chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at injection site; Fatigue; Muscle aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site), FATIGUE (Fatigue), MYALGIA (Muscle aches) and PYREXIA (Fever) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included Allergy (No known allergy).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site), FATIGUE (Fatigue), MYALGIA (Muscle aches) and PYREXIA (Fever). On 09-Apr-2021, VACCINATION SITE PAIN (Pain at injection site), FATIGUE (Fatigue), MYALGIA (Muscle aches) and PYREXIA (Fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported. Concomitant product use was not provided by the reporter.
Within 1 hour of receiving my first shot a 1/3 inch red/purple line appeared on my life arm from above the sight of the shot continuing down to my wrist.  Within 3 hours I started to feel discomfort in my wrists and knuckles, like what I imagined arthritis would feel like.  That discomfort increased to pain and spread to my elbows and shoulders.  Over the next 8 months the pain increased until it was disabling. Eventually I was diagnosed with Reactive Arthritis, by a Rheumatologist.  In Addition over the year my loss of energy has increase until now I have very little.  I also have Brain Fog and Memory loss.
I started feeling very tired and not wanting to do anything, I started having pains in my joints and under my arm. I noticed I had a lump underneath my left armpit. It was painful. I called my doctor and they told me to start icing it, that was on 11/07/21. It's still there, not as painful but hasn't gone away completely. The doctor said it could take 2 weeks.
A report was recieved from a health professional on 11/02/2001, concerning a 55 year old female patient who developed an intolerance to eggs, after receiving the Fluvirin vaccine on an unknown date in 1999 and 2000. On an unknown date in 1999, the patient developed an intolerance to eggs, after receiving the Fluvirin vaccine. The patient experienced a similar reaction after receiving the Fluvirin on an unknown date in 2000. At the time of report, the patient had not recovered. There was insufficient information to determine the reporter's causality assessment.
Moderna COVID-19 Vaccine EUA-  Received vaccine on 12-30-20, 10:30 AM. Woke up on 12-31-20, at approximately 2:30 AM,  with cold chills, headache, and muscle/joint aches. The symptoms lasted until 01-01-21, at approximately 9:30 AM. The headache persisted longer than the other symptoms.
autoimmune injury/Systemic lupus erythematosus (SLE); Celiac Disease; Postural Orthostatic Tachycardia Syndrome (POTS); Chronic Fatigue Syndrome (CFS); Small Fiber Neuropathy; Information has been received on 25-JUL-2023 from a lawyer regarding a case in litigation, concerning an adolescent female patient (pt). Her medical history, concurrent conditions and concomitant medications were not reported. Pt's mother agreed to her daughter receiving Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) after being exposed to marketing that the vaccine is very safe, it prevents cancer, and that teenagers must get it. Prior to receiving her vacciantions, pt had no autoimmune, autonomic, or neurological issues. She enjoyed playing the piano, dancing and running cross country. She was identified as a gifted student and was in good health. On 30-AUG-2011, when the pt was 13 years old, she received her first dosage of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, units, route of administration, anatomical location, lot#, and expiration date were not reported), which was touted as a safe and effective vaccine for preventing cervical cancer. Soon after vaccination, pt began to show symptoms that were eventually diagnosed as symptoms of postural orthostatic tachycardia ayndrome (POTS), chronic fatigue syndrome (CFS), small fiber neuropathy (SFN), and celiac disease. On 22-NOV-2011, pt received her second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, units, route of administration, anatomical location, lot#, and expiration date were not reported) and shortly thereafter her symptoms significantly worsened. As a result of her post-GARDASIL symptoms, pt has been unable to engage in normal activities that a normal young person would enjoy. Based upon her chronic and severe post-GARDASIL symptoms, pt has been diagnosed with various medical conditions, including but not limited to, POTS, CFS, SFN, and celiac disease. Pt's GARDASIL injections caused her to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to systemic lupus erythematosus (SLE), as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by GARDASIL or otherwise linked to her GARDASIL-induced autoimmune disorder. At the reporting time, the pt has not recovered from all the events. All the events were considered to be related to GARDASIL.  Upon internal review, the events of SLE and celiac disease were considered to be medically significant. Additionally, all the events were considered to be disabling.
Nasal Congestion; Runny nose; took the vaccine back in February and I have covid; Shortness of breath; cough; Loss of smell; Muscle aches; headache; nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (took the vaccine back in February and I have covid), DYSPNOEA (Shortness of breath), COUGH (cough), NASAL CONGESTION (Nasal Congestion) and RHINORRHOEA (Runny nose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID symptoms.) on 28-Jun-2021. Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (took the vaccine back in February and I have covid), DYSPNOEA (Shortness of breath), COUGH (cough), NASAL CONGESTION (Nasal Congestion), RHINORRHOEA (Runny nose), ANOSMIA (Loss of smell), MYALGIA (Muscle aches), HEADACHE (headache), NAUSEA (nausea) and VOMITING (Vomiting). At the time of the report, COVID-19 (took the vaccine back in February and I have covid), DYSPNOEA (Shortness of breath), COUGH (cough), NASAL CONGESTION (Nasal Congestion), RHINORRHOEA (Runny nose), ANOSMIA (Loss of smell), MYALGIA (Muscle aches), HEADACHE (headache), NAUSEA (nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment  medications includes :-Vitamin A, C and D,Ginger and Zinc,Inhaler   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Medical history, lab data, Treatment medication and New events added
Headache, Myalgia, left neck & ear pain, nausea Narrative:  Other Relevant History:
.3After receiving the vaccine, being monitored for 15 minutes the patient returned home.  At approximately 1530  she called clinic concerned  about a  rash, redness and itching on left arm.  On arrival to the clinic she was found to have erythematous macules on her upper inner arm staring to extend down her left arm.  She also had a large red macule on upper inner right arm and some small areas under her eyes, all that were itchy.   There was no throat swelling, wheezing, SOB or chest pain.   She was given 60 mg of prednisone and 50 mg of diphenhydramine orally and observed for 30 minutes.  Her rash intensity reduced and the itching stopped.  Advised she should not receive second dose of vaccine
AT SITE OF VARICELLA VACCINATION, DEVELOPED LOCALIZED REACTION AT SITE FOR 3 DAYS, THEN RESOLVED, THEN 13 DAYS LATER DEVELOPED ERYTHEMA NODOSUM DIFFUSELY ON BOTH LEGS.  NO OTHER PRECIPITATING EVENT IDENTIFIED. OTHERWISE HEALTHY.
Vaccine administered in the dorsogluteal.  24 hours following administration developed red rash of the upper body. No pain or itching, no raised, blistered or textured areas.  On day 5 following vaccination patient reports rash is unchanged.
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: pt was given booster dose 7 pm on 1-26-22 in left arm, called thursday morning the pharmacy complaining that she was in severe pain all night and is having trouble lifting her arm.
Patient post vaccine (2min) started to fall over, felt faint, staff lowered him to the ground. Patient reported not eating anything this morning, only had coffee, and minimal sleep. As he woke up he was jerky/combative and then presented normal. EMS called and assessed him/ declined further services, had juice and snack and left. Encouraged him to go in to see his provider.
Patient recieved two vaccines Flucelvax and Comirnaty (one in each arm) was sat down and waited 10 minutes before getting up, got up and fainted and fell and hit there head. Patient did report that they have had nausea/ trouble with vaccines in the past. They were checked out by paramedics and released without further care needed.
Patient developed and itchy rash beginning on the bottom of her feet and spread to arms and face. The rash resolved on it's own in an hour.
Blood in stool; Stomach Pain; Blood in Urine; Uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stool), ABDOMINAL PAIN UPPER (Stomach Pain) and BLOOD URINE PRESENT (Blood in Urine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) 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 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced HAEMATOCHEZIA (Blood in stool) (seriousness criterion intervention required), ABDOMINAL PAIN UPPER (Stomach Pain) (seriousness criterion intervention required), BLOOD URINE PRESENT (Blood in Urine) (seriousness criterion intervention required) and DISCOMFORT (Uncomfortable). At the time of the report, HAEMATOCHEZIA (Blood in stool), BLOOD URINE PRESENT (Blood in Urine) and DISCOMFORT (Uncomfortable) outcome was unknown and ABDOMINAL PAIN UPPER (Stomach Pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not reported.  Patient went to ER and was treated there on 01Apr2021.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Hypertension, possibly associated with orthostasis and lack of sleep. At 11:45, patient reported dizziness when standing after receiving the vaccine. Manual BP of 160/100. Atypical pulse of 128 BPM. Patient was reseated and monitored, PCP was called.
FELT LIGHT HEADED; SHAKING; HAD A BUNCH OF CHILLS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced felt light headed. On 2021, the subject experienced shaking. On 2021, the subject experienced had a bunch of chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt light headed on 2021, and the outcome of had a bunch of chills and shaking was not reported. This report was non-serious.
Syncopal episode following vaccination -was seated and states she felt tingly, dizzy and vision changes and then had brief LOC witnessed by mother and MA staff. She then immediately needed to use the bathroom to have bowel movement and felt nauseous and was pale. She was then seen by the provider in the bathroom appeared pale and advised to take deep breaths, she then went to exam room and layed down and improved. BS and hgb were tested and normal. She noted she only had caffeine/coffee in AM. Episode c/w vasovagal syncope, verbal educ provided, drink fluids and f/u prn. Pt was baseline at time of d/c.
After patient received this vaccine dose, it was discovered that the vial had been stored outside of the recommended temperature range calling into question its efficacy  After conferring with immunization experts it was determined that this dose needs to be repeated.  Patient was contacted by the person completing this form and made aware of this information.  The patient plans to repeat vaccine on 4/26/21 or 4/27/21.
blood coming out of sinuses; still getting blood out of nose; everything tastes salty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient in his 60's received bnt162b2 (BNT162B2), administered in arm, administration date 20Jan2022 11:45 (Lot number: FD0810) at the age of 7 decade as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "ex-tobacco user" (unspecified if ongoing), notes: I've quit smoking late it now. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Time (24hr): 9:00 AM, Anatomical Site of injection: Shoulder, Batch/Lot number: ER8734), administration date: 20Mar2021, for COVID-19 immunization, reaction(s): "I got covid", "sinus infection", "hard time breathing"; Bnt162b2 (Dose: 2nd, Time (24hr): 11:00 AM, Anatomical Site of injection: Shoulder, Batch/Lot number: EW0153), administration date: 20Apr2021, for COVID-19 immunization, reaction(s): "I got covid", "sinus infection", "hard time breathing".  The following information was reported: PARANASAL SINUS HAEMORRHAGE (non-serious), outcome "not recovered", described as "blood coming out of sinuses"; EPISTAXIS (non-serious), outcome "not recovered", described as "still getting blood out of nose"; DYSGEUSIA (non-serious), outcome "unknown", described as "everything tastes salty".  Additional Information: Patient age at time of vaccination was reported as 60 and 61 years. Booster dose administered due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Patient did not receive prior vaccinations with four weeks. There are no family history relevant to the adverse events. There are no relevant tests or specific relevant test for thromboembolic events with thrombocytopenia. Eight months after the second dose, four days from getting the booster, patient got covid, probably omicron and sinus infection on top of it. Patient has very hard time breathing for first 3 days. Patient thought he was going to have a heart attack. Thirty days later and after getting the booster, patient is till getting blood out of nose and sinuses stuff the size of quarters, looking like blood clots everything tastes salty. Only good thing is patient quite smoking late it now. Patient is worried about Blood coming out of sinuses reminds him of distemper his dog died of years ago. Patient is also somewhat familiar w/mRNA and crisper.  No follow-up attempts are possible. No further information is expected.
A non-serious spontaneous report of gave expired FLUMIST to an 11-year old was received from a Nurse Manager concerning a 11-year-old male. The patient's medical history and concomitant medications were not available. On 29-Dec-2008, the patient received expired FLUMIST (expiration date 24-Dec-2008) at an immunization clinic. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 07-Jan-2009 that no delayed adverse events resulted from this error. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
6AUG98 3PM temp low grade by 7PM T102 tympanic;advil given by 7AUG98 T99;1PM 7AUG98 T inc;had sz 255PM;taken by care to ER;child stopped breathing on way to ER;mom did mouth to mouth was bagged in ER;adm to ped ICU;
hard swelling occurred @ site immed; pt returned to work, called husband 15-20 mins later c/o redness, swelling, itching; husband advised DPH, ice arm;p/ 1 hr,sxs cont,felt hot,neck/chest red;to clinic,tx w/ dph;
I got a second period (prior to my standard 29 days) shortly after the first one. It occurred a week after my normal period, and a few days after the second shot. I have had non-stop vaginal bleeding/spotting for almost three weeks. It?s has not subsided yet.
feels like a ball in her throat; Chest is very tight; Stomach pain; Weird pain deep in ear through the core of her crown of her head like electricity; Had a hard time breathing; Very itchy; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Had a hard time breathing), PRURITUS (Very itchy), ABDOMINAL PAIN UPPER (Stomach pain), EAR PAIN (Weird pain deep in ear through the core of her crown of her head like electricity) and OROPHARYNGEAL DISCOMFORT (feels like a ball in her throat) in a 38-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.     Concurrent medical conditions included Asthma.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DYSPNOEA (Had a hard time breathing) and PRURITUS (Very itchy). On 09-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and EAR PAIN (Weird pain deep in ear through the core of her crown of her head like electricity). On 12-Mar-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (feels like a ball in her throat) and CHEST DISCOMFORT (Chest is very tight). On 09-Mar-2021, PRURITUS (Very itchy) had resolved. On 11-Mar-2021, ABDOMINAL PAIN UPPER (Stomach pain) and EAR PAIN (Weird pain deep in ear through the core of her crown of her head like electricity) had resolved. At the time of the report, DYSPNOEA (Had a hard time breathing), OROPHARYNGEAL DISCOMFORT (feels like a ball in her throat) and CHEST DISCOMFORT (Chest is very tight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided aside from asthma inhaler.  Treatment of events as reported by patient included use of asthma Inhaler.
My autoimmune condition has been in remission for 3+ years and has flared up severely about a week after my 2nd shot. No other changes in diet work home or medication just the vaccine.   Pemphigoid causes the mucosal membranes in my body to peel currently effecting my mouth sinuses and throat
CHILLS; FELT RUN DOWN; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced chills. On 2021, the subject experienced felt run down. On 2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The patient recovered from chills, felt run down, and fever on 2021. This report was non-serious.
Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L027733 with exp 13-SEP-2017, lot# L048236 with exp 31-MAR-2018, lot# L039660 with exp 04-FEB-2018, dose, frequency and route were not reported). These vaccines were stored in temperature of 34.5 F, some doses had been out of range for 7 days when administered to patients while other doses had been out of range for 30 days when administered to patients (it could not be determined which of the provided lot numbers were out of range for 7 days vs. 30 days). There was no previous temperature excursion. No symptoms were reported. Additional information has been requested.
ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a consumer concerned a 63 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious.
Pt passed out when leaving facility. Was assisted back to exam room, given water and sugar source. MD discussed with mom vasovagal syncope process. Pt left facility walking with mom and sibling.
-Black out/loss of vision 8 hours after vaccine -Dizziness, lightheaded, chills, vertigo, loss of energy, loss of balance, slight head pressure -All the above symptoms have been continuous everyday since day of vaccination
Myalgia & fever Narrative: dose 1: Sore arm at site of injection only dose 2: sore arm/swelling day 1-3; day 1- fatigue/chills; day 2- fever, aches, fatigue; day 3-aches, fatigue; day 4- aches