chrisvoncsefalvay/vaers-outcomes huggingface dataset:
insomnia,sleep problems,can not sleep; "felt tired"; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (insomnia,sleep problems,can not sleep) and FATIGUE ("felt tired") in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 015M20A) for COVID-19 vaccination.     No medical history were reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced FATIGUE ("felt tired"). On an unknown date, the patient experienced INSOMNIA (insomnia,sleep problems,can not sleep). The patient was treated with TEMAZEPAM at an unspecified dose and frequency; LORAZEPAM (ATIVAN) at an unspecified dose and frequency; HALOPERIDOL (HALDOL [HALOPERIDOL]) at an unspecified dose and frequency; FAMCICLOVIR for Shingles, at an unspecified dose and frequency and PREDNISONE for Shingles, at a dose of 5 milligram. On 26-Mar-2021, FATIGUE ("felt tired") had resolved. At the time of the report, INSOMNIA (insomnia,sleep problems,can not sleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal CT scan was fine. On an unknown date, Magnetic resonance imaging: waiting for results.         No concomitant medication was mentioned.
Pain; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. On an unspecified date, after the first dose of vaccination, the patient had pain to the point of needing to get a steroid shot. The outcome of the event was unknown. The patient had not taken the second dose of vaccination (at the time of reporting) because of her rheumatoid arthritis, and was asking for data on the effect of vaccination to rheumatoid arthritis on patients who do not take steroids.  Follow-up attempts are possible. Information of lot/batch number has been requested.
Information was received on 25-JUL-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with the ZOSTAVAX vaccine on or about 29-FEB-2013 (sic) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-JUL-2013, the patient was treated by a physician for the onset of a painful vesicular outbreak accompanied by weakened immune systems, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed acyclovir (manufacturer unknown) for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
covid 19 Pfizer updated booster was administered as a 1st dose to the patient instead of the original 1st series covid 19 Pfizer vaccine
12/30 Patient to ER with fever, weakness recently with UTI and did not complete antibiotics EKG with afib heart in the 70s Tmax 101.5 Elevated troponin  Reported chills and fever (1 day prior admission, 12/29)  so covid test was obtained  patient not requiring supplemental oxygen
Left underarm (arm pit) swollen; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN603) via an unspecified route of administration in the left arm on 18May2021 at 09:30 AM (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and penicillin allergy. The patient previously took Tamiflu and experienced allergy to it. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. On 19May2021 at 13:00, one day after vaccination, the patient experienced left underarm (arm pit) swollen and fatigue. The patient did not receive any treatment for the event. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left underarm (arm pit) swollen and fatigue was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Patient's mom stated that patient's left arm was swollen and red along with a fever the next day after the vaccine was administered. Mom was informed to admin TYLENOL for the fever if there was no drug allergy to medication and have medical provider examine arm. Mom was told to report back to pharmacy with results
Significant dizziness/blacking out starting within about 30 seconds of the injection and lasting for about 5 minutes. Did not feel quite like I was going to pass out, but definitely had to remain sitting down for several minutes.
Red, sore, hot and bumps around the red splotch; Big red splotch on left arm of the injection site; Red, sore, hot and bumps around the red splotch; Red, sore, hot and bumps around the red splotch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Red, sore, hot and bumps around the red splotch), VACCINATION SITE ERYTHEMA (Big red splotch on left arm of the injection site), VACCINATION SITE PAIN (Red, sore, hot and bumps around the red splotch) and VACCINATION SITE SWELLING (Red, sore, hot and bumps around the red splotch) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Red, sore, hot and bumps around the red splotch), VACCINATION SITE ERYTHEMA (Big red splotch on left arm of the injection site), VACCINATION SITE PAIN (Red, sore, hot and bumps around the red splotch) and VACCINATION SITE SWELLING (Red, sore, hot and bumps around the red splotch). At the time of the report, VACCINATION SITE WARMTH (Red, sore, hot and bumps around the red splotch), VACCINATION SITE ERYTHEMA (Big red splotch on left arm of the injection site), VACCINATION SITE PAIN (Red, sore, hot and bumps around the red splotch) and VACCINATION SITE SWELLING (Red, sore, hot and bumps around the red splotch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
Around 3/27/2023, I started out with just a cough that progressed into a much worst cough with some flehm and a fever between 100-102. I also had a headache and couldn't sleep for about 24-48 hours.
Patient received multiple vaccines on 12/14/18. She received varicella in L arm SQ. Two days later, she developed fever for about 12 hours with swelling/redness at injection site. She took ibuprofen that helped improve symptoms. On Monday, 12/17/18, she returned to clinic with swelling mostly gone and some remaining pinkness at injection site. Tenderness improving per patient.
Headache, Rash, Light sensitivity, Sweats and Chills, Mild injection site pain Narrative:  Received the 2nd dose at 1400 1/20/21 and had some mild injection  site pain. Woke up at 2:30 am on 1/21/21 with headache (light sensitive), sweats and chills. Missed 1/2 day of work. Also noted a rash at the injection site 8 days after the 1st does - treated with topical hydrocortisone. No known prior COVID infection.   Other Relevant History:
had gone to administer the shot the needle disconnects and product splashed on the nurse with no adverse event reported; Initial information received on 20-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via Agency (under reference: 00821026).  This case is linked to case 2021SA351020.  This case involves adult patient (unknown gender) who had gone to administer the shot when the needle disconnects and product splashed on the nurse while giving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ765AC, expiry date: 30-Jun-2022) (occupational exposure to product).  A Product Technical Complaint (PTC) details: Global PTC number: 100168466 Main Investigation ID: 200176567 lot number: UJ765AC Expiry date: 30-Jun-2022 Sample status: Requested & Awaited Requested Start Date: 21-Oct-2021 Issue status: In Process End date: not applicable  Conclusion: A complaint for 372- FLUZONE HIGH DOSE vaccine, batch UJ765AC was reported and the complaint stated that Doctor calling in a PTC for FLUZONE HD PFS. Caller states that the hub on the end of the syringe is loose (like it's stripped) and needle will not properly attach. When they go to administer the shot the needle disconnects from the syringe and the product leaks out everywhere. Product splashed on the nurse and the patient.  It was a case of occupational exposure to product [Latency: on the same day].  It was reportedthat the hub on the end of the syringe is loose (like it's stripped) and needle will not properly attach. Product splashed on the nurse and the patient.  Number of units affected: 17 PFS affected so Far. Information to be gathered on the type of needle that was used by the end-user: 25G Mckesson 1.5' same brand and size has been used for prior administration with no issue.  At time of reporting, no adverse event reported.
No additional AE; temperature excursion for VARlVAX have been administered to patients; This spontaneous report was received from a nurse referring to a 2-year-old patient of unknown gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported.  On 07-SEP-2021 and 09-SEP-2021, the products including varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced an excursion of 4 degree Celsius (C) from -10 C to 8 C for 20 minutes during each transport. On 13-SEP-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 dose (strength, route, frequency were not provided; Lot# U015682 has been verified to be a valid lot number, expiration date reported as 18-MAY-2023) for prophylaxis. Previous temperature excursion included from -10°C to 8°C (4C) for 7 hours and 30 minutes. And no adverse events were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2109USA005628: US-009507513-2109USA005648: US-009507513-2109USA005618: US-009507513-2109USA005639: US-009507513-2109USA005632: US-009507513-2109USA005910: US-009507513-2109USA005742: US-009507513-2109USA005891: US-009507513-2109USA005964: US-009507513-2109USA005651: US-009507513-2109USA005918: US-009507513-2109USA005744: US-009507513-2109USA005758: US-009507513-2109USA005760: US-009507513-2109USA005705: US-009507513-2109USA005776: US-009507513-2109USA005901: US-009507513-2109USA005662: US-009507513-2109USA005641: US-009507513-2109USA005945: US-009507513-2109USA005881: US-009507513-2109USA005902: US-009507513-2109USA005648:
Itching; Tongue redness; Tongue swelling; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1283 and Expiration Date not reported) dose 1 via an unspecified route of administration on 04Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received historical vaccine of flu shot  (no details provided) in September. The patient has no known allergies. The patient received the first dose of the COVID-19 vaccine a week ago and had a reaction of itching and the tip of her tongue got a little red and a bit swollen. She says she was scheduled to take the next dose of the vaccine on the 25th of this month and had some concerns. She said that the reason she called was she wanted to make sure it was ok for her to take second dose. She said she already talked to her doctor who told her to call Pfizer. The patient told that, the itching was probably for 12 hours. The patient said that, the tongue redness and being a bit swollen did not last long, she came home and had lunch and drank a lot of water. She said that the itching stayed until almost the next day and her tongue was better. She said she was concerned and went to her doctor. The patient received treatment with Benadryl one time at night, UPC: Unknown and product did not have a barcode on it and it was small tablet size and Diphenhydramine HCI 25mg said it as antihistamine on the label, with EXP Dec2021 and LOT SEF004 and took one by mouth one time. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Headache and nausea that persisted 3 weeks after vaccine was administered. I usually don?t get headaches at all and they became constant. I was sensitive to light and sound for a few days at the onset of symptoms. I took Tylenol a couple of times when headache was at its worse. After 3 weeks symptoms diminished.
No Adverse Event; Patient received expired Moderna COVID-19 vaccine for the second primary series dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine for the second primary series dose) and NO ADVERSE EVENT (No Adverse Event) in a 58-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 052B22A and 052B22A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: SHINGRIX on 27-Oct-2022, PREVNAR on 27-Oct-2022 and Flu Vaccine on 27-Oct-2022. Past adverse reactions to the above products included No adverse event with Flu Vaccine, PREVNAR and SHINGRIX.   On 27-Oct-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Nov-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine for the second primary series dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine for the second primary series dose) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine for the second primary series dose).    It was reported that Individual  vial of monovalent, size 5.5 ml was initially stored in the refrigerator on 01-Nov-2022. The vial did not undergo any temperature excursions. No other adverse reactions were reported with both doses.  No treatment medications were reported.
11:37 am - pt received vaccine for COVID  12:08 pm - pt reported itching in throat, sensation that tongue was swelling and itching on bilateral hands, forearms and arms 12:10 pm - pt took diphenhydramine (50mg) by mouth.  Assessed by provider and vital taken while being monitored.  (The symptoms experienced were same as her reaction to chocolate or apples.)  Vitals remained stable, symptoms began to improve and patient was monitored for over an hour before release to be watched by family members
APAP suppos; 10 minutes p/vax; napped awakened p/ 2 hrs had uncontrollable trembling; t104 R & sz & vomited;
Stroke- hearing loss in right ear, extreme headache left temple lobe, nausea, dizziness, diarrhea, inability to move legs. Hospitalized for 5 days  Continued weakness left side of the body
administered a fourth dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 9-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 5N259, expiry date 5th October 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received 1st dose on 25 August 2021), Pediarix (received 2nd dose on 20th October 2021) and pediatrix (received 3rd dose on 16th December 2021).   On 9th March 2022, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 9th March 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Pediarix series and the patient was then inadvertently administered a fourth dose which led to extra dose administered.   The reporter consented to follow up.  The health care professional gave permission for follow-up.
Low grade fever, redness, heat 2 1/2 x 3 in.
Vomiting twice an hour to an hour and a half later. Chills and a fever as well. There was a small rash at injections site, inner elbow and other leg.
Report dizziness, fatigue and sore throat day 1 post vaccination. Treatment: Aleve, Outcome: dizziness resolved, continues with sore throat and fatigue. possible exposure to COVID+ person. Referred for testing. Does not interfere with ADLs.
Injection site hurt, malaise, joint pain in all joints especially those that have hurt before vaccine. Treatment consisted of Mortrin 600 mg PO and rest.
fever; This is Spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is a First of Two reports. This consumer reported for A 83-year-old female patient (mother) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 13Feb2021 at single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2. Patient medical history included high blood pressure. On 14 Feb 2021 the patient experienced fever, she reached about 100. Treatment: Reporter stated, "I think they just took Tylenol." When probed for any other concern, Reporter stated, "Okay is there anything that help them other than Tylenol. The outcome of the events was unknown.  Information on batch/lot number was requested. ; Sender's Comments: Linked Report(s) : PFIZER INC-2021191131 same drug/reporter/event, different patient
nausea,  diarrhea (for 2 hours) treatment:  increase fluids headache, chills, body/muscle ache, low fever (for 60 hours) treatment:  fluids and Tylenol  fatigue (for 60 hours) treatment:  sleep
sharp pains in her head/sharp pains in head was reported as worsened; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 (Lot number: 330308D) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "Headache" (unspecified if ongoing), notes: she suffered from headaches prior to the booster. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Single; Batch/Lot Number: ER8735), administration date: 07Apr2021, when the patient was 67 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Single; Batch/Lot Number: EN6205, Caller states the lot number is hard to read because they did not have good handwriting.), administration date: 10Mar2021, when the patient was 67 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "sharp pains in her head/sharp pains in head was reported as worsened". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated she received a Comirnaty booster dose on 29Oct2021 and since then she has been getting sharp pains in hear head in the morning and it lasts for about half an hour and sometimes it woke her up at night as well. She wanted to know if anyone else has reported that. Caller said that this was harrowing for her. Caller asked if this has anything to do with the dose and a possible error in administration.Reporter stated she could not recall the exact date it started, but it started after the booster. After the booster, she had headache and all the symptoms then was fine. Then the sharp pains started happening. The sharp pains occur every day. Sharp pains in head was reported as worsened. She had a flu shot but that was from her doctor that retired. She was not sure of the exact date. She did not have the lot number or information for the flu shot. Reporter stated that she did not want to give her medical information out.  Follow-up attempts are completed. No further information is expected.
Developed temp of 100.3ºF. Tested positive for COVID-19. Known exposure from positive roommate.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 08-MAY-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route of administration were not reported) (lot # R022117 and expiry date 02-AUG-2020) for prophylaxis (product storage error). Other suspect therapy included sterile diluent (strength, dose and route of administration, lot# and expiry date were not reported). There was no adverse effect reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.
Fever, headache, and chills onset the evening of the immunization and lasted approximately 36-48 hours. Fever peaked at 39* C the next evening (approximately 24 hours after onset). Treated with bed rest and cold packs; no medications ingested.