chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From initial correspondence received at manufacturer, on 03/11/2003 it was reported that a 42-year-old male pt who was a Tetanus Plasma Donor, received a Tetanus Toxoid Adsorbed vaccination, administered IM in the right deltoid on 03/06/2003. The pt was observed for 15 minutes post-vaccination and was fine Pt has no history of allergies to Tetanus. Reportedly the pt passed away on 03/06/2003 or 03/07/2003, this is still under investigation. According to further info received on 03/12/2003 frm reporter it was reported: "The donor (the patient) successfully and without incident donated a unit of Source Plasma on 03/06/2003, was found dead in his bed on either March 6 or 7, 2003. There appears to be no relationship between the donor's death and his donation of plasma on the previous day. In a telephone conversation with the Coroner's office this morning, March 12th, Aventis Bio Services were informed that the cause of death in this case was due to severe Atherosclerotic Cardiovascular Disease." "The decedent was a 42-year-old male who was a regular donor. He weighed 166 pounds, and had donated a unit of Source Plasma (approximately 30 mL) on 03/06/2003 between approximately 6:30 AM and 9:30 AM. The donor's vital signs, including his pulse (86), blood pressure (153/79), temperature (99.0 F), hematocrit (43) and total protein (7.5) were all within acceptable limits. Info obtained during annual physical examinations conducted on this donor on 02/19/2003 indicated that he was healthy and suitable to donate. On 03/10/2003, manufacturer was contacted by the donor's brother and was informed that when the donor returned home sometime after donating that he complained of lightheadedness and numbness below the elbows in both arms. The brother reported inquiring if medical care was needed but the donor declined and elected to 'lay down for a while and try to feel better.' The donor's brother reported that when he tried to wake the donor on either Thursday afternoon or evening or Friday morning, that the donor had passed away. The decedent's brother speculated that the donor might have taken the dietary supplement 'Minithins' which contain ephedra since he had known him to take the supplement in the past. An autopsy was performed; a copy of the post-mortem report will be forwarded to manufacturer. The cause of death was reported by the Indiana Coroner's Office on 03/12/2003 to manufacturer as being due to severe atherosclerotic cardiovascular disease.
Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with case 2019SA024908 (same reporter). This case involves a 15 years old female patient who was vaccinated with a dose of IPOL that was stored outside of acceptable ranges had temperature excursion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE; MMR; BOOSTRIX; TDAP; and MENACTRA. On 14-Jan-2019, the patient received a dose of suspect 0.5 ml IPV (VERO) (lot number: P1A371M and expiry date: 27-Apr-2020) (dose in series and route was not reported) in the left deltoid. It was a case of actual medication error due to incorrect product storage. The IPOL administered had been stored outside of acceptable ranges. The vaccine was initially at a different location where the original reporter is located. That clinic had the temperature excursion. The vaccines from that clinic were then sent on 20Dec2018 to the Department of Public Health for storage because there was no backup generator at the school. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Information has been received from a consumer concerning her daughter a 13 year old female who in October 2008, was vaccinated with a third dose of GARDASIL.  There was no concomitant medication.  In December 2008, the patient experienced muscle pain, weakness and joint pain and weakness and the symptoms persisted since to present.  The patient did not sought medical attention.  Additional information has been requested.
arm area was so sore; arm  area was red; arm area was inflamed; arm area was very itchy; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm, erythema of extremities, inflammation localized and itchy upper limbs. On an unknown date, the outcome of the pain in arm, erythema of extremities, inflammation localized and itchy upper limbs were unknown.   It was unknown if the reporter considered the pain in arm, erythema of extremities, inflammation localized and itchy upper limbs to be related to Shingles vaccine.     Additional Information: GSK receipt date: 25-September-2022 Reporter's comment:  Patient reported that had arm area was sore and red, also had inflamed and very itchy. The follow up would not possible as no contact details were available.
severe reaction; Initial information was received on 21-Mar-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (under reference number: US-SA-SAC20210329000112).  This case involves an adult patient who experienced severe reaction, while the patient received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious severe reaction (adverse reaction) unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information on batch number for this case.; Sender's Comments:  SanofiPVPortal20210325000507:
FLUZONE HIGH DOSE QUADRIVALENT was administered to 3 patients instead of FLUBLOK QUADRIVALENT with no AE; FLUZONE HIGH DOSE QUADRIVALENT was administered to 3 patients instead of FLUBLOK QUADRIVALENT with no AE; FLUZONE HIGH DOSE QUADRIVALENT was administered to 3 patients instead of FLUBLOK QUADRIVALENT with no AE; Initial information was received on 18-Oct-2021 regarding an unsolicited valid non-serious case from other healthcare professional, consumer/non-healthcare professional and physician via call center via agency (Reference number- 00816964).  This case involves a 64-year-old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (wrong product administered, overdose and Product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 28-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ747AB and expiry date: 30-Jun-2022) via an intramuscular route in the left deltoid for prophylactic vaccination instead of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported).  It was an actual medication error case due to wrong vaccine administered (latency: same day).  It was reported "Caller/Office Manager would like to know side effects of administering FLUZONE HIGH DOSE QUADRIVALENT instead of FLUBLOK QUADRIVALENT. Caller reports that FLUZONE HIGH DOSE QUADRIVALENT was administered to 3 patients instead of FLUBLOK QUADRIVALENT."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I had muscle aches, fatigue, hot flashes, eye floaters, and some covid like illness symptoms for the first 2 days. Then I was fine except for I?ve developed a pain in my right leg that?s been getting progressively worse. It started in the ankle and top of my foot area and now it?s migrated a little below the knee. Sometimes I feel pins and needles but only on the right leg. The pain has gotten progressively worse. It went from a dull ache and now it?s hard to rotate my ankle fully and my leg hurts if I lay down and put pressure on it so I?ve been sleeping on my left side to keep my weight off of it. I can still walk fine though so I?m not sure if it?s related to the vaccine or not.
palpitations, lightheaded, anxious.  Monitored for 30+ minutes.  Resolved.
Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm ). At the time of the report, PAIN IN EXTREMITY (Pain in arm ) outcome was unknown. Not Provided      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.   This case was linked to MOD-2021-038512 (E2B Linked Report).; Sender's Comments:  MOD-2021-038512:cluster case (Other people at work took the vaccine)
Case completed 2 doses Covid vaccine in Feb 2021, then was hospitalized for Covid in July 2021. COVID-19 Assessment & Plan Positive on admission screen. Reports cough starting on 6/25. No daytime hypoxia (mildly hypoxic at night chronically). May be contributing to vertigo and generalized malaise. Dexamethasone started on admission primarily for vertigo, but was discontinued after five days due to lack of improvement in vertigo. Remdesivir not indicated. This is a mild covid infection so 10 days of isolation from positive test (last day 7/10) should be adequate.
On 11/29/02, 5:00 pm, pt started with chills, body aches. On 12/01/02, wake up with red pimply rash on face, neck, chest, abdomen, and some on extremities, Rash itchy, Rash viewed by RN 12/02/02 and appeared typical of rubeola rash, Recommended Benadryl and Aveno bath
Injection site muscle soreness; general fatigue; This is a spontaneous report from a contactable consumer. A 12-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 13May2021 at 17:30 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. The patient medical history included COVID-19. The patient did not report any allergy to food, medications or other products. Patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14May2021, the patient experienced injection site muscle soreness and general fatigue. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events.  The clinical outcome of the events injection site muscle pain and fatigue were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
High fever of 103.9 degrees occurred 10 pm on 3/28/2019, treated with ibuprofen and showered to bring down fever. Then temperature fell to 99.9 degrees at 12 am on 3/29/2019. At 3 am temperature spiked again to 103.7 degrees 3/29/2019, took two 500 mg tablets TYLENOL AND arm red and swollen 6 inches wide (looked like an arm band), with profuse sweating. At 8 am on 3/29 temperature dropped to low of 95.5 degrees. Blood pressure continued to drop during the morning and at 12 pm noon it was 86/49. Went to doctor's office at 3 pm and blood pressure taken in office was 90/52. Doctor sent for arm scan test and prescribed amoxicillin.
no adverse event; expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) in a 71-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) 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 (expired vaccine used).    Patient age was reported as 71 Year 10 Month.  Concomitant medications details were not reported by the reporter.  Reportedly, the patient at facility received Moderna vaccine between 08-Apr-2022 and 15-Dec-2022.  ID was reported as 80777027399.  Completion date provided as 19-Jul-2022  Treatment details were not reported by the reporter.
has like really big low muscle trauma he can barely pick up a cup.; Really unbalanced; uncoordinated; low muscle tone; This is a spontaneous report received from a contactable consumer.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, in Arm, on 06Mar2021 (yesterday afternoon), as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that the patient got the Pfizer vaccine yesterday afternoon and today (on the day of this report, 07Mar2021) he has like really big low muscle trauma he can barely pick up a cup. It's all over it's not just the arm he got the injection in, it's like both arm and his legs he is really unbalanced and uncoordinated. It's very low muscle tone. The reporter asking is that normal?. Outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Redness, swelling, warmth, pain/soreness at injection site.   Pt went to ER where she was given benadryl and ibuprofen and sent home.  Pt also applied ice pack to the site.   As of today, 8/18/19 pt still has a little soreness in her right arm but not significant.
Case number PHEH2015US000671, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 54-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 12 Oct 2014. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist does not believe that the vaccine was frozen instead thinks it was thermometer malfunction. No adverse event was reported following the maladministration. No further information was provided.
pt dizzy, lethargic, difficulty in waking up, twitching, cold sweats, hives on arms;
It started the evening of the 14th. I had a dry cough and a runny nose. That night I felt severe chills and took my temperature and it was below normal. It was 96.6. The chills lasted for days and I decided two days later and took a at home COVID-19 test. I started feeling very fatigue and congested. I never developed a fever. I contacted my PCP telehealth and he prescribed PAXLOVID. The symptoms never got worse and the symptoms have subsided and today 07/22/2022, I will finished my PAXLOVID. I feel much better than I have been.
Local reaction due to atopic dermatitis with hyperpigmentation and slight scaling/itch in are 4x6cm surrounding injection site.
IMMEDIATE BODY TINGLING, IMMEDIATE DIZZINESS, MUFFELED HEARING, HEAT WAVE, CHEST WAS TIGHT, RAPID HEART RATE, NUSEA. TREATMENT WAS OBSERVATION, OJ, WATER, CRACKERS, ICE TO THE WRISTS AND NECK.  ULTIMATELY EMS FOR EVALUATION.  HOOKED 4 LEAD EKG AND BP AND SINUS RHYTHM WAS NORMAL.  DID NOT TRANSPORT.
18 hours after second dose I had Temp 99.0, chills, body aches, fatigue, headache not relieved by Tylenol or Advil, injection site pain. The symptoms were so severe that I was unable to go to work this morning. I have a headache, fatigue, feel foggy, and injection site pain still.
Moderna COVID-19 Vaccine EUA 5 days after I received the vaccine my lymph nodes in the armpit of the arm I received my shot swelled up causing pain and pressure in the area.  It lasted for 3 days.
No adverse events noted.  Patient received dose but at the time was ineligible due to age of 15.
Starting at approximately 2 to 2.5 hours after the vaccine was administered, the patient experienced: coughing non-stop, sensation of tonsils swelling in her throat, dizziness, weakness, heart racing, face felt numb to the touch. Became very cold and had to wear extra clothes to stay warm, ski started itching (non-specific location of itching). Became thirsty and drank 60 ounces of water in 30 minutes, had a chemical / metal taste in her mouth, developed red eyes that had a yellow colored drainage/discharge. Most of these symptoms resolved within 1 to 2 hours from their onset. She remained dizzy and nauseous for 2 days after the injection.
client complained of headache after receiving 1st Moderna Covid Vaccine (lot 041B21A Exp. 5/6/21). Client was leaving after completing 20 min observation when he approached PHN and asked if he could leave. When PHN asked how he was feeling, client mentioned headache that begun after receiving vaccine. Client was asked to sit down for further assessment. 1238 vitals: blood pressure/90, pulse 77, oxygen 96%. Medical history: chronic migraines, sleep apnea, chronic back pain, and joint pain. Client unable to provide medication names. Client alert and oriented. Headache feels same as when a migraine is starting. Denied chest pain, blurry vision, no dizziness. Headache pain 1/10, described as "pressure" to back of head. Client wanted to leave, PHN spoke to client regarding high blood pressure, per client it was fine. PHN  gave ER precautions and advised to see primary care provider regarding blood pressure. Client left facility at 1248 with steady gait.
swelling, discomfort and pain in the left arm; incorrect dosing schedule; swelling, discomfort and pain in the left arm; pain in the left arm; This is a spontaneous report from a contactable consumer (Patient) reported for herself via. A female patient of an unspecified age received dose 2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and Expiration date were Unknown), via an unspecified route of administration on 21Feb2021 as a SINGLE DOSE and dose 1 via an unspecified route of administration on 21Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Patient medical history and concomitant medications were not reported. The Caller was wondering about the possible side effects of the Pfizer Covid-19 vaccine. She already finished the series of 2 doses of the vaccine a month ago. And is confused if the swelling, discomfort and pain in the left arm that she is experiencing in the past weeks are normal side effects of the vaccine. Also she had an incorrect dosing schedule when she took the vaccine. The 1st dose was given on January 21, 2021 her 2nd dose has been delayed into February 21, 2021 which was supposed to be taken on February 11, 2021. The outcome for the event is unknown.  Information on the lot/batch number has been requested
Presented to ED with nausea/vomiting and abdominal pain the day after second dose of Moderna. Patient had 2 weeks of upper abdominal pain as well as intermittent nausea and vomiting.  She denied having any diarrhea.  She said that she had had gastric ulcers in the past, though at least several years ago.  She was not on any acid blockers prior to admission.  She denied any hematemesis or coffee-ground emesis, and did not have any melena.  On admission, she had lab work significant for elevated WBC of 12.6.  Serum chemistries were significant for a sodium of 133, bicarbonate of 19, glucose of 273, and calcium was initially elevated at 10.5.  Magnesium was low at 1.4.  The patient also did have some wide complex tachycardia, which resolved, and she was given magnesium. Patient admitted and found to have grade B esophagitis, and also multiple gastric ulcers which were not bleeding at the time of the study.  The patient had been empirically placed on Protonix and was kept on this throughout her hospitalization.  She was discharged with a prescription for omeprazole and will need to take it daily and have repeat EGD in 2 months.
headache, runny nose, and sore/itchy throat; headache, runny nose, and sore, itchy throat; headache, runny nose, and sore,itchy throat; headache, runny nose, and sore/itchy throat; they were not feeling well; This spontaneous report has been received from a consumer, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 30-AUG-2023, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, dose, route of administration, lot number and expiration date were not provided).  On an unknown date in 2023, the patient not feeling well (malaise), the patient developed Headache, runny nose (Rhinorrhoea), sore troat (Oropharyngeal pain), and itchy throat (Throat irritation). The outcome of the aforementioned events was unknown at the time of the report, as well as the action taken with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) regarding the events.  The causality assessment between Headache, Rhinorrhoea, Oropharyngeal pain, Throat irritation, Malaise and the suspect vaccinate was reported as related.