chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weakening disease; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of weakness 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, an unknown time after receiving Shingles vaccine, the patient experienced weakness (Verbatim: Weakening disease). The outcome of the weakness was not recovered/not resolved.   It was unknown if the reporter considered the weakness to be related to Shingles vaccine.     It was unknown if the company considered the weakness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received second dose of Shingles vaccine and the vaccine gave him/her a weakening disease which was still have him/her 9 months later. Follow-up would not possible as no contact details were available.
Still sick with severe cough. Had severe runny nose fever fatigue weight loss headache x4 weeks
Two days after DTaP vaccine administration to left deltoid, a diffuse indurated patch developed over left shoulder with mildly painful red nodules surrounding the indurated patch.  There were also a red nodule with central clearing on the right shoulder, right axilla, and at midline lumbar area.  The rash was treated with loratidine and lasted for a total of 5-6 days, with full recovery.
Information has been received from a registered nurse (RN), concerning a 25 year old female patient, who on 22-FEB-2008 was vaccinated IM, with the second dose, 0.5 ml, of Gardasil (lot #659657/1487U).  There was no concomitant medication.  On 02-MAR-2008 the patient developed "hives all over the body after receiving her second dose of Gardasil."  The patient went to an emergency room (ER), and was treated with prednisone and BENADRYL.  At the time of this report, the patient was recovering.  The RN considered the event to be serious as on other important medical event.  Additional information has been requested. This is in follow- up to report (s) previously submitted on 4/7/2008. Follow up from the RN, indicated that after the patient went to urgent care for treatment, there was no further follow up information provided to the office. No further information is available.
My daughter started her period less than 24 hours after receiving vaccine.   She is on the pill and always very regular.  This has something to do with the vaccine.    This has happened to many of her friends as well and is not right.
Warmth, redness, small amount of bruising and edema 50mm below site of injection. Edema extends down to elbow. Patient reports vomiting x3 last night with no appetite.
Severe kidney pain; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in left arm on 12Mar2021 at 15:45 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Relevant medical history included diabetes and had allergies to medications, food, or other products. Concomitant medications included curcuma longa rhizome/turmeric, cinnamomum verum (CINNAMON) and metformin. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 20Mar2021 (ninth day of vaccine) at 04:00, the patient had severe kidney pain. Therapeutic measures included intake of tylenol. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe kidney pain was resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021316651 same reporter/drug/event, different patient;US-PFIZER INC-2021316652 same reporter/drug/event, different patient
12 hours post vaccination I developed chills, headache, unable to relax (shaking). 24 hour post vaccination I was exhausted and slept for 24 hours. Now, at day 3 post vaccination, I am still tired, unable to do anything that requires exertion.
Approximately 2 pm, 30 minutes post vaccine, legs began to itch. felt like heart rate had increased, itching on palmar and plantar surfaces bilaterally. felt like she became "anxious".  continued to finish shift and left to pick up child and went home and then went to ER. was seen quickly. developed hives on stomach, arms. took 2 benadryl prior to ER. was given pepcid and solumedrol IV. discharged within an hour with prescription medrol dose pack, po benadryl; other symptoms: chills, major head ache, body aches, light sensitive, jaw pain, shoulder, back and neck aching. day 2 and 3 following injection- leg weakness and intermittant itching palm, scalp, and soles. last symptoms were intermittant itching thursday the 25th. No residual complaints as of 11/29/2021.
Information has been received from a registered nurse concerning a 21 year old female with no known drug allergies who on 02-AUG-2006 was vaccinated with Varivax (Lot #652078/0940R) 0.5 mL subcutaneously. Concomitant therapy included lisinopril and "water pill" (therapy unspecified). On 21-AUG-2006 the patient developed a red, raised rash to the arms, legs, chest and face. Subsequently, the patient recovered from the red, raised rash to the arms, legs, chest and face. Additional information has been requested.
Sore arm starting fee hours after, waking me through night. ?Covid arm? next morning noticed. Red, swollen, itchy, raised. Achy muscles. Slight fatigue. Tylenol and Advil taken, ice pack to arm.
On 3/23/21 patient self-reported a red rash on both wrists/hands/forearm.  There was no rash present at injection site.  Patient self-reported feeling hot and light headed.
Elevated fever of 103ºF for approximately 36 hours; chills; full body aches.
G2P2(now) delivered via urgent cesarean on 3/2/2020 at 29 weeks and 2 days after being admitted for severe preeclampsia on 2/27/2020, hours after Tdap administration. Prior to administration, BP 122/88 on 2/27/2020 at 0900, hours later (1417) BP 158/102 and 166/110 (1449). Highest BP during antepartum hospitalization 203/131. No history of preterm delivery, first baby delivered vaginally at 41 weeks. Readmitted 3/9/2020 for continued issues with elevated BPs despite multiple oral blood pressure medications (300mg Labetalol BID, 90mg Procardia XL BID).
This case was reported by a nurse and described the occurrence of injection site pain in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 27th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In October 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site swelling and injection site erythema were recovering/resolving. It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid and experienced the severe pain at the injection site, swelling that was 3 cm in diameter, and redness at the injection site. The swelling and the redness were subsiding but she was experiencing severe pain at the injection site at the time of reporting. It felt like a major league baseball player threw the baseball at her left deltoid. The reporter did not had additional product details.
The patient presented with her father for the 2nd dose of her COVID vaccine. They did not have the card, was torn up and the father stated she needed a new card today and received Moderna as her 1st dose. Child was given a dose of Moderna inadvertently by the Medical Assistant and the Provider realized afterwards she was only 13 years old, and could not have gotten Moderna as her first dose. Father and child both made aware and understand.  Will reach out to Moderna to find out next step, if child needs to be re-vaccinated with Pfizer or what course of action to take next.
Information has been received from a pharmacist referring to a female patient of unknown age. Patients relevant medical history, concurrent conditions and drug reactions/allergies were unspecified. On 19-AUG-2015 the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, lot # and expiration date was unavailable). No concomitant medications were reported. Since an unspecified date in August 2015 (reported as 1-2 days later), the patient developed 3 inch by 2 inch blisters (injection site vesicles), redness (injection site erythema), tingling (injection site paraesthesia) and warmth at injection site. Reporting pharmacist stated that the patient required medical attention and went to the emergency department on an unspecified date. She was not hospitalized. The patient received treatment with Clobetasol and was 5released after an unspecified amount of time. Outcome of  the events were reported as resolved. Reporting pharmacist did not assessed the causality of the events with respect to vaccination with ZOSTAVAX. Additional information has been requested.
Increased liver enzymes (ALT and AST); Increased liver enzymes (ALT and AST); This case was reported by a consumer via call center representative and described the occurrence of alanine aminotransferase increased in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 3rd December 2020, 100 days after receiving Shingrix, the patient experienced alanine aminotransferase increased and aspartate aminotransferase increased. On an unknown date, the outcome of the alanine aminotransferase increased and aspartate aminotransferase increased were unknown.   It was unknown if the reporter considered the alanine aminotransferase increased and aspartate aminotransferase increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Patient did not have lot number or expiration date information to provide. The patient received the dose of Shingrix vaccine.  The patient reported increased liver enzymes (ALT and AST) that was reported to her by her doctor. The reporter did not consent to follow up.
I had been at a gathering over the weekend and then someone was positive for COVID-19 so got I got tested the next day. I got the results Tuesday got and was positive and I felt sick as well that day. I was having a sore throat, a cough, an altered sense of smell and I just felt really crummy. I was really tired as well all of my symptoms were in my upper chest as well. After having COVID I now have EPI which started in July of 2022, and I got the diagnosed in November of 2022 and I am unsure if this is related to the COVID-19 or not but is has started about seven months after having COVID-19.
Information has been received from a pharmacist referring to a female patient of unknown age. There was no medical history of concurrent condition reported. Many years ago, on an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# were unknown). No concomitant therapy was reported. An unspecified time after receiving the dose of ZOSTAVAX, the patient had a "mild case" of shingles. The outcome of the event was unknown. Causality was not provided. Varicella zoster virus (VZV) packet was not sent to pharmacist as the patient's event occurred "many years ago". Additional information has been requested.
VACCINE GIVEN ON 7/29/04.OFFICE VISIT ON 7/30/04 FOR REDNESS, SWELLING (2CMX5CM) AT INJECTION SITE R LEG HURT TO WALK
12/26/2021 - In ED with c/o sudden weakness/stroke possibility. BP 138/70, HR 101, Temp 97.8, RR 24. Tested Covid positive. Admitted metabolic encephalopathy/r/o stroke. Received MAB in ED. Does have Cough. CRP-1.1. GFR-57. Mild AKI.  CTA-no acute intracranial abnormality.  12/27/2022-MRI Brain-Probable small subacute infarct left centrum semiovale. Start Eliquis. 12/28 - started on Decadron/Lovenox therapeutic. O2 stable on rm air. Continuing to monitor. Vitals WNL. 12/30 - EGFR decrease-33, Covid symptoms improved.Discharged to home.
Headache, sore injection site, muscle cramps, sore muscles, tired  Started about 24-30 hours after injection
15 patients received doses from vials that were more than 6 hours post initial puncture; A spontaneous report was received from a health care professional concerning a 14 patients who received doses from vials that were more than 6 hours post initial puncture.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.    The health care  professional reported that they had four Moderna vaccine doses that were administered from vials which had been more than 6 hours post initial puncture. The health care professional wanted to know if they needed  to revaccinate those patients? During follow-up call: HCP stated that there were actually 14 patients that received doses from vials that more than 6 hours post initial puncture. The HCP was unable to provide any additional information at the time of the call and stated that a colleague would call back with further details. Consent for Safety to follow up with HCP was not provided as she does not have any additional information to   Action taken with mRNA-1273 in response to the event was not provided/unknown.  The event,14 patients received doses from vials that were more than 6 hours post initial puncture, was recovered/resolved.; Reporter's Comments: This report refers to a case of Product administration error where total of 15 patients had experienced expired product administration for mRNA-1273(unknown batch). This case had no associated AEs.
We gave patient Moderna vaccine booster, instead of half a dose, we gave full dose (0.5 ml). We called patient and she is doing fine.
having really severe pain in his armpit as well as his spleen; having really severe pain in his armpit as well as his spleen; Fever; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283), on 18Jan2021 10:10 at single dose for COVID Prophylaxis. Medical history included Hyperlipidemia, Attention deficit disorder. Concomitant medication included atorvastatin at 20 mg for Hyperlipidemia, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) Extended release at 10 m for Attention deficit disorder. The patient previously received first dose of BNT162B2 on unknown date at single dose for Covid prophylaxis. The patient received his second dose at 10:10 am on 18Jan2021. The patient has had some of the symptoms as the first vaccine. But just now he was having really severe pain in his armpit as well as his spleen. He also had a low grade fever at this time around. He took 650 mg Tylenol, Twice a day as treatment. The outcome of fever was unknown, of other events were not recovered.
Symptoms included fever, coughing, sinus congestion, and headache on August 14.  Tested positive for Covid with at home test on August 15.  Went to family physician on August 15 who prescribed Paxlovid.  Symptoms gradually got better over the next 5 days.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 20-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 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 29-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.   No concomitant medications were reported.  No treatment information was reported.
Hallucinations; Could not eat for 2 days; On the floor for 2 days; Chills; Fever; A spontaneous report was received from a 77 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hallucinations, could not eat for 2 days/decreased appetite, on the floor for 2 days/asthenia, chills and fever/pyrexia.  The patient's medical history was not provided. The relevant concomitant medications were also not provided.  On 10 Mar 2021, prior to the onset of the events, the patient received their first dose of two planned doses of mRNA (Lot number: 001821A) through intramuscular route of administration for prophylaxis of COVID-19 infection.  On 10 Mar 2021, the patient experienced hallucinations, chills, fever, could not eat and was on the floor for 2 days.   No laboratory data was provided. Patient took paracetamol and hydroxyzine as treatment.  Action taken with mRNA-1273 in response to the events was not reported.   The events could not eat and on the floor for two days were recovered on 12 Mar 2021.  The outcome of hallucinations, chills and fever were not known.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Tiredness; Headache; Nausea; Decreased appetite; Arm pain; Feeling unwell; This is a spontaneous report from a non-contactable consumer, the patient. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 18Nov2021 at 14:15 (at the age of 15-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 19Nov2021 at 09:30, the patient experienced tiredness, headache, nausea, decreased appetite, arm pain and feeling unwell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events tiredness, headache, nausea, decreased appetite, arm pain and feeling unwell were not recovered at the time of this report.
Pt complained of dizziness, nasal/sinus drainage, flushing, and appeared clammy. Pt did not have elevated Temp.
I had all my shots and I still got shingles/suspected vaccination failure; I had all my shots and I still got shingles; had a lot of painful things, but this has been the worst; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had all my shots and I still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I had all my shots and I still got shingles) and pain (Verbatim: had a lot of painful things, but this has been the worst). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-JUL-2023 This case was reported by a patient via interactive digital media. The patient had all his/her shingles shots and he/she still got shingles.  The reporter stated that health wise he/she had a lot of painful things but this had been the worst. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Patient c/o chest pressure and weakness about 10 minutes after receiving the vaccine.  She was placed in supine position, was tearful and lethargic for first 4-5 minutes, never loss consciousness. After 10 minutes in supine position she reported feeling back to normal.
ZOSTAVAX administered 7/17/15. The next day pt noted pain at site. On 7/21 noted area of redness/warmth/pain and expanded in 24hrs seen 7/22 by me. Exam: 14 cm x 5.5 cm area of erythema/warmth/tenderness dx's with cellulitis-> tx'd with KEFLEX 500,g QID x 7d. Pt has f/w with PCP 7/24/15.
No known adverse effects; An adult patient received a pediatric dose of VAQTA; This spontaneous report was received from a nurse and refers to a adult patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, concomitant therapies and drugs or allergies reactions.   On 16-APR-2019, the patient was vaccinated with a pediatric dose of Hepatitis A Vaccine, Inactivated (VAQTA) by intramuscular route and the indication was reported as not applicable (strength, dose, lot number and expiration date were not reported).   The patient received a incorrect dose administered. No adverse effects was reported.   The outcome for the event was reported as unknown.
administered VAQTA at two months of age; administered VAQTA at two months of age; This spontaneous report as received from a patient's mother refers to a 2-month-old female. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.      On 09-AUG-2019, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) injection, 1 dosage form (reported as 1 shot),  lot # S005723, expiration date 10-JUL-2020 (exact dose and route of administration were not provided) for prophylaxis.