chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2016US020175 is an initial spontaneous report received from pharmacist on 09 Aug 2016. This report refers to 52 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (Expiry date: not reported, batch number: 1618701), intramuscularly at a dose of 0.5 ml into the left arm on 08 Aug 2016. On the same day, the patient had mild fever, localized rash in the left arm at injection site and itching that occurred about 15 to 20 minutes after injection. The outcome of events was reported as unknown. The seriousness of the event was not reported. Causality of events was reported as suspected.
This case was reported by a pharmacist via call center representative and described the occurrence of welts in a 68-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th October 2020) for prophylaxis. On 19th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced welts. The patient was treated with BENADRYL. On an unknown date, the outcome of the welts was unknown. It was unknown if the reporter considered the welts to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left deltoid. The patient had welts from her shoulder down to her elbow on the injected arm. The reporter asked if the patient should receive the 2nd dose. It was informed to the reporter that it would be best for the patient to follow up with her healthcare professional who knew her medical history, and that they cannot provide recommendations. The reporter stated that the patient did consult with her physician who recommended that she get the 2nd dose and take BENADRYL. The reporter was provided with information from the frequently asked questions (what if I had a reaction to the first injection, does that mean that I would also will have a worse reaction on the second injection). It was unknown by the reporter how soon after the injection the patient had the incidence or when or if they resolved.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Additional Details: This was reported by patient's wife.  She stated pt has difficulty breathing and chest pain after his vaccine.  they took him to an urgent care who ran tests and stated patient was "fine".  They gave him some type of shot (steroids?) and pt felt better the next day.  This was patient's booster--first vaccine was Janssen.
Day after vaccination severe itching began at wrist of injection arm only (thought she was bit by something), progessed from itching to warm sensation and tingling/occasional shooting aches for a few days from elbow to wrist only on injection arm. warm sensation has resolved but 7 days post vaccination still gets occasional shooting/sharp pain sensation from elbow to wrist. No swelling or pain at injection site. No range of motion issues. Felt tired and ran slight temperature for 1 day after.
Achy body; Slightly weak; Developed a swollen and tender lymph node on base of neck by collar bone (left side); Developed a swollen and tender lymph node on base of neck by collar bone (left side); This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 10:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient medical history included hypothyroidism and hashimotos disease. The patient had no allergies to medications, food, or other products. Concomitant medications within two weeks of vaccination included levoxothyrine (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Feb2021 at 10:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 20Mar2021 at 12:00, the patient developed a swollen and tender lymph node on base of neck by collar bone (left side) about 24-27 hours after vaccine. On 21Mar2021, the patient had slightly weak and achy body for a few hours but nothing more severe. No headache, fever, chills. Just sore swollen lymph node. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events The clinical outcome of the events swollen and tender lymph node on base of neck by collar bone (left side), achy body and slightly weak were not resolved at the time of this report.   Information about lot/ batch number cannot be obtained. No further information expected.
12/27/2021 developed acute onset SOB, tachycardia and dyspnea on exertion.  Went to urgent care where EKG demonstrated sinus tach, labs normal aside from mildly elevated d-dimer .  Sent to BI ER to r/o PE.  CT neg, troponin neg, tele with resting sinus tach., covid/flu/rsv neg.   Ruled out for MI and sent home.  Symptoms persisted causing me to spend a week on the couch, unable to do anything without exacerbating symptoms.  Had echo demonstrated mildly thickened mitral/aortic valve (not cliniycally significant according to cardiology) repeat troponin and inflammatory markers neg.  Second week was able to return to work with a reduced schedule as symptoms were improving but will occurring with activity.  Over month sx gradually improved.  Saw cardiology, 01/28/2021 who diagnosed me with POTS.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6205), on 23Mar2021 as dose 2, single (Lot number: EN6206) and on 18Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: The patient did not receive any other medications in 2 weeks. Adverse event: Flu-like symptoms. Cough, sneezing and headache. There was no treatment for AE.  No follow-up attempts are possible. No further information is expected.
pt recvd pneumococcal vax & w/in 24 hrs devel urticarial type rash around the inject site which extended up onto the trunk; pt also had swollen, tender lymph nodes in the inguinal area; sx persisted & pt was treated w/doxycycline;
arm and entire shoulder area were very sore; arm and entire shoulder area were very sore; I felt a lump in the area of my armpit/I was quite sore in that area; swelling; I felt a lump in the area of my armpit/I was quite sore in that area; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 73-year-non pregnant old female patient received bnt162b2 (BNT162B2 Formulation: Solution for injection), dose 2 via an unspecified route of administration on 16Feb2021 at 16:15 (Batch/Lot number was not reported) as DOSE 2, SINGLE (at the age of 73-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included high blood pressure, Barrett esophagus and Known allergies to Shellfish, Codeine, Adhesive from an unknown date and unknown if ongoing. The patient did not have covid prior to vaccination. Concomitant medications (Other medications in two weeks) included omeprazole, levothyroxine, gabapentin and triamterene taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 an unknown for covid-19 immunisation. The patient previously took codeine and experienced Known allergies. The patient did not receive any other vaccine in four weeks. On 16Feb2021 at 23.00, the patient experienced arm and entire shoulder area were very sore, felt a lump in the area of my armpit and swelling. It was reported that patient was rubbing it to make it feel better when felt a lump in the area of my armpit. The patient became concerned and since recently had a mammogram and she did not know what should do next. It reported that it was quite sore in that area for a few day. It was reported that after about 3 days it started to feel better, the lump and swelling went away and by one week it was pretty much ok with mild soreness for another week. The patient underwent lab tests and procedures which included mammogram: unknown results on an unknown date and sars-cov-2 test (Nasal Swab) (tested post vaccination): negative on 08Mar2021. No treatment received for events. The outcome of events reported as recovered on an unknown date of 2021.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Hours after the client received the vaccine she said her "face felt flushed," and she was "sweaty."  This morning (day after vaccine administration) ,  her eyes were "glassy and dilated," she felt fatigued, and her face is itchy. She says she "feels off," and unable to focus, and  "out of it." She went to work today but "is dragging." She denies nausea and diarrhea. She said her throat never "closed up." She said her arms are sore because she received a Tdap vaccine at a different clinic on 6/26/2019 , the day before she received the Typhoid vaccine.  She has taken ibuprofen. She has not taken her temperature to determine if she has a fever.
Patient started experiencing cough, chest tightness, wheezing 10 minutes after Pfizer vaccine administration. In 90 minutes after vaccine administration, patient started having loose stools.  Given albuterol PRN.  Patient refused to go to the ED.  Patient stated symptoms relieved after taking the albuterol.  During the course of observation, patient was able to verbalize needs and ambulate with assistance.
sore muscles; muscle spasms; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 19-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient experienced sore muscles and muscle spasms on an unknown date. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as the result of adverse event. The clinical outcome of the events sore muscles and muscle spasms was unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
At school, the next day, post vax, the teacher noticed whelp on right upper outer arm. Teacher called mom and mom states child only had redness at site last night. Today redness is 5cm X 6cm whelp with warmth and intense itching. Mother is giving Benadryl for relief. Whelp persisted as of 19:00 on 9/12/00. On 9/13/00, was told to put hydrocortisone cream on it.
Information has been received from a physician concerning an 18 year old female who on 19-JAN-2006 was vaccinated with a second dose of Varivax. On 20-JAN-2007, within 24 hours of vaccination, the patient experienced redness, swelling and a hard nodule at the injection site. Unspecified medical attention was sought. No product quality complaint was involved.
Pt. c/o pounding headache, body aches, palpitations, extreme weakness, chills, "lumpy throat", low grade fever, very red eyes, runny nose. Symptoms began about 4 hours after receiving flu vaccine, lasted about 24 hours.
AFIB; Chronic Heart failure; Asthma got out of control out of no where.; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine and was admitted to hospital for atrial fibrillation and chronic heart failure, a feeling of wasn't feeling well, Asthma got out of control out of nowhere.  Patient's medical history was not provided, and concomitant medicines taken by the patient, within two weeks prior to the event was not provided.  On 16 JAN 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly  for prophylaxis of COVID-19 infection.  On 11 FEB 2021, the patient was admitted in hospital for atrial fibrillation and chronic heart failure, a feeling of wasn't feeling well and asthma got out of control out of nowhere and was discharged on 19 FEB 2021. Treatment was not provided.  Action taken with mRNA-1273 was not reported.  The outcome of the events, to hospital admission for atrial fibrillation and chronic heart failure, a feeling of wasn't feeling well, Asthma got out of control out of nowhere was unknown.; Reporter's Comments: Very limited information regarding this event of heart attack has been provided at this time. Patient's medical history, list of concomitant medications, onset date and clinical details of the event is lacking. Further information has been requested.
This spontaneous report was received from a nurse refers to a patients of unknown age and gender. Since 01-OCT-2015, the patients were vaccinated with PNEUMOVAX 23 (dose, frequency, route of administration and indication were not reported; lot#K007262 expiration date:25-NOV-2015, L012215 expiration date: 13-JAN-2017), which were exposed to temperatures outside of the recommended range. This is one of several reports received from the same reporter. Additional information has been requested.
During the middle of the night on Thursday April 1, 2021 when I was sleeping I woke up with terrible cramping in both calves of my legs and in left foot after receiving my first dose of Pfizer Covid-19 vaccine on Mar. 29 at a pharmacy at 1:53 P.M. I have had cramping in my legs/feet/toes before so this could be totally unrelated. I have Theraworx in my nightstand and put some of it on which helped and they went away. I heard about blood clots possibly associated with other Covid-19 vaccine from another mfg. so just wanted to report this and make sure it is safe for me to get my 2nd dose of Pfizer vaccine on April 19th.
After 2nd dose 100 fever; After 2nd dose some light fatigue; After 2nd dose headache was a bit stronger than the first one; After 2nd dose red rash on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (After 2nd dose 100 fever), FATIGUE (After 2nd dose some light fatigue), HEADACHE (After 2nd dose headache was a bit stronger than the first one) and VACCINATION SITE RASH (After 2nd dose red rash on the injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A, 039K20A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (After 2nd dose 100 fever), FATIGUE (After 2nd dose some light fatigue), HEADACHE (After 2nd dose headache was a bit stronger than the first one) and VACCINATION SITE RASH (After 2nd dose red rash on the injection site). At the time of the report, PYREXIA (After 2nd dose 100 fever), FATIGUE (After 2nd dose some light fatigue), HEADACHE (After 2nd dose headache was a bit stronger than the first one) and VACCINATION SITE RASH (After 2nd dose red rash on the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-354613, MOD-2021-354702 (Patient Link).
pt recv vax & shortly afterward exp flu-like sx which recur periodically;pt has been dx w/metastatic ovarian cancer which believes  was caused by swine flu vax;
This case was reported by a physician via sales rep and described the occurrence of rash in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient was an older gentleman. The patient developed severe rash all the way under his arm pit.
raised lumps on legs unable to barely walk due to severe muscle aches starting evening of vaccine. Severe chills and night sweats x two weeks. Numbness, tingling in packages. Almost unable to walk.Gait is affected.
Breakthrough case of COVID Sx began on 05/16/2022 ? exhaustion, we were traveling, and I slept the whole hour and a half flight, when I got to the hotel I went right to sleep. Carrying the luggage was tough. I also had a slight cough. I had gotten Paxlovid as a precaution from my physician prior to the trip and I was very happy that I had them. Currently I am fine, I tested negative yesterday.
severe chills; vomiting; Diarrhea; lots of nausea; her whole body was trembling violently; she was very cold; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient started experiencing severe chills and her whole body was trembling violently, she was very cold. Followed with vomiting, diarrhea and lots of nausea. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Right sided neck pain 3 days after vaccine , Superventricular tachycardia 6 days after vaccine, right eye blurry vision 5 days after vaccine, ringing in right ear 5 days after vaccine.
vaccine administered after temperature excursion and before temperature excursion evaluation occurred; This spontaneous report was received from a medical assistant and refers to a 4 year old patient of unknown gender. Information about the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was not provided.     On 28-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S006830 with an expiration date in 02-SEP-2020), for prophylaxis (strength, dose, route and frequency were not provided), that underwent an initial temperature excursion of 4.8 degrees Fahrenheit, during a time frame of 60 hours, and an additional one of 5 degrees Celsius during a time frame of 12 hours. Digital data logger was involved.
On 05/02/2022 I began to cough and get a runny nose. By the evening I began coughing a lot. In the morning of 05/03/2022 I took two at-home tests and tested Positive. After that, we decided to do a PCR. My PCR test came back positive. I called my PCP and he prescribed Paxlovid and some OTC medications to treat the cough and fever. I went into quarantine and by today I have felt better. I could also feel my fever had broke and the feeling of being sick is completely gone but I was advised to continue to Quarantine for five days. I am traveling.  After my 4th dose I did have some lower back muscle spasm and have been taking some ibuprofen. I feel recovered but I am sure my doctor would say I am not.
Pt reported flu like symptoms and Upper respiratory symptomsafter receiving Gardasil lot#0279x exp10-23-2010
Extreme thirst; Injection site pain and soreness; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er2613) via an unspecified route of administration in the left arm on 19Mar2021 at 14:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ibuprofen (ADVIL) and paracetamol (TYLENOL); from an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 17:00, the patient experienced injection site pain and soreness, fatigue and extreme thirst. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of injection site pain and soreness, fatigue and extreme thirst was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Pain/soreness at injection site starting at injection and lasting until the next day so far; This is a spontaneous report from a non-contactable consumer, the patient. A patient of unspecified gender and of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 01Mar2021 at 14:15 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medications within two weeks of vaccination. The patient had no known allergies to medications, food, or other products. 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. On 01Mar2021 at 14:15, the patient experienced pain/soreness at injection site starting at injection and lasting until the next day till the time of report. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain/soreness at injection site starting at injection and lasting until the next day till the time of report was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.