chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she started getting really bad body aches; she got really dizzy; nauseous; throw it up; her arm was sore where they gave the vaccination; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (21Dec2020), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient reporting for herself). A 21-year-old female patient received bnt162b2 (also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 19Dec2020 18:00 on the left arm at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she got the vaccine, the Covid-19 vaccine, Saturday 19Dec2020 around 6PM. On Sunday 20Dec2020, she went about her day and around mid day, about 5PM she started getting really bad body aches and then after she showered she got really dizzy, states she would try to eat and she would get nauseous and throw it up. She wanted to know how fast the symptoms are showing after vaccination. She went to get a COVID test today as well because she is not sure if this is due to the vaccine or what. She took Ibuprofen 400mg around 10PM last night 20Dec2020 because the body aches are so bad. States she took a shower last night and got really dizzy but that has resolved and has not happened since. On 21Dec2020, she ate some breakfast and at 11AM she got very nauseous and threw up. Initially (in Dec2020), her arm was sore where they gave the vaccination which she was expecting and then it started going all over her body, states it is like menstrual cramps but like all over. The events did not require a visit to Emergency Room and Physician Office. The event dizzy recovered on 20Dec2020. The outcome of her arm was sore where they gave the vaccination was unknown and the rest of the events was not recovered.
Information has been received from a registered pharmacist reporting on a male patient of unknown age. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On an unknown dates, the patient received the first and second dose of M-M-R II that were reconstituted with sterile diluent (STERILE DILUENT) for prophylaxis (doses, anatomical locations, routes of administration, lot numbers and expiration dates were not reported). On an unknown date, the patient had negative titers (measles antibody negative, rubella antibody negative and mumps antibody test negative). It was unknown by the reporter if the patient sought medical attention or if received treatment for the aforementioned events. The outcome of the events measles antibody negative, rubella antibody negative and mumps antibody test negative and their causal relationship with M-M-R II or sterile diluent (STERILE DILUENT) were not reported.
COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
This spontaneous report as received from a pharmacist refers to a patient of unknown gender and unknown age. On 20-JUN-2014, the patient was vaccinated with an expired dose of ZOSTAVAX lot # H021459, expiration date 30-APR-2014 (dose, route and indication not reported). No adverse effect reported. Additional information has been requested.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 10-DEC-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius) for 912 hours. The vaccine status was reported as excursion and storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No concomitant therapies not adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
pt recvd vax 13JAn93 & on 17JAn93 pt had temp 102.4 on 18JAn93 t103-104, vomited x 2; pt had a sz which lasted several minutes; MD gave Valium to pt for sz activity; not responsive; found to have ear infect; low temp next day;
if something is on the nerves; so much pain after having a shingle shot/neck is where the pain is; so much pain after having a shingle shot/shoulder is where the pain is; This case was reported by a consumer via interactive digital media and described the occurrence of abnormal sensation of limbs in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced abnormal sensation of limbs, neck pain and shoulder pain. On an unknown date, the outcome of the abnormal sensation of limbs, neck pain and shoulder pain were unknown.   It was unknown if the reporter considered the abnormal sensation of limbs, neck pain and shoulder pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-JUL-2022 Reporter's comments; This case was reported by a patient via interactive digital media. The patient never get any answer for their question. They had been in much pain after having the single shot of vaccine The patient never had this kind of pain even though they had trouble with their left hand where there was no pain at all and all of the pain was in shoulder and neck pain as if something was on their nerve. Follow-up would not possible, as no contact details were available.
three hours after administration felt fatigued (drunk) and uncoordinated. slept for four hours woke up with no affects
pt recv 1 dose of varivax 4/3/98 & approx 4/5 devel a ``few pox''
Within a few hours after vaccination, complained of cough, trouble breathing for a few minutes, chills, aching, loss of appetite.  Lasted about 24 hours.
Patient presented to the ED on 8/18/2021 for fevers, shortness of breath and vomiting. He was seen earlier in the day and diagnosed with a UTI, started on BACTRIM. He has a history of quadriplegia with neurogenic bladder with indwelling Foley in place. Upon arrival to the ED patient also tested positive for COVID-19, no prior infections. Fully vaccinated. He was admitted to the hospital for further treatment.
Low oxygen while sleeping.  Still present 2 weeks later. Using an oxygen machine at night.  Other standard symptoms included 101 fever for 24 hours, site swelling and pain for 6 days, redness at site for 6 days, headache, severer muscle aches
Dizziness (lightheaded); Nausea; This is a spontaneous report received from a non-contactable other healthcare professional. A 54-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH) (Lot number: EN6206) via an unspecified route of administration on 15Mar2021(at the age of 54-year-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 15Mar2021, the patient experienced Dizziness (lightheaded) and nausea after 15 mins of vaccine administration. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. Therapeutic measures included received water, snacks and Pepcid for nausea. Follow up response to the treatment was excellent. The patient was discharged on stable condition and did follow up with primary care physician. The clinical outcome of the events was resolved in Mar2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated information about patient, suspect product indication, Vaccination Facility Country, treatment, Concomitant Therapy.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 09-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 208 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
fever-  headache- flu like symptoms - vomit  - lasted 24 hours , now just sense of weakness
My last period (menses) was Sept 1, 2019. I am post menopausal with 18 months since my last period. However, this morning I had a regular period, not just spotting.  I also had night sweats for a week after my first dose and have had night sweats for the past week and a half since my second dose. Reporting this as it seems my period could be vaccine-related and I saw some reports on-line of others saying it may affect their periods.  My only other symptom was fatigue and a sore arm, both already expected.
Lip and lower part of the face is getting puffy; Lip and lower part of the face is getting puffy; This spontaneous case was reported by a consumer and describes the occurrence of FACE OEDEMA (Lip and lower part of the face is getting puffy) and LIP OEDEMA (Lip and lower part of the face is getting puffy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FACE OEDEMA (Lip and lower part of the face is getting puffy) and LIP OEDEMA (Lip and lower part of the face is getting puffy). At the time of the report, FACE OEDEMA (Lip and lower part of the face is getting puffy) and LIP OEDEMA (Lip and lower part of the face is getting puffy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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. Further information has been requested. Upon in internal review on 21 May 2021, the age was corrected to unknown age.  Upon internal review on 04 Jun 2021, it was discovered that the patient age was incorrectly captured as 121 years and DOB mentioned in source document was 01-Jan-1900, which was a MI error. The patient age and narrative has been updated to unknown age with reports re-submission and significant amendment is performed for the correction   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: Upon internal review on 04 Jun 2021, it was discovered that the patient age was incorrectly captured as 121 years and DOB mentioned in source document was 01-Jan-1900, which was a MI error. The patient age and narrative has been updated to unknown age with reports re-submission and significant amendment is performed for the correction; 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. Further information has been requested.
In the middle of August 2021, I started having shortness of breath. I went to see a doctor on 9/20/2021. I was diagnosed with A-Fib. They prescribed me with Metoprolol ER 100mg 1xday, Pradaxa 150mg 2xday, and Amiodarone 200mg 2xday. I am currently still experiencing A-Fib.
Expired vaccine used; Vaccine administered as if it had a preservative; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and INCORRECT PRODUCT FORMULATION ADMINISTERED (Vaccine administered as if it had a preservative) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and INCORRECT PRODUCT FORMULATION ADMINISTERED (Vaccine administered as if it had a preservative). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and INCORRECT PRODUCT FORMULATION ADMINISTERED (Vaccine administered as if it had a preservative) had resolved. Not Provided          vaccine was administered after 7 days from the punctured vial  vaccine administered as if it had a preservative  No treatment and concomitant medications was reported   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up document contains no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-332638:Cluster case same reporter
(RL) was 27cm round with redness from the top of the thigh to the knee. (LL) is 25cm round.
Given H1N1 shot on 11-10-09. He started to cough on his way home. His skin began to itch within 40 minutes of the injection, his skin became red, hives developed and upper eyelids became swollen. No respiratory difficulties. Went to urgent care, give IM SOLU-MEDROL, IM BENADRYL and D/C home on oral prednisone and BENADRYL.
102F fever, headache, chills, nausea, Bone and muscle pains, dizziness- for first 3 days,  Up till now - on and off headaches, nausea, tiredness, lack of appetite, low grade fever, brain fog, depression, anxiety, chills, enlarged lymph node.
Redness in neck and face; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown.   It was unknown if the reporter considered the erythema to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-OCT-2022 Reporter's Comment:  This case was reported by a patient via interactive digital media. Reporter stated that had second shingles shot and have redness around my neck and part on my face. Additional supportive information: Follow-up would not possible as no contact details were available.
This spontaneous report as received from a pharmacist refers to a unspecified patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 29-DEC-2014, the patient was vaccinated with improperly stored ZOSTAVAX (Dose/Frequency: 0.65 ml) subcutaneously that was exposed to 8 Fahrenheit (F) for 12 hours. No adverse events were reported. No product quality complaint (PQC) was reported for ZOSTAVAX. Additional information has been requested.
2 hours, post vax, in the left deltoid, pt developed pruritus of left upper arm. This continued to increase throughout the day and night until we saw her at 10:00 on 10/19/01. At that time, she had diffuse erythema of the left upper arm below the injection site and just above anticubital area, measuring about 10cm.
Per caller mild sx with 1st Moderna vaccine.   Friend who is calling was inpatient and disconnected. Spouse was planning to call 911. Per caller, patient is complaining of headache, chills, nausea, fever 101.9 Fahrenheit and abdominal cramps.  At 0700 pt took x 2 apap unk mg.    No Bld glucose check done.  4/15-Follow up call Patient has taken Tylenol and is feeling better than earlier this morning, she states, "the fever is starting to break", in addition the body aches has subsided with some relief. Will follow up tomorrow.  4/16-4/16/21 Follow Up- Patient states she still has the chills and feels light headed, a slight headache as of this morning, fever has subsided. She only takes tylenol. Advised her to stay hydrated, rest, eat light and will follow up on Monday 4/19/21.
pt recvd vax & began to have dazed/lightheaded feeling;rt arm only had a burning sensation & was swollen & red around site;swelling inc to 3";8-9pm feel short of breath;rn called;to er,given meds;pt feels fine now;
Missed 1 day of work due to fever, body aches, chills, headache, and sore arm.
Flu shot left arm covered with band aid over nite, Next day removed band aid and has small blister at injection site. Filled with yellow fluid. Area not red, no pain, no warm to touch. First flu shot not allergic to latex, alcohol or band aid adhesive.
Creat was 1.44; GFR 40 on 2/15/2022 Creat 1.72; GFR 33 on 3/4/2022 Renal status normal until vaccine.  That night, I was in renal crisis: almost no urine output for 36 hours,  severe whole-body musculoskeletal pain, and mental status change.  I was unable to get to a doctor until it passed.  The Creat was on the up-swing by the time I could get to the lab; the symptoms largely subsided.  This event was constitent with prior (remote) events where the Creat was >2
Severe headache between the eyes, fever about 100 degrees, extreme nausea and weakness. All started about 3 hours after the shot. Headache lasted 24hrs, fever about 2 days, extreme nausea about 3 days. Couldn't eat much or sleep for 2 days. When fever stopped, still had hot flashes for a couple days. Some muscle pains, and lower back went out at day 3. Some constipation. General weakness/tiredness lingered at least 6 days.  Also, large 2-part bruise at injection site, still present 10 days later.  Some swelling and stiffness for a couple days at injection site also.
Large local reaction on Lt upper arm noted 11-5-08.  Client received DTaP and Varivax in Lt arm on 11-3-08.  No fever. Site is uncomfortable.  Client taken to see Dr on 11-5-08; she reports area of erythema is 10cm long and 6cm wide and MD thinks it is related to DTaP injection. MD advised mother to watch area and use ice for discomfort.
Itchiness; Rash; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), RASH (Rash) and VACCINATION SITE SWELLING (Swelling at injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PRURITUS (Itchiness), RASH (Rash) and VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, PRURITUS (Itchiness), RASH (Rash) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up received on 20-APR-2021 updated contact details.
itching at the injection site; little bit of burning; little tired arm; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little tired arm), AXILLARY PAIN (sore arm), INJECTION SITE PRURITUS (itching at the injection site) and VACCINATION SITE WARMTH (little bit of burning) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.  On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (little tired arm) and AXILLARY PAIN (sore arm).   On 05-Mar-2021, the patient experienced INJECTION SITE PRURITUS (itching at the injection site) and VACCINATION SITE WARMTH (little bit of burning). At the time of the report, VACCINATION SITE PAIN (little tired arm), AXILLARY PAIN (sore arm), INJECTION SITE PRURITUS (itching at the injection site) and VACCINATION SITE WARMTH (little bit of burning) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Flu mist given 10:00am. By 7pm that night left eye was becoming red & weeping clear fluid. By the next morning left eye was extremely red, draining clear fluid and vision blurred. Condition slowly improving. No eye injury.