chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reporting large golf ball OR SOFTBALL SIZED WELT; hot to touch; swollen at the injection site; drunk/dizzy feeling; drunk feeling; This case was reported by a physician via call center representative and described the occurrence of injection site wheal in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than a month after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site wheal, injection site warmth, injection site swelling, dizziness and feeling drunk. On an unknown date, the outcome of the injection site wheal, injection site warmth, injection site swelling, dizziness and feeling drunk were unknown.   It was unknown if the reporter considered the injection site wheal, injection site warmth, injection site swelling, dizziness and feeling drunk to be related to Fluarix Quadrivalent 2019-2020 season.  Additional information received were as follows: The age at vaccination was not reported. The patient had large golf ball or softball sized welt, hot to touch, swollen, at the injection site, drunk and dizzy feeling, after vaccinated with Fluarix Quadrivalent 2019-2020 season. This case linked with US2019AMR181650, US2019AMR181432 and US2019AMR181652, reported by same reporter.
Redness and soreness on shot area, itching, swollen and hot. She also stated she had a headache.
Vial was initially stored in the refrigerator on 27Jul2022, vaccine administered on 31Aug2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 27Jul2022, vaccine administered on 31Aug2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 27Jul2022, vaccine administered on 31Aug2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 27Jul2022, vaccine administered on 31Aug2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 27Jul2022, vaccine administered on 31Aug2022).    No concomitant medications were reported. It was reported that 3 kids who got the Moderna 6 month to 5-year-old lot number AS1412B yesterday 31Aug2022 and it looks like it expired on the 27th.  The patient was under 5 years of age. The vial was initially stored in the refrigerator on 27-Jul-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.
Developed papular rash 6/15/2004. Seen in our office 6/16/04 for diagnosis of varicella. Benadryl for itching.
noticed a darkened urine color and still its happening; Fever & Body pain - almost gone; Fever & Body pain - almost gone; dose number 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2022 18:45 (Lot number: FL3209) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0182, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 07May2021, when the patient was 32 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 16Apr2021, when the patient was 32 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 18:45, outcome "unknown", described as "dose number 3"; CHROMATURIA (non-serious) with onset 05Jan2022 19:15, outcome "not recovered", described as "noticed a darkened urine color and still its happening"; PYREXIA (non-serious), PAIN (non-serious) all with onset 05Jan2022 19:15, outcome "recovering" and all described as "Fever & Body pain - almost gone". Therapeutic measures were not taken as a result of chromaturia. Therapeutic measures were taken as a result of pyrexia, pain.  Additional information: Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient was getting following side effects or events after 3rd COVID-19 Vaccine Pfizer BioNTech. The patient noticed a darkened urine color and it still was happening. The patient had fever and body pain - almost gone. The patient took 2 times Tylenol. The patient had no other medical issue and no known allergies.  No follow-up attempts are possible. No further information is expected.
Directly following vaccine adminstration patient experienced minor bleeding, instant swelling, and formation of a small knot at adminisrtation site.
Total body rash, erythematous macules, upper arms and legs, largest approx 5cm in diameter at injection site
pancreatitis Narrative:  Patient received his first COVID vaccine on 1/27/21 (per policy/protocol) and on 1/29/21 he presented to our ER with c/o abd pain, nausea and vomiting, vital signs stable, CT done and he was found to have gallstones, lipase done and was 2606; therefore he was admitted to acute care medicine with a diagnosis of pancreatitis. He was given IV fluids and made NPO and lipase improved (on 2/5/21 it was 70). On 1/31/21, he was given a liquid diet and on his IV fluids were stopped on 2/1/21 and he was advanced to a regular diet.
Lips itchy, edema, given Benadryl 25mg. symptoms resolved.
moderna vaccine cause hypothermia; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (moderna vaccine cause hypothermia) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOTHERMIA (moderna vaccine cause hypothermia). At the time of the report, HYPOTHERMIA (moderna vaccine cause hypothermia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment drug information was not given.  Company Comment: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.
Patient experienced a vasovagal reaction to the vaccine. 911 was called to further assess as patient displayed seizure like behavior as well. He lost consciousness momentarily. When he came to, he still was not able to respond well to our questions . His pulse was steady and his breathing was not labored. He threw up 3 times. His complexion was very pale. While EMS providers evaluated him, he continued to respond better to questions, regained his color, and was ultimately able to leave the clinic with his family. EMS determined that he experienced a vasovagal reaction and all his assessments came back within normal limits.
INCORRECT PRODUCT STORAGE; RECEIVED THE JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLES TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported. On 05-MAR-2022, the patient experienced received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220649370, 20220650014, 20220649704, 20220649804, 20220649045, 20220650111, 20220649417, 20220649421, 20220649137, 20220649884, 20220649488, 20220649626, 20220649915, 20220650185 and 20220650933.
patient experienced reaction after covid shot. had a swollen lymph node on bottom front of neck. Had rash on right arm (just below site of administration) which patient characterized as red and about the size of 2 quarters (currency) and was not itchy. occurred a few days following vaccine and has nearly dissipated. patient requested rph file report.
Day of injection, patient felt nauseated with dry heaves. Continued for 1.5 days on and off. No other symptoms or adverse effect. Stated that she may have had the series of hepatitis B before but couldn't remember.
Information has been received from a health professional concerning an 18 year old female, with a history of cystitis cystica, no known allergies, and urinary tract infection at the time of vaccination. On 07/11/2001 was vaccinated with the first dose of hep b vaccine recombinant IM in the left deltoid, following a physical examination. Concomitant therapy, that day, included the first TB test (tubersol) administered in the right forearm. There was no other concomitant medication. Two hours later, at 4pm on 07/11/2001, the pt experienced lightheadedness and dizziness, didn't feel well and thought she may pass out. She complained of feeling "weak and drained." The pt sought unspecified medical attention. It was reported that she did not require any hospitalization or further check-up. It was noted that she "felt better later on that evening." Subsequently, the symptoms resolved and the pt recovered on 07/12/2001. It was noted that neither the pt or a sibling experienced any adverse events following prior vaccinations. No further info is available.
Pt had symptoms start 05/24 including difficulty breathing, chills, 102 fever, pneumonia. Patient was hospitalized from 05/25 through 05/29 for pneumonia and covid.
13 days after the injection, the pain at the injection site came back and developed a rash, which spread from my shoulder to wrist.  I had severe pain that ran up my cranial nerve, behind my ear, and above to the top of my skull.  The pain was a burning, stabbing, electrical-shock type pain.
The patient says yesterday went into a pharmacy, got second set of her Shingles shot. Arm is sore, red, feels warm to touch, tender. Redness has gotten redness. Not sure if should be concerned but she is, has gotten larger. No subjective fever. No nausea/vomiting. No dyspnea. No tongue swelling/throat swelling/trouble swallowing. +PCN allergy noted - got bad hives. Has tolerated cephalexin in past when had sinusitis and has tolerated bactrim in past for UTI's.
52 y/o female received Moderna Covid vaccine dose #1 on 12/31, noted some mild injection site discomfort at the time and for several days after.  She developed HA, fatigue after the vaccination    On Tuesday she noted some discomfort in her left axilla and may have felt some enlarged lymph nodes.  Today she noted a swelling in her left deltoid that felt warm to the touch but has not been painful or itchy After getting home she noted a red patch near her left eye.  She denies difficulty breathing or swallowing.  Currently denies fever/chillls, HA. No prior h/o vaccine reaction.  She has not received another vaccine in the past several months.  She is not currently taking any medications including vitamins or supplements Has not yet tried any interventions for her symptoms
Caller is asking if there is any clinical trials for patients that have symptoms of long Covid/the Pfizer BioNtech Covid-19 vaccine gray cap bivalent along with a seizure drug help with her tremors; 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 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "neurological symptoms." (unspecified if ongoing), notes: has neurological symptoms. She is experiencing shaking of her hands.; "Shaking of her hands" (unspecified if ongoing), notes: has neurological symptoms. She is experiencing shaking of her hands.; "Tremors" (unspecified if ongoing); "compression fractures" (unspecified if ongoing), notes: She also reported 2 compression fractures from her Covid due to excessive cough.; "Cough" (unspecified if ongoing), notes: She also reported 2 compression fractures from her Covid due to excessive cough. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Caller is asking if there is any clinical trials for patients that have symptoms of long Covid/the Pfizer BioNtech Covid-19 vaccine gray cap bivalent along with a seizure drug help with her tremors".  Additional information : Caller is asking if there is any clinical trials for patients that have symptoms of long Covid. She states her and her husband are experiencing symptoms post Covid diagnosis and they both feel better after taking the Pfizer BioNtech Covid-19 vaccine gray cap bivalent.Symptoms described by caller: 66 year old female, has neurological symptoms. She is experiencing shaking of her hands. She states that the Pfizer BioNtech Covid-19 vaccine gray cap bivalent along with a seizure drug help with her tremors. She also reported 2 compression fractures from her Covid due to excessive cough. Caller also reported symptoms experienced by her husband: 62 year old male experiencing fatigue and neuropathy. Lies on the couch for a month, doesn't have the strength to do anything. He can't take a shower without a chair and is now on permanent dsability. States that the Pfizer BioNtech Covid-19 vaccine gray cap bivalent gives him energy and helps alleviate the fatigue. After a few days after taking his booster he has a lot of energy and feels better for a couple of month.   Follow-up attempts are completed. No further information is expected.
Client arrived at our mass covid vaccination clinic.  Medic asked if he was there for his second Pfizer vaccine.  He stated yes.  Medic provided vaccine then scribe noticed on Immunization card that his first vaccine was Moderna.
Patient had been very fussy and when mom picked baby up had become very tense and arched back and then proceeded to be hyperflexed for a few seconds. then was "out of it" for about 30 seconds. seen in ED had recovered and was diagnosed as breath holding spell. patient seen in clinic and is back to normal with feeds etc. afebrile through whole incident.
1day after vaccine,developed severe headache & later blister in head officially Shingle . Then decreased platelet count fatally to 29(ITP).now hospitalized getting treatment.
no adverse event; expired vaccine used/ Patients received this Moderna vaccine (lot 070H21A) between 8-Apr-2022 and 15-Dec-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ Patients received this Moderna vaccine (lot 070H21A) between 8-Apr-2022 and 15-Dec-2022) and NO ADVERSE EVENT (no adverse event) in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ Patients received this Moderna vaccine (lot 070H21A) between 8-Apr-2022 and 15-Dec-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ Patients received this Moderna vaccine (lot 070H21A) between 8-Apr-2022 and 15-Dec-2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ Patients received this Moderna vaccine (lot 070H21A) between 8-Apr-2022 and 15-Dec-2022).    Patient age was reported as 18 Year 11 Month. It was reported that lot 070H21A, that has an expiration date of 7-Apr-2022. Patients received this Moderna vaccine between 8-Apr-2022 and 15-Dec-2022. No concomitant medication were reported. No treatment medication were reported.
Starting 6 days (16 Jan) after primary Smallpox vaccine (3 jabs) presented to urgent care with complaints of sore throat, cough, vomiting and dizziness.  VS BP 144/77, Pulse 78 afebrile at 98.3. Care plan to inc fluids, otc Motrin/Tylenol, light diet, sick call in am if still feeling bad.  According to prescription history, patient seen at ER on 17 Jan and given prescription for azythromycin. No note available.  On 19 Jan he presented to primary care complaining of sore throat, cough, sinusitis, axillary lymph node enlargment, chills, flu like sx.  VS BP 100/69 HR 87 Temp 97.8.  Exam with tender neck, enlarged lymph nodes in cervical region.  A/P - Given treatment for pharyngitis/URI including -  Albuterol Inhaler 90 mcg Guaifenesin 600/PSE 120 Tylenol with Codeine #3 Advair 100/50 Solumedrol 125mg IM  On 20 Jan patient again presented to primary care - stating medicine effective would like quarters for another day.  Additional problems noted enlarged lymph nodes and sore throat.  Sent home for 24 h of quarters. Pt was seen at medical clinic treatment room on 25 Jan.  Unable to ambulate without assistance, repsonsive to opening eyes only, but no other commands, temp 103.2.  Transported immediately to Emergency Room.   Patient was admitted to hospital on 25 Jan and diagnosed with viral encephalitis.  At time of this report, patient is not communicative, "picking" at bed linens in disoriented way.  Able to move all extremities, fevers ranging from 103 to 101.  Treatment includes acyclovir and fluids, rocephin given initially with rash developing.  Hospital contacted by infectious disease MD for advice in treatment plan.  Advised no steroids at this time. 2/22/06-reviewed d/c summary and the primary diagnosis was stated  as 'aseptic encephalitis secondary to smallpox vaccination' and the secondary diagnoses as 'altered mental status, seizures, and chills secondary to above'.  2/23/06 Review medical record indicates patient had a temp of 103.2. 2/23/06-Review of ER record and handwritten progress notes essentially confirms above information.
8/25/2010 10PM had abdominal pain, irritability, and difficulty sleeping. 8/26/2010 11AM, fever detected by touch. 8/26/2010 4PM, fever of 100.5. 8/27/2010 1AM fever still persists.
3 WEEKS AFTER 2ND DOSE, PT EXP ITCHING AROUND MOUTH AREA, BACK OF NECK ITCHING. BRIGHT RED, LARGE HIVES APPEARED OVER ENTIRE BODY. SHE WAS TREATED WITH SOLU-MEDROL DOSEPACK, ATARAX(PRN), BENADRYL. BROKE OUT AGAIN(4-20-90) AND GIVEN ACTH GEL
Td left arm pt received 10 days ago. Still has big lump there. Warm to touch, pink, lower half of arm feels "funny". Feels like pulling a little by elbow. No soreness unless bumped. Induration about 1 cm left arm at vaccine site.
Rash welts scattered locations. Treatment - Prednisone - Hydroxyzine.
She felt the vaccine go down her arm; Rash around 3 inches down from the injection site; Vaccine really hurt; A spontaneous report was received from a consumer concerning 75 years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced felt the vaccine go down her arm,, rash around 3 inches down from the injection site and vaccine really hurt.  The patient's medical history was not reported. No relevant concomitant medications were reported.  On 25 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot: 042L20A) intramuscularly and on 23 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (lot: 023M20A)  in for prophylaxis of COVID-19 infection.  On 23 Feb 2021, after the second vaccination, the patient said it really hurt. She stated that the first person who did her vaccine shot, made the injection painless. She was concerned that the person who did the second vaccine dose, did not do the shot properly. She reported that she felt the vaccine go down her arm. She developed a rash around three inches down from the injection site and that was where she felt the vaccine in her skin.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s), therefore action taken with the drug in response to the events is not applicable.  The outcome of the events of felt the vaccine go down her arm,, rash around 3 inches down from the injection site and vaccine really hurt was unknown.   The reporter did not provide an assessment for the events felt the vaccine go down her arm,, rash around 3 inches down from the injection site and vaccine really hurt; Reporter's Comments: This report refers to a case of exposure via skin contact mRNA-1273 (lot # unknown)  with associated AEs reported as injection site rash and injection site pain.
LOSS OF FEELING IN CHIN AND LIPS . ACCORDING TO PATIENT THE VACCINE CAUSED NERVE DAMAGE IN CHIN/JAW THAT CAUSES PAIN WHEN HE IS TRYING TO EAT WITHOUT BITING LOWER LIP. IT IS STILL NUMB AND VERY UNCOMFORTABLE.  BITING THE LIP CAUSED FURTHER DISCOMFORT TO SEVERE PAIN. RESULTED IN SORE AND MADE EATING UNBEARABLE AT TIMES. PT WAS GIVEN MEDROL DOSE PACK BY DOCTOR BUT IT WAS NOT EFFECTIVE.
upper arm where i got the shot began to swell intensely. injection site was hot and painful to the touch. swelled up to about the size of a mandarin orange. swelling went down on day three, however a week and a half later i still have a red circle about the size of a US half dollar coin.