chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a 4 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 12-OCT-2016, the patient was vaccinated with an improperly stored PROQUAD lot # M022402 with expiration date of 01-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 15 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
This case was reported by a other health professional via call center representative and described the occurrence of generalized pruritus in a 52-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 5th March 2019, the patient received the 1st dose of SHINGRIX. On 5th March 2019, less than a day after receiving SHINGRIX, the patient experienced generalized pruritus, injection site pain, injection site erythema, feeling hot and cold, muscle weakness lower limb and feeling bad. On an unknown date, the outcome of the generalized pruritus, injection site pain, injection site erythema, feeling hot and cold and muscle weakness lower limb were recovered/resolved and the outcome of the feeling bad was not reported. It was unknown if the reporter considered the generalized pruritus, injection site pain, injection site erythema, feeling hot and cold, muscle weakness lower limb and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient felt so bad after getting SHINGRIX that she missed work for 2 days. Her body itched, she had a lot of pain and redness at the injection site, she felt hot and cold and felt like her legs were not strong enough. This is 1 of the 5 cases, reported by the same reporter.
Patient received 1st dose on 4/13/2021 and received the 2nd dose on 4/30/2021. No immediate reaction.
Patient fainted in waiting room about 5 minutes after shot. He had not eaten (much) prior to immunization. He had history of fainting on vaccination so I encouraged him to eat something but he insisted that it was the site of needle that made him queasy. Patient now feeling fine as he was about 20 minutes later after sitting and eating banana, drinking apple juice.
she received her second Moderna Bivalent mid May and about a week later "I had a persistent cough that lasted 3 weeks/sometimes dry and sometime not; she had Covid December of 2022/symptoms were, cough, sore throat, and nasal stuffed; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (she had Covid December of 2022/symptoms were, cough, sore throat, and nasal stuffed) and COUGH (she received her second Moderna Bivalent mid May and about a week later "I had a persistent cough that lasted 3 weeks/sometimes dry and sometime not) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-May-2023, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. In December 2022, the patient experienced COVID-19 (she had Covid December of 2022/symptoms were, cough, sore throat, and nasal stuffed). In May 2023, the patient experienced COUGH (she received her second Moderna Bivalent mid May and about a week later "I had a persistent cough that lasted 3 weeks/sometimes dry and sometime not). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (she had Covid December of 2022/symptoms were, cough, sore throat, and nasal stuffed) and COUGH (she received her second Moderna Bivalent mid May and about a week later "I had a persistent cough that lasted 3 weeks/sometimes dry and sometime not) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.
Arm pain that started night of vaccination. Was subtle that night but has progressively gotten worse, with range of motion affected. Had trouble sleeping last night due to pain, has been taking tylenol and ibuprofen for pain. Has scheduled doctors appt to take a look at arm and make possible diagnosis.
Tachycardia. Severe hot flashes. Shortness of breath. Fatigue.
Woke up at night feeling hot; Feeling chills for several hours; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 06Mar2021 at 17:45 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included Gastroesophageal Reflux Disease (GERD) and Sjogren's. 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 received other medications within two weeks prior to the vaccination. On 06Mar2021, the patient woke up at night feeling hot. Then felt chills for several hours. Some concern since this was first shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events woke up at night feeling hot and feeling chills for several hours were recovered on an unknown date Mar2021.  No follow-up attempts are needed. No further information is expected.
Flu vaccine was given first. No immediate reactions. Then 1-2 minutes later, the MenACWY was given and almost immediately, pt c/o blurry vision. About 3 minutes later she had difficulty breathing, almost apneic and passed out (never lost a pulse).- anaphylactic reaction. 911 was called while an Epipen was immediately and simultaneously given. About 1.5 minutes later, she gained consciousness and began to breathe normally again. Vital signs were stable. 911 appeared and transported to the hospital.
SEVERE FATIGUE; HEADACHE; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on left arm on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2020, Laboratory data included: (NR: not provided) Negative. On 12-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced severe fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache on MAR-2021, and was recovering from severe fatigue. This report was non-serious.
pt recvd vax; began to exp low grade fever, myalgias & arthralgias; no inject site rxn; no tx initiated
She has had to use her inhaler a lot more the past week; Acute anxiety disorder; 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 47 year-old female patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 01Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "She hacks a lot and brings up mucous" (ongoing), notes: Verbatim:She hacks a lot and brings up mucous and she has been doing this for the past three years. The patient's concomitant medications were not reported. Past drug history included: Singulair, notes: Verbatim:She takes Singulair, Flonase and a nasal rinse for these symptoms and she has been taking them for a long time; Flonase, notes: Verbatim:She takes Singulair, Flonase and a nasal rinse for these symptoms and she has been taking them for a long time. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset Apr2021, outcome "unknown", described as "She has had to use her inhaler a lot more the past week"; ANXIETY DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "Acute anxiety disorder". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, states she received the Pfizer COVID vaccine first dose on 01Apr2021 and the second dose on 22Apr2021. Patient like to know if she was protected? Patient states she hacks a lot and brings up mucous and she has been doing this for the past three years. she takes Singulair, Flonase and a nasal rinse for these symptoms and she has been taking them for a long time. She has had to use her inhaler a lot more the past week and she was waiting for her doctor to prescribe her something stronger. She also has acute anxiety disorder and she has been very worried. She doesn't go anywhere and she stays in her room and all the people in her house have been vaccinated. She has the ability to check her vital signs and they have all been perfect her blood pressure and oxygen. She just wanted to make sure she was protected.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Blurred vision; Feels like the flu; Aching bones; Very sore; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision), INFLUENZA LIKE ILLNESS (Feels like the flu), BONE PAIN (Aching bones), PAIN (Very sore) and CHILLS (Chills) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reported.  Concomitant products included AMLODIPINE and ROSUVASTATIN for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VISION BLURRED (Blurred vision), INFLUENZA LIKE ILLNESS (Feels like the flu), BONE PAIN (Aching bones), PAIN (Very sore) and CHILLS (Chills). At the time of the report, VISION BLURRED (Blurred vision), INFLUENZA LIKE ILLNESS (Feels like the flu), BONE PAIN (Aching bones), PAIN (Very sore) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 09Apr2021 as dose 2, single (Lot number: ER2613), in right arm and on 09Oct2021 as dose 3 (booster), single (Lot number: PE3590) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MRNA (MRNA 1273)), on 29Apr2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA [FEXOFENADINE HYDROCHLORIDE], start date: 05Sep2022; MUCINEX, start date: 05Sep2022, stop date: 14Sep2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Sep2022) Positive, notes: Positive antigen rapid test was on Day 13; (2022) Positive, notes: COVID 19 Treatment; (2022) Positive, notes: tested positive with mild symptoms after testing negative and feeling better; (2022) Negative, notes: tested positive with mild symptoms after testing negative and feeling better. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that, Patient took other medication in 2 weeks and Patient took Paxlovid for treatment covid 19, treatment start date is 07Sep2022 and treatment stop date is 12Sep2022 for indication treatment of COVID-19.
pt recv vax 14FEB97 as of 15FEB97 area of inj red, hard, swollen, painful, mild nausea;reported to MD 18FEB97;used DPH w/dec discomfort;saw MD 21FEB;still sl painful to touch;
Progressive and marked muscle weakness without any focal signs of viral illness. Duration about 4 to 6 weeks. No specific treatment administered.
This spontaneous report as received from a other health professional (licensed practical nurse) refers to a patient of unknown age. Medical history and current condition were not reported. On an unkonwn date, the patient was vaccinated with PROQUAD (Merck), 0.5 milliliter, subcutaneous. Concomitant medications were not reported. It was reported that PROQUAD (Merck), was exposed to temperatures warmer than -15 degrees Celsius (C) but no warmer than -8.5 degrees C on 17 different occasions for a total time of 17 hours out of range, have been administered. No adverse effect reported. No product quality complaint reported. This case is linked to 1410USA003460 (same reporter). Additional information has been requested.
Fully vaccinated and boosted on 10/31/21.   COVID infection breakthrough with inpatient hospital stay.   Cancer with active chemo treatments
Patient experienced chest pain the day after getting vaccine. He took a nitroglycerin tablet and chest pain was resolved. Patient has a history of heart attack.
Moderna vaccine was inadvertently administered past the 30 day use by date.  Moderna company was contacted and case ID given.  No signs or symptoms reported at this time.
On 9/25/18, patient's mother called to report child's reaction to vaccine. She reports right deltoid region began swelling and redness appx 2 hours after receiving vaccine. Area was sore and swollen. Child was taken to urgent care provider for evaluation. Advised ice, TYLENOL or ibuprofen prn for pain. The area of concern was outlined with a marker and patient's mother was instructed to seek care if swelling increased. The swelling did increase by next day, (9/22/18) so mother took him to Emergency dept, where he was treated with IV BENADRY; and antibiotics, per mothers report. He is feeling better today and mother says swelling is resolving, site still tender, but he feels better.
This spontaneous report as received from a Certified Medical Assistant refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with an improperly stored dose of VAQTA (dose, route lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information is not expected, because the reporter refused additional contact.
3 days after 1st dose tinnitus and hypacusis started.  Side effect still remains as of today.
pt recv vax&w/in 12hrs has inc temp (unk#) followed by grand mal sz-hosp;pt has hx of neuro problems-?meningitis;? encephalopathy-poor hx from honduras-recently in US w/no immunization records
shortness of breath  chest pain both would come and go i waited about 3 months before i went to hospital  i would  wake up in middle  of the night hyperventilating  got to the point i could not walk up a small hill with out  going completely  out of breath and forced to stop and try to breath
A week after the injection I have a small red bump, about a half inch in diameter, at injection site. My arm is itchy around the bump, but the bump itself is painful to the touch. My upper arm in general is still a little sore, although much better than the day after my shot.  Additional reactions: The evening of my shot and the day after I had typical symptoms. My entire arm, from shoulder to wrist, was very sore. This started within 30 minutes of injection. I had nausea starting about 2-3 hours after injection. That lasted the majority of the following day, on and off. I was able to eat and drink. The second day after injection I felt mostly back to normal aside from my arm being sore. My arm gradually felt better through out the week. However, the whole week I was extremely tired.
She was having high fever.; she is  having like stuffiness.; This is a spontaneous report from a contactable consumer or other non hcp. A 12-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: FA7484 and expiration date: unknown), via an unspecified route of administration on 29Jul2021 as dose 2, single (at the age of 12-year-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jul2021, the patient experienced high fever and she is having like stuffiness. On an unspecified date, the patient underwent lab tests and procedures which included body temperature is high. Therapeutic measures were taken as a result of event fever with Tylenol and Motrin and therapeutic measures were not taken for event stuffiness. The outcome of event fever was recovered on an unspecified date in 2021 and stuffiness was not recovered.  Follow-up attempts are completed. No further information is expected.
A consumer reported that her 36 year old husband received a dose of FluMist on an unspecified date in 2003. On 12/13/03, he experienced dizziness and was subsequently involved in a car accident. The reporter indicated that the event was life-threatening. No additional information was available at the time of this report.
temp 100.2 oral; body aches; chills; fatigue; headache; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (temp 100.2 oral), MYALGIA (body aches), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) in a 42-year-old male patient 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 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (temp 100.2 oral), MYALGIA (body aches), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (Nausea). At the time of the report, PYREXIA (temp 100.2 oral), MYALGIA (body aches), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, Body temperature:. On 01-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Body temperature: 100.2 (High) 100.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 Moderna COVID-19 Vaccination was Not applicable.  No Concomitant medication was provided.  No Treatment medication was provided.   This case was linked to MOD-2021-006050 (Patient Link).
03/02/07 mom calls and reports that about 9:30am) one hour after administration, pt became confused and had difficulty speaking. Had trouble putting words together. Today he seems more like himself, not confused. Activity normal. There was no loss of consciousness.
Left arm/red swollen - golf ball sized knot 3 x 3 1/2 inches in diameter.
Information regarding PREVNAR was received from a healthcare professional regarding a 6-month-old female patient who experienced a linear, raised, red, bumpy, "cellulitis like" reaction at the injection site on her leg which developed into a hard lump and pain.  The patient experienced a linear, raised, red bumpy "cellulitis like" reaction at the injection site on her leg which developed into a hard lump. The redness lasted 3 to 4 weeks and the lump lasted for 2 months. The pain was treated with TYLENOL and MOTRIN and completely resolved. No additional information was available at the time of this report.
The patient was given the wrong vaccine. DTaP was drawn up and administered to the patient. The patient was supposed to get combination PediaRix as a third dose to finish off the series. Patient was notified and asked to come in to receive additional vaccines. Patient did receive missing vaccines (Hep A, Hep B, IPV) on same day.
The patient described a red rash that started about a week after the vaccination and resolved over a couple of days.
I had a stroke 21 days after taking my first moderna vaccine. I soent 2 days in the hospital and have seen many doctors. I am only 39 and had a stroke.
pt hospitalized w/in 4 wk period following vax per moms report; dx @ the time of hospitalization was RSV & cerebrovascular accident (stroke); mom notified CHN office 3FEB95;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), in Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lymphoma" (unspecified if ongoing), notes: other medical history: Lymphoma; "IBS" (unspecified if ongoing), notes: other medical history: IBS; "Intestional Blockages" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After vaccines were given, client watched her brothers receive their vaccines. Client was sitting on the floor and started to pass out. Nurse in room at time and helped lower client to floor. Client was unresponsive with eyes open for less than 1 minute. She verbally responded to mother. She was able to sit up and drink water and eat crackers. Mother and brothers at her side. Client states she was fine and left with mother and brothers