chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm is sore; Difficulty raising arm; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 09Aug2021 at 17:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, pneumonia, sinusitis and liver disorder (reported as liver psoriasis). It was unknown whether the patient had any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: FC6780) via an unspecified route of administration in left arm on 19Jul2021 at 17:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 10Aug2021 at 00:00, the patients left arm was sore, she had difficulty raising arm and diarrhea after midnight. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event left arm was sore, difficulty raising arm and diarrhea was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
weak; slept on and off all day; nauseous; super tired; achy - Soreness; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weak), PAIN (achy - Soreness), SOMNOLENCE (slept on and off all day), NAUSEA (nauseous) and FATIGUE (super tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 043B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Multiple concomitant medications are reported, but no historical medical condition is reported.).   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced PAIN (achy - Soreness) and FATIGUE (super tired). On 28-Apr-2021, the patient experienced ASTHENIA (weak), SOMNOLENCE (slept on and off all day) and NAUSEA (nauseous). On 29-Apr-2021, ASTHENIA (weak), PAIN (achy - Soreness), SOMNOLENCE (slept on and off all day), NAUSEA (nauseous) and FATIGUE (super tired) had resolved.            No treatment medication was reported.   This case was linked to MOD-2021-109711 (Patient Link).
Rash started in middle of chest 2nd day after vaccination. Has spread daily to now cover entire body within 2 weeks. Itchy and red. Taking allergy meds to help alleviate. Working slightly. Seeing doctor tomorrow for more information.
Do not feel good; No energy; Arm sore; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Do not feel good), ASTHENIA (No energy), PAIN IN EXTREMITY (Arm sore), CHILLS (Chills) and MYALGIA (Body aches) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 030M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL AND HYDROCHLOROTHIAZIDE) and LEVOTHYROXINE SODIUM for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (Do not feel good), ASTHENIA (No energy), PAIN IN EXTREMITY (Arm sore), CHILLS (Chills) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (Do not feel good), ASTHENIA (No energy), PAIN IN EXTREMITY (Arm sore), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
Tired, achy on 10/3. On 10/4, increasing tiredness & weakness, baseball sized flat red spot at injection site on arm. Symptoms did not resolve until 10/5.
Pt took hot shower at 10:30 PM on 11/24/2009 prior to bed, at around 1 am pt started itching on legs and felt heavy breathing, after awhile he got up and noticed hive like rash on trunk,legs and arms.  Called ER and then went into ER.  They treated him with liquid Benadryl.  When RN called him at 11:00 am 11/25/2009 pt was better but still had hives. Continue as ordered to take Benadryl.
Adverse reaction to HD flu vaccine. Patient had fever, soreness and itching at injection site.
Tragic accident; Psoriasis flare-up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 22K-163-4278961-00 (AbbVie).  A 32-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), since 19Jan2022 (Batch/Lot number: unknown), subcutaneous for psoriasis, psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ACCIDENT (medically significant), outcome "unknown", described as "Tragic accident"; PSORIASIS (non-serious), outcome "not recovered", described as "Psoriasis flare-up". The action taken for risankizumab was unknown. Therapeutic measures were taken as a result of psoriasis. The patient had flares of Psoriasis. He had tragic accident and investigation and that he had ok  Skyrizi injection on 19Jan2022, had spots break out over his body. Since he was covid vaccinated he was not able to keep his skin clear especially spots on his chest and back. He used clobetasol cream and it would go away after a few days and stay gone for 2 to 3 weeks since he had started Skyrizi. But before Skyrizi he would not clear at all. He stated that a couple weeks ago he started getting five or six spots on his legs and back that were dry and not red which were much better for him and his doctor said it was okay since his injection due next week. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Adverse event information provided by patient was not related to covid vaccine. The patient was treated with Clobetasol.  The reporter's assessment of the causal relationship of "tragic accident" and "psoriasis flare-up" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter's causality for the event(s) of Tragic accident and flares of Psoriasis was not provided with Skyrizi (Risankizumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known disease pathophysiology, the events of psoriasis and accident are assessed as not related to BNT162B2 and psoriasis is more likely due to underlying medical condition and accident was mostly a incident event.
Coughing up greenish phlegm, achy, headache,chills,fatigue  This has been going on since 09/04/19. Still feeling ill.
The following pains were NOT managed by 2 Aleve every 12 hours, even with adding: aspirin every 4 hours,  Voltaren  cream, and  bio freeze spray every several hours, simultaneously. Significant Headache  Significant Muscle aches Significant Joint aches Significant pain in arm Minor Loss of appetite  General Malaise If these symptoms had not started dismissing some by day 3 a Dr. Visit would have been required.
Slept a lot; not really felt good since; having trouble thinking; dizzy; Headache; felt hazy/feltcrappy/felt strange/feeling yucky; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EN6205) at the age of 73 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: THINKING ABNORMAL (non-serious) with onset 11Mar2021, outcome "not recovered", described as "having trouble thinking"; DIZZINESS (non-serious) with onset 11Mar2021, outcome "recovering", described as "dizzy"; HEADACHE (non-serious) with onset 11Mar2021, outcome "recovered" (13Mar2021), described as "Headache"; FEELING ABNORMAL (non-serious) with onset 11Mar2021, outcome "recovering", described as "felt hazy/feltcrappy/felt strange/feeling yucky"; HYPERSOMNIA (non-serious), outcome "not recovered", described as "Slept a lot"; MALAISE (non-serious) with onset 11Mar2021, outcome "not recovered", described as "not really felt good since". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of thinking abnormal, dizziness, headache, feeling abnormal, hypersomnia, malaise. Additional information: On 11Mar2021, the patient got the first shot of the vaccine after which the patient got dizzy and has not really felt good since. The patient was having trouble thinking and felt hazy. The patient experienced headache and slept a lot and felt worse when waking up. The patient stated starting to feel better but did not know if this was a side effect or not. The patient had a headache for 2 days. It was reported that they gave the shot and the patient had to go up to the second floor and on the way up to the second floor, the patient started getting dizzy and felt strange, but the patient was not sure. The patient did not know why and sat down for 15 minutes and felt a little dizzy. But it just kind of continued a little bit and then the patient just started feeling crappy when the patient got home. The patient reported feeling yucky. The patient did not receive treatment for the events. The second dose was scheduled for 01Apr2021.  No follow-up attempts are possible. No further information is expected.
Following the vaccine I have Redness on my right hand fingers on the knuckles right below the fingernail. On the middle finger it started on the center knuckle and is still red. All 4 fingers are somewhat swollen. I can make a fist with ease to pain. No itching just discomfort of being swollen.
Temp - 102 degrees  Body aches.chills,fever, red swollen left arm.  Applied ice to left arm, Tylenol
suspected vaccination failure; shingles; 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.   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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles 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 case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient said it once and the patient would say it again that, he/she got the Shingle shot and got the shingles it sucked. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 07-NOV-2012 11:10, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Pt. recieved COVID vaccine on 4 Feb and came to hospital on 5 Feb with Chest pain; Elevated troponin; Exertional chest pain; Symptomatic bradycardia.  Admitted for ACS and being treated with heparin. syncopal eisode.  she was discharged on 9 Feb.  Home course unknown
Here for COVID #2. Administered while patient lying down due to history of seizure and syncope post-vaccination. Tolerated COVID vaccine #1 with no symptoms immediately post vaccination. Approximately 10 mins post vaccination, patient began complaining of mild left arm numbness and tingling. VS stable (BP 122/70, P 84). Continued to monitor and numbness and tingling did not resolve. At approximately 1030, she began to complain of mild throat numbness. She was speaking well, Alert and Oriented x4, Strength in all four extremities was equal and 4/4. VS remained stable (BP 128/80, P 80, O2-99%). Gave apple juice per Dr. After apple juice was given, patient's mom informed nurse that patient has mild allergy to apples (itching). Allergy added to patient's chart. No itching occurred after drinking however symptoms were stable but not resolving. Dr. offered trying 10ml of honey to see if it would ease her throat. She remained stable throughout and had intact swallowing with no coughing or other symptoms. At 1042 BP remained 122/78, P 100, O2 99%. Her arm symptoms were beginning to subside and her throat symptoms were improving. Patient ambulated to the bathroom with no difficulty. Rechecked vital signs at 1100- symptoms "almost completely" resolved. BP 126/78 P 100 98%. Patient released from the clinic with the direction to go to ED if worsening or returning symptoms. Mom verbalized understanding.
Information has been received from a registered nurse concerning an 8 year old male, with no medical history and no allergies, who on 08-SEP-1999 was vaccinated with Varivax (Merck). There was no illness at the time of vaccination. There was no concomitant medication. On 14-NOV-2006 the patient developed 30-35 "maculopapular lesions vesicular" on the hair line, trunk, groin, arms, and legs. The patient sought medical attention. Treatment included diphenhydramine (Benadryl) and another unspecified therapy. No diagnostic laboratory tests were performed. Subsequently, the patient recovered. Additional information has been requested. No further informtion is epxected.
Menstrual spotting after 9 months of no period (perimenopausal), severe cramping, severe fatigue
The wife called the pharmacy on Sept 15, 2022, informing us that her husband was rushed to the emergency room on Sept 13, 2022. According  to her, the husband was fine after the vaccination (Sept 12th) but on the morning the next day (Sept 13th), he suddenly fell from a chair and he was so weak, hot, sweaty, delirious, speaking garbled. She brought him to the emergency room and was treated with IV fluids and antibiotics. Doctors from the ER said his condition might have come from the vaccine. He was discharged the same day. His husband was just in bed since then, not able to eat, drinks only water.   I called on Sept 16th to check on patient's condition and she said he still weak. Her husband who is healthy and never gets sick suddenly  became weak after getting the Pfizer Bivalent booster dose.
nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     No medical history reported.     On an unknown date, the patient received dose of mRNA-1273 (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced NAUSEA (nausea). At the time of the report, NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No concomitant medication listed.    Reporter did not allow further contact
rt leg red, swollen, hard lump under skin 24hr p/vax;warm to touch;applied warm compresses & APAP given;
1-14-10 Late afternoon-fatigue, feverish, nausea-woke 1 AM-HR 162, nausea, vomit and increased back pain over L kidney area. Injection site normal-no swell, no redness. 1-15-10 3PM vomit, chest tight, HR 137, mouth, lips are dry. No hives, dizziness, wheezing, SOB. Tried ginger in water-eased nausea-drink water, powerade. No further vomit. 1-16-10 HR 80-no further symptoms. He felt "ginger and fluid flushed problem from system". No hx of kidney stones/problems
Mom called and stated he woke with 3-4 inch oblong reddened area at site of injection. Underneath the area is a now circular welt that is swollen beyond the red margin. It is itchy, red and warm to touch.
EXTREMELY sore left arm within two hours of the shot. This lasted until I woke up the next morning. My entire arm, down to the wrist hurt.  Also within two hours of the shot my knee joints were very stiff and sore to the point that my right knee would not bend. I iced the knee all evening. I didn't feel like I had a fever but my body felt hot.  Then the fatigue and fogginess set in to the point I just went to bed. The brain fog, tiredness and stiff knee lasted for 2 days.  Please note that I'm in extremely good physical health and workout daily.
No adverse effects reported; Improperly stored vaccine was administered to one patient; Assistant confirmed route of administration was "intramuscular"; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 13-SEP-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml, once, intramuscularly, lot No. S002736, expiration date 28-JAN-2021, for prophylaxis (strength was not reported). Varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT), possible lot # S000130, expiration date reported as 23-AUG-2021.  The temperature excursion was of 8.1 Fahrenheit degrees (°F), during 20 minutes. However, a previous temperature excursion of 8.1°F for 17 minutes and 9.5°F for 21 minutes were also reported. A digital data logger was involved. No adverse effects were reported.
a pretty decent sized, red, warm, firm welt that's about 2 inches in diameter at the injection site; a pretty decent sized, red, warm, firm welt that's about 2 inches in diameter at the injection site; a pretty decent sized, red, warm, firm welt that's about 2 inches in diameter at the injection site; This is a spontaneous report from a contactable other hcp (patient). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unknown route of administration in left arm on 03Jan2021 10:45 at single dose for COVID-19 immunization. Medical history included birth control. No known allergies. Concomitant medications included drospirenone, ethinylestradiol (OCELLA) for birth control, escitalopram oxalate (LEXAPRO). Patient had a pretty decent sized, red, warm, firm welt that's about 2 inches in diameter at the injection site. She noticed it about 4-5 hours after the injection and it hadn't changed since. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The outcome of the events was not recovered.   Information about Lot/batch number has been requested.
Upon returning for her second dose, patients states that several days after her first dose, a small bump was felt near her left collar bone. 4 weeks later, it is still present
Pt was administered second dose of pfizer after assessment by PA. Pt reported that he felt "hot" within min of administration. Vs stable and pt skin was warm and dry. Pt tolerated po water w/o difficulty. Pt bp and pulse monitored after 30 min watch over at 1335 as pt aroused and still c/o feeling warm. Sandwich and juice offered and refused, cold pack offered and pt placed behind his head. Pt then noted to sleep with easy rr, skin remained warm and dry, no c/o nausea, no redness, itching or hives noted.  After 1 hr watch, 1405,  pt aroused and was ambulated in the hall with continuous pulse ox which remained above 93% on ra with ambulation 40 feet. Pt c/o "not feeling well', c/o still feeling hot and has a cough that leads to sob. Pt noted to have slight audible wheezing as reported by PA. O2 sats at this time are still maintained above 93% which is pt baseline. Pt was slightly unsteady on his feet while ambulating. Pt to take rescue inhaler but did not bring it with him. Medical response called and pt taken to ED across the hall via WC with this writer. Report given to RN in ED.  1310 152/87 93% 18 1344 147/87 69 96% 97.9 18 1354 130/87 77 94% 18 1404 89 95% 20
This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient had a single dose of Shingrix in 2018).   In December 2021, the patient received the 2nd dose of Shingrix. In December 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had a single dose of Shingrix in 2018 and another dose this week at the time of reporting, which led to lengthening of vaccination schedule.  The reporter asked that he/she need a second dose or was the one I just had considered a second dose.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified date in March 2018, reported as between the 8-MAR-2018 until 14-MAR-2018, the patient was vaccinated with and improperly stored dose of RECOMBIVAX HB injection, lot # M022077 expiration date 10-MAR-2019 (also reported as 10-MAY-2019) for prophylaxis (route and anatomical location were not provided). The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F during 55 minutes as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported.; Sender's Comments:  US-009507513-1803USA006513: US-009507513-1803USA009619: US-009507513-1803USA009620: US-009507513-1803USA009621: US-009507513-1803USA009622: US-009507513-1803USA009623:
Within 6 hours, sore throat; 24 hours conjunctivitis, then full blown head/chest cold.