chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 3rd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache, pain in arm and extra dose administered. On an unknown date, the outcome of the headache, pain in arm and extra dose administered were unknown. It was unknown if the reporter considered the headache and pain in arm to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient was vaccinated with the 3rd vaccine for Shingles. The patient experienced headache, arm soreness and she was very concerned after vaccination. The patient was vaccinated with the 3rd dose of SHINGRIX, which led to extra dose administered.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site rash in an unspecified number of children who received FLUARIX. On an unknown date, the patients received Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX, the patients experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown. It was unknown if the reporter considered the injection site rash to be related to FLUARIX. Additional details were received as follows: This case was previously reported to the manufacturer. The reporter stated that, the clinic provided GlaxoSmithKline Flu vaccine unspecified season to pediatric patients from the age of 3 years and above. The reporter stated that there was increase in frequency and severity of injection site rashes after receiving the vaccine. It was unknown which vaccine was used and how often the event had occurred.
2 days after receiving vaccine, patient complains of swollen lips, and wheezing. Patient used inhaler and took Benadryl to relieve symptoms. Symptoms subsided but came back a couple days later with signs of a swollen left eye, she proceeded to take Benadryl and symptoms subsided. Today, patient is experiencing a swollen right eye and feels as though her throat is tightening.  An appointment was made today to see  provider at 1400.
Severe tremors during night. First one lasting about 15 minutes. Second one slightly less time.  Pain in right arm, shoulder and neck. Might also have experienced chills.
Outdated Varivax given to patient on 9/4/03, lot #0971L 1/7/03 (3 other patients this happened to as well).
Vaso Vagal, No loc At 12:36 BP 134/88 HR 66 O2Sat 99 Skin Signs: Diaphoretic  Resp: Other: Mild elevated respiratory effect. Noticeable tremor At 12:47 BP 136/78 HR 81 O2Sat 99 At 13:02 BP 132/78 HR 71 O2Sat 99 RR 14 Vaccine administered at 12:25 (covid) Vitals taken at 12:36. Apple juice given at 12:38.  Tremor reduced by 12:44  Pt released by medical staff Disposition: Home by self
stated a dose of IPOL vaccine, that expired on 10OCT2022, was administered yesterday 12OCT2022 with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 years old male patient who experienced was administered a expired dose of IPV (VERO) [IPOL] vaccine, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  IPOL vaccine (strength: standard) (lot T1E872M, exp: 10-oct-2022) , that expired on 10-Oct-2022, was administered yesterday at dose of 0.5 ml total dose on 12-Oct-2022 via intramuscular route in the right deltoid for immunization with no reported adverse events (expired product administered) (latency: same day),   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
About 1 hr after vaccine sudden dizziness. Later nausea & headaches. Since then has been diagnosed with POTS (postural orthostatic tachycardia syndrome, orthostatic intolerance, dysautonomia. Still trying to treat symptoms with medication.
Nausea, sweating, slight dizziness.  At first, attributed it to climbing ladder and moving head to look up and then down at tools.  Had to quit working outside and go inside to sit in front of fan.  Pretty much had to do that all day.
Nausea and diarrhea starting the day after receiving the booster, and continuing into the 2nd day.
Immediate swelling around insertion site.  Monitored and given Benadryl 25 mg orally x 1.
ACUTE RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY
she has diverticulitis and is on an antibiotic; This is a spontaneous report from Pfizer-sponsored program . A contactable consumer (patient herself) reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had the first shot of COVID vaccine on an unspecified date and stated that she had the shot and issue arose that she has diverticulitis on an unspecified date and was on an antibiotic from an unspecified date. Patient was due to get her second and wanted to know if this would interfere with getting second shot of COVID vaccine. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Patient received her second dose of Shingrix on 1/6/21 around 11:30am. She states that within half an hour her right arm was extremely painful, red and swollen. Soon after, she was unable to lift her arm or move her hand due to the pain. She called her primary care doctor and then went to urgent care by about 2:00 pm. She was given a shot of toradol and a script for 800mg of ibuprofen was sent to the pharmacy. She has been taking the ibuprofen three times a day and today (1/7/21 around 10am) she is still in  a lot of pain. She is still having difficulty moving and using her arm and said she would call it an 8 on the pain scale.
This spontaneous report was received from a registered nurse via Pfizer, referring to a patient of unknown gender and age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent polysaccharide vaccine (manufacturer unknown) reported as (PPSV) (concentration, dose, route of administration, lot # and expiry date were not reported). There was no concomitant medication reported. On an unknown date, the patient had a cellulitis after receiving the polyvalent polysaccharide vaccine (manufacturer unknown). Therefore, the patient was hospitalized and given antibiotics. At the time of the reporting, the outcome of cellulitis was unknown. Upon internal review, cellulitis was also considered a medically significant event. Additional information has been requested.
nodule in the lung; large chicken pox like blisters; inflammation in the lungs; This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient developed large chicken pox like blisters on an unspecified date. She also developed inflammation in the lungs and a nodule in the lung on an unspecified date. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events lung nodule,blisters, Pneumonitis and the suspect drug "BNT162B2" cannot be completely excluded.
This spontaneous report as received from a consumer refers to a 63 year old female patient. The patient has no pertinent medical history or drug reactions/allergies. On 2011 (reported as 2 years), the patient was vaccinated with dose of ZOSTAVAX, (lot number not provided) subcutaneous. On 24-APR-2013, the patient was diagnosed with the shingles. The patient stated if was on her upper mid section on her right side from chest to upper arm. The outcome of shingles is unknown. The action taken with ZOSTAVAX was not provided. The reporter did not assess the relationship between the event and ZOSTAVAX. Additional information has been requested.
Fever of 102.9, when I took her temperature again it went up to a 100; She still has fever; Fever of 102.9 was the highest and then this last one I took was 103.1, so it's probably 102; Little sore in her arm; This is a spontaneous report from a contactable consumer (patient mother). A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 22Jul2021 15:45 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter concern was her daughter had the Pfizer at 3:45 yesterday afternoon and she was doing fine and then she has a little sore in her arm Jul2021, but the time she woke up with a fever of 102.9, and this afternoon when I took her temperature again it went up to a 100 and, we had two different thermometers so, for her fever, so she still has a fever. Patient has a Fever of 102.9 was the highest and then this last one I took was 103.1, so it is probably 102 on 23Jul2021. Reporter was informed about the roles of Pfizer Drug Safety and also informed about the role of Pfizer Medical Information and offered the number. The outcome of the event Pain in arm was unknown and not recovered for another event.  Information on Lot/Batch number has been requested.
Heart palpitations throughout the day.  I walked the dog and felt it more.  I got back to the house and decided to sit down.  I felt a dull tightening of the chest.  It was primarily on the left side, but I felt it a few times on the right side as well.
I have had acute numbness in my hands and feet. The symptom started after the first vaccine and was extremely intense after the second. This neuropathy  is still persistent.
This spontaneous report was received from a 63-year-old female patient with an allergy to penicillin and sulfur, who was reporting on herself. The patient was not pregnant at the time of this report. The patient's pertinent medical history and concurrent conditions included: asthma, acid reflux and unspecified surgeries. On 15-AUG-2017, the patient was vaccinated with ZOSTAVAX injection (dose, route of administration, lot # and expiration date were not reported) for prevention of shingles. Concomitant medication included unspecified inhaler. On 17-AUG-2017, reported as two days after getting the shot, the patient experienced rash on her arm and leg. Lab diagnostics studies included: unspecified stress test medications and "Upper gastrointestinal (GI)" (both performed on an unknown dates): results not provided. The patient sought medical attention. It was reported that there was no treatment given for the adverse event, however the patient stated that she was taking over the counter BENADRYL and unspecified eczema medication. The outcome of the event of rash on her arm and leg as well as the relatedness between the event and ZOSTAVAX were not reported. Additional information is not expected since there was no consent to further contact.
Information has been received from a registered nurse referring to a 22 year old female patient. The nurse reported that on 03-JUN-2013 the patient was administered a dose of VARIVAX (merck), 0.5 ml subcutaneously and a "pregnancy test was performed the same day" and returned results that the patient was pregnant when VARIVAX (merck) was administered. The nurse was unsure if this was the patient's first dose of VARIVAX (merck). No adverse effect reported. Additional information has been requested.
COAGULOPATHY, UNSPECIFIED TYPE 3/28/2023 ANEMIA ACUTE RESPIRATORY FAILURE 3/28/2023 ANEMIA
Immediate severe headache 102 temp within 4hrs Heart racing, beating hard Extreme tiredness Irregular blood pressures Cough, congestion Doctor gave needs for flu like symptoms they went away Irregular blood outside persist extreme high for me went to internal dr was given 25mg atenolol beta blocker 10/14/2021 to lower as of date still have elevated bp. Trying to schedule CBC lipid for follow up
2 days after the immunizations, the patient's  right arm became red, hot to the touch, and swollen. Area grew as the day progressed but stopped before reaching the elbow or the top of the shoulder.  She went to the urgent care where she was diagnosed with cellulitis and given Keflex 500mg QID for 10 days.  The cellulitis resolved with a coupled of days after starting antibiotics.
Patient states had symptoms few hours after receiving influenza and Tdap vaccines yesterday afternoon.  Patient states at 7pm last night noticed fatigue and decided to take a nap.  States woke up 1-2 hours later with entire body pain and aches in legs and knees. States bones, joints, and muscles were painful and felt needed to move and stretch but was painful to do so.  C/O headache almost a migraine, extreme nausea, skin sensitivity and irritation, arms felt prickly.  States felt weakness everywhere, states had difficulty opening bottle of pain med (states OTC, doesn't remember name). Patient states she had similar symptoms immediately after all her Covid vaccines. States first 1-2 hours today had stomach cramps, was nauseated and sensitive to smells, thought she smelled latex and marijuana. States still has headache today, weakness and fatigue, joint soreness mainly in knees but reduced in rest of the body.
Vial expired on 25-Nov-2022 and taken out from freezer on 02-Dec-2022; No adverse event; expired dose administered to 1 patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to 1 patient), PRODUCT STORAGE ERROR (Vial expired on 25-Nov-2022 and taken out from freezer on 02-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Dec-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to 1 patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 25-Nov-2022 and taken out from freezer on 02-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered to 1 patient), PRODUCT STORAGE ERROR (Vial expired on 25-Nov-2022 and taken out from freezer on 02-Dec-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (expired dose administered to 1 patient) and PRODUCT STORAGE ERROR (Vial expired on 25-Nov-2022 and taken out from freezer on 02-Dec-2022).    No concomitant medications were provided by the reporter.  Pharmacist administered a pediatric vaccine for a pediatric patient on 03-Dec-2022 and realized later that expiration date on vial was 25-Nov-2022. It was taken out of the freezer on 02-Dec-2022.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-Dec-2022: Live significant follow up received contains patient information and secondary reporter updated.
Approximately 14 hours after receiving the vaccine, I began shivering / teeth chattering and was unable to get warm. My body and everywhere to the point that I could not get comfortable. I also get a mild headache and fever of 99.9. This episode lasted for about two hours. Twenty four hours after the vaccine, the symptoms mentioned above started all over again. This is when I began doing some research on the vaccine to see if there were any side effects.
05Nov90 pt vax w/ MMR; along w/ HIB conj.  09Nov90 devel temp 102F + 2 days later 104F. found listless + tremulous w/ twitching.  Temp rose 105.6F and tx w/ cold compress. Fever dropped to 102.5F.  Tx w/ Augmentin.  See worm...
FOUR DAYS AFTER I RECEIVED THE FIRST DOSE I STARTED WITH TINITIS IN BOTH EARS.
" feels rough" + DM + drinking fluids + 100.1 + ibuprofen + DOE (not new) Pulse ox: 90-95%; during triage: 90-93%
Client within view. Guardian called out client was going to vomit. Client seen going unresponsive. Quiet, Pale but did assist with lowering to floor. Client laid on side. Diaphoretic, lips dusky, flaccid, rare tremoring of muscles. B/P 80/40 Ap 88 strong. Opened eyes to name.  After a few minutes able to answer questions. States he did not eat breakfast this am and was apprehensive of injections. Client given water and crackers. Denies anything, states feeling fine but remains pale, and unsteady when sitting. Laid back down on floor and checked frequently. Remains awake but weak. B/P 104/74. Remained in clinic for 45 minutes after the episode. Telephone call to physician's office to report occurrence.
Patient reports dizziness and myalgia. Dizziness resolved on 5/16/21.
Tinnitus-ringing in ears; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration on 30Oct2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the right arm on 26Feb2021 at 14:00 (at the age of 65-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on an unknown date in 2021 at 14:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. On 31Oct2021, the next morning of vaccination at 04:00, the patient experienced tinnitus-ringing in ears. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus-ringing in ears was not resolved at the time of this report.
About 24 hours post injection redness, succinct, itching began at injection site. In another 12 hours hives all over body. 3-4 cm induration, red, raised and itching. Treating with Zyrtec and steroid injection.
Started feeling very sore and tired right away however by 6 pm felt feverish and a bit nauseated. Through the night very feverish, sweats, body aches and headache.  Slept most of day following felt nausea, headache and body aches until about 9 p.m. when it let up some.  Slight lingering headache with new red rash on arms and torso.  Still feel a bit off, a bit tired.
Headache, Myalgia, NauseaVomiting, Pain/Discomfort, redness, and swelling at injection site, fatigue Narrative:
p/vax pt felt lousy/woozy & uncomfortable;soon had pain & swelling @ inj site which spread to whole arm;devel flu like sx;also reported malaise, dizziness & pain/tingling in neck;light-headed & disoriented & found it hard to work;spasms;
Had immunization 08/15/2005 , DTAP, IPV, HIB, Varivax, HBV, and MMR.  The following day Mom called that child developed swelling and pain in left axilla.  Brought to clinic the next day and examined with swelling and pain, tenderness left axilla with nodes.
I was ill with diarrhea, sick to stomach, blood clots coming out of my rectum for 24 hrs., body aches.
Patient reported significant pain, including nerve pain shooting down her arm and into her hand.  She also noticed a hardened area at the site of the vaccine and a band of redness around her arm.  No treatment was given, but the symptoms initiated within a couple of hours after vaccine administration and lasted for about 4 days.
10cmx8 cm red/tender/warm area on Rt thigh were shots were given
This case was reported by a physician via a sale representative and described the occurrence of not responding to therapy in a 22-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject receive 3rd dose of ENGERIX B to complete the three dose series. At an unspecified time later, the subjects titer was tested and found to be negative. The subject had not responded to therapy.
Varivax injection given approx. 1715 hrs 5/19/03.  Patient began vomiting approximately 2200 hrs, and was lethargic.  She was taken to the emergency room.  There was no fever, no other symptoms.  Tigan suppositories failed to improve her vomiting, and she returned to the ER the next morning.  Evaluation there failed to show any focal problems.  CBC & BMP were normal.  U/A (cath.) also normal save for ketonuria.  Phenergan suppositories have controlled the vomiting, though the infant is still somewhat lethargic and has a decreased appetite.  The mother reports a similar response to Varivax in an older son, and in herself in response to influenza vaccine.
Next day rt deltoid w/warm red area 2in x 2in; not raised, not tender but feels warmth; no edema;
Breakthrough case admission after 2 vaccines Moderna 6/30/21 Lot# 040B21A; Moderna 7/28/21 Lot# 043B21A
Myalgia, Fever, chills, fatigue, axillary swelling, decreased appetite, facial swelling, flushing, tingling/paresthesia in bilateral lower extremities Narrative:
Patient complains of swollen, pain, and red of injection site. No fever. Patient did not provide how big was redness.
pain; vomiting; felt bad; This case was reported by a consumer via call center representative and described the occurrence of pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart transplant (In 2012, the patient had heart transplant).   On 7th May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a month after receiving Shingrix, the patient experienced pain, vomiting and feeling bad. On an unknown date, the outcome of the pain, vomiting and feeling bad were recovered/resolved.   It was unknown if the reporter considered the pain, vomiting and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient was the report's wife. After vaccination with 2nd doase of Shingrix, the patient was in bed for 3 days, after which the symptoms were resolved related to the patient.