chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 14-AUG-2013 (reported as last Wednesday), the patient was vaccinated with a dose of ZOSTAVAX (Lot #, dose and route not reported). Concomitant therapy was not reported. It was reported that after receiving ZOSTAVAX, in August 2013 the patient experienced a lump on her arm near injection site, swelling and hot (warmth) around injection site. The patient also stated that the area near injection site was hardened. The patient sought medical attention by speaking with the pharmacist, and no treatment was given for the adverse events. At the time of the report, the patient's outcome was not recovered. Additional information is not expected.
Mother phoned stating baby was fine yesterday. He woke up at 04:00 and is screaming (not crying) until 11:00, napped for 1/2 hour and woke up screaming. Advised MD visit. On Tylenol.
redness; swelling; pain; didn´t feel well; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 31st July 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site pain and feeling abnormal. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pain and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 66 or 67 years old. The patient received vaccine in left arm. The patient experienced pain, swelling and redness at the injection site which was huge. The patient body overall didn't felt well. These began on the same day of the injection and lasted about a week. The patient consented to follow up. For tolerance of 2nd dose refer case US2019AMR204749.
Diarrhea; Fatigue; Chills; Body aches; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, DIARRHOEA (Diarrhea), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache) and PYREXIA (Fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicine were reported.  No treatment medicine were reported.
Severe sinus congestion and headache starting 5 hours after vaccination, sore shoulder and arm, all increasing until I went to bed that night around 11:30 PM . Following day, woke up with  severe muscle aches all over and sick headache with fever developing later in the day which got to 100.2 by 9:00 PM. Fever started to drop at 11:30 PM Woke up today with most symptoms resolved, but still have very sore shoulder, and a foggy head, and a moderate headache.
Forced abortion; Maternal exposure during pregnancy; Feeling unwell; Crohns flare up; Digestion issues; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CROHN'S DISEASE (Crohns flare up) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included No adverse event (No reported medical history).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 UNK. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On 04-Apr-2021, the patient experienced CROHN'S DISEASE (Crohns flare up) (seriousness criterion medically significant) and DYSPEPSIA (Digestion issues). On an unknown date, the patient experienced ABORTION INDUCED (Forced abortion), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (Feeling unwell). The delivery occurred on an unknown date.  At the time of the report, CROHN'S DISEASE (Crohns flare up), DYSPEPSIA (Digestion issues), ABORTION INDUCED (Forced abortion), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (Feeling unwell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The fetus was exposed to maternal use of humira in utero.Physician had given a new drug to induce labor and force abortion but she went off after five days because she did not well with it. Unspecified medication for labor and force abortion was also considered suspect.  No concomitant medications were reported. No treatment information was provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction). At the time of the report, ADVERSE REACTION (Adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications and treatment  were reported by the reporter.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Critical details is lacking in this case repot to include, the specific event or signs and symptoms, mRNA-1273 vaccination, onset dates of the event, patient's underlying medical history and concomitant medication. Further information has been requested.
Laying in bed sick, and the card is in the other room.,; Body wracking chills; Temperature 101.5 degrees; Headache; Body aches; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12Mar2021 at 09:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Concomitant medications not reported. 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 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 19Feb2021 at 09:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. On 12Mar2021 at 20:00, the patient experienced body wracking chills, temperature 101.5 degrees, headache, body aches, weakness and was lying in bed sick. On the same day and same time, the patient underwent temperature test and the result was 101.5 degrees (unspecified units). 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 reported events. The clinical outcome of the events body wracking chills, temperature 101.5 degrees, headache, body aches, weakness and lying in bed sick were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Began menstruating the next day, even though it was early. This is unusual. The same thing happened after second dose. Subsequent cycles were irregular culminating in a totally skipped cycle in September/October 2021. Upon recommencement of menstrual cycle it has been twice a month. All of this is atypical prior to the vaccine. These menstrual irregularities have been associated with some unexpected and atypical fluctuations in weight.
temperature excursion involved a low temperature of 29.0F and the total excursion time was for 45 minutes with no adverse event; patients received FLUZONE QIV NP from pre-filled syringes after a temperature excursion with no adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to 2022SA408679.  This case involves Adult and unknown gender patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] from pre-filled syringes after a temperature excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE , Suspension for injection (Dose, strength expiry date: unknown) lot UT7689LA via unknown route in unknown administration site for immunization (poor quality product administered) (Latency: same day) after temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no adverse event (product storage error) (unknown latency) .  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   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 the 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.
Pt recvd 3 doses of Recomb & following vax lab eval revealed pos anti-HBc titer, & inc levels of SGPT;
Initial case received from a hospital pharmacist on 30 January 2014. A patient, with no reported medical history or concomitant medications, received a dose of FLUZONE (lot number not reported) on an unspecified date. The reporter stated that the hospital infection control nurse reported that the patient began experienced "symptoms of optic neuritis" within a couple of days after vaccination. No additional information was reported. Documents held by sender: None.
After the 1st dose, my child experienced Fever 102; chills, light-head ness; body aches
Vaccine was fine, but when I went for my physical my cholesterol was high, I went to a dietician to check my diet, but cholesterol keeps climbing and I went to a Cardiologist and put me in medication, I feel more tired than usual. I am going to the doctor next week for a recheck.
Date of symptom onset: extreme fatigue, body aches, dizziness, lost of taste. Progressed with headache throughout the day followed by severe joint pain. Symptoms mostly resolved except for dizziness and loss of taste the next day (today 2/5/21).
Light side effects from the first two doses.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Light side effects from the first two doses.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, 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 COMPLICATION (Light side effects from the first two doses.). At the time of the report, VACCINATION COMPLICATION (Light side effects from the first two doses.) outcome was unknown.            Concomitant medication was not reported.  Treatment information was not reported.   This case was linked to MOD-2021-419522, MOD-2021-419551 (Patient Link).
Appoximate date.  Developed restless leg syndrome after receiving Gardasil.  Was given medications for Parkinson's. Was dizzy immediately after vaccine.
? 1st dose Pfizer was on 04/24/21, 2nd 05/15/21, patient was only 15yrs old at the time.    No adverse affects, just reporting age at time of first dose.
Staff member reported; nausea, vomiting and diarrhea symptoms subsided within 24 hours not treatment needed
On October 7, 2009 Patient received the flu shot (regular flu shot) Two days later noticed redness, hot sensation at shot site, the size of a grapefruit. On October 15th became ill vomited. Oct. 16th had a seizure and lost memory. Hospitalized for 7 days. He was tired and easily winded just days after shot.  12/03/09 & 12/04/09 MR and DC summary for DOS 10/17/09  10/22/09 DX: aseptic meningitis  Pt c/o malaise, fever, HA, altered mental status, tonic clonic seizure.  Tx: vancomycin, ceftriaxone, Dilantin.  On examination: mild hepatosplenomegaly.   12/03/09 & 12/04/09 MR and DC summary for DOS 10/17/09  10/22/09 DX:   Pt c/o malaise, fever, HA, altered mental status, tonic clonic seizure.  Tx: vancomycin, ceftriaxone, Dilantin.  On examination: mild hepatosplenomegaly.  12/28/2009 duplicate DC summary for 10/17-10/19/2009 received 12/28/2009 ED records for 10/17/2009 12/30/2009 ED records for 10/16/2009 c/o's fever, chills, malaise   1/4/2010 VA records for f/up visits post hospitalization, 10/23-12/28/2009 noted on visit 11/16/2009 patient with c/o's cough, SOB and frontal headaches, rx'd ABX and albuterol inhaler Also included is Opthalomology consult for c/o's eye pain, diplopia, and eye fluttering, Rx'd eye gtts, noted per eye exam peripheral retinal holes  01/11/10 Vaccine records received.
dizziness and shortness of breath, follow-up visit with cardiologist, angiogram, diagnosed with coronary artery disease, angioplasty scheduled for 12/16/2022
Progressive erythema, induration, tenderness, and heat over injection site on left deltoid, ultimately progressing to 11 x 11 cm area.  Back arthralgias and myalgias.  No objective fever, though episodic evening chills.  Systemic symptoms resolved over subsequent 48 hours. Local symptoms/signs resolving over three days.
Shingrix was given in left arm on 08/28/2019.  The following morning pt had a raised, warm, red 3" by 1 & 1/2" oval shape red mark three to four inches BELOW the injection site.  It continued to be same 2 days later on 08/30/2019
Information has been received from a licensed practical nurse concerning a 12 month old female with no pre-existing allergies or medical history who on 10/20/04 was vaccinated SC (previously reported as IM) in the right deltoid with the first dose of varicella virus vaccine live (lot # 646676/0711N). There was no illness or concomitant medication at the time of vaccination. On 10/26/04 (previously reported as 10/27/04) the patient developed chicken pox and on 10/28/04 she was seen in the doctor's office. The patient had more than 50 lesions all over her body and no fever. No laboratory or diagnostic testing was performed. It was reported that the patient recovered. There was no product quality complaint. Additional information has been requested.
Expired Bexsero administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 27th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received expired dose of Bexsero vaccine which was expired on 30th September 2022. No symptoms was reported. The reporter did not had the patient initials, gender and date of birth. Consent unspecified inadvertently forgot to request for consent. Additional supportive information: The patient received a Bexsero which was already expired, which led to expired vaccine used.
Patient complained that she had hives 2 days after receiving the vaccine.  She was out in her garden and was bit by fleas which would usually not caused hives (has happened many times without hives) and she believes that her getting the vaccine may have exacerbated the flea bites causing hives.  She wanted it reported.  She said it wasn't too problematic.
Redness, swelling, whole thigh, limping. recommended benadryl, ice packs, 2 days, antibiotics, close follow up in the office.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient was inadvertently vaccinated subcutaneously with a dose of VARIVAX (Merck) (dose and lot # not reported) instead of ZOSTAVAX on 23-OCT-2012. No adverse effect was reported. Additional information has been requested.
The vaccine expired in the freezer on 6Apr2022 and the vial was initially stored in the refrigerator: 28Apr2022, and 4Apr2022; administer expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine) and PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 6Apr2022 and the vial was initially stored in the refrigerator: 28Apr2022, and 4Apr2022) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 6Apr2022 and the vial was initially stored in the refrigerator: 28Apr2022, and 4Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine) and PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 6Apr2022 and the vial was initially stored in the refrigerator: 28Apr2022, and 4Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not had any allergies (medications, food and other products). Patient neither tested nor diagnosed with COVID positive ever. It was unknown whether patient received other vaccines within 1 month prior to Modena COVID-19 vaccine. No concomitant medications were reported.  Dose administered after 30-day Use By Date or after manufacturer date of expiry. On 28-Apr-2022 and 04-Apr-2022, the vials were stored in the refrigerator. The vials did not underwent any temperature excursions. It was unknown whether the AE caused patient to seek medical care. It was unknown whether patient experienced similar event in the past.   This case was linked to MOD-2022-593844, MOD-2022-593855, MOD-2022-593856, MOD-2022-593859 (Patient Link).
1 shot within 30 minutes I had intense burning sensation on brain. Lasted for about 2 hours and went away 2nd shot about 25 minutes after shot face went numb. Hoped it would just pass about three months my tounge went numb. Contacted Dr and had blood work done.  After daystar arms and legs went numb. Had a MRI last Friday October 1.
It was reported that a patient (12 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. Reportedly sometime after the vaccination the patient developed a local reaction. No specifics were provided. Further information is requested.
FEVER 101.4 F LASTING ABOUT 6 HOURS. TOOK 2 TABLETS  TYLENOL. RESOLVED
pt began exp limpness upon arriving home approx 30 mins p/vax given; pt exp fever, chills, loss of appetite cont throughout next wk w/fever escalating to 104.2;
Site: Pain at Injection Site-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: numbness in fingers-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: Patient just moved from out of country and does not have a PCP
The caller confirmed no side effects were experienced; The caller confirmed the dose given to her mother and father was 0.5 ml dose of RECOMBIVAX; This spontaneous report was received from the patient's daughter and refers to her father of unknown age. The patient's concurrent conditions pertinent medical history, drugs reactions or allergies, and concomitant therapies were not reported.  In approximately August 2022 (reported as "a month ago"), her father was vaccinated with first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 0.5 ml dose, lot number T032918 with expiration date 12-NOV-2022 (route of administration and anatomical location were not provided) for prophylaxis (Incorrect dose administered). The caller confirmed no side effects were experienced.; Sender's Comments:  US-009507513-2209USA008565.
Received FLUZONE vaccine at 0920; one hour later pt. reports "I was just not feeling well" - trouble breathing; needed inhaler; felt need to lay down; swelling of lips, face & fingers; had fever.
Breakthrough seizure  - shaking of all extremities, drooling and left eye gaze deviation  No symptoms prior to episode, noted to be warm and potentially febrile per patients mother
Pt started to bleed from site. Called at 1 PM to say pain in arm is severe, has trouble lifting left arm, has tingling in hand.