chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hot flash; small black and blue and a big red patch with lump; Later that night small black and blue and a big red patch with lump; itchy; Injection area hot to touch/ hot to touch,; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Apr2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food or other products. 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 08Apr2021, after the 15 minutes wait, the patient experienced hot flash and injection area hot to touch. Later that night small black and blue and a big red patch with lump which was hot to touch and itchy. Every day it was getting larger. The event 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 hot flash, injection area hot to touch, small black and blue and a big red patch with lump which was hot to touch and itchy was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Lips, face, tongue, throat swelling and inflammation.  At day 2 my tongue, throat and mouth broke out in lesions.  It took a steroid to lesson the swelling and pain after 4 days.  I had to go to the ED as throat was closing. I had an event in Dec 2020, March 2021 and July of 2022 - following each dose:  dec 2020, jan 2021, nov 2021, July 2022 Pfizer
High fever starting 2 hours after the vaccine, and reaching over 105 degrees F. Fever lasted 7 days. General feeling of malaise.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 02-JUL-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K027566, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Administered expired vaccine to the patients with the lot number 067F21A; The vaccine expired in the freezer on 6Apr2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patients with the lot number 067F21A) and PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 6Apr2022) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 prophylaxis.     Allergies of the patient were unknown. It was unknown if the patient had ever had COVID + test or diagnosis.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-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 received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patients with the lot number 067F21A) and PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 6Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patients with the lot number 067F21A) and PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 6Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was reported that the vaccine expired in the freezer on 6-Apr-2022. The vial was initially stored in the refrigerator on 28-Apr-2022 and 04-Apr-2022. The vaccines were administered on the following days :18-Apr-2022, 26-Apr-2022, 25-Apr-2022, 16-May-2022 and 17-May-2022. The patient received second booster dose. The vial did not undergo any temperature excursions. It was unknown if other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Treatment information was not provided.   This case was linked to MOD-2022-593844, MOD-2022-593857, MOD-2022-593856 (Patient Link).
sore left arm; Received 1st Moderna dose in error/Under age 18; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st Moderna dose in error/Under age 18) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Dec-2021, the patient experienced VACCINATION SITE PAIN (sore left arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st Moderna dose in error/Under age 18). On 06-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st Moderna dose in error/Under age 18) had resolved. At the time of the report, VACCINATION SITE PAIN (sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. No treatment medications were provided.  It was reported that the caller reported that her daughter may receive PFIZER as her second dose.
Pt developed severe discomfort in the injection arm 9 hours after the injections. 27 hours later a diffuse rash developed on the injection arm. At 46 hours (time of reporting) pain and rash are unresolved despite aleve and tylenol treatments for the past 24 hours.
Covid; Covid; diarrhea; throwing up at the time; headache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (NOT AVAILABLE). Other Case identifier(s): US-ABBVIE-4134369 (Company).  A 74-year-old female patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Batch/Lot number: unknown), on 10Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 2022, outcome "unknown", described as "diarrhea"; HEADACHE (non-serious) with onset 2022, outcome "unknown"; VOMITING (non-serious) with onset 2022, outcome "unknown", described as "throwing up at the time"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2022, outcome "recovering" and all described as "Covid". Clinical information: In Jul2022, the patient had covid. She was still recovering and getting her strength back. She was throwing up at the time as well as diarrhea and headache for eight days straight.  The reporter's assessment of the causal relationship of "covid", "diarrhea", "throwing up at the time" and "headache" 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 Broke Hip, Blisters popped up on left leg, Covid/words that was trying to say was not coming out, Fell and Leg and foot swell up/right leg a bit swollen with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was No Reasonable Possibility. The reporter's causality for the event(s) of Covid/words that was trying to say was not coming out with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility.  Sender comment: Company's Alternative Etiology for Covid/words that was trying to say was not coming out with Adalimumab Solution for Injection: Event is more likely related to SARS CoV 2 global pandemic outbreak in this elderly age patient with underlying crohn's disease. Company's Alternative Etiology for Covid/words that was trying to say was not coming out with Adalimumab Solution for Injection: More likely related to concurrent covid infection in this elderly age patient.  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 provided, a causal relationship between BNT162b2, and the events Suspected covid-19, drug ineffective, diarrhea, vomiting, and headache cannot be excluded.,Linked Report(s) : US-ABBVIE-4134369 Company;
Itching and swelling at injection sight. Turned red and is about 3" in diameter.
4 days post vaccine continue with icepick headache, general malaise with severe fatigue, experienced suicidal thoughts day 2, unable to carry out routine activities through day 4 post vaccine.
Information has been received from a licensed practical nurse concerning a 71 yr old Caucasian male pt with allergy to tetanus, abdominal aneurysm, high cholesterol and hypertension who on 02Nov04 at 4:40PM was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot649912/0529P), IM in the right deltoid. On 03Nov04 the pt was now having reaction red/swollen was itchy, now painful warm to touch. The pt also c/o of flu symptoms achy all over. There was noted swelling and redness to the right upper arm. The impression was reported as cellulitis/allergic response, with an onset date of 02Nov04 at 4:40PM. The pt was prescribed cefdinir (Omnicef) (300mg) (BID) (for 10 days) and fexofenadine hydrochloride (Allegra). The pt recovered. No product quality complaint was involved. No further information is available.
This spontaneous report was received from a licensed practical nurse referring to an unknown number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions or concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M023932 with an expiration date in 24-DEC-2017 and Lot # M023932 with an expiration date 09-NOV-2017), for prophylaxis, that underwent a temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit, for a time frame of 32 hours and 13 minutes. The vaccines had a previous temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for a time frame of 14 hours. No digital data logger was involved, no adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Patient was given the wrong vaccine at 9 month PE, this was discovered with next PE. Child had no adverse reactions to vaccine.
Started losing my voice around 6 pm the same day as shot.  Then my lip swelled up just on the right side.  Little trouble swallowing.  Went to ER.  Dr. did ask if I was taking Lisinopril and told me to stop taking it immediately.  Gave me an IV of Prednisone and Benadryl.
Blood clot formed in leg then went to lungs.  Bilateral PE is diagnosis. Almost died from the event.  In hospital for 5 days,  went into a fib and now has heart issues.
Swelling in scalp and forehead; Swelling on face including eyes and nose; This spontaneous case was reported by a physician and describes the occurrence of SKIN SWELLING (Swelling in scalp and forehead) and SWELLING FACE (Swelling on face including eyes and nose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 016M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced SWELLING FACE (Swelling on face including eyes and nose). On 06-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN SWELLING (Swelling in scalp and forehead). At the time of the report, SKIN SWELLING (Swelling in scalp and forehead) and SWELLING FACE (Swelling on face including eyes and nose) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information provided by the reporter.  She has no history of receiving dermatological fillers  It was reported that Patient visited emergency room on the night of booster dose and received IV fluid, antibiotics and allergy medicine.  Symptoms settled slightly but still ongoing.
Unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients/ the product reached a highest temperature of 9C; This non-serious spontaneous safety report, with reference number 02268180/ Interaction# 02268162 was received on 17-OCT-2022, from a non-health Professional.   Due to the nature of the event, the causality between the event "Unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients/ the product reached a highest temperature of 9C" and Vaxelis was not applicable.  Further information is expected.  For reference purposes this case is linked to MCM-004173, MCM-004203 and MCM-004204.
Mother states that child collapsed and was having DIB. 911 was called. Pateint temp was 99.0 when ambulence arrive. Child vomited. Temp was 102.7 at hospital. Tylenol given. Chest xray, UA, and strep test was negative. Child was released. Dr. suspected febrile seizure r/t MMR. Referred to Pediatric Neurologist.
Pt appeared w/redness, soreness and hot area where shot was administered. Also a little swollen w/a small knot.
On November 8, pt had strange feeling in tongue, hard to talk. On November 9, had stroke, worse than the day before. Hospitalized, as of this date speech still affected. Also coordination in the right hand affected.alxo Dysarthria. Per 1 year follow up:  Pt has not recovered. I have been left with a speexh impediment. Also a weakness in my voice and unable to sing like before. I have difficulty writing.
Patient was given second vaccine too early. Patient received second vaccine only 13 days after first vaccine.
Pt exited building, returned to complain of rash on face. Redness to cheek, chin, neck, and chest was found. Benadryl 25mg/10ml  oral soln administered @1:18pm. Pt declined going to ER. Second dose of Benadryl given. Reported she will go directly to ER if she feels any worsening reaction.
Immediately following vax, the injection site appeared red and irritated, no lesions were present. Approximately 4 weeks post vax, the pt developed a little hard ball at the injection site. Six weeks post vax, the child was seen by her MD and he noted a red, indurated area at the site of the vax, no lesions or vesicles present. Sometime later, the pt was playing and bumped her leg at which time the indurated area began to drain. the pt was referred to a dermatologist for evaluation and possible biopsy.   It was noted that the site was a nodular infiltrated necrotic plaque on the left leg. They attempted to biopsy the area but the tissue was quite necrotic and friable. The physician reported that they had a hard time getting a good specimen. They ended up excising the entire area.  Additional information from a woman in the lab stated she could not do PCR on any specimen fixed in formalin.   Upon medical review the pt's experienced of injection site reaction and possible related foreign body was considered to be an "other medical event". Additional information has been requested. Prior to vax, pt was a healthy child with no known immunosuppression. Follow-up from the pt's physician indicated the pt's experiences were not likely related to the vaccination with varicella virus vaccine live, since after checking the pt's records, it turned out that the varicella vaccine was given in the other leg (right) and not the leg in which the pt experienced the symptoms. The reporter stated that they never made a definitive dx and never found anything from the tissue excised. He stated the child's experiences could have been from a bug bite or from a foreign body and previous injection in the leg; however, they did not know for certain. The reporter stated the pt completely recovered from the experiences and was "fine" at the time of the report. Follow-up states that it has been determined that information pertaining to this pt had been previously received and assigned a separate mfr control number. This submission is a consolidation of 2 reports. Therefore, all data pertaining to this pt has been consolidated into WAES00082904.
Patient received H1N1 injectible and seasonal flu injection. Approx 20 min after injection patient stiffened fists and arms and per teacher almost passes out. Did not fall or injure self. BP 98/palpated Pulse 100 RR 20.
Pt complained of headache 5 min after injections. Placed pt on left side SXS within normal limit. Headache after 15 min. Pt remained on left side for additional 15 min. SXS continued within normal limit called pt at 4:00 pm husband stated she is out driving and feels fine.
Received second dose of the Moderna COVID-19 vaccine on 3/29/2021. On 3/31/2021, I was awoken at approximately 0230 am with severe chest pain. I went to the emergency room later that day and medical staff stated a blood test showed my heart was under stress. My systolic blood pressure also dropped into the low 80's. I was admitted to the hospital and stayed for two nights as multiple tests were conducted. I was discharged from the hospital on 4/2/2021 with the diagnosis of myocarditis and pericarditis. It was determined the only cause of this condition for me could be the COVID vaccine.
Employee reported having a rash, erythema and welts begin to develop at injection site immediately after receiving the vaccine, then over the next 24 hours worsened too involve entire left arm and right-hand 5th finger only, which she reported as "having a change in sensation- like numbness, tingling in that finger."  Employee also had a Tb skin test placed that same day on the left forearm.
Flu shot was given above the proper muscle, given in the burses(sp?)  It has left me with painful use of my arm and my current Dr. feels I need therpy to get the use back in my arm.
Mother said the pt. is fine, no adversed reactions.  We used the adult primary vial to  mix with diluent and given 0.2ml instead of the pediatric vial.
left upper arm swelling, redness and tenderness since 3/3, was improving but redness spread down to elbow
Information has been received from a registered nurse (R.N.) concerning a female who on an unknown date, was vaccinated with ZOSTAVAX (Merck) (dose, route and lot# not reported). Subsequently the patient experienced rashes. It was unknown if the patient sought medical attention. At the time of reporting, the outcome was unknown. No further information is available.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 69-year-old female patient who received SHINGRIX for prophylaxis.  On 2nd August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 3rd August 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, pain and fever. On an unknown date, the outcome of the influenza-like symptoms, pain and fever were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on unknown arm. The patient stated the day after she had the 2nd dose of SHINGRIX, she developed flu like symptoms as aches and fever. The patient provided the contact details of physician. This case has been linked with US2018141960, reported by the same reporter.
site became increasingly red, warm, tender to touch, swollen, did not respond to over the counter analgesics or ice, left axilla swollen, raised area approximately 40 X 60 cms located 20cms below injection site
hey i got mine my arm still hurts ouch ha ha; Initial information received on 18-Oct-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer).  This case is cross linked with 2020SA296074 (cluster)   This case involved a patient of an unknown age and gender who get the Pain in arm (Pain in extremity), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient stated hey i got mine my arm still hurts ouch ha ha (Pain in extremity).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as not resolved for the event of Pain in extremity.  There will be no information available on the batch number for this case.
Difficulty and pain when extending my arm straight up, reaching behind my back, and if strongly pulled, when extending my arm forward (when I'm walking my dog and he lunges forward.
1/6/21:  tiredness 1/7/21:  swelling, erythema, induration & pruritis at injection site, increased over next 9 days to size of 4" x 3", until 1/15/21.  Symptoms resolved on 1/16/21.
Second dose, left pins and needle foot pain. Both right and left leg from knee down numbness, tingling, feels static like. When walking I feel like I'm wobbling, sometimes feels like lower portion of my leg is both there. Have had extreme tiredness but legs numbness affecting sleep. Walk really slow and cannot stand for long since I feel unstable. When walking left foot hurts. All symptoms started day one into day two.
After immunizations given, pt crying & then become very pale, sleepy & difficult to keep awake. Pt was seen in ER. After a period, resolution of symptoms & discharged home.
Made sleep worse; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Made sleep worse) and MYALGIA (Soreness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced INSOMNIA (Made sleep worse) and MYALGIA (Soreness). On 01-Mar-2021, INSOMNIA (Made sleep worse) had resolved. At the time of the report, MYALGIA (Soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-120833-second dose (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Additional Dose 1 information and dose 2 (new case created)  No treatment related information has been reported.