PRURITUS (Itching), INDURATION (Hardness), FEELING COLD (Which feels like she was getting a cold) and FATIGUE (Tired) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PERIPHERAL SWELLING (Swelling arm), PRURITUS (Itching), INDURATION (Hardness), FEELING COLD (Which feels like she was getting a cold) and FATIGUE (Tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling arm), PRURITUS (Itching), INDURATION (Hardness), FEELING COLD (Which feels like she was getting a cold) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Additional information received vis Telephone contact report: Updated event onset dates. Consent to follow up updated to denied.; 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
heavy tired; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021, at 10:30 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. After vaccine the patient had no fever but feels really tired, 'heavy tired'. Has taken two aspirins for symptoms. The outcome of the event was unknown.  The information on the lot/batch number has been requested.
Acute respiratory failure with hypoxia - started on supplemental oxygen and steroids and did well with this. Given the progression of her COPD she was recommended to discharge on home O2. ED visit to hospital admission within 6 weeks of receiving he COVID vaccine.
Pt received both doses of the COVID-19 Moderna vaccine, on 4/5/21 and 05/03/21.  He still developed mild symptoms of COVID and tested positive on 7/29/2021 via PCR test.
Eight days after the injection, my left arm began to itch in the evening in the area of the injection site. On the ninth day post-injection, the area was red and itchier. Not severe, merely annoying. I was already aware that this occasionally happens after the Moderna vaccine, more often after the first shot, and that it's not cause for concern. I'm reporting it so you can have the data. I'm also reporting it before it resolves, but I expect it will do so soon. I have a faint bruise-like discoloration on the same arm, several inches below the injection site, and that showed up the day I got the shot and has never cleared up.  It's below the part of the muscle that was sore for 2 days after the shot, and was never painful.
Vaccine inadvertently administered to patient less than 18 years old - no complications from vaccine for patient