chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered at 3:30pm on  8/21/2016. That night she had swelling in area then it has migrated down arm and near elbow. Patient stated it hurts but arm functioned.
SWOLLEN RED ENLARGED LYMPH NODE UNDER LEFT ARM, LASTED 3 DAYS. AND SEVERE MENSTRUAL PAIN SINCE 2ND VACCINE
This writer did not administer vaccine. Pt received vaccine at clinic and reported feeling shaky and nausea . Denies sob chest pain headache feeling dizzy or lightheaded. No respiratory distress
Fever to 103, marked UE, chest neck swelling mucosal break down in oropharanx and burning, fatigue and arthralgias (diffusely).
SORE SHOULDER; SWEATS; CHILLS; 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 was previously treated with influenza vaccine for drug used for unknown indication. 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. Non-company suspect vaccine included mrna 1273 (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for drug used for unknown indication. No concomitant medications were reported. On MAR-2021, the patient experienced sweats, and chills. On an unspecified date, the patient experienced sore shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, sore shoulder, and sweats was not reported. This report was non-serious.
Body aches, set SOB, chest tightness approx 4 hrs after vaccine better in am - residual achiness.
herpes simplex, has not had a breakout; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic drug effect in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex. Concomitant products included famotidine (Pepcid Ac).   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced unexpected therapeutic drug effect. On an unknown date, the outcome of the unexpected therapeutic drug effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic drug effect to be related to Shingrix.     Additional Information: GSK Receipt Date: 9-Aug-2022 Reporter's comment: The patient self reported the case. The patient stated that he had contracted herpes simplex virus in college when he was younger and has had frequent breakouts for over 40 years. The patient received the Shingrix vaccine about two years ago and had not had a breakout since that day. Spoke per package insert and content. The reporter consented to follow up.
Patient returned to office this morning with 10 x 11 in rash on LD. Rash is warm to touch, firm and itches. Advised per Dr. to take BENADRYL and prednisolone as directed and return to clinic if worsening.
cold-like symptoms; got Covid-19 after Covid-19 vaccination; got Covid-19 after Covid-19 vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "got Covid-19 after Covid-19 vaccination"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold-like symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive. Patient was infected with Omicron variant and he had some cold-like symptoms.  The lot number for bnt162b2 was not provided and will be requested during follow up.
swollen lymph node on side shot was asministered; This is a spontaneous case from a contactable consumer (patient). A 67 years old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm right on 19Feb2021 10:00 (Lot Number: EL9269) at the age of 67 years old as single dose for covid-19 immunisation. Medical history included heart attack from 2012; Known allergies: Naproxin. The patient's concomitant medications were not reported. Facility type vaccine was Other. The patient experienced swollen lymph node on side shot was asministered on an unspecified date in Feb2021. No treatment received for the event. No covid prior vaccination and no covid tested post vaccination. The outcome of the event was recovering.
Information has been received from a nurse practitioner concerning a 25 year old female patient with no pertinent medical history and no known allergies who on 02-FEB-2010 was vaccinated IM with a 0.5 ml dose of GARDASIL (lot number 663573/0969Y) in the left deltoid. Concomitant therapy included birth control therapy (unspecified). The patient was monitored post vaccination and was fine when she left the office. The next morning, on 03-FEB-2010, the patient woke up with hives, rash going down her left arm with small bumps on the end; it was reported as localized reaction. The nurse practitioner states clients "now" (at the time of the report, on 04-FEB-2010) had systemic reaction of hives from head to toe. Unspecified medical attention was sought. There was no lab studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Two weeks (2/23/21)after vaccination she noticed the left side of tongue felt like it was burnt, it did not improve. She also noticed that on her right thigh developed a rash that appears to have blisters, the rash is approximately the size of womens fist (closed/ 90mm) and is round. Rash and tongue issue have persisted,then 2 weeks ago (3/23/21)on the left side of face she noted  that her jaw, nose and cheek became numb and at time of report remain numb. She also reports  falling about 8 weeks ago, was  being treated by chiropractor yesterday, 4/7/21, that diagnosed her with Bells Palsy, she received treatment. She saw her primary provider today, 4/8/21 , and had rash checked,is now referred to dermatologist.
Just achy; Chills real bad; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Just achy), CHILLS (Chills real bad) and NAUSEA (Nausea) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (Just achy), CHILLS (Chills real bad) and NAUSEA (Nausea). At the time of the report, PAIN (Just achy), CHILLS (Chills real bad) and NAUSEA (Nausea) 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 did not provide any causality assessments.   No concomitant drugs were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up information received on 15 Jul-2021 contains information with updated event out come.
Injection site reaction to the right arm. Red, hot, swollen, and painful. PCP does not think this is more than an injection site reaction with no infection and no fever.
Fever with distinct bone pain. A year earlier (Jan 2020) I was a bone marrow donor that required a heavy course of Filgrastim in preparation for the donation. As expected, the Filgrastim made me feel sick with a lot of bone soreness and pain, especially in my hips and legs. It lasted a few days after the donation and then was gone. Upon getting my second shot of the Moderna vaccine, the second day brought back the exactly soreness/pain that I felt under the filgrastim with distinct bone pain, especially in my legs/hips.
I feel this program is unfair. I was inoculated in boot camp with several of these vaccines. The problem lies upon the way it was administered. The use of an air injection gun was used to inoculate every one. If you were to flinch, the air gun would slice you open causing you to bleed. Then they would go right up to the next person and use the gun to inoculate him. Never once was the gun cleaned of the other persons blood. This has been confirmed as to the sorce of my contacting hepatitis-C. They didn't discover hepatitis-C until the early 1990's. It can take up to twenty years before the systems show up. Now what are we supposed to do? The VA does very little for a person who has contacted a disease that most likely will kill him. <y interferon treatment did not work.
severe abdominal cramping, constipation/diarrhea, elevated blood pressure, (with no diagnosis of hypertension), low pulse, no appetite, acid reflux, no bowel movement sensation, weight loss, stitch in left side and tightness in stomach area.
Dizziness began 36 hours after 2nd injection. Getting out of the bed, I felt like I was going to pass out. Have also had brain fog. Ongoing as of day 8 post vaccine.
This spontaneous report was received from a pharmacist via a company representative and refers to several patients of unknown age, gender and demographics. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, indication, route of administration, lot number and expiry date were not reported). On an unknown date, after receiving ZOSTAVAX, the patients experienced mild cases of shingles. The outcomes of the event were unknown. The relationship between the event and ZOSTAVAX was not reported. Additional information has been requested.
Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) 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 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown. Not Provided    No concomitant medication was provided. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-114251 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114251:MOD21-088160
Patient received booster and next day noticed chest discomfort and pressure.  I told her I would check with her 3 or 4 days later to see if she still has same symptoms.  She informed us yes, and believes the booster caused this.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Additional Details: Pt stated he didn't like needles.  Post vaccine injection stated he felt warm and had nausea.
10 days after injection developed sharp pleuric pain first on the right then 3 days  later moved to the left axila and left anterior chest. Worsened with cough sneeze and supine position. Relieved with sitting up and leaning forward.  Very suggestive of acute pericarditis. At one point cause moderate squeezing pain on inspiration. Resolved in additional 10 days with high dose NSAIDs.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-JUL-2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. 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. Additional information has been requested.
Sore arm (like the first shot?s side effects), but most notably, muscles aching in entire body, noticeable increase in body temperature (felt like a fever, temp was 99.5)
Diarrhea; So sick; Bone aching; Can't walk hardly; Throwing up; 100 degree fever; Headache worse than migraine; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ILLNESS (So sick), BONE PAIN (Bone aching), GAIT DISTURBANCE (Can't walk hardly) and VOMITING (Throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), ILLNESS (So sick), BONE PAIN (Bone aching), GAIT DISTURBANCE (Can't walk hardly), VOMITING (Throwing up), PYREXIA (100 degree fever) and HEADACHE (Headache worse than migraine). At the time of the report, DIARRHOEA (Diarrhea), ILLNESS (So sick), BONE PAIN (Bone aching), GAIT DISTURBANCE (Can't walk hardly), VOMITING (Throwing up), PYREXIA (100 degree fever) and HEADACHE (Headache worse than migraine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (abnormal) 100 degree fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication use was provided by the reporter.  No treatment of events was reported.
13 year old male administered a full undiluted vial of the Pfizer COVID 19 vaccine; administered a full undiluted vial of the Pfizer COVID 19 vaccine; fever; This is a spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported that a 13-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose (NDC number: not provided/Expiry Date: unknown /lot: EW0181) on 16Jun2021 as single dose for COVID-19 immunization. Patient medical history and Family medical history was unknown. Prior Vaccination (within 4 weeks) was None. Concomitant medications were unknown. Reporter is a pharmacist  who stated that the patient was administered an undiluted vial of the Pfizer COVID 19 vaccine. She was asking for recommendations for procedures and follow up if the next dose is needed and would like to know if there is any information or guidance from Pfizer on this case and if the second dose should be given as scheduled. Reporter clarifies that another pharmacist gave the vaccine to the patient. Patient was doing OK for first 24hrs after the 1st dose full vial overdose. After the first 24 hrs the patient had little bit of a fever. The patient received second dose on 08Jul2021, Batch/Lot number: EW0198 (exp unknown). Relevant test was unknown. Investigation Assessment was Not Provided. The outcome of the event was unknown.  Follow-up (23Jul2021): New information reported from a contactable Pharmacist in response to HCP letter sent via telephonic follow-up activity which included: New event (fever), Deleted event (Inappropriate age at vaccine administration and Off label use), Product details, Event detail, Patient history.
15 minutes after vaccination began to feel ill with nausea and dizzyness.  five to six hours after vaccination had fever and chills.  Noted right periorbital swelling, difficulty opening right eye, headache, tingling of right lip and chin area as well as fatigue and diarrhea the following day so she visited the emergency department of the hospital.  Presumptive diagnosis of possible Bell's Palsy made and started on treatment with Valtrex and oral steroids by ED physician.  Seen by me in the office 11-05-07 for further evaluation.  I did not agree with Bell's Palsy diagnosis and entertained possible Trigeminal neuropathy and referred patient to neurologist.  Neurology visit on 11-07-07.  Dr. ordered MRI of brain which was negative and patient improving over course of this week.  According to neurologist, probable self-resolving neuropathy from vaccine???  11/13/07 Reviewed hospital ER medical records which reveal patient experienced right eye drooping, blurred vision right eye, right cheek numbness, right upper lip numbness on 11/3/07.  Tx w/antiviral & steroids. FINAL DX: Bell's palsy, right side.
rash /after first Shingrix shot; This case was reported by a consumer via call center representative and described the occurrence of rash in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included penicillin allergy (no milk allergy was reported).   On 16th March 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In March 2019, 2 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The patient reported rash on chest few days after first dose of Shingrix which was administered a few years ago from reporting day.  The patient did not get rash with second dose of Shingrix. The reporter consented to follow up. Discrepancy: the event onset date and outcome date were reported as 16th March 2019 which was same as vaccination date however TTO was captured as 2 days as per both source document field and narrative information.
Pfizer vaccine was administered outside of Facility- reported by patient- ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------------------  I95.9 HYPOTENSION 4/18/2023 DM 2 WO COMPLICATIONS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/27/2023 DM 2 WO COMPLICATIONS R09.02 HYPOXEMIA 3/27/2023 DM 2 WO COMPLICATIONS I95.9 HYPOTENSION 4/18/2023 ESOPHAGEAL VARICES J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/27/2023 ESOPHAGEAL VARICES R09.02 HYPOXEMIA 3/27/2023 ESOPHAGEAL VARICES I95.9 HYPOTENSION 4/18/2023 HX OF ESOPHAGEAL VARICES J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/27/2023 HX OF ESOPHAGEAL VARICES R09.02 HYPOXEMIA 3/27/2023 HX OF ESOPHAGEAL VARICES I95.9 HYPOTENSION 4/18/2023 ASCITES J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/27/2023 ASCITES R09.02 HYPOXEMIA 3/27/2023 ASCITES I95.9 HYPOTENSION 4/18/2023 HX OF ESOPHAGEAL VARICES J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/27/2023 HX OF ESOPHAGEAL VARICES R09.02 HYPOXEMIA 3/27/2023 HX OF ESOPHAGEAL VARICES
This is a spontaneous report from a contactable pharmacist. A 56-year-old female patient received the 1st dose of PREVNAR 13 (Lot# N34935, Exp date Nov2017, NDC 00005-1971-01), intramuscular in left deltoid, on 16Oct2017 around 02:00 PM, at 0.5 ml single, for immunisation. Patient was vaccinated at a pharmacy/drug store. Relevant medical history included ongoing wheezing and breast biopsy (right side). Concomitant medications included 1st dose of FLUCELVAX (Lot# 195222) on 12Oct2017 for immunisation and VENTOLIN INHALER from Oct2016 and ongoing for wheezing. The patient experienced red mark at injection site on 17Oct2017 with outcome of not recovered, painful injection site on 17Oct 2017 with outcome of not recovered, redness on the underside of arm from injection site on 18Oct2017 with outcome of unknown, hot at injection site on 18Oct2017 with outcome of unknown. Therapeutic measures were taken as a result of the events and included treatment with XYZAL (Lot# 17A101, Exp date Jan2020) tablet, on 18OCT2017, which did not seem to help. The events red mark at injection site, painful injection site and hot at injection site were considered serious as per medically significant. The events were considered related to PREVNAR 13. Sender's Comments: A causal association between administration of PREVNAR 13 and the onset of events cannot be excluded, considering the temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
I have had a fever since the 10th. My left arm, left arm pit, and left side of my chest is sore. I have a dry cough. My head hurts occasionally. I feel fatigued and get cold chills occasionally. I've had stomach issues on and off.
Information has been received from a 22 year old female with allergic reaction to erythromycin who on 07-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot number was not available). Concomitant therapy included hormonal contraceptives (unspecified). On 08-JUL-2008 the patient experienced a rash of brown spots on her hands and arms. The patient's a rash of brown spots on her hands and arm persisted. Medical attention was sought via physician and nurse. No product quality complaint was involved. No further information is available.
Fever 102- 104.8, increased heart rate and blood pressure, chills, headache, achy  Symptoms for 24hrs then fever broke Tylenol/Advil and cool towels to reduce fever
Numbness / tingling / extreme weakness in both legs  beginning 5 minutes past vaccination. Following night in a combination with nausea. On day 3 post vaccine tingling and numbness started to include unbearable pain in both legs. 6 Months later nothing has changed. Neither neurologist, nor orthopedists could help. MRI showed plenty of inflammation and bine marrow edema in right ankle