chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9.5 out of 10 on the pain scale; Not even able to sleep; Can barely move around; Knee hurting; Stiff knee; Difficulty in bending knee; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Stiff knee), JOINT ADHESION (Difficulty in bending knee), PAIN ASSESSMENT (9.5 out of 10 on the pain scale), INSOMNIA (Not even able to sleep) and GAIT DISTURBANCE (Can barely move around) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced JOINT STIFFNESS (Stiff knee), JOINT ADHESION (Difficulty in bending knee) and ARTHRALGIA (Knee hurting). On an unknown date, the patient experienced PAIN ASSESSMENT (9.5 out of 10 on the pain scale), INSOMNIA (Not even able to sleep) and GAIT DISTURBANCE (Can barely move around). At the time of the report, JOINT STIFFNESS (Stiff knee), JOINT ADHESION (Difficulty in bending knee), PAIN ASSESSMENT (9.5 out of 10 on the pain scale), INSOMNIA (Not even able to sleep), GAIT DISTURBANCE (Can barely move around) and ARTHRALGIA (Knee hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Follow-up received on 08 April 2021. Additional events added
mild fatigue; Double vision; headache all the way to the jaw line; weak; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (mild fatigue), HEADACHE (headache all the way to the jaw line), ASTHENIA (weak) and DIPLOPIA (Double vision) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced ASTHENIA (weak). On 19-Apr-2021, the patient experienced HEADACHE (headache all the way to the jaw line). On 20-Apr-2021, the patient experienced FATIGUE (mild fatigue) and DIPLOPIA (Double vision). At the time of the report, FATIGUE (mild fatigue), HEADACHE (headache all the way to the jaw line), ASTHENIA (weak) and DIPLOPIA (Double vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were reported. No concomitant mediations were reported.   This case was linked to MOD-2021-081479 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-081479:1st dose
Fever, chills, muscle aches for approximately 8 hours followed by some fatigue for 16 hours.
Severely itchy and red skin (rashes) on the front neck at night during sleep. It's gone better after waking up, but it is still bothersome and itchy (not as severe as at night).
+edema, +erythema, +heat 8cm x 5cm;ATB given;
Blood pressure dropped from 123/64 per pt to 91/54, arm was swollen from shoulder to elbow twice its size, extremely red, felt weak and shaky, stated couldn't move her left arm...... Patient took BENADRYL for itching and swelling for 2 to 3 days, as of Saturday 10/13 pt stated felt better, checked on patient again 10/16 feeling better no longer weak not red or swollen and blood pressure back to normal for her.
SkinRash, Rash & UrticariaPruritus Narrative: day 1-2 noted soreness and slight swelling to injection site; day 8, 0600 noted hive to injection site, 1200 noted hives to abd, in afternoon had noticed hives to B thighs, all hives with itchiness. Went to PCP and was prescribed Benadryl. Symptoms started to resolve over the next 2 days. day10 s/p #1 vacc dose is last day noted symptoms.
Initial report received from a non healthcare professional (consumer) on 15 NOVEMBER 2012. A female patient born on 02 MAY 1947, whose age, medical  history and concomitant medications were not reported and was reported allergic to sulfa, received a dose of FLUZONE (lot number, route and anatomical site of vaccination was not reported) on an unspecified date, about "two weeks ago". Two hours post vaccination, patient experienced feeling of tongue swelling and throat swelling. The patient stated she d rank water and the symptoms resolved after a while with no further symptoms or reactions noted. Laboratory investigations and corrective treatments were not reported. List of documents held by sender: None.
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 74-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL9261), in left arm, on 12Mar2021 as dose 2, single (Lot number: EN6207), in right arm, on 25Sep2021 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 17Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: LOVASTATIN, start date: 30Jun2014, stop date: 12Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received vaccine and other medication in two weeks. The patient received COVID 19 Treatment from 12Jun2022 to 17Jun2022. Covid-19 recurred a week after testing negative after the previous infection.
Received shingles shot Jan 21, 2010.  On Feb 16 began to get an "electrical shock" sharp nerve pain in area of shot - under left arm.  * These continue at present, altho fever.
Hives immediately after MMR administered- ice pack to leg- hives resolved within 20 minutes.
Felt really sore in arm and had a line across chest and back that was really sore. Broke out in hives on face, neck, arm and upper body. Called ER and was advised to take Benadryl and drink plenty of water. Hives were gone in about 2-3 hrs, hurting and soreness lasted for 3 days.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # M009377, expiry date 17-JUN-2017) (doses, route and site of administration were not reported). The doses of vaccine were stored under temperature of 53.1 F for 63 hours (total of 5 excursions). There was no previous excursion. No data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information bout patient's concomitant medications and pertinent medical history reported. On 22-OCT-2015, and expired dose of PNEUMOVAX23) lot # K006681, expiry date 21-OCT-2015 (dose, route and site of administration were not reported) was inadvertently administered to an unspecified patient. No adverse effects were reported. Additional information has been requested.
dry cough; fever; Tested positive for COVID; chills; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID), COUGH (dry cough), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle aches) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID). On an unknown date, the patient experienced COUGH (dry cough), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle aches). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown, COUGH (dry cough) and PYREXIA (fever) had not resolved and CHILLS (chills) and MYALGIA (muscle aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Events added. Lab data added.
Breakthrough covid. No fever. Cough, sinus congestion, runny nose, weakness, fatigue for about 5 times. Lingering weakness and fatigue continuing to date.
Where they give the shot it started become red and that part is getting bigger; it's red and itches; Where they give the shot it started become red and that part is getting bigger; it's red and itches; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on an unspecified date in Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Bad knees/my knees are bad and don't have a cartilage from an unknown date and unknown if ongoing (Bad knees, but patient was not taking anything for it but patient have not had once since march because patient knees were bad and was not had a cartilage). Concomitant medication included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) and acetylsalicylic acid (ASAPRIN) drugs were taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of bnt162b2 administered in right arm on an unspecified date for covid-19 immunisation. It was reported that, where they gave the shot it started become red and that part was getting bigger, it was red and itches on an unspecified date in Mar2021. It was reported that, it was started probably patient was not sure, an hour after the shot. It just seemed like after two days it was going bigger. Just wanted to know is it the normal side effect that it is still get bigger (reporter question). The patient underwent lab tests and procedures which included physical examination: unknown result (there was a Physical a week before) and urine test was normal on an unspecified date in Mar2021. Patient did not receive any treatment for the events. Outcome of events were not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Woke up in the middle of the night; Shaking; Cold; Headache; Shivering; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Woke up in the middle of the night), TREMOR (Shaking), NASOPHARYNGITIS (Cold), HEADACHE (Headache) and CHILLS (Shivering) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 015M20A and 048A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (got the flu shot in left arm sore and stated that it hurt after the shot). Past adverse reactions to the above products included Pain in arm with Flu shot. Concomitant products included VITAMINS NOS for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Woke up in the middle of the night), TREMOR (Shaking), NASOPHARYNGITIS (Cold), HEADACHE (Headache) and CHILLS (Shivering). At the time of the report, INSOMNIA (Woke up in the middle of the night), TREMOR (Shaking), NASOPHARYNGITIS (Cold), HEADACHE (Headache) and CHILLS (Shivering) outcome was unknown.            Other concomitant medication included some medications to keep the patient going but did not  provide names of the medications.  No treatment was received by the patient.  The patient stated that after receiving the "3rd dose" but later clarified that it was the booster dose and stated that, woke up in the middle of the night, was shaking, shivering, was cold and had a headache. The patient also stated that got the flu shot in left arm so had to get the booster dose in the right arm and stated that it hurt after the shot but got the other 2 shots in the left arm for the moderna vaccines. The patient stated that the left arm was also sore due to flu shot.
Vial was placed in the refrigerator on 16-Jun-2022 with a use by date of 17-Jul-2022 and was administered on 19-Jul-2022; Moderna dose administered to patient after use by date of 17-Jul-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after use by date of 17-Jul-2022) and PRODUCT STORAGE ERROR (Vial was placed in the refrigerator on 16-Jun-2022 with a use by date of 17-Jul-2022 and was administered on 19-Jul-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after use by date of 17-Jul-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was placed in the refrigerator on 16-Jun-2022 with a use by date of 17-Jul-2022 and was administered on 19-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after use by date of 17-Jul-2022) and PRODUCT STORAGE ERROR (Vial was placed in the refrigerator on 16-Jun-2022 with a use by date of 17-Jul-2022 and was administered on 19-Jul-2022) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  The vial did not undergo any temperature excursions.  No treatment medication information provided.
Healthcare Branch was contacted via 24/7 Support line on 1/1/2017 questioning if recurrent body - muscular aches and pain with headaches were from her 12/1/2016 MMR, Hib, and first Hep B vaccinations. She had several concerns that these reactions could be early onset of MS or another autoimmune disorder. She stated 1 week after receipt of 12/1/2016 vaccinations she began to experience scattered muscular pain to various body parts (arms, legs, chest, back, abdomen) and she had a headache. She sought medical care with her HCP to R/O cardiac issues reporting a normal echo, stress test and EKG. Since Md's had no definitive diagnosis, she questions whether the vaccines caused her issues. A medical record review was completed with several scattered orthopedic issues to include lumbar sprain, right leg pain, and variety abdominal issues (GYN evaluations) since 2014. Labs documented 6/6/2016 MMR titer: positive for varicella, mumps, rubella but negative to rubeola, Hep B surface Ab was negative, and Hep A Ab was positive (reactive). As of 5/16/2017 she no further medical care for myalgia, headaches or diffuse muscular pain was identified in medical records. Her reaction was most likely commonly reported vaccine side effects (body aches, headaches, arthralgia, etc.) that may may not have exacerbated prior musculoskeletal issues (back and leg strains/pain).
Extreme redness and swelling on the site of the injection, itchiness. Saw a primary care physician prescribed AUGMENTIN.
Pt received Tdap 5/22 - then returned to clinic 5/27 c/o sore throat and swollen lymph nodes with fever and fatigue pt. returned 5/29 same symptoms - referred to ID.
Chills, headache, chest pains, vomiting. Went to Occupation health doctor and was tested for COVID, it was positive.
Flu like symptoms. Very achy all over but no fever.  Right arm super sore from infection site.  No redness around injection site
Pt received Fluzone at 10:15am. Returned an hour later with swollen right eyelid (upper and lower). No repiratory distress, pain or itching. Awake and alert. Benadry 50mg elixir given and ice pack applied to right eye. No fever.
Chills / muscle aches / headache / Brain fog / exacerbated MS in many form  - Gait - balance
Pt bobbed her head while seated, appearing to briefly pass out during the 15 minute monitoring period after receiving a dose of moderna covid-19 vaccine.  Pt remained upright sitting in chair and did not fall.  Pt was given juice and water, and offered to call 911 several times; pt refused each time.  Pt was told to remain under observation for 30 minutes instead of 15. After 30 minutes pt stated she felt better, still did not want us to call an ambulance and left the store.  Although on the VAR form pt indicated that she has never had a reaction after receiving a vaccination, the pt later told technician that she had a similar reaction after getting a HPV vaccine. today's event has been reported through the VAERS system.  I called pt an hour and a half after, pt states she was doing okay, I encouraged pt to contact her primary care physician with any further questions or concerns.  I also contacted pt's primary care provider listed on VAR sheet, the prescriber's MA said she would reach out to the pt tonight or tomorrow to follow up with the pt.
Pharmacist injected syringe without medication (unknowingly). Re-did vaccine and injected correctly after.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 27-JUN-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 384 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Her aunt just had the Pfizer Covid vaccine but ended up getting the delta variant then died; Her aunt just had the Pfizer Covid vaccine but ended up getting the delta variant then died; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient (aunt) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. The consumer reported her aunt just had the PFIZER covid vaccine but ended up getting the delta variant then died. The patient died on 06Aug2021. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Her aunt just had the Pfizer Covid vaccine but ended up getting the delta variant then died; Her aunt just had the Pfizer Covid vaccine but ended up getting the delta variant then died
Myalgia, Fever, NauseaVomiting, Chills Narrative:  Other Relevant History:
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (21May2022) Negative, notes: Negative test on 21May; (26May2022) positive, notes: Symptoms came back on 26May and test was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: If vaccine received: yes, other medication in 2 weeks: No. adverse event: Negative test on 21May. Symptoms came back on 26May and test was positive. Known allergies: No, Other medical history: No.
Diarrhea; Vomiting; Headache; Body aches; Slept all day; Pain when breathing; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 02May2021 at 08:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, allergy to sulphate drugs and eggs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control medications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 11Apr2021 at 13:15 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. On 03May2021, at 05:00, the patient experienced diarrhea, vomiting, headache, body aches, slept all day and pain when breathing. The events did not result in doctor or other healthcare professional office/clinic visit, 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 diarrhea, vomiting, headache, body aches, slept all day and pain when breathing was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.