chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Typical Fever; Headache; Body aches; spotting; had constipation; This is a spontaneous report from a contactable pharmacist, the patient. A 30-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264), dose 2 via an unspecified route of administration, administered in Arm Left on 26Feb2021 15:00 (at the age of 30-years-old) as a single dose for covid-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 17:00 (at the age of 30-years-old) as a single dose for covid-19 immunization. Medical history included orthostatic hypotension, postural orthostatic tachycardia syndrome, pneumothorax spontaneous, irritable bowel syndrome. The patient had known allergies with hydrocodone, codeine, latex, triptans, adhesives. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) in two weeks included propranolol, folic acid, prenatal vitamins, omeprazole. On 26Feb2021, she had constipation the day of and day after. On 28Feb2021 11:00, the patient experienced along with the typical fever, headache, and body aches on the day after, had some spotting about 36 hours post-vaccination. My menstrual cycle had ended 4 days prior, so she know it wasn't part of her cycle. It never showed up on a panty liner, it was only when she wiped. Occurred after urination twice within 5 hours. The patient did not receive any treatment. Outcome of the event was recovered, at the time of this report. No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacist concerning his 8 year old granddaughter with no pertinent medical history who was vaccinated with a dose of Varivax (lot # not provided). On 27 Mar 2006 the patient developed 12-24, itchy, bite-like lesions on her neck and torso. No other symptoms were noted. The patient outcome was reported as recovering. There was no product complaint involved. Additional information has been requested.
Cough, fever , sneezing,  nose congestion,  chills, body ache. High blood pressure.
Patient had redness and pain. Vomited liquid once on 8/30. No fever, chills or decreased appetite.
Fever 101.5 oral; Nausea; Myalgias; Chills.
ball in breast doesn't hurt unless it is pressed; felt a ball in right breast; ball hurt; a little ball in left armpit; After two days ball was bigger and after two more days it was gone; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (a little ball in left armpit), SWELLING (After two days ball was bigger and after two more days it was gone), BREAST MASS (felt a ball in right breast), BREAST PAIN (ball in breast doesn't hurt unless it is pressed) and AXILLARY PAIN (ball hurt) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced AXILLARY MASS (a little ball in left armpit), SWELLING (After two days ball was bigger and after two more days it was gone) and AXILLARY PAIN (ball hurt). On 16-May-2021, the patient experienced BREAST MASS (felt a ball in right breast). On an unknown date, the patient experienced BREAST PAIN (ball in breast doesn't hurt unless it is pressed). On 14-May-2021, AXILLARY MASS (a little ball in left armpit), SWELLING (After two days ball was bigger and after two more days it was gone) and AXILLARY PAIN (ball hurt) had resolved. At the time of the report, BREAST MASS (felt a ball in right breast) and BREAST PAIN (ball in breast doesn't hurt unless it is pressed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by reporter. Treatment information not reported.
9/20/03 T 101.4 for 2 days. Rash on abdomen, back.
Swelling with edema and tenderness at right deltoid.  Pustules present.  No fever noted for past two days per mother.  BENADRYL ordered for inflammation and MOTRIN ordered for pain control.
At 6 days after my second COVID-19 Pfizer vaccine (first dose given 12/17/20), I had acute onset of chest pain and shortness of breath prompting a trip to the Emergency Department.  A chest CT Angio to rule out pulmonary embolus was done and negative for pulmonary embolus. My EKG showed some mild ST changes and a troponin I level was elevated at 0.08 (normal 0.04). Subsequent troponin levels 90 minutes apart showed a rising troponin at 0.18 and 0.38. An echocardiogram was performed which showed regional wall motion abnormalities consistent with Takotsubo cardiomyopathy and an ejection fraction of 45%. I was then taken to cardiac catheterization lab for coronary angiograms which were normal. My LV angiogram was consistent with Takotsubo cardiomyopathy and my LVEDP was elevated. I was started on a beta blocker and sent home the following day.
Fever, nausea, headache, bodyaches, tiredness, lack of sleep, cough, nasal stuffyness, sore throat
is early in her first trimester of pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (is early in her first trimester of pregnancy) 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) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (is early in her first trimester of pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (is early in her first trimester of pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
currently 5 weeks pregnant; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (currently 5 weeks pregnant) 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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 26-Dec-2020 and the estimated date of delivery was 06-Oct-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (currently 5 weeks pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  first week of the pregnancy.  On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (currently 5 weeks pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MATERNAL EXPOSURE DURING PREGNANCY (currently 5 weeks pregnant) to be not related.    It was reported that the patient is getting their second dose of the vaccine on 2Feb2021. Patient is calling to sign up for the registry. No concomitant information was reported. No treatment information was reported.
About an hour after the shot, I felt a single wave of light dizziness that quickly passed, then I felt some swelling in my throat. The swelling did not interfere with my breathing, but it did feel difficult to swallow. This swelling has continued off and on for the past 3 weeks. I have had to take multiple doses of Benadryl to keep it under control and I am still having to take Benadryl. I will be making an appointment to see a doctor.
The pt experienced cellulitis to the right deltoid with redness, induration and warmth to the touch. It was initially treated with ice, ibuprofen and Benadryl. Keflex was prescribed but never given. By 12/31/00 the pt's symptoms had resolved.
Extremely painful arm, 1 day later diarrhea started which continued, notified Dr.  2nd-3rd day constant cough, talked to Dr. about it. Dr. sent me to the emergency ward on Feb. 11th.   I was hospitalized with COVID from Feb. 11th - 17th.  It has taken about 8-9 weeks for me to recover .  I have just gone & gotten my second shot on 4/13/21.  So far, I have is a sore arm.
RESLTESSNESS IN ALL OVER BODY; TREMORS  ALL OVER THE BODY; SHOOTING PAIN  IN LEGS; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included car accident, surgery for disk infusion c 4 5 6 7, left foot surgery for neurological issue, and right foot surgery for neurological issue, and other pre-existing medical conditions included on an unknown date in feb-2021, after surgery, left arm started to lose muscle tone, muscles started to get smaller and weaker and on left hand he felt tremors and weakness.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027 expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced resltessness in all over body. On 09-JUN-2021, the subject experienced tremors all over the body. On 09-JUN-2021, the subject experienced shooting pain in legs. Laboratory data (dates unspecified) included: Blood test (NR: not provided) No Parkinson, no other disease, and EEG (NR: not provided) No Parkinson, no other disease. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the resltessness in all over body, tremors all over the body and shooting pain in legs was not reported. This report was non-serious.
Complained of Shortness of breath, difficulty breathing, tingling hands, dizziness. Epi Pen x1 given. ems called.
Client report receiving second COVID vaccine on 03/22/21 at 1100.  After first vaccine on 03/02/21, she had hives that went away quickly.  After second vaccine, client had a lump at site the size of a "half dollar" and very sore at injection site.  On 03/24/21 noticed raised red, itchy rash on left arm, stomach and legs.  Not seen by medical provider, treated at home with Benadryl, Zyrtec (during the day), Aleve and hydrocortisione on legs.  Rash has improved today (03/26/21).
I got fever; runny nose; felt bad; cough and still have symptoms and Started on Paxlovid.
5 patients administered double the dose (1mL); 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 ACCIDENTAL OVERDOSE (5 patients administered double the dose (1mL)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced ACCIDENTAL OVERDOSE (5 patients administered double the dose (1mL)). At the time of the report, ACCIDENTAL OVERDOSE (5 patients administered double the dose (1mL)) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
some chills; light headedness; feeling out of it; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headedness), FEELING ABNORMAL (feeling out of it), FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (some chills) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced DIZZINESS (light headedness), FEELING ABNORMAL (feeling out of it), FATIGUE (fatigue) and NAUSEA (nausea). On an unknown date, the patient experienced CHILLS (some chills). On 04-May-2021, DIZZINESS (light headedness), FEELING ABNORMAL (feeling out of it), FATIGUE (fatigue) and NAUSEA (nausea) had resolved. At the time of the report, CHILLS (some chills) had resolved.            No information on concomitant products were reported. No information on medical history was reported. No information on Treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Event outcome was resolved. On 05-Aug-2021: Significant Follow-up included, Updated reporter information from HCP to consumer, Dose 2 information and events were added.
adverse reaction; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's covid-19 vaccine (mRNA-1273) and experienced adverse reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received unknown dose of mRNA-1273 (lot/batch: Unknown) unknown route and in unknown site of administration for prophylaxis of COVID-19 infection.  On an unspecified date, the patient was experiencing some adverse reaction after taking the vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   Outcome of event, adverse reaction was not reported.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested
The next day after my vaccination I experienced the following symptoms: Nausea, Fatigue, Diarrhea and stomach cramps, Loss of appetite and ended up losing 50 pounds in total, Loss of concentration (not able to do multitasking)  and this went on for a couple of months since my 2nd dose. I went to see my Primary Care doctor and was advised to see a GI doctors and had endoscopy and they found a cyst and pre cancer follicle. I was prescribed with Bentyl for the stomach pain and was also sent to pain management to see if the medical marijuana to help with my appetite. Up to this day 02/11/2022 I have not fully recovered from my symptoms.
7 DAYS AFTER MMR VACCINE, PATIENT SPIKED A FEVER OF 102 AND IT REMAINED HIGH FOR 5 DAYS.   WENT UP TO 104 A FEW TIMES.   KEPT COMFORTABLE WITH MOTRIN.  SHOWED NO OTHER SIGHNS OF COLD/FLU BUT REAL FUSSY AND IRRITABLE.   AFTER FEVER BROKE A RASH APPEARED ALL OVER TRUNK AND ARMS.
Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Intermittent episodes of acute sharp back pain; This is a spontaneous report from a contactable pharmacist reported that a 57-year-old female patient (no pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL1284 and Expiration Date unknown) via Intramuscularly on 30Dec2020 03:00 PM (Left arm) at single dose for covid-19 immunisation.  Medical history includes mild asthma, B-Cell Thymoma (Resected), multiple allergies. Diagnosed allergies included Sulfa drugs-swelling; Celebrex-Itchy; Clindamycin- Unknown reaction; Doxycycline- Sick to stomach; Iodinated radiocontrast dyes- Iodinated radiocontrast dyes cause generalized swelling (takes diphenhydramine prior to contrast use when needed); Keflex- Rash; TDAP Vaccine; Levofloxacin- Unknown Reaction; Penicillin; Prednisolone- Itchy; Septra- Eyes get glossy and lips swell.The concomitant medication was not reported. There is no other vaccines within 4 weeks prior to the COVID vaccine. About 4 Hours after receiving 1st (of 2) doses of Pfizer COVID-19 Vaccine (30Dec2020 30Dec2020 08:00 PM), Patient went to Emergency room (ER) with complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling. Also had intermittent episodes of acute sharp back pain while in ER. Upon arrival in ER, patient received routine precautionary care with peripheral IV placement. She was kept under observation in ER for approximately 5 hours until subjective symptoms resolved. On exam patient did not have objective signs of throat obstruction. Vitals were stable and O2 saturation on Room Air was within normal limits. Patient did not receive any medications, oxygen, fluids, or any interventions other than observation. Once symptoms resolved, patient was discharged from ER in improved condition. The outcome of event was recovered on an unknow date without treatment. There is no covid tested post vaccination.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In approximately 2010 (reported as: on or about 2010), the patient was inoculated with ZOSTAVAX (strength, route, anatomical location, dose, frequency, dose number, lot number and expiration date were not reported), for the permanent prevention and protection against shingles and zoster-related conditions/injuries (prophylaxis). On an unknown date, the patient was diagnosed with shingles (herpes zoster) and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure), and suffered serious physical, emotional, and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering (Emotional distress and pain), extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life (Quality of life decreased); increased risk of premature death, aggravation of pre-existing conditions and activations of laten conditions (condition aggravated), lost wages, loss of earning capacity and other losses and damages. On or about 2014, the patient was treated for shingles. At the time of the report, the outcome of the aforementioned adverse events was unknown, excepting for the events of emotional distress and pain that was reported as not resolved. The relatedness assessment between the aforementioned adverse events and ZOSTAVAX was related. The reporter considered the events as serious for the following reasons: Hospitalization, life-threatening, disability and medical significant.
Narrative:  He reported the following adverse effects after the initial  vaccination: *Mild dizziness w/ in an hour of the initial vaccination a/w subjective feelings of increased heart rate w/o palpitations. Issues also a/w chills and all spontaneously resolved w/in 30 minutes. He denied itchiness, urticaria, flushing,  swelling, confusion/disorientations, weakness, shortness of breath/difficulty breathing, nausea, abdominal cramping, or feeling the need to vomit/have diarrhea. He was able to drive, eat/drink, ambulate, and continue ADLs/IADLs w/o difficulty. *Headache the following day - took acetaminophen and sumatriptan.  Headache resolved after about another day. No other a/w adverse effects at that time.
Patient complains that she has occasional/sporadic pain going up her arm after she got the vaccine.
bladder infection or UTI pain or cramping prior to urination, occasional blood in urine starting 3 days after vaccine and continuing so far to 8 days after.
Information has been received from a physician concerning a female (demographics not provided) who on an unspecified date was vaccinated with Gardasil (lot # not provided).  Concomitant therapy included DTAP-IPV.  Subsequently at an unspecified time post vaccination the patient experienced syncope.  The patient sought unspecified medical attention.  Subsequently, on an unspecified date the patient recovered from the syncope.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included chickenpox (had chickenpox more than once) and shingles (had shingles more than once).  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and drug use for unapproved schedule. On an unknown date, the outcome of the vaccination failure, shingles and drug use for unapproved schedule were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had shingles more than once and got the shingles vaccine every year, which led to drug use for unapproved schedule. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Fever, debilitating fatigue, muscle aches, headache, chills with rigors, nausea and loss of appetite , severe left ans right upper abdominal pain
pt recv vax 14AUG97 & 19AUG97 pt devel blistering lesions on both hands consisting of closed & open lesions on the bilat palms;
The next morning (11/07/2020)  after receiving the vaccine, patient experience hives on her left shoulder, arm, left side of neck, and left side of face.
This case is linked to case number 2013-06751 (same reporter after ACTHIB). Initial misuse report received from a healthcare professional on 21 May 2013. A nurse administered ACTHIB powder (batch number: UH767AA) with an expired diluent (batch number: UF640AB) to a child. No adverse event was reported. List of documents held by sender: none.
Information has been received from a physician concerning a 55 year old male with high blood pressure, high cholesterol and no allergies who on 22-MAY-2006a was vaccinated subcutaneously with a second 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot#650453/0791P).  Concomitant therapy included "many medications".  On 23-MAY-2006 the patient developed pain at the injection site and a fever. On 24-MAY-2006 the patient was seen in the office and noted to have cellulitis of the left arm ( at the site of injection and the inner arm, with fluid at the elbow).  He also had a fever and was achy.  He was treated with cephalexin (KEFLEX) and soaks to the area.  No lab tests were performed.  It was noted that 6 years prior (in 2000) the patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine and had no adverse reactions.  At the time of report the patient had not yet recovered.  No product quality complaint was involved.  Additional information has been requested.