chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 22-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N023828 and expiration date 25-JUN-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018   was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709:
neck and chest rash; Felt dizzy and spacey; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration on 01Mar2021 at 13:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history reported as none. Concomitant medication was not reported. The patient was allergic to sulfur drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 03Mar2021, patient experienced neck and chest rash about 4-5 days after vaccination and continued for 3 weeks, at 3 weeks patient developed a light rash on left arm from shoulder to forearm and about 3 days after the vaccination she felt dizzy and spacey. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatments received for the events rash and dizziness was unknown. The clinical outcome of events rash and dizziness were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
dizziness; body pains; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), FATIGUE (fatigue), PAIN (body pains) and NAUSEA (nausea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIZZINESS (dizziness), FATIGUE (fatigue), PAIN (body pains) and NAUSEA (nausea). At the time of the report, DIZZINESS (dizziness), FATIGUE (fatigue), PAIN (body pains) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment medication included advil.
I had fatigue after first covid vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (060820).  A 51 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "I had fatigue after first covid vaccine".  Additional Information: Patient was taking anastrozole 75 mg daily times 21 days out of which for 7 days it was on and off. Patient reported that she had fatigue after first covid vaccine as like that with bone density medication. she slept a lot and received second vaccine on 14Apr2021. At that time she was feeling good and she went for camping. Lab done on 07Apr2021 and both tumor markers were way down. she visited medical doctors office on 13Apr2021. will start next cycle today. MD aware.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nov. 24th experienced itching at site of injection. After scratching she noticed a burning sensation in her arm. Sunday AM she noticed small red spots on left arm around the bend in her arm. Monday AM the same spot increased in size & a couple of new small spots appeared. Her whole arm was sore and pain was moving up her arm into her shoulder and neck. Tuesday AM she went to her doctor and was diagnosed with shingles and started on antiviral FAMVIR.
Feeling flush/heat in (L) ear (L) side of face and in her throat.
103 degree fever on 6/14/14, rash not present at that time. No other symptoms with fever.  On 6/17/14, rash began and increased in severity. Presented to physician on 6/19/14 covered from head to toe, including palms and soles with a morbilliform rash.
pt recv vax 14AUG97 & w/in a half hr of vax pt c/o swelling in the throat;5hr p/vax pt exp wheezing;24hr p/vax pt exp a gen tingling for 2 to 3 hr;
2nd day couldn't raise their arm over the sink; sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (2nd day couldn't raise their arm over the sink), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included Ovarian cancer. Concurrent medical conditions included Brain tumor. Concomitant products included METFORMIN, PITAVASTATIN CALCIUM (LIVALO), EZETIMIBE (ZETIA), DENOSUMAB (PROLIA), ACETYLSALICYLIC ACID (ASPIRIN 81), LACTOBACILLUS REUTERI, LACTOBACILLUS RHAMNOSUS (VAGISAN [LACTOBACILLUS REUTERI;LACTOBACILLUS RHAMNOSUS]), GABAPENTIN (NEURONTIN) and TRAMADOL for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOVEMENT DISORDER (2nd day couldn't raise their arm over the sink), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, MOVEMENT DISORDER (2nd day couldn't raise their arm over the sink), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-307464, MOD-2021-307467 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up received contains additional concomitant products.
This seemed to affect every joint (arthritic) by evening couldn't bend legs, move, stand or walk. The pain was unbelievable it took 3 days to be able to move legs, still not 100%. Chills, headache, cough, runny nose. Everything was gone by next morning except continues pain and spasms in legs
My shoulder injury of eight months duration  abated totally! So not an adverse effect but a positive one which I thought should be reported.
heart palpitations; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received unknown dose of bnt162b2 (Pfizer COVID-19 vaccine, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. No patient identifiers were provided but the reporter had firsthand knowledge of the patient and was reporting on a specific patient. Reporter stated a patient that had the covid-19 vaccine and experienced heart palpitations, caller stated that patient did not have the vaccine at their clinic, caller stated they called the patient about the paperwork from Pfizer and now they received another letter. The outcome of the event was unknown.
body aches, chills, fever (102.5), sweaty,  shortness of breath, increased BP, increased HR, swelling/knot at injection site,
Patient developed a red ring around her arm below the injection site (above the elbow) and it is slightly swollen and warm.
Red area around injection site approximately 4 inches in diameter, 10 ml of diphenhydramine  given in office @ 1145, asked  mom to call in the morning if not looking better
Moderna COVID-19 Vaccine EUA At approximately 9:30 PM (14 hours after receiving 2nd dose of Moderna), I started with chills and being cold. At the same time, I started a fever that gradually went up to 102.2 by 3:30 AM (20 hours after receiving 2nd dose). Also noticed a headache. At 3:30 AM I did take 2 extra strength Tylenol caplets.  Fever went down, but I did notice even 24-36 hours after receiving 2nd dose, my temperature was at 99.5-99.9.  The headache remained 24-36 hours but has since subsided now at 48 hours after receiving. I do still feel mild fatigue, but I reported to work without any issues. I did notice that my arm was hardly even sore compared to 1st dose received on Feb. 6, 2021.  One week after my 1st dose on Feb. 6, I developed the COVID rash which lasted 2-3 days and went away w/o any medication.   All in all, I did not find the side effects to be bad for either dose. I would do it all over again. The side effects were more of a nuisance than anything. I would have honestly reported to work as normal if it was during the week when I received vaccine. The side effects were not that bad.
no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 02-APR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
patient reports left arm pain and weakness, mostly positional particularly when reaching behind her. Slowly improving but started a few days after the inection
This spontaneous report was received from a medical as, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored PROQUAD (route, dose and anatomical location were not reported) (lot # M022399, expiration date 01-NOV-2017). Temperature and time frame: 5.7 degrees F for 1 hour and 34 minutes. Data logger was reported as yes. No adverse effects were reported. There was no product quality (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Extreme itching on hands and feet; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old, male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration on 16Apr2021 at 13:45 in right arm (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and 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 within 2 weeks of vaccination included cetirizine hydrochloride (ALLER-TEC) started on an unknown date for an unknown indication and unknown if ongoing. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 26Mar2021 at 15:00 in the right arm as a single dose for COVID-19 immunisation. On 19Apr2021, at 01:00, the patient experienced extreme itching on hands and feet. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event with benadryl and hydrocortisone cream.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme itching on hands and feet was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
I took Benadryl 30 minutes before my second dose, then 2 minutes after the vaccine my lips swelled and then my face swelled. My throat did not close up, I was watched for 45 minutes. I was told to take another Benadryl once I got to my son's house. I continued to have swollen lips and allergy reactions with my face for 5 days. I had to keep taking Benadryl. I had an ultrasound done and they noticed that my spleen was swollen. I saw my doctor, was not prescribed any medication due to underlying medical conditions. I also experienced extreme fatigue and a mouth sore. I have had periods of itching as well.
fever; felt a litte bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US163876.  A 58 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt a litte bad".  Additional information: It was reported that Patient stated that he had fever for few days and felt a little bad after his second COVID-19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I almost fainted after the injection and I?ve had a sore throat and nasal drip since then.
stiff neck; very very severe vomiting; body aches; fever of 102.7; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (very very severe vomiting), PAIN (body aches), PYREXIA (fever of 102.7), HEADACHE (severe headache) and MUSCULOSKELETAL STIFFNESS (stiff neck) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced VOMITING (very very severe vomiting), PAIN (body aches), PYREXIA (fever of 102.7), HEADACHE (severe headache) and MUSCULOSKELETAL STIFFNESS (stiff neck). At the time of the report, VOMITING (very very severe vomiting), PAIN (body aches), PYREXIA (fever of 102.7), HEADACHE (severe headache) and MUSCULOSKELETAL STIFFNESS (stiff neck) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; 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. Further information has been requested
Numbness in fingertips to knuckles bilaterally  RN assessed VS temp 98.4, HR 101, BP 150/88 RR 16
A vaccinator administered an incorrect dosage of the Pfizer vaccine. Specifically an 10 year old received the Pfizer dosage (Lot no. FJ6369) that is routinely administered for recipients 12 years old and above instead of a pediatric dosage (5-11 years old).  The dosage received was an initial dose.   The 10 year old went through both points of registration and was checked into the vaccine administration room and not sent to the pediatric administration room.  The registration staff.  The vaccinator (RN) stated she confirmed the recipients DOB, but administered the .30 dosage.    While the father was waiting to receive his vaccination, I asked the recipients age and she stated that she was a 10 years old.    The medication error was reported to the parent as well as how to report adverse reactions.  The parent voiced understanding.  I collected the contact information from them as well.  After the standard observation period, the parent and child left without incident.  Follow was completed with the registration staff as well to confirm age requirements for each vaccination room.  Reviewed vaccine process with RN and staff at the vaccination table.   Patient: (scheduled for 2nd dose on 2/5/22) Parent:
Information has been received from a registered nurse concerning a 45 month old female with no known drug allergies and no medical history who on 20FEB2001 was vaccinated in the thigh with a first dose of varicella virus vaccine live (lot 634479/0767K). There was no concomitant medication. There was no illness at the time of vaccination.  The registered nurse reported that on 17-MAR-2003 the patient was seen in the physician's office for a "mild case" of varicella. The reporter noted there were " a few lesions present" and the patient was afebrile. The reporter indicated that no diagnosti or laboratory tests had been ordered for the patient. The reporter stated the patient was exposed to several cases of varicella at school. Follow up information was received form the registered nurse which indicated that on 17-MAR-2003 the patient had a "mild case of possible chickenpox." It was noted that the patient recovered. Follow up information received form the registered nurse indicated that in March 2003 the patient had a mild case of chickenpox. No further information is expected. The reporter mentioned that "5 to 6" other children also had varicella following vaccination with varicella vaccine live (WAES 0304USA01500).
Patient had 3 COVID Moderna vaccines on 3/10/21, 4/8/21, and 8/15/21, and was hospitalized with SOB and COVID symptoms on 12/18/21, and remains hospitalized at present 12/20/21.
The patient started with symptoms of numbness and tingling of her left foot two weeks post COVID vaccination , now has absent left ankle reflex and ascending symptoms of her bilateral LE and UE.  Has diminished position sense. No respiratory muscle weakness.
Large swollen hard  knot size of 1/2 a baseball that was approx 3? in diabetes, red and extremely itchy vegan on day two after second shot and is still present on day four after shot. Multiple fever blisters on bottom lip began on day 2 1/2 after shot and still present on day four after shot  Multiple blisters on sides of tongue began on day 2 1/2 after  shot and still present. Fever blister at left nostril began on day 2 1/2 after shot and still present on day 4. Cramping of toes began on day 2 after shot and still experiencing on day 4.  Cramping in legs  began on day 2 after shot and still experiencing. Day 1 only after shot : fever. Chills and body aches
Vomiting & dehydration with hematemesis onset 2/2/12 diagnosed with pyloric stenosis on 2/4/12 had surgery & has improved.
No additional adverse effects reported; an improperly stored dose of VARIVAX was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant therapies were not reported.  On 31-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S022755, expiration date: 02-JUL-2021, but upon internal validation established as 22-JUL-2021 (dose, unit, route and anatomical location were not reported) for prophylaxis. There were no previous temperatures excursion. The vaccine was exposed at the temperature -13.4 degrees Celsius for 1 hour and 30 minutes. Data digital logger was involved. No additional adverse effects were reported.
Severe HSV2 outbreak occurred within 48 hours of booster shot. Treated with valtrex, combo of Tylenol and advil, topical lidocaine and topical zorivax. Started with typical tingling and swelling prior to full blown outbreak of blisters and sores
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 20-FEB-2019, the patient was vaccinated with a dose of improperly stored PROQUAD injection, lot # R006216 with expiration date 28-AUG-2019, subcutaneously for prophylaxis. The dose of the vaccines were reconstituted with properly stored sterile diluent. The vaccine experienced a temperature excursion from -14 degrees Celsius to -10 degrees Celsius for 30 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effect was reported.
Reaction on dorsal side of right wrist:  what appeared to be tiny red pin pricks  over an area of  about 1.5?x2? was observed at night of injection date. I applied Hydrocortisone cream USP, 2.5% to area and bandaged that night, and the next morning it appeared to be a rash.  Reapplied ointment and  rebandaged after shower every morning since then, through today 2/3/2021 It appears to be itching her and causing her to scratch until  ointment is applied. No improvement so far.
Pain in my arm; Pain in my under arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in my arm) and AXILLARY PAIN (Pain in my under arm) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in my arm) and AXILLARY PAIN (Pain in my under arm). At the time of the report, PAIN IN EXTREMITY (Pain in my arm) and AXILLARY PAIN (Pain in my under arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information on concomitant medications were reported.  No information on treatment medications were reported.  It had been a week and 2 days and  patient still have pain in  under arm and  arm.
High Fever 101-103 degrees, chills, lethargy, body aches, head ache
Throbbing pain from elbow to shoulder unable to raise arm unassisted by other arm occasionally relieved by use of Motrin-varies in intensity; occasionally feels warm to touch; called MD but was not seen; advised motrin;
I had a headache, felt like a cold, low grade fever of 101 for a week, lost sense of taste, nausea, and dry cough. I went to a clinic to test and I was positive for COVID-19.