chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jun2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxi, reaction(s): "known allergies: Amoxi". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "recovered" (Jun2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2023) Positive, notes: I took Paxlovid immediately symptom onset and positive test; (Jun2023) Negative, notes: on day 6 I tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 13Jun2023 to 17Jun2023. On day four and five, patient felt great and on day 6, she tested negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231702 Same patient, different drug and different AE;
I may have had some mild nasal symptoms I believe I had a scratchy throat so I home tested for COVID and it was positive.
Severe muscle  pain ( mostly middle back)  lasted 2 days Red swollen arm with bruising  started as baseball size and got to softball size. The redness is still on going with itching and redness in certain areas. ( it is still present at this time) NO pain or hard area. Trouble breathing while sleeping 1/13 AM. Woke me in the night and had to get out of bed.  After a hour or so it subsided.
Brain zaps and once several in one day and I blacked out nearly breaking my neck. Brain scan and other tests showed no reason.
Generalized weakness, tremor, numbness and tingling.  12/10/09 ED, hospital medical records received, orthopedic consultation, neurological consultation. Service dates 12/1/09 to 12/8/09. Assessment: Guillain-Barre Syndrome. Patient presents with acute onset generalized weakness including upper extremities. Can walk only 2-3 steps at a time. Legs tremble. Short of breath. Used walker or wheelchair. To admit to hospital. Numbness fingertips and toes. Depressed reflexes. Frequency of urination. IVIG administration.  12/16/09 Discharge summary, hospital records received. Service dates 12/1/09 to 12/9/09. Additional information abstracted. Assessment: Guillain-Barre syndrome following the H1N1 flu vaccine. Mild weakness throughout, more pronounced bilateral upper arms. Decreased vibratory, termperature, pinprick sensation extremities. Reflexes zero except for bilateral knee (trace). Extensive Candida intertrigo. IVIG administration followed by significant improvement. Discharge to home with out patient PT, OT.
had a reaction twice; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (had a reaction twice) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 10-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced IMMUNISATION REACTION (had a reaction twice). At the time of the report, IMMUNISATION REACTION (had a reaction twice) outcome was unknown.     No concomitant drug was reported. No treatment drug was reported.   Reporter did not allow further contact
I was awoken with chills at 2 am.  I felt tightness in my Right side of my face. very swollen and difficulty opening my eye. sight fine. had a headache, muscle soreness and aches, felt terrible, itching on my face and right ear lobe and behind the ear.  for several days still feeling awful.  chills, sweats, headache, muscle weakness especially at injection site, itching is terrible, utilizing hydrocortisone cream...but relief is very temporary.  on July3  went to urgent care as my face continued to swell.  rash become very prominent and proceeded down my neck. continues to itch and is on my arms and legs...bilaterally.  primary physician visit yesterday.  stated "it looks like an adverse reaction form the Shingles vaccine."
Swelling, redness, burning at injection site. 3inch diameter around site is red and hot to the touch.
December 2021 6 days after booster broke out in hives head to toe.  Went to ER and needed steroids to calm them down. June 2022 Had a confirmed stroke  Still get random rash- take a zyrtec a day
I received my 2nd Pfizer shot on 5/5/2021 at around 12:30 pm. I typically require ED meds to maintain an erection. The evening of 5/5/2021, and without any medications, I had a very firm erection. The next day and each subsequent day, I have not been able to maintain an erection even with my ED meds. I researched on-line via Google and noticed that some websites were indicating some correlation with ED by either having COVID or receiving the COVID shot. I seem to have had some sort of reaction in which there is potentially a vascular problem with my penis. I needed to convey this information just in case this is a pervasive problem.
Patient passed out in chair after vaccine administration at 1353. Assisted to floor and MD called. Vitals taken and blood sugar. EMS arrived at 1359. Patient connected to EKG machine and full set of vital signs obtained. Assisted patient up and vital signs dropped again. Patient guided to floor again. Paramedics activated to transfer to local ER for further evaluation.
Swelling, and pain at injection site. Fever, chills, diffuse joint pain.
Information has been received from a healthcare worker referring to an unspecified number of patients with unknown age and gender. On unknown dates, the patients were vaccinated with doses of improper stored ZOSTAVAX (lot # K026365, expiration date 15-MAR-2016) (dose and route were not reported). It was reported that the temperature fluctuated periodically with the worst case scenario 1 month. The vaccine was supported until expiry. There was no previous temperature excursion. This was not a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was due for Orange Top Monovalent COVID 5-11yr dose 2.  Was given Gray Top Bivalent 12 and up Patient tolerated vaccine no reaction
it cause him to have more strokes n more sizures n more chest pain n emotially melt done makes bipolar worse as well
Intense left arm pain. (L) arm hot to touch oral temp 99 degrees. Swelling in the left subacromial region the morning after injection given. BACTRIM BID #20 & VICODIN 5/500 1 q 6 hours PRN pain #20. Follow-up Tues with health services. Go to ED if symptoms worsen.
Pt noticed itching and redness at injection site 10/16/16 - right arm where ZOSTAVAX was administered.
Significant hearing loss in right ear, starting approximately 2 months after second dose.  Started suddenly.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 58-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 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Approximately 45 minutes after the injection, patient states that she had shortness of breath and tightness in her throat.  She took Benadryl and her condition improved.  The patient is an employee in the vaccinating facility.  She reported it to this reported 2 days after the incident.  Her supervisor is a Dentist.  He monitored her until symptoms resolved.  This patient has received the Flu vaccine for many years and has never had egg allergies.
Patient experienced dizziness following administration of the COVID vaccine.  She states she woke up and found it hard to lift her arm.  She said the arm was pained. She stated she was
PT STOPPED BY PHARMACY AND SAID SHE STILL HAVE A PAIN ON HER LEFT DELTOID SINCE LAST MODERNA BIVALENT BOOSTER SHOT ON 12/13/2022
Breakthrough COVID case, fully vaccinated, with booster dose. Immunocompromised.
Feeling ill and tired went to sleep 3:30pm. Could not focus to read text or email. Memory issues with dizziness. 19 days since and improving but memory and focusing occasionally an issue. Dizziness stopped on day 16. Had one of the worst migraines on about day 10.
Pain in muscle right down to the elbow that started the day of shot and lasting thru 12/3/13 but getting progressively better. Vaccine administered 11/25/13.
Severe abdominal pain, N/V/D, elevated temp >102°, full body hives,  mild seizures (x2), severe headache/migraines. Symptoms lasted overall approximately 2 weeks total with severity decreasing the last week.
Patient received covid booster on 1/23 at pharmacy, 12 hours after developed arm pain that now has concentrated over Left lateral chest and Left upper arm .   Was seen in office on 1/25- Doctor examined, has redness at the injection site, provider stated normal neurologic exam, to give Ibuprofen Q 6-8 hours prn pain.
Severe joint inflammation 36 hours after injection.  He was unable to dress himself. Still under physician care for inflammatory arthritis.  Taking methotrexate.
This spontaneous report has been received from a registered nurse referring to a 68 year old female patient. The patient had neither concurrent condition nor medical history. On 25-MAY-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L029073, exp data 19-APR-2017, 0.5 ml, dose number and frequency unknown) intramuscularly due to vaccination, post PREVNAR 13. Concomitant therapies included NASONEX, SINGULAIR and XOPENEX. On unknown date in May 2016 "the following day" the patient experienced a localized reaction described as "reddened area that had a rash appearance, and itching" and "following this she also experienced bilateral swelling of arms and hands." The patient seek unspecified medical attention by telephone call to physician office. No lab diagnostic studies were performed. The nurse reported that the patient self administered "some CLARITIN" at home for the localized reaction and the patient experienced "some improvement" in the adverse symptoms of the localized reaction. The outcome of the events were reported as recovering. Additional information has been requested.
Heavy diarrhea that lead to very bloody stool. Major pain on lower right side. Dr thought perhaps it was appendix but then identified an infection in colon close to appendix . Admitted to hospital 3 days of antibiotics and not identified reason for illness. System seemed compromised. Also, after vaccine, all metal objects stuck to skin where shot was administered.
Patient reported tenderness in hips and edema on inner thighs 9/26/2010. He talked with his primary doctor 9-27-10 and felt it was gout related. Did follow up call 9/30 and he is better. MD feels gout aggravated by flu vaccine.
After receiving vaccine patient began experiencing urinary incontinence and was altered compared to her baseline per spouse. Pt had c/o fatigue and weakness.
Initial unsolicited report received from a nurse (patient's parent) on 08-AUG-2017. This case involves a 21-year-old male patient who was vaccinated with a dose of MENACTRA (batch number: U5514AB, expiry date, dose, dose in series and route of administration were not reported) in the left deltoid on 24-JUL-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at the time of vaccination were reported as none. Concomitant medications were not reported. On 24-JUL-2017 at evening, following the vaccination, the patient's left side of neck began to feel achy. On 25-JUL-2017, in the next morning, following the vaccination, the achiness progressed to Left shoulder and swelling noted Left side of neck, and neck was tender to touch and the patient began to feel overall body aches and nausea as day went on. It was reported that the patient was previously vaccinated with three doses of MENACTRA. The patient's Lab test was reported as none. As corrective treatment, the patient took Advil, and used warm compress to neck. The patient was recovered from all the events (reported as symptoms persisted for 3 days). List of documents held by sender: none.
Information has been received from a physician concerning a 16 year old female who on an unknown date was vaccinated with an unspecified GARDASIL (lot number was not available).  Physician reported that he heard from a nurse at the local hospital that on an unspecified date a patient experienced cardiomyopathy after receiving a dose of GARDASIL. The patient went to the emergency room and from there was transferred to a different hospital.  It is not known if she was admitted.  Additional information has been requested.
sugar has been double and triple what it should be; slight aches (body aches); chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (sugar has been double and triple what it should be), PAIN (slight aches (body aches)), CHILLS (chills) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus (on insulin pump).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (slight aches (body aches)), CHILLS (chills) and HEADACHE (headache). On 10-Mar-2021, the patient experienced HYPERGLYCAEMIA (sugar has been double and triple what it should be). On 26-Feb-2021, PAIN (slight aches (body aches)), CHILLS (chills) and HEADACHE (headache) had resolved. At the time of the report, HYPERGLYCAEMIA (sugar has been double and triple what it should be) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Blood glucose: double (High) sugar has been double and triple than what it should be.         No relevant concomitant medications were reported. The patient did not take any treatment medication. The patient's sugar level had been double and triple than what it should be. She changed to a fresh pump. She was not sure if the blood sugar surge was due to vaccine or not.
swollen, firm, warm to touch indurated area on triceps area of L arm ~ 2.5 inches X 2.5 inches
Admitted to the hospital on 1/31/2022 for Traumatic rhabdomyolysis (*).  He has a history of schizoaffective disorder, GERD, hypertension, hypernatremia likely secondary to lithium induced diabetes insipidus, BPH, history of small-bowel obstruction and ileus, impaired fasting glucose, splenomegaly, who presents to our emergency room from his group home where he was found down.  Admitted to hospital within 90 days of booster COVID vaccine.
p/ pt recv vax approx 3 mo later lab evaluation revealed lack of seroconversion.
Hospitalization for COVID 8/16/21-8/23/21. Treated with dexamethasone 6 mg IV daily; Remdesivir for 5 days.
Unable swallow, Water stuck in the throat. Tong was not working.  Unable to breath since the water stuck. Numbness in the tong. Numbness in the left arm, left shoulder, left side of the face, ear and scalp - Went to urgent care and follow up visits to doctors office.
Pt recvd 3 doses of Engerix-B 6MAY91, 4JUN91 & 12NOV91 & p/3rd doses pt exp burning while inject was being given which cont for a few hrs;
Complained of diffuse pain radiating from site of injection (right deltoid) down to wrist. Pain began a day or two after injection and continues to present time. Has been using ibuprofen for pain. Has not been seen by physician at this time.
Administered 2/24/14, red, raised area noted 2/26/14. 2/27/14 Seen by provider. (L) upper arm red, raised, and hot area 4" wide by 7" long. Dx - rash reaction to vaccine. Treatment 1) prednisone, 2) BENADRYL.
sweating; Last night I woke up with chills; fever/This afternoon I had fever about 102degF; I'm not so good; I feel like I have flu; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I'm not so good), INFLUENZA LIKE ILLNESS (I feel like I have flu), HYPERHIDROSIS (sweating), CHILLS (Last night I woke up with chills) and PYREXIA (fever/This afternoon I had fever about 102degF) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 08-Apr-2021, the patient experienced FEELING ABNORMAL (I'm not so good), INFLUENZA LIKE ILLNESS (I feel like I have flu), CHILLS (Last night I woke up with chills) and PYREXIA (fever/This afternoon I had fever about 102degF). On 09-Apr-2021, the patient experienced HYPERHIDROSIS (sweating). On 09-Apr-2021, PYREXIA (fever/This afternoon I had fever about 102degF) had resolved. At the time of the report, FEELING ABNORMAL (I'm not so good), INFLUENZA LIKE ILLNESS (I feel like I have flu), HYPERHIDROSIS (sweating) and CHILLS (Last night I woke up with chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The  concomitant medications  were not provided.  No treatment information was provided.
9:00 am. patient presented with rash (hives) starting 09/25/2016, today still presenting rash full body. No shortness of breath or any other symptoms. Advised patient to go see MD. 2:05PM phone call patient, she stated seen by MD this morning and started BENADRYL, rash improving.
Initial unsolicited report received from a non-healthcare professional on 30 September 2015. If applicable: "This case was linked to 2015SA151762". This case involves a female patient (age not reported) who was vaccinated with a dose of Flu vaccine [dose, dose in series, batch number, expiry date, route and site of administration were not reported] on an unknown date (10 years ago). The patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as unknown. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had experienced convulsions. Laboratory data and corrective treatment were not reported. On an unknown date, the patient was recovered from the event. Upon medical review, the case was considered as serious due to important medical event: convulsions. List of documents held by sender: none.
bouts of shooting pain in my thing; This case was reported by a consumer via interactive digital media and described the occurrence of shooting pain 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 shooting pain. On an unknown date, the outcome of the shooting pain was unknown.   It was unknown if the reporter considered the shooting pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-Apr-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient self reported this case. The patient had not broken out but had terrible bouts of shooting pain in his/her thing, mainly early morning. The patient had all the shots but could not image what else it could be. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Increased heart rate / has not resolved; This case was reported by a pharmacist and described the occurrence of heart rate increased in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 4JE2L, expiry date 17th September 2022) for prophylaxis.   On 6th January 2021, the patient received Shingrix. On 7th January 2021, 1 days after receiving Shingrix, the patient experienced heart rate increased. On an unknown date, the outcome of the heart rate increased was not recovered/not resolved.   It was unknown if the reporter considered the heart rate increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter did not provide the patients exact date of birth or initials. The patient received Shingrix and experienced increased heart rate.
Duplicate dose of flu vaccine given. 1st dose-10/1/18. 2nd dose-11-5-18.
Pt recv vax on 1/22/99; on 1/24/99 pt exp left arm edema, erythema, itching x 5 days
both have now got the Delta strain; both have now got the Delta strain; both very sick; This is a spontaneous report from a contactable consumer or other non-HCP. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter said that the 2 I know of that got the virus before the shot was available, they are both lucky to be alive, however, both have now got the Delta strain, both very sick on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: got the delta strain on an unspecified date. The outcome of all the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101017243 same reporter/drug, different patient/AE;US-PFIZER INC-202101017356 Same reporter/events/product, different patients
Pt recvd 1 dose of Engerix-B & exp chills which do not require treatment;
Developed severe chills, fever, bone pain, malaise that persisted over 3 weeks and then required antibiotics for lung infection. Also had an episode on the the third and fourth night feeling constant and immediate need to void, yet unable to void that lasted all night. This then ceased, no prior urinary, obstruction problems.