chrisvoncsefalvay/vaers-outcomes huggingface dataset:
More Inflamed all over the body; Arms Hurt from Shoulder to Elbow; Soreness on the injection site (left arm); This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (More Inflamed all over the body), MYALGIA (Arms Hurt from Shoulder to Elbow) and VACCINATION SITE PAIN (Soreness on the injection site (left arm)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis, Seasonal allergy, Pain and Acid reflux (oesophageal) (Stomach acid reflux). Concomitant products included GABAPENTIN for Pain, ADALIMUMAB (HUMIRA) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced INFLAMMATION (More Inflamed all over the body) and MYALGIA (Arms Hurt from Shoulder to Elbow). 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness on the injection site (left arm)). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency; FAMOTIDINE (FAMOTIDIN) ongoing since an unknown date for Acid reflux (esophageal), at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) at an unspecified dose and frequency. At the time of the report, INFLAMMATION (More Inflamed all over the body) and VACCINATION SITE PAIN (Soreness on the injection site (left arm)) outcome was unknown and MYALGIA (Arms Hurt from Shoulder to Elbow) had resolved with sequelae.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-242466 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received contains no newinformation. On 30-Jun-2021: Significant follow up received: treatment drugs were updated, events were updated.   No treatment information was reported.; 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. Additionally, concurrent Arthritis in this patient may have been a contributory factor. Additional information is requested.
Pt. had about 30 second seizure with arms bent, hands clenched, eyes rolled back, that started approx. 1 minute after vaccine was given. Father states he had same reaction 1/18/14 with first Hep B given. Prior to vaccine pt Father only stated pt "passed out last time". But after further discussion - symptoms were the same.
Vaccine was used after BUD. patient was monitored for 15 min, nothing out of the ordinary was observed.
Dramatic and sudden change to menstrual cycle. I have been diagnosed with menopause per blood test measure of my estradiol and FSH. There were no indications of the onset of menopause prior to the vaccine. My 45 yo sister also experienced sudden onset menopause immediately following her first COVID-19 vaccine. Our mother did not experience menopause until having a hysterectomy at age 54. My average cycle was 24 days long with a standard deviation of 4 days for the year and a half prior to the immunization. My cycle after receiving the immunization was an average of 35 days with a standard deviation of 16 days. As of February 18, 2022, I have begun HRT in an attempt to minimize the numerous negative impacts of early and sudden menopause.
charlie horse in both calves; pain was ' out of control'; 'calf muscles felt like it was going to explode'; urinating all night non stop; This is a spontaneous report from a non-contactable consumer or other non HCP (patient).  A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on 24Feb2021 (Age at vaccination was 67 years) as dose 1, single for covid-19 immunisation. Medical history included drug hypersensitivity (Penicillin allergy) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. After received first dose of Pfizer COVID vaccine yesterday on 24Feb2021 and later in the evening patient experienced Charlie horse in both calves. Patient also experienced pain which was out of control and his calf muscles felt like it was going to explode. The patient had pain for 2 hours. Also reports he has been urinating all night non-stop despite not drinking anything. He was continuing to urinate every 15 minutes. States he had never experienced anything like this and there was nothing wrong with his prostate. Patient notified his health care professional (HCP) and was told that if he continues to urinate like that he may have to see a urologist urgently. It was also reported that patient won't take the second dose because of this (his reaction to the vaccine-captured in first request), he feels like the vaccine was not safe. Reports that his HCP said he don't know what the hell was in the vaccines and until we know he don't think it's safe to take. On an unspecified date the patient underwent lab tests and procedures which included urine output with result urinating all night non-stop, Also reports he had urinating all night non-stop despite not drinking anything. He was continuing to urinate every 15 mins. The patient received Advil as therapeutic measure for Charley horse, pain, Calf discomfort. On an unspecified date in 2021 patient was recovered from pain and outcome of rest of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever of 100 degrees; headache; soreness/sensitivity to touch on arm at site of injection/sensitivity at injection site; soreness/sensitivity to touch on arm at site of injection/sensitivity at injection site; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EP6955, Expiration date was not reported), via intramuscular in arm left on 24Mar2021 at 11:00 AM (at the age of 46-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history was reported as none. Allergies to medications, food, or other products was reported as no. The patient's concomitant medications received within 2 weeks of vaccination included ongoing spironolactone, 1x/day (150mg/day, 15+ years ago), from an unspecified date in Mar2021, taken for acne. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3247, Expiration date was not reported), via intramuscular in arm left on 04Mar2021 at 11:45 AM (at the age of 46-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. On 24Mar2021 at 23:00, the patient experienced fever of 100 degrees, headache, soreness/sensitivity to touch on arm at site of injection/sensitivity at injection site. All developed overnight after receiving second dose in the late morning. The symptoms developed 12 hours after 2nd dose. They were pretty steady during the next 18 hours with little variation in fever, severity of headache, etc and then all symptoms suddenly stopped at 05:00 pm the following day (on 25Mar2021). The reporter considered the seriousness of the events as non-serious. Treatment was not received for the events. On 03Feb2021, the patient underwent lab tests and procedures which included COVID-19 test, resulted as negative and body temperature, resulted as 100 Centigrade, fever of 100 degrees on 24Mar2021. The outcome of the events was recovered on 25Mar2021 at 17:00.  No follow-up attempts are needed. No further information expected.
PREVNAR 13 vaccine given in (R) thigh 9/7/10. Mom noticed redness and warmth at site on 9/8/10. Today in office erythema & warmth measured 3" X 2" slightly tender to touch. Started on abx. Afebrile. No limping.
Red, prickly rash appeared all over tops of thighs, tops of hands and on ankles. Extremely uncomfortable, burning and itchy sensation.
5cm round  lump under where the injection occured.  the area is hot, irritated and hard.
I had no AE to the vaccine, but on 8/6/2021 I developed a severe nonstop headache, my eyes begin to itch and diarrhea came. The next day I developed a fever and my eyes itched even more.  Lost my sense of taste and d/t the symptoms not going away on 8/9 I went to the Urgent Care where a COVID-19 test was performed and I was positive. I quarantined at home, but after about 2 or 3 days I began getting worse and developed SOB so on 8/19 I went to the Hospital and was referred to a Cardiologist. EKG, EEG, 2 CT scans and chest X-rays were performed. IV fluids were given for hydration and after a few hours I was released. Still to date I am experiencing the headaches, still a little lethargic and still haven't regained my strength but I push through as best I can daily. 8/23 I saw the Cardiologist who prescribed a heart medication d/t my heart pounding so hard. I am since off of it but I had to take that for about 3 weeks to stop the heart palpations.
Within 8 hours of the shot experienced: full-body muscle aches.  Full body joint pain to the point that I couldn?t move. My body felt like it was on fire. Stomach ache, severe headache.  This pain lasted around 14 hours. After that, the joint/muscle pain lingered for about 3 days. The headache for about 3 days.  I felt and still feel weak, and have a fuzzy head.  My sense of smell and taste still hasn?t fully recovered. I feel fatigue from Covid-19 since I had it in December and this vaccine seemed to make me feel worse all over again.
Information has been received from a physician concerning a patient who was vaccinated with a dose of VARIVAX. On approximately 27-AUG-2007 the patient experienced a bad allergic reaction to the vaccination and was hospitalized. The patient was administered EPINEPHRINE. At the time of the report the patient's status was unknown. No further information is available.
Information has been received from a Nurse Practitioner referring to a 58 year old female patient. Information about concomitant medication, pertinent medical history or drug reactions/allergies was unknown. On an unknown date in 2014 (reported as 2 years ago) the patient was vaccinated with a 0.65ml dose of ZOSTAVAX (lot#, expiration date and route unknown) for prophylaxis. The Nurse Practitioner stated that the patient started a "methylprednisolone (MEDROL) Dose Pack" for unknown reasons, one day after the injection. No side effects reported. The outcome of the event was unknown. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. On 19-AUG-2013 the patient was vaccinated with a dose of M-M-R II (Lot # H017435, exp date 20-SEP-2013), subcutaneous, that was improperly stored, was exposed to 9 degrees C for 24 hours on 16-AUG-2013 and 9 degrees C for 24 hours on 19-AUG-2013. Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
Information has been received from a physician concerning a 17 month old male with allergies to soy milk, egg white, wheat and ZANTAC who on 15-NOV-2004 was vaccinated with the first dose of VARIVAX (Merck) (lot # not reported). On 10-FEB-2005, the patient was vaccinated with the first dose of MMR II (lot # not reported). The patient also received  PREVNAR on 10-FEB-2005. On 06-APR-2005 the patient was diagnosed with idiopathic thrombocytopenic purpura and was hospitalized. The patient was treated with intravenous gammaglobulin. Subsequently, the patient recovered from idiopathic thrombocytopenic purpura and was discharged from the hospital. The reporter considered idiopathic thrombocytopenic purpura to be immediately life-threatening, disabling and an other important medical event. In follow-up the physician reported the patient never had a reaction to VARIVAX (Merck). He was inquiring whether there was any problem with VARIVAX (Merck) and reports of idiopathic thrombocytopenic purpura. Additional information is not expected.
Stick/sore neck; Stick/sore neck; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 15Mar2021 at 12:30 (at the age of 40-years-old) as a single dose and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 05Apr2021 at 11:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. 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. Concomitant medications included zinc (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN), colecalciferol (VIT D), ascorbic acid (VIT C) and probiotics (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On an unknown date in 2021, the patient experienced stick/sore neck after the first shot and it went away, and then a stick/sore neck after the second shot that the patient still had at the time of reporting. It got much worse with alcohol consumption. 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 stick/sore neck was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient came in 2 days after vaccination and shows arm to the pharmacist on duty, which redness and swallowing was observed. Patient was asked to go to urgent care in the vicinity to be checked. She was given Cephalexin 500 Mg , 1 capsule three times a day for 10 days, with dx Cellulitis.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. Between 29-APR-2015 and 17-AUG-2015, the patients were vaccinated with the improperly stored doses of PROQUAD (Merck) (lot # reported as L005294 with expiration date 17-AUG-2016 and lot # L010142 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Mom states that child "broke out" with a rash (small, red bumps over entire body). She took the infant to ER and was told it was due to immunizations. She was cautioned by the ER physician to have no further immunizations. She was told she might need to skin tests. No medicines in ER. Mom was instructed by ER physician to use Caladryl lotion.
This case was reported by a nurse via sales rep and described the occurrence of rash in a male patient who received INFANRIX for prophylaxis. On 30th October 2017, the patient received INFANRIX. On an unknown date, unknown after receiving INFANRIX, the patient experienced rash, injection site lump and injection site warmth. On an unknown date, the outcome of the rash, injection site lump and injection site warmth were unknown. It was unknown if the reporter considered the rash, injection site lump and injection site warmth to be related to INFANRIX. Additional details were reported as follows: The patient experienced a golf ball size knot at injection site, hot to touch and rash all over his thigh, front and back, which did not go below the knee. No intervention was required, a pediatrician saw it and said it was normal. The reporter agreed to follow up with GlaxoSmithKline.
headache, dizzy, muscle aches, disorientated, feel drunk, difficulty concentrating
3/4: Axillary rash 3/11: Prescribed oral fluconazole for "yeast infection" - itching and swelling in groin 3/20: Initiated Pred taper: 60mg x 4 days, then taper by 10mg every 2 days, currently on Pred 10mg daily. Initially had improvement of rash, now recurring. 3/30: Moderna vaccine #2 4/1: initial evaluation by dermatology in emergency department. Prednisone taper 40mg x3 days, 20mg x3 days, 10mgx3 days then off
This spontaneous report was received from a registered nurse refers to five unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL inj (lot # K004205 expiration date 12-JAN-2017 and lot# K006960 expiration date 19-FEB-2017) (dose and route were not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided.  In 2013, the patient was inoculated with ZOSTAVAX by a physician at a healthcare facility for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 20-NOV-2015, the patient was treated by the physician, at the healthcare facility, for a vesicular outbreak, which was diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Itchy rash around the injection site, red and swollen around injection site about the size of a large orange, sore and hard to touch. I did not treat it or go to the doctor, it gradually started getting better. Still have slight reaction as of today, 02/25/2021.
Doses administered beyond expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered beyond expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered beyond expiration date). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered beyond expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  All 4 were second doses and/or third ones. No first doses. The vials were expired while being stored in the freezer. It was unknown if the vial undergo any temperature excursions.
patient had Covid 19 vaccine from Pfizer with lot #EJ1686 with expiration date 3/2021 on 1/7/2021 and after 45 minutes, she came back and stated she has chest tightness, lip swelling, chest congestion,  shortness of breath, asthma-like symptoms with mucus type in her chest. her BP at that time was 184/109. She was given 1 EpiPen and 2 Benadryl 25mg tablets.
Initial report was received from a healthcare professional on 20 December 2012. A three-year-old female patient had received an intramuscular injection of Act-Hib, lot number UF880AB on 10 August 2010. The patient was admitted to the hospital on 09 December 2012, and diagnosed with a culture showing positive Haemophilus B. It was unknown if the patient had any illness at the time of vaccination or past medical history. Previous vaccines included PENTACEL, lot number C3387AA on 03 August 2009, 09 September 2009 and 05 November 2009. Outcome was not reported. Documents held by sender: None.
After 2nd vaccine the next evening had Body aches low grade fever. That was a Sunday I started feeling aches and short of breath from that point on. Mostly when I moved around I couldn?t breathe. Couldn?t walk up stairs without resting on each step. Went to urgent care where oxygen was 80 something percent. Took covid test it came back negative. Lung X-ray looked like I had pneumonia or something . Urgent care told me I had to go to the emergency room. Went to the emergency room and was admitted for two days from June 3 until the fifth. They wanted me to stay an extra day but I had to work so I left. They said it was bacterial pneumonia, but there nobody was for sure. While there I developed blood clotting under my left eye and I started urinating blood as well. I was putOn a lot of antibiotics and steroids while I was there and when I went home.
adverse effect; Knot in the arm; vaccination site erythema; vaccination site rash; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse effect), MASS (Knot in the arm), VACCINATION SITE ERYTHEMA (vaccination site erythema) and VACCINATION SITE RASH (vaccination site rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On an unknown date, the patient experienced ADVERSE REACTION (adverse effect), MASS (Knot in the arm), VACCINATION SITE ERYTHEMA (vaccination site erythema) and VACCINATION SITE RASH (vaccination site rash).   At the time of the report, ADVERSE REACTION (adverse effect), MASS (Knot in the arm), VACCINATION SITE ERYTHEMA (vaccination site erythema) and VACCINATION SITE RASH (vaccination site rash) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: New adverse event "knot in the arm" and "red rash around the injection site" are added.