chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a nurse practitioner in the USA on 21-OCT-2005. A 47-year-old female developed redness of her neck and face (no rash) and joint pains of her hands and elbows three hours after receiving the injection (route not reported) of FLUZONE, lot # U1818AB, in the left deltoid on 20-OCT-2005. As per reporter symptoms resolved with no medical intervention. Follow-up information received on 13-FEB-2006. There were no other vaccinations within four weeks of the date of vaccination. Additional information is not expected.
My left arm was mildly sore for a week, then one week after I began extreme pain in upper left arm. Nothing had changed in my left except getting the vaccine. After seeing 2 NPs and an orthopedic doctor, they advised not moving the arm if it was painful. I finally went to another orthopedic when it kept getting worse and the NP there diagnosed me with a frozen shoulder, gave me cortizone pills and prescribed physical therapy.  After over 3 weeks, it's now getting better, but still a long way from normal (pre-COVID shot). I do not think it was the shot itself; I think it was the administration of it. The Pharmacy did not give me a shot card (went back a few days and requested one), did not ask anyone to wait the 15 minutes to monitor reactions, and they did not schedule the 2nd shot at the time of the first shot. When I called to let them know I had issues with the first shot, they just said, "OK" and hung up.
Starting morning after booster shot, patient had a raised circle around injection site, patchy redness about 2.5 inches in diameter around the raised circle. It is tender and there is a hard lump at the injection site.
A patient received a dose of improperly diluted vaccine.  It was found that a vial only produced 3 doses and one dose was given to a patient.  Patient contacted and no complaints at time of call.
After injection I had muscle twitching in my left arm. I had some wheezing about 2 hours after injection. I still have pain in shoulder on 5/11/21 (injection performed 4/21/21)
20 minutes after receiving vaccine, Se felt like her throat was closing, her tongue got numb, her lips felt numb.  She said she developed a tightness in her chest.  No trouble breathing.  She said her throat does not feel like it is closing so much as just her lips and tongue feel numb.  She said the chest discomfort is not a heaviness, it is not a pressure.  She said it almost feels like a tingling in her chest.  Here she is awake, alert, she is oriented to person, place, time, situation, and in no acute distress. Treated with diphenhydramine
Information has been released from a physician, via a company representative, concerning a 26 year old female patient, who on 18-JUN-2007 was vaccinated with the second of Gardasil (Lot #657736/0389U). On 18-JUN-2007, two hours after the vaccine was administered, the patient experienced ongoing numbness and tingling in her legs. At the time of this report, the patient had not recovered from the events. The patient sought unspecified medical attention. Additional information has been requested.
Resident received 2nd Covid 19 vaccine from Moderna on 1/26 in Rt deltoid.  Immediately felt a little lightheaded during the 15 min window afterward but was able to ambulate independently with walker just afterward.  After taking a nap, she woke with a headache, chills, a little shaky and feeling very tired.  She was able to eat and take Tylenol at the time.  For the rest of the day, she felt under the weather.  The next morning she was very weak, unable to ambulate and tachycardic prompting nursing staff to send her to the hospital for assessment.
Pt was inadvertently stuck by a needle in Feb91 was vax w/ Hep B vax and Hep B immune globulin. Did not receive 2nd dose in Mar91. Restarted series 26Jun91 & following day devel pruritic urticaria & was tx w/ meds.10Jul91 exp 2nd episode.
Immediate large baseball size welt at injection site. Lasted several days. No known sensitivity to eggs or Thimerosal.
Moderate vertigo Oct 9 & 10 2021. Loss of hearing Right Ear on Oct 12th, 2021 at approximately 1pm. Still unable to hearing any sounds from the right ear along with severe tinnitus. making life miserable.
A 62 year old female who has completed a 30-minute observation period with the following signs and symptoms of an adverse reaction: swollen and tingling lips area after . Pfizer-BioNTech  COVID-19 vaccine # 1 in series administered.   Vital sign at 10:40 blood pressure ; 190/120, heart rate: 94, respiration ; 18, Spo2: 99% Repeat Vital sign at 11:02: blood pressure ; 189/102, heart rate: 89, respiration ; 16, Spo2: 99% - patient denies chest pain ,shortness of breath, nausea vomiting, diarrhea, abdominal pain, difficulty swallow, headache, dizziness, or vision changes  Action(s) taken: Transferred to higher level of care  Patient advised to discuss second dose considerations with a clinician
The COVID vaccine that was given had been out of the refrigerator longer than 12 hours. No adverse reaction reported.
Throat started to close up after 20 minutes of receiving the vaccine. Went to the ER before it got worse and told that I was breathing ok. I was given medications because I was still feeling the tightness in my throat. I was given Benadryl, Prednisone & Famotidine via IV. Was observed unto an hour after the medications were administered. I left the ER feeling better. I was prescribed the same medications listed above via pill form to use for the next 5 days. The next morning both my arms were itchy in the same spots. About an hour later, my cheeks started itchy then were red and hot but I had no fever. I thought my reactions were from the Prednisone, so I spoke to my primary DR about substituting the medication. She recommended taking and allergy pill every day and the Pepcid for the next 4 days to see if the symptoms improved as well as Benadryl. She did say that the symptoms sounded more like they were reactions from the vaccine and not the medication, She recommended that after the 4 days if I still felt symptoms to take the Prednisone. On the third day, my arms felt heavy and my feet were swollen. I took Benadryl to alleviate the swelling.  On the fourth day, my eyes were puffy. This is when I decided to take the Prednisone, I started to think that the allergy pill and  the Benadryl wasn't enough. It did alleviate the swelling, I felt better. On that same evening, my forearms were tingling and my left hand was swollen. It took Benadryl again. On the fifth day, I feel better just feel heaviness in my shoulders.
p/recv vax pt c/o painful site 6''wide cm area encircling lt arm); temp up & chills; given benadryl & motrin; some relief; recovered 6-7 days p/vax.
Received Moderna on 2/11/21. She was exposed to COVID 19 on 2/15/2021. She was tested for COVID on 2/19/2021 and was negative. On 2/21/2021 she developed redness and itching at the injection site. On 2/22/2021 she developed hives on her hands and has had fatigue and intermittent nausea and chills.
VACCINE ADMINISTRATION ERROR- pt received the pfizer covid-19 vaccine at a drive through clinic at another site 7 days ago, pt received the shingrix and pneumovax 23 at our pharmacy on 1/30/21. Shingrix and pneumovax 23 should not have been administered and should have been waited until 14 days after covid vaccine or until 14 days after covid vaccine series complete per CDC.  I checked the injection site, and there does not seem to be any rash of any kind on the left arm (where both the pfizer covid 19 vaccine was administered and then shingrix administered 7 days apart), the skin on the bandaid just seems to be a little inflammed. Pt only reports arm soreness and pain at injection site. Pt received the pfizer covid 19 vaccine and shingrix on the same arm and the pneumovax 23 on the other arm. MD will be advised as well.
Patient was stuck one time with no med in the  syringe the stuck a second time in the same arm with correct COVID vaccine
Developed shingles after the first dose.   Doctors do not believe it was related to the Pfizer shot.  I am reporting it, just in case.
Patient reported a large area of swelling, redness and warm to the touch about 3 inches below injection site, she says it started almost immediately. She took 2 BENADRYL the day following injection and that made it better, though at time of report it is still swollen and a little red/warm. Advised her to continue BENADRYL and let us know if it doesn't resolve.
Rash on hand, right arm, back and right side of face, Benadryl and hydrocortisone cream applied to affected areas Sudden onset of period Saturday @ 1:30. Bleeding was severe and keep increasing. Bleeding through tampon, pad and underwear within 15 minutes. ER visit occurred. Given progesterone to stop bleeding.
pt recv vax 20FEB98 & 2MAR98 pt devel greater than 50 varicella-like pruritic lesions on face, behind the ears, chest, back, buttocks & under the bilat arms;pt exp fever 99.7, runny nose & irritability;
Patient complains of constant "heat from inside my body".  No fever reported.  Also complains of weakness and lack of concentration.
i feel awful; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (i feel awful) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (i feel awful). At the time of the report, FEELING ABNORMAL (i feel awful) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Root canal and infection; Foggy feeling in head/Brain fog; COVID-19; Sleeplessness; Cold; Fatigue; Postoperative infection/Mouth infection due to root canal procedure; This spontaneous case was reported by a consumer and describes the occurrence of ROOT CANAL INFECTION (Root canal and infection), FEELING ABNORMAL (Foggy feeling in head/Brain fog), COVID-19 (COVID-19), INSOMNIA (Sleeplessness) and POST PROCEDURAL INFECTION (Postoperative infection/Mouth infection due to root canal procedure) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Plaque psoriasis and Psoriatic arthritis.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In December 2021, the patient experienced POST PROCEDURAL INFECTION (Postoperative infection/Mouth infection due to root canal procedure). On an unknown date, the patient experienced ROOT CANAL INFECTION (Root canal and infection), FEELING ABNORMAL (Foggy feeling in head/Brain fog), COVID-19 (COVID-19), INSOMNIA (Sleeplessness), NASOPHARYNGITIS (Cold) and FATIGUE (Fatigue). At the time of the report, ROOT CANAL INFECTION (Root canal and infection) and POST PROCEDURAL INFECTION (Postoperative infection/Mouth infection due to root canal procedure) had resolved, FEELING ABNORMAL (Foggy feeling in head/Brain fog), INSOMNIA (Sleeplessness), NASOPHARYNGITIS (Cold) and FATIGUE (Fatigue) had not resolved and COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No concomitant medication was provided. No treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. It was reported that on DEC-2021 patient had root canal procedure. The reporter's causality for the events of brain fog, fatigued, sleeplessness, mouth infection due to root  canal procedure onset in December 2021 and cold was not provided. The reporter's causality for the events of COVID positive with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the events of mouth infection due to root canal procedure onset in December 2021 with HUMIRA(ADALIMUMAB) was no reasonable possibility.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Live follow up received on 06-Apr-2022. Suspect product information, new events, lab test, causality were added.
Pt reports sudden onset of itchy palms.  Pt denies any other symptoms.  symptoms resolved with no treatment.  PT denies Transport.
This case was reported by a physician, via a representative, and described the occurrence of rash in a 12 month old male subject who was vaccinated with Havrix (GlaxoSmithKline), Proquad vaccine and PCV 7 vaccine. On an unspecified date, the subject received 1st dose of Havrix (720 elisa unit, unknown), 1st dose of Proquad vaccine and 3rd dose of PCV 7 vaccine. Within 24 hours of receiving these vaccinations, the subject developed a red rash described as urticaria over his body. Hives were also reported. The child was taken to the emergency department and treated with oral Benadryl and Prednisolone (30mg over three days). The rash resolved within three hours after receiving Benadryl and Prednisolone in the emergency room. In the physician's opinion, the events were possibly related to treatment with Havrix. It was stated that the child planned to see an allergist prior to administration of next doses of vaccine.
Patient states she experienced "heart racing" only when laying down in bed at night. Patient states it has happened the past two nights, and it started the night that she received her first Moderna Vaccination.
Administered a vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 56-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273. There were no reported AEs associated with this case of product storage error.
loud ringing in ears at injection, fever & aches, subsequent menstruation extreme and increased/new in blood flow, blood clots, fainting spells, nausea....increase in asthma difficulties and severity
Pt felt warm, aching of joints still. Developed rash on arms & back of neck & upper abdomen. Went to ER, Dr not sure, but had inflammed ears. 11/10, vomiting,ear pressures, sweating. 11/13, Dr tx'd w/Ceclor. Now, sorethroat, tingling legs.
Patient was accidentally given a Pfizer 6mo-4yr Bivalent instead of a 1st dose Monovalent, no treatment was needed, Mom, Manager, Immunization coordinator, Provider, and occurrence report was made.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by a physical therapist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 79-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. It was reported that 173 doses were administered on 08-Apr-2022, 12-Apr-2022 and 13-Apr-2022 from batch 070H21A. No information was reported on date of the storage of vaccine in refrigerator. The vial did not undergo any temperature excursions. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant follow up received.
11-6-07:  Vaccine administered and pt felt fine on this day.  11-7-07:  Pt had headache all day, aches all over body, felt very fatigued, was nauseated, couldn't move, and felt like passing out due to dizziness.  No fever or chills.  Pt took tylenol every evening unti felt better.  11-14-07:  Pt started to feel better.
Appendicitis; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A, 007B21A and 039F21A) for COVID-19 vaccination.     Concomitant products included HYDROXYCHLOROQUINE and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criterion hospitalization). The patient was hospitalized from 22-Nov-2021 to 23-Nov-2021 due to APPENDICITIS. The patient was treated with ZOLPIDEM TARTRATE (AMBIEN) for Appendicitis, at a dose of 1 dosage form and Surgery for Appendicitis. At the time of the report, APPENDICITIS (Appendicitis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   she had appendicitis and her appendectomy was on 22 Nov 2021. she was hospitalized for a day for the surgery and was in the hospital overnight for the surgery.  This is a regulatory authority case concerning  a  23-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of appendicitis. The events occurred approximately 6 months after the second dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events were reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2021: Significant Live Follow up : hospitalization added as seriousness; Sender's Comments: This is a regulatory authority case concerning  a  23-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of appendicitis. The events occurred approximately 6 months after the second dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events were reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 69-year-old male patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included shingles (diagnose with shingles 20 years ago). On 8th April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th April 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm. On 16th April 2019, the patient experienced allergic reaction and rash. On an unknown date, the outcome of the allergic reaction was unknown and the outcome of the pain in arm was recovered/resolved and the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the allergic reaction, pain in arm and rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for himself. The patient received a dose SHINGRIX on left arm in a physician's office. Lot number was not known. The patient reported that he experienced a sore arm that lasted for 8 days. Eight days after receiving SHINGRIX, the patient also experienced rash to the bottom of the injection site on the left arm, behind the back of the left arm, and across the forehead and above the eyebrows. The patient was seen by a physician but no diagnosis was made. The physician said that the patient might have been allergic to the vaccine. The patient was tested and would consult with a specialist. The reporter gave consent to be followed up.
Pt s/p pfizer vaccine 5/14/2021 to Left deltoid, pt reports 10 min later left 4-5 th finger stiffness, Staff brought her to EMS, who evaluated her, elevated blood pressure checks at the time, unclear cuff size. Improved and DC and overall improved today without further ssx. To Urgent care for further evaluation. Pt in NAD, no limitations in full arom, no angioedema, no urticaria, lungs cta, regualr rate/rhythm. Left deltoid site c/d/i no erythema or streaking. 5/15/2021 VS at urgent care: Temp 97.5 F, HR 85 /min, BP 124/81 mm Hg large cuff needed, RR 16 /min, Oxygen sat % 99 %, Ht 5 ft 7 in, Wt 250 lbs, Wt-kg 113.4 kg, BMI 39.15 Index, Ht-cm 170.18 cm Will continue to monitor and will follow up with pcp on Monday
After 12 hours started a fever of 101F  and a sever headache, chills, body aches, nausea and fatigue. Lasted for 32 hours. After that it was still severe headache and joint pain, and fatigue for another 12-16 hours. After 3 days I still experienced fatigue and brain fog.
I had really bad vertigo. I also had a migraine that I had to take Tylenol for.
Heavy nosebleeds. 3 so far. I've never had a nosebleed to speak of. I've had three now that have started at night and are difficult to stop.
expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  Treatment details were not given