chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches; Joint pain; fatigue; Tickling in the throat; Dry cough; Headache; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), ARTHRALGIA (Joint pain), FATIGUE (fatigue), THROAT TIGHTNESS (Tickling in the throat) and COUGH (Dry cough) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.     On 24-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced MYALGIA (Body aches), ARTHRALGIA (Joint pain), FATIGUE (fatigue), THROAT TIGHTNESS (Tickling in the throat), COUGH (Dry cough), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with DICLOFENAC for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (Body aches), ARTHRALGIA (Joint pain), FATIGUE (fatigue), THROAT TIGHTNESS (Tickling in the throat), COUGH (Dry cough), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), ARTHRALGIA (Joint pain), FATIGUE (fatigue), THROAT TIGHTNESS (Tickling in the throat) and COUGH (Dry cough) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.     On 24-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced MYALGIA (Body aches), ARTHRALGIA (Joint pain), FATIGUE (fatigue), THROAT TIGHTNESS (Tickling in the throat), COUGH (Dry cough), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with DICLOFENAC for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (Body aches), ARTHRALGIA (Joint pain), FATIGUE (fatigue), THROAT TIGHTNESS (Tickling in the throat), COUGH (Dry cough), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
High fever (104F), severe body aches, weakness, chest pain, fatigue, sweating, chills. These items lasted from approximately 6pm on 9/7, until 5am 9/8 and have been beginning to subside since then.
almost paralyzed; stroke; nerve damage; numbness in left-hand fingers/arm numbness; pain all in his left arm; the needle going in the wrong way and hitting a nerve; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003908. A male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 2021, outcome "unknown", described as "the needle going in the wrong way and hitting a nerve"; PARALYSIS (medically significant), outcome "unknown", described as "almost paralyzed"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; NERVE INJURY (non-serious), outcome "unknown", described as "nerve damage"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness in left-hand fingers/arm numbness"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain all in his left arm".  Clinical course:  It was reported the patient experienced a bad reaction. It was reported that patient was left him with nerve damage and described the needle going in the wrong way and hitting a nerve. The patient also experienced numbness in left-hand fingers, whole arm numbness and was almost paralyzed for 3 months. He had pain all in his left arm almost like he was having a stroke. The patient stated since last April, it took 3 months to get use back in his arm, that was the fear  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PATIENT DID NOT REMEMBER FIRST DOSE 12/18/2019, SHE HAD SECOND AND FINAL DOSE 02/21/2020.  SHE IN DECEMBER SHE ALSO RECEIVED PREVNAR AND THERE WAS SOME CONFUSION ON HOW MANY SHINGRIX SHE HAD BECAUSE SHE ASKED FOR HER SECOND ON 7/16/2020 BUT IT WAS ACTUALLY HER THIRD. PT STATES SHE WAS MORE FATIGUED THIS TIME THAN SHE REMEMBERED. PREVIOUSLY THIS WAS ONLY ADVERSE REACTION TO THE THIRD VACCINE.
Pt rec dose of MENACTRA vaccine on 7/24.  Approximately 15 min after vaccine, pt passed out and hit head on carpeted floor.  She had just left clinic rm and was paying.  Pt exhibited signs and symptoms of head injury.  EMS phoned, responded, transported. 8/21/08-records received for DOS 7/24-7/25/08-DC DX: Concussion secondary to syncopal episode. After receipt of vaccination subsequently passed out, striking head hard.  Initially intubated due to confusion and subsequently extubated in ED. In intensive care for monitoring. Exam intact. Loss of memory for the event.
On the same day of vax the pt woke at 11:00 pm complaining of itching, and breaking out with hives. He also complained of a sore throat. On the next day, the pt complained of swollen throat and lips which bilaterally resolved prior to evaluation.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 01-JUL-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23 0.5 ml, which had a lot # of L003188 and an expiration date of 06-JUL-2016 (route and anatomical location of administration were not reported). The sum of hours in excursion was 64 hours and the lowest recorded temperature reported was 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
With 24 hours of Pneumovax developed severe redness on arm and tenderness (at injection site), plus fever/ malaise above 101F, was reported in case this lot for some reason was affected somehow, since usually reactions I've seen are not this bad.
SHOULDER PAIN FROM PREVIOUS INJURY WAS COMPLETELY HEALED/UNEXPECTED THERAPEUTIC BENEFIT; PAIN UPON INJECTION; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included: shoulder injury in the right arm, and concurrent conditions included: shoulder pain from the previous injury. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the patient experienced pain upon injection. On 30-APR-2021, the patient experienced shoulder pain from previous injury was completely healed/unexpected therapeutic benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain upon injection on 30-APR-2021, and the outcome of shoulder pain from previous injury was completely healed/unexpected therapeutic benefit was not reported. This report was non-serious.
off label use: received Moderna 0.5 ml for immunocompromised despite receiving Johnson and Johnson initially,received third dose for immunocompromised individuals despite not being immuno compromised; received Moderna 0.5 ml for immunocompromised despite receiving Johnson and johnson initially; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (off label use: received Moderna 0.5 ml for immunocompromised despite receiving Johnson and Johnson initially,received third dose for immunocompromised individuals despite not being immuno compromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received Moderna 0.5 ml for immunocompromised despite receiving Johnson and johnson initially) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE NRVV AD26. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE NRVV AD26. Concurrent medical conditions included Diabetes and Down's syndrome.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (off label use: received Moderna 0.5 ml for immunocompromised despite receiving Johnson and Johnson initially,received third dose for immunocompromised individuals despite not being immuno compromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received Moderna 0.5 ml for immunocompromised despite receiving Johnson and johnson initially). On 28-Oct-2021, ACCIDENTAL OVERDOSE (off label use: received Moderna 0.5 ml for immunocompromised despite receiving Johnson and Johnson initially,received third dose for immunocompromised individuals despite not being immuno compromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received Moderna 0.5 ml for immunocompromised despite receiving Johnson and johnson initially) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.
Pt had seizure x2 while in clinic during observation period. Son stated that pt does have seizure disorder and anxiety does exacerbate seizures. Pt denies feeling anxious about vaccine. Initially pt was unresponsive to stimulii, but then opened her eyes and was able to follow commands and answer questions. O2 sats during initial seizure was 86% and BP 190's/80's. Pt with tonic clonic movement during initial seizure. Pt then had subsequent seizure but did not lose consciousness during this one but was unable to respond to stimulii or commands. O2 sats low 90's during this event. Pt's son stated that it was not normal for her ot have clusters of seizures like this and so EMS was called.
Information has been received from a physician referring to unknown number of patients of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with GARDASIL 9 (lot # L044475, expiration date 12-MAY-2017, dose, dose# and route unknown). The vaccines were stored under 34F for 13 hours and the vaccines were back in range without previous excursion (incorrect product storage). No adverse reactions reported. This is one of two reports received from the same source. Additional information has been requested.
Tiredness or fatigue Symptoms that get worse after physical or mental activities (also known as post-exertional malaise) Difficulty thinking or concentrating (sometimes referred to as ?brain fog?)
2ND DOSE IN MODERNA SERIES WAS GIVEN AT 3 WEEKS INSTEAD OF 4.   FIRST DOSE GIVEN ON 3/11/21 AND SECOND DOSE WAS GIVEN ON 3/31/21.
pt recv vax & exp flu sx on 18DEC96 described as myalgias, sore throat, fever & cough for 1wk p/vax;pt recovered;
The vaccine was given at 11:30 AM. The next day, I woke up with shortness of breath. I went to the emergency room around noon that day since symptoms were worsening. I was given fluids and told to follow up with my primary doctor. I could not get an appointment until November 4 and was still having shortness of breath and tightness in my chest along with dizziness. I had a headache for a week post-shot. On November 1, I noticed swelling in the lymph nodes of that arm which lasted about a week.
Fever, chills, headache, nausea, lightheaded. Lasted over 24 hours. Didn't feel normal until late March  12th.
Fever (max 105F), generalized tonic clonic seizure lasting >60minutes resulting in rhabdomyolysis ,  leukocytosis (16k) s/p ceftriaxone x 1 with COVID-19, Flu A/B, RSV all PCR negative followed by transfer to hospital (2/25/2021) with ongoing high fever (Tmax 104F), Admission labs found rhabdomyolysis (CK >100,000 on day 2), elevated lactate (4.4), acute liver injury (AST/ALT >5000), elevated Cr (3.8) requiring CVVHD, DIC, shock, and respiratory failure requiring urgent intubation.
ringing in her ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 10Feb2021 (Lot number: EL9269) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:2, Lot: EN6201), administration date: 03Mar2021, when the patient was 57 years old, for covid-19 immunisation, reaction(s): "mental health issues", "tinnitus". The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "ringing in her ears". The event "ringing in her ears" was evaluated at the physician office visit. No follow-up attempts are possible. No further information is expected.
Syncopal episode presumably vasovagal as patient was aswell bradicardic. LOC for about 10 seconds. Fall hitting head/ face with concrete floor from chair  No apreciable injury on physical exam.  Episode resolved 10 seconds after listing legs. Intent to call EMS was done but patient refused. As she was living to Boston
ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/10/2023 ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE
pt recv vax 6SEP95 & 5APR97 pt devel what father believed to be shingles from around the waist on lt side of the naval to the spine;6APR97 to ER & examined by a MD who felt rash was shingles;
- sleeplessness, headache and night sweats - 5/17/21 8PM - 6AM - passed out - 5/18/21 6:30AM - light headed and headache - 5/18/21 7AM - 10PM - shortness of breath when talking - 5/19/21 10AM - 6PM - headache has dissipated - 5/19/21 12PM
This spontaneous report as received from a physician refers to an 11 years old male patient. The patient was vaccinated with first dose of GARDASIL (lot number reported as H009746, expired date unknown) on 22-AUG-2012. The patient also received a dose of MENACTRA on the same date. No other co-suspects were reported. The patient experienced malaise, general muscle pain and fatigue after administration of first dose of GARDASIL on 22-AUG-2012. The muscle pain was generalized but especially involved both legs. The symptoms resolved after 2 days without requiring treatment. The patient's parents declined to continue to GARDASIL series. It was unknown if the patient had sought medical attention. Additional information is not expected. This is one of several reports received from the same source.
I am in month 5 of an all over body rash that doctor originally diagnosed as Pitarysis Rosea. It has continued to cover my entire body. Doctor's last diagnosis was hives. Burning and itching, skin looks like it is sunburned. Huge red welts and patches all over entire body.
Got shot at 1:40pm on 4-22-21. Sore arm only in Eve. Woke up at 3:21 am shivering so hard I though I?d crack a tooth or wet my pants. Felt like I had a hatchet in my head. Fever. Quite delirious all morning from high temp and aching head and arm and neck. Calves and forearms kept charliehorsing. Fever started to come down to 101.7 around 11am on 4-23.  Aching and fever continued even with Tylenol and ibuprofen switched off every 3 hours. By evening if 4-23, lymph nodes very swollen and aching. Symptoms subdued but still present today. 2nd day in bed. And I am not a wimp!! Or a medicine taker, and I desperately wanted those pain and fever reducers. Can?t remember being this sick in 30 years or more!
With the second Dose I started getting a rash  all over my body ( allergy Looking) with bumps about 2 weeks after I took it.  The itching was unbearable.
This spontaneous report as received from licensed practical nurse refers to a patient of unknown age and gender. On 06-NOV-2014, the patient was vaccinated with improperly stored GARDASIL (dose: 0.5 ml, intramuscular, lot # K004205, expiration date 12-JAN-2017, anatomical location not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fatigue, muscle aches, chills started day after administration and lasted for 2 days, pain at injection site started day of administration and lasted for 3 days. Patient reports no adverse reaction from first dose.
pt recvd vax 31JAN92 & 11 days p/vax pt devel a rash; No further details were provided;
Rash; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a male patient that a 50-year-old male patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date (at the age of 50 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter was calling on behalf of her 50-year-old boyfriend. He received the Pfizer COVID19 Vaccine and a week later reports a rash. He called reporter this AM saying he has a rash and he thought it may be from the vaccine. The reporter does not think this was so because it "has been over one week." She stated, "he was going to be honest, reporter don't think it has anything to do with the vaccine. For most people if they get a bee sting or eat something body reacts right away because it recognized something abnormal. Usually people get rashes and different things right away, not a week later. It doesn't correlate or make sense. She stated she just wanted to see if we had any data or anything that would suggest that. Reporter also questions possible reaction to the detergent that linens were washed in at the hotel that he stayed at last night as being a possible cause of his reaction/rash today. Response: What are the risks of the Pfizer-biotech covid-19 vaccine? A bad rash all over your body. Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine included: non-severe allergic reactions such as rash. Advised caller per attached document regarding "how long side effects last" In general, local side effects; the ones they get on the arm where they got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that they may experienced throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days. The outcome of event was unknown.  Information about batch/lot number has been requested.
Dizziness, Headache, Fatigue Narrative:  symptoms lasted 3 days. Missed 1 day of work  Other Relevant History:
Patient Diagnosed and hospitalized post vaccination.  Patient also had booster vaccine on 8/30/21 prior to diagnosis
Heavy pressure in chest area, causing difficulty breathing. Also caused headaches that caused blurry vision, and muscle tightness in shoulders and back on side of injection.
patient received dose of expired IPOL with no reported adverse event; Initial information received on 10-Nov-2021 regarding an unsolicited valid non-serious case from a other health care professional and physician via Global Medical Information (Reference number- 00852217) in the United States  This case involves a 12-year-old male patient received an expired dose of IPV (VERO) [IPOL] (expired product administered).  The patient medical history, past medical treatments, vaccinations concomitant medication and family history were not provided.  On 10-Nov-2021, the patient received 0.5ml total dose of suspect IPV (VERO) (lot number: : R1F972M and expiry date: 03-Oct-2021) (Frequency: once, Strength: standard, Drug Interval Dosage: (1x) once) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "Caller/ Practice Site Manager reports that patient received dose of expired IPOL on 10Nov2021, they did not catch the expiration date when product was administered, safety report will be completed. Caller would like to know if dose needs to be repeated since expiration date of 03Oct2021 was fairly close to administration date. "  At the time of reporting, no adverse event.  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.
"Upon injection I had pain that shot down my arm from the injection site to my pinky finger. I continued to have a sore arm and also decreased mobility. I have lost strength in the arm. the symptoms have gradually worsened since the infection. I can no longer do my normal daily functions with my right arm. The pain wakes me up at night."
pt recv vax 9OCT95 & devel an inj site rxn characterized by warmth, burning, itching & a hard knot;pt was treated w/DPH;no further details were known as of the date of this report
he can no longer smell or taste food; he can no longer smell or taste food; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine last Monday on 21Dec2020, and 6 days later he noticed that he can no longer smell or taste food. He wanted to know if that was still part of the side effects of the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
One week after each injection, my CPAP report showed Cheyne-Stokes breathing patterns. This also happened a few times in the next 3 or 4 months, but had never happened before.
Patient c/o chest discomfort, dizziness, and achiness.  Denies struggling for breath but admits to heaviness of chest and a slight red rash around injection site.