chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very strong nosebleed; Little pain in her shoulder; Inappropriate age at vaccine administration; off label use; unapproved population; This is a spontaneous report received from a contactable consumer(mother) or other non hcp. A 15-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration in Arm Left on 19May2021 12:00 (at the age of 15-years-old) as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks, prior to the vaccination and adverse event following prior vaccinations. Caller was a consumer (Consumer daughter) calling regarding the Pfizer Covid-19 vaccine and his daughter was the patient, who will be 16 in 2 months got the Covid-19 vaccine on Wednesday, 19May2021. Caller reported that the patient didn't feel anything bad other than a little pain in her shoulder. Next day on Saturday, 22May2021, the patient got a very strong nosebleed in the morning. Caller stated that he doesn't know if the patient's nose-bleed was related to the Covid-19 vaccination and maybe it's not related. Caller reported that the patient's second dose of the Covid-19 vaccine is already scheduled. Caller reported that the patient strongly believes that her nosebleed was not related to the Covid-19 vaccine. Caller stated that he does not know honestly if the Covid-19 vaccine was related to the patient's nosebleed, but he does not want the patient to get the second dose if she had this kind of reaction. Caller inquired what they should do. Caller didn't know the patient's exact weight. Caller declined to provide his address and that he did not have the patient's primary care physician's information. The patient experienced just slight pain in her shoulder later in the day on 19May2021. Caller reported that the patient was done after 2 days with the arm pain and patient got the nosebleed on the morning of Saturday, 22May2021. Caller reported that he doesn't remember the patient having any nosebleeds in the last 5 years. Patient's nose bled just the one time and nose stopped bleeding within half an hour and an hour later the patient felt fine. Caller reported that the patient's nosebleed was pretty bad. The whole sink was covered in blood from the patient's nose. Caller unable to provide product details for the patient's Covid-19 vaccine as he does not have the patient's vaccination information with him at time of call on 24May2021. The patient Didn't any AE(s) require a visit to Emergency Room and Physician Office. The outcome of the very strong nosebleed, little pain in shoulder was recovered and unknown for other events.  Information on lot/batch number has been requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021 at 1:47 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Mar-2021 at 1:47 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On 02-Mar-2021, Excursion time was 09 AM, temperature was 27, total doses given for the day was 177, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 02-Mar-2021. 16 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021, Excursion time was 10AM, temperature was 29, Excursion time was 11AM, temperature was 32, Excursion time was 12PM, Excursion time was 33, Excursion time was 2PM, temperature was 35, Excursion time was 3PM, temperature was 36. Vial was stored on cooler 1, on 02-Mar-2021, Excursion duration At 9 AM: 27, 10 AM: 29, 11 AM: 32, 12 AM: 33, 1PM: 36, 2 PM : 35, 3 PM: 36, 4 PM: 37 and 5 PM : 37. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Patient was under-dosed an given 0.25 ml rather than 0.5 mL
I tested positive for COVID-19 on 3/9/23. I had very mild symptoms. I had a sore throat and a small amount of congestion. I contact my doctor and was prescribed Paxlovid. After finishing Paxlovid I had a rebound case on 3/23/23. I had congestion, and nasal congestion. I was not prescribed medication this time, but I took Ibuprofen and Sudafed. I tested negative again on 3/26/23.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 95-year-old male patient received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 02Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 95 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Feb2021 at 14:00 as dose 1, single (Lot number: 032L20A), in left arm and on 03Mar2021 at 13:30 as dose 2, single (Lot number: 032L20A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "htn" (unspecified if ongoing); "PVD" (unspecified if ongoing); "BPH" (unspecified if ongoing); "DM" (unspecified if ongoing); "Parkinsonism" (unspecified if ongoing); "MI" (unspecified if ongoing); "CAD" (unspecified if ongoing); "Afib" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN oral, start date: 23Jun2022; METOPROLOL TARTRATE oral; METFORMIN oral; MELATONIN oral; LEVOTHYROXINE [LEVOTHYROXINE SODIUM] oral; GABAPENTIN oral; PROSCAR oral; FERROUS GLUCONATE oral; LIPITOR oral, start date: 23Jun2022; ACETAMINOPHEN oral; ASPIRIN (E.C.) oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jun2022, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2022) positive; (08Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid Treatment received (from 23Jun2022 to 27Jun2022) for COVID 19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
Pt was brought into triage area by vaccinator after receiving 1st dose of Pfizer vaccine @ 2:30 pm. Vaccinator notified writer that pt reported he was feeling dizziness related to needles. Pt stated he wanted to sit for a moment after his vaccination. On-site NP were notified. Vaccinator completed vital signs BP 92/58, HR 69, O2 98% room air. Pt denied experiencing SOB or any abnormal symptoms. Continued to monitor pt for approximately 20 minutes. Encouraged pt to drink more water. Pt stated improvement in sx and was cleared by onsite NP to go home. Encouraged Pt to call 911 for any new or abnormal sx, and to bring companion with him to next appointment. Pt left clinic A/O x4 with stable gait.
Fever, hot and cold chills (cellulitis). TX. KEFLEX, 1 tab, TID for 7 days - 500mg.
Asthma; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthmatic attack (2 Asthma attacks Occurred During at High school Graduation 1962/1963.) from 1962 to 1963. Concurrent medical conditions included Asthma.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-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 ASTHMA (Asthma). At the time of the report, ASTHMA (Asthma) had not resolved. Not Provided          No concomitant treatment was provided. No treatment medication was provided.  Patient had experienced Difficulties with Asthma but those difficulties substantially lessened and he was not experienced in his school age that 1957-1961 after that he had 2 attacks in his high school graduation that is in 1962-1963. From 1963 onwards patient had no difficulties with Asthma and until recently Seldom gave it a thought but Asthma has no become a daily and continuing problem. Patient was curious about is there any linkage between Moderna covid vaccine  and Asthma.
Expired dose; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B2A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were provided.
Information has been received from a physician concerning an adult female with no known medical history or allergies who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient had the gpELISA antibody test performed and the results was 0.91 equivocal. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information from the physician indicated that he was inquiring to request information regarding ELISA titers that would be expected after vaccination, not because of an adverse experience. No further information is expected.
Aching body after first shot; Joint pain after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aching body after first shot) and ARTHRALGIA (Joint pain after first shot) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN (Aching body after first shot) and ARTHRALGIA (Joint pain after first shot). At the time of the report, PAIN (Aching body after first shot) and ARTHRALGIA (Joint pain after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported.  Treatment medications was not reported.   This case was linked to MOD-2021-329346 (Patient Link).   Reporter did not allow further contact
inflammation; warm; redness; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported same events for 2 patients. This is 2nd of 2 reports. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number X62324), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported inflammation, warm and redness in a patient previously vaccinated with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The reporter suspected that these reactions were caused by the same lot number (X62324). Outcome of the events was unknown.; Sender's Comments: Linked Report(s) : PR-PFIZER INC-2019345709 Same reporter/ drug/ event for different patients
Strong cramp-like feeling in front, below breaststroke, both sides of chest which moved to the back and located primarily between the scapula. Deep breaths and walking did not relieve the symptoms. Symptoms worsened while lying down. Similar symptoms occurred after the second dose but not with the first dose. Ibuprofen 200 MG (2 tablets) relieved the symptoms after 1 hour. Symptoms have not returned.
tested positive for covid; Little cough; Body aches; Sore throat; Congestion; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Congestion), COVID-19 (tested positive for covid), COUGH (Little cough) and MYALGIA (Body aches) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression and Mood disorder. Concomitant products included BUPROPION for Antidepressant therapy, LAMOTRIGINE for Mood disorder.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Congestion), COUGH (Little cough) and MYALGIA (Body aches). On 13-Aug-2021, the patient experienced COVID-19 (tested positive for covid). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Congestion), COVID-19 (tested positive for covid), COUGH (Little cough) and MYALGIA (Body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded but is unlikely as the events are more likely related to the event of COVID-19.
diarrhea started within 3 hours of receiving vaccine and has continued for 3 days. he started having moderate-severe fatigue 1 day after and has lasted since.
going to pass out on; blurred vision; little lightheaded; This is a spontaneous report from a contactable consumer reported for self. This 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 07Apr2021 for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient was a "little lightheaded" the first day (on 07Apr2021) but "it wasn't bad". He then explained since Saturday, 10Apr2021, he was experiencing "dizziness, a blurred vision, and was lightheaded". He specified he thought he was "going to pass out on" that Saturday 10Apr2021. He explained that his symptoms "won't go away" and he was concern about their persistence. He asked if similar symptoms were reported as side effects from the vaccine. Patient was concerned on getting the second dose due this coming Monday. He then said he would need medical advice. The outcome of events was not recovered.  Information about Batch/Lot number has been requested.
swelling on her face, ears and across the bridge of her nose; ear swelling; swelling on her face, ears and across the bridge of her nose; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling on her face, ears and across the bridge of her nose) and SWELLING (swelling on her face, ears and across the bridge of her nose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VITAMINS NOS for an unknown indication.    The patient's past medical history included No adverse event (no medical history found). Concomitant products included MACROGOL 3350 (MIRALAX) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and VITAMINS NOS (unknown route) at an unspecified dose. On an unknown date, the patient experienced SWELLING FACE (swelling on her face, ears and across the bridge of her nose) and SWELLING (swelling on her face, ears and across the bridge of her nose). At the time of the report, SWELLING FACE (swelling on her face, ears and across the bridge of her nose) and SWELLING (swelling on her face, ears and across the bridge of her nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient using blood pressure medication no treatment provided
No adverse event. This is a medication administration error. She is 17 and received Moderna.
Muscle fatigue and lightheadedness.  Treated with rest and Ibuprofen.
Fever, chills, nausea, sore achy muscles,  swelling and pain at injection sight, no energy - exhausted, headache and unable to get warm, dizziness. Little appetite and dizzy several times 6 hours after receiving the shot.     Illness hit hard Monday afternoon (2/7) left work early, Tuesday was no better (2/8) unable to work,.  Finally made my self have a shower at 5:00 pm.  Now I was clean and sick.  Still no change, very ill.  Through Tuesday night, waking several times, felt awful.  Awoke Wednesday morning (2/9) feeling much better, enough to work.
big red rash the size of his palm; his arm was sore; stiffness; swelled up; rash; an itch near his injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (big red rash the size of his palm), PAIN IN EXTREMITY (his arm was sore), MUSCULOSKELETAL STIFFNESS (stiffness), VACCINATION SITE PRURITUS (an itch near his injection site) and VACCINATION SITE SWELLING (swelled up) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A or 001M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (an itch near his injection site). On an unknown date, the patient experienced RASH ERYTHEMATOUS (big red rash the size of his palm), PAIN IN EXTREMITY (his arm was sore), MUSCULOSKELETAL STIFFNESS (stiffness), VACCINATION SITE SWELLING (swelled up) and VACCINATION SITE RASH (rash). At the time of the report, RASH ERYTHEMATOUS (big red rash the size of his palm), PAIN IN EXTREMITY (his arm was sore), MUSCULOSKELETAL STIFFNESS (stiffness), VACCINATION SITE SWELLING (swelled up) and VACCINATION SITE RASH (rash) outcome was unknown and VACCINATION SITE PRURITUS (an itch near his injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received the first dose on 13FEB2021 and his arm was sore for two days and then went away. On 26FEB2021 last night he had an itch near his injection site. He saw that the area has swelled up with a rash and a stiffness. It is a big red rash the size of his palm and now the itchiness went away. He states it looks as if someone had slipped a cardboard underneath his skin
Patient presented in normal healthy condition. After describing side effects and precautions, patient was administered vaccine through intermuscular route. Patient appeared to have a normal response to the administration and showed no reaction. The patients wife was the administered the vaccine within 2-3 minutes in the same treatment room. After her administration, the patient was noted with his head positioned forward, pale skin color and no response to questioning. At that point an emergency response was called. The patient remained unresponsive. At the time he was seated. Within about 2 minutes, the patient was laid on the floor and quickly returned to normal consciousness. The emergency squad was called and responded in about 10 minutes. By the time the emergency arrived the patient was fully recovered; he did not require further medical intervention.
I tested positive for Covid on June 16. I had direct exposure to someone else who had tested positive. My symptoms have been mild - primarily congestion and loss of taste and smell.
The soreness in my arm lasted less than 48 hours which was an improvement from the first shot. However, I experienced really bad chills for several hours starting at 9:30 PM and lasted until approximately 3:00 AM. Other than that, I have fully recovered from all symptoms.
tinnitus was reported as worsened; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Apr2021 17:30 (Lot number: EW0172) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: TINNITUS (non-serious) with onset 30Apr2021, outcome "not recovered", described as "tinnitus was reported as worsened".  No follow-up attempts are possible. No further information is expected.
Pt recvd 3 doses of Engerix-B on 18DEC90, 18JAN91, & 18JUN91; Antibody tests on 25JUL91 indicated pt was a non responder;
inconsolable crying all noc long, (>3hr) resolved 6AUG96 4AM; small local rxn lt thigh-muscle soreness refused to walk until 6AUG96 afternoon;