chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT DEVELOPED "HOT SPOTS" ON BACK OF HIS NECK ON 2/1/21 THAT BECAME BLISTERS AND THEN MORE BLISTERS ON THE LEFT SIDE OF HIS BODY THAT STARTED TO BURN. PT ALSO STATES HIS HEARING ON HIS LEFT SIDE WAS AFFECTED INTERMITANTLY FOR ABOUT A WEEK, AND THE BLISTERS APPEARED NEAR HIS LEFT EYE BEFORE SEEING HIS MD ON 2/11/21 AD BEING DIAGNOSED WITH SHINGLES. PT WAS GIVEN ORAL VALACYCLOVIR PO X7 DAYS, WHICH HE COMPLETED AND PT IS STILL RECOVERING.
Localized reaction of erythema swelling of 6mm x 4 mm at site of injection. Recommended Benadryl, cold packs.
I wear earplugs at night, and I started hearing a whooshing sound of my heart in my ears. Then, I could actually feel my heart skipping beats. I started testing my heart rate via feeling my wrist. I could again, feel the beats skipping. My doctor did an EKG and confirmed my heart rate was irregular and skipping beats. An appointment with my cardiologist was made immediately. I wore a heart monitor for 2 weeks. I have not received the results yet. At first, the skipping occurred every day, it has since decreased but is still there. It has gotten a little better, but it is still pronounced when it happens. I have not had this problem before the vaccine. I am a vegetarian and have been for years, but my doctor suggested I might be low on magnesium. I took magnesium but it did not help.
Vertigo when I woke up 4 days after vaccination; rest and avoiding sudden movements, Benadryl
1 inch swelling in diameter, migraine, red and extreme soreness for 3 days
did not feel great the next day; malaise/felt blah; sore right arm after second shot; This spontaneous case was reported by a non-health professional and describes the occurrence of FEELING ABNORMAL (did not feel great the next day), MALAISE (malaise/felt blah) and VACCINATION SITE PAIN (sore right arm after second shot) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced MALAISE (malaise/felt blah). 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore right arm after second shot). On 10-Feb-2021, the patient experienced FEELING ABNORMAL (did not feel great the next day). At the time of the report, FEELING ABNORMAL (did not feel great the next day), MALAISE (malaise/felt blah) and VACCINATION SITE PAIN (sore right arm after second shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were reported.   This case was linked to MOD-2021-403976, MOD-2021-404031 (Patient Link).
Right arm swelled by 1/4 of normal size, very painful, lasted several days before swelling subsided. I also had itching in both arms and elsewhere on my body for months afterwards (possibly unrelated).
Caller is an HCP reporting an expired dose of VARIVAX (Lot: T025947, Expiration Date: 30JUL2022) was accidently administered to a patient. No additional clarifying statements or details were provided. See additional related AE case 02287159. No PQC.; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unspecified day in August 2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliter (ml) (strength, anatomical site of vaccination and route of administration were not reported; lot number T025947, expiration date was reported and validated as 30-JUL-2022) as prophylaxis (expired product administered).
The pt complained of vertigo and was unable to drive home. The pt also experienced nausea, vomiting. Vertigo is about 95% improved as of today.
Pt presented to provider, noted to have erythema and swelling of left upper extremity at the site of the pneumonia vaccine on 07/30/13. Patient noticed redness/swelling/blanching erythema later the same day she received the vaccine. Was getting better. Denied shortness of breath.
Patient presented with a rash all over the body.  The treatment she used was Ibuprofen and Benadryl PRN.  Steroids were not prescribed because the patient is Diabetic.  She stated the rash lasted about two days.  Received the Covid Vaccine on 2/8/22 at Pharmacy, Telephone  (privacy)
Information has been received from a 63 year old female patient with sulfonamide allergy and a history of shingles 15 years ago who on 06-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck). Concomitant therapy included PRAVACHOL, NASONEX, and vitamins (unspecified). On 25-JUN-2008 the patient experienced Shingles rash. On 02-JUL-2008, the patient recovered from Shingles rash. The patient sought medical attention and visited doctors. This is one of several reports from the same source. Additional information has been requested. 12/23/2008 This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a physician and a 63 year old female patient with sulfonamide allergy and a history of shingles 15 years ago who on 06-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck) in the left arm. Concomitant therapy included PRAVACHOL, NASONEX and vitamins (unspecified). On 25-JUN-2008 the patient experienced shingles rash at the right T4 dermatome. On 02-JUL-2008, the patient recovered from shingles rash. The patient sought medical attention and visited doctors. This is one of several reports from the same source. Additional information has been requested.
Case number PHEH2013US022850 is an initial spontaneous report received from a pharmacist on 29 Oct 2013 with a follow up information received from the pharmacist on 19 Nov 2013. This report refers to a 58-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1309201) intramuscularly in the left arm deltoid at a dose of 0.5 ml on 26 Oct 2013. On 27 Oct 2013, he develo9ped blisters that appeared around the injection site. Outcome was reported as complete recovery on 04 Nov 2013. No seriousness and causality was reported. Follow up information received from the pharmacist on 19 Nov 2013: Site and dose of vaccination, event onset date and stop date and outcome updated.
4/5- was a delayed reaction after a week of receiving Moderna vaccine. Symptoms were redness, blisters, swelling, itchiness.
syncopal episode; Swollen lymph nodes in left neck and left arm pit; Nausea within a couple of hours of vaccine /continued nausea; Fatigue; fever; chills; headache; dizziness; This is a spontaneous report from a contactable other health professional (patient). A 47-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283), via an unspecified route of administration in left arm on 27Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included very infrequent anxiety and headaches, only after illness. Concomitant medication included sertraline, ethinylestradiol, norethisterone acetate (JUNEL), fluticasone propionate (FLONASE). The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies to Compazine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140), via an unspecified route of administration at the age of 47-year-old in left arm on 06Jan2021 10:30 at single dose for COVID-19 immunization. The patient experienced nausea within a couple of hours of vaccine. The patient experienced fatigue, fever, chills, headache, continued nausea, dizziness with 1x syncopal episode, swollen lymph nodes in left neck and left arm pit, mostly resolved after 3 days. She had still with headache. All events occurred on 27Jan2021 14:30. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The patient did not receive any other vaccines in four weeks. The patient was no pregnant. The patient had no COVID prior vaccination. The patient had not been tested for COVID-19 post vaccination. The outcome of the event headache was not recovered and the outcome of the other events was recovering.; Sender's Comments: Based on a compatible temporal relationship causality between  event syncopal episode and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Case number PHEH2014US003854 is an initial spontaneous report received from a pharmacist on 21 FEB 2014 with a follow-up received on 21 MAR 2014. This report refers to a 15-year-old female patient. She was vaccinated with seasonal influenza vaccines (manufacturer and batch number: unknown) on undetermined dates in the past which were well tolerated. She was inadvertently vaccinated with FLUCELVAX (batch number: 01003A and expiry date: JUN 2014) intramuscularly in to the left arm at a dose of 0.5 ml on 09 JAN 2014. This vaccination with FLUCELVAX was an initial application of the vaccine. No adverse event was reported following this administration error (inappropriate age at vaccine administration).   Follow-up information received from the pharmacist in 21 MAR 2014. Updated information about application, vaccination history and site of administration of FLUCELVAX.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 MAR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, injection site pain, fatigue, chills Narrative: Employee reports fever, chills, headaches, joint pain, body aches, fatigue, vomiting, and injection site pain/discomfort. Reports took Tylenol and Benadryl (no dose/frequency reported).
Injection site pain for both arms (started almost immediately)  Swollen and painful lymph nodes under arm that had the COVID booster administered (started within 24 hours)  Muscle pain and stiffness around shoulder of arm given the Flu vaccine (started right around 24 hours)
Presented to ER evening of 26AUG92 w/approx 8 hrs hx of stiffness, eyes deviating inward head turning to the rt & crying; pt was adm to hosp; head CT & spinal tap performed (neg) given meds;
Patient received the Covid-19 vaccine. She reports symptoms of dizziness after 30-minute observation period post-Covid vaccination.  Patient was alert and oriented, with no other symptoms present.  Vitals at 1045: HR 102, SpO2 97%, BP 150/97.  Dizziness dissipated while seated.  Due to elevated blood pressure and tachycardia, RRT was called at 1045 - arrived at 1053.  Patient taken to ED for further observation and monitoring.   Patient remained alert and oriented with no further symptoms upon departure from Covid vaccine clinic
Itching all over my body; Blisters; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BLISTER (Blisters) and PRURITUS (Itching all over my body) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Feb-2021, the patient experienced BLISTER (Blisters). On an unknown date, the patient experienced PRURITUS (Itching all over my body). The patient was treated with CORTISONE for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), BLISTER (Blisters) and PRURITUS (Itching all over my body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt described an asthma attack on Monday night - the day she got shingles vaccine. She was not seen and this resolved. Reported to us 10/21/09.
Hard lump injection site; warm to the touch injection site; itchy injection site; Rash injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Hard lump injection site), INJECTION SITE WARMTH (warm to the touch injection site), INJECTION SITE PRURITUS (itchy injection site) and INJECTION SITE RASH (Rash injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE MASS (Hard lump injection site), INJECTION SITE WARMTH (warm to the touch injection site), INJECTION SITE PRURITUS (itchy injection site) and INJECTION SITE RASH (Rash injection site). At the time of the report, INJECTION SITE MASS (Hard lump injection site), INJECTION SITE WARMTH (warm to the touch injection site), INJECTION SITE PRURITUS (itchy injection site) and INJECTION SITE RASH (Rash injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
at 24 hours, the muscle became inflamed (hot, red, swollen, itchy, painful).  Remained so for 5 days, slowly reducing in severity.  No noticeable reaction from days 6-8.  On day 9 (today), became inflamed again, with welts that look like hives, and the severity of the itching, swelling, heat, and redness started increasing again.
nausea, headache, soreness and redness at injection site.  Suggested cold compress and either tylenol or ibuprofen
One day post vax the pt developed a fever. Approximately nine days post vax the pt developed a cold with cough. The pt was treated with Robitussin and recovered. A copy of this report has been forwarded to Merck, manufacturer of Varivax.
on the evening of 21OCT pt exp lt arm swelling & difficulty breathing;went to ER MD confirmed swollen glands under lt arm, redness & swelling @ inj site;also lumps @ throat;
Information has been received from a nurse practitioner concerning a 9 year old female student who was vaccinated with the second dose of VARIVAX (Merck) (Lot# 664712/0799Y). The patient developed a red raised area the size of softball at the site of injection. Follow-up information received from a nurse indicated that a 9 year old female student with no known drug allergy who was vaccinated SC with the first dose of VARIVAX (Merck) (Lot# 664025/0844Y) at right arm. On 15-AUG-2009 at 13:57pm the patient experienced injection site red and swollen. The patient had not sought medical attention. At the time of the report the patient's status was unknown. This is one of several reports from the same source. Additional information has been requested.
Pt after received varicella and human papilloma virus vaccine, felt faint and fell to the floor, positive loss of consciousness less
Swelling in the upper lip (angioedema); A Spontaneous report received from a non-health care professional concerning  a unknown year of age male patient who received Moderna's COVID-19 (mRNA-1273) vaccine and experienced angioedema.  The patient had already known food and drug allergies. No relevant concomitant medications were reported.  On 06 Feb 2021 prior to onset of events the patient received second of two planned doses of COVID-19 (mRNA-1273) vaccine, for prophylaxis of COVID-19 infection.  On 09 Feb 2021 patient experienced swelling in upper lip (angioedema). He was in the hospital for a few hours and then discharged. The lip swelling has since subsided.  Treatment information was not provided.  Action taken in response to mRNA-1273 vaccine events the patient was not applicable.  The outcome of event was resolved.; Reporter'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.  The patient's history of known food and drug allergies remains confounding factor.
Breakthrough case admission after 2 vaccines Moderna 2/12/22 Lot# 083J21A;  Moderna 3/19/22 Lot# 066K21A
No adverse event; Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    Concomitant medications were not reported.  It was reported that, the 27 adult patients received pediatric dose of Bivalent COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                  No treatment information was provided by the reporter.  This case contains information for the 25 of 27 adult patients described by the reporter.
Case number PHEH2014US016419 is an initial spontaneous report from a consumer (patient's wife) received on 12 AUG 2014. This report refers to a 57-year-old male patient. Past medical history and concomitant medication was not reported. On 12 AUG 2014, the patient was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: unknown) intramuscularly instead of quadrivalent flu vaccine. No adverse reaction reported following this medication error (wrong vaccine administered).
First dose: ?Covid arm? red, painful, itchy rash and swollen injection site.   Second dose: ?Covid arm? again. vomiting, fever for 2-3 days, headaches, body aches.
Immediately developed swelling around the injection site. Gave patient an ice pack and she applied it for 15 minutes. Swelling went down to normal. Patient had no other symptoms.
Adverse event: Pt was administered vaccine that was 2 days past the beyond use date in fridge. Treatment: Pt will be receiving another booster in office as beyond use date vaccine is less effective.
he was out sick for 2 weeks; Initial information was received on 15-Jan-2021 regarding an unsolicited valid serious from a consumer/ non-heath care professional.  This case involves a patient of unknown age who was out sick for 2 weeks (illness), while being received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (batch number and other dosing details were not reported) at an unknown dose via unknown route and unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient was out sick for 2 weeks (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  Outcome of the event was reported as unknown.  There will be no information available regarding batch number in this case.
Pt  received first dose Moderna vaccine and second dose Pfizer. Pt aware. He missed his original appt and rescheduled. It was overlooked that he rescheduled on a day with a different manufacturer.
Upon withdrawing the needle some of the vaccine leaked out; Shot hurt; This is a spontaneous case, initially received from pharmacist via Agency (reference number: SEQ19-02429) on 09-Sep-2019, concerning a 73-year-old, female patient.   The patient's medical history included unspecified cardiac issues.   The patient's concomitant medications included: oxygen, diltiazem, water pill, potassium, warfarin, propranolol and Albuterol (salbutamol); all for unknown indication.   On 03-Sep-2019, the patient was administered Fluad [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscularly, anatomical location: deltoid, batch number: 260389, expiration date: 31-May-2020] for influenza prophylaxis. The patient stated that the shot hurt. The patient was treated with ice.  As reported, while administering the vaccine, the reporter stated that she might have backed out a little bit (also reported that half of it came out), but still administered the full dose. Upon withdrawing the needle, some of the vaccine leaked out (explicitly coded as Inappropriate dose of vaccine administered'. The reporter wanted to know if the patient should be re-vaccinated.   On 05-Sep-2019, the patient recovered from the vaccination site pain.  The reporter assessed the case as non-serious and did not provide causality assessment.  The reporter gave consent to be contacted for further follow up.  Follow up received by pharmacist on 18-Sep-2019: Reporter did not give us permission to contact the patient therefore there would be no additional information provided.  Company comment :The patient developed vaccination site pain on the same day after vaccination with the suspect product, Fluad. Chronology is plausible. Reportedly, upon withdrawing the needle some of the vaccine leaked out, which suggests incorrect dose administration. The patient recovered from the vaccination site pain two days after, as reported. Based on this information, causal relationship between the suspect product and the event vaccination site pain is assessed as related, while for incorrect dose administered as not related.; Reporter's Comments: The patient developed vaccination site pain on the same day after vaccination with the suspect product, Fluad. Chronology is plausible. Reportedly, upon withdrawing the needle some of the vaccine leaked out, which suggests incorrect dose administration. The patient recovered from the vaccination site pain two days after, as reported. Based on this information, causal relationship between the suspect product and the event vaccination site pain is assessed as related, while for incorrect dose administered as not related.