chrisvoncsefalvay/vaers-outcomes huggingface dataset:
roof of mouth is swollen; roof of mouth has painful bumps; her tongue is swollen and painfu; her tongue is swollen and painfu; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (roof of mouth is swollen), ORAL DISORDER (roof of mouth has painful bumps), SWOLLEN TONGUE (her tongue is swollen and painfu) and GLOSSODYNIA (her tongue is swollen and painfu) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included UTI (UTI double infection) from 19-Mar-2021 to 01-Apr-2021 and Colostomy on 25-Jun-2015. Concomitant products included LOSARTAN for Blood pressure management, VITAMIN D [VITAMIN D NOS], ASCORBIC ACID (VIT C), ACETYLSALICYLIC ACID (ASPIRIN 81) and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced MOUTH SWELLING (roof of mouth is swollen), ORAL DISORDER (roof of mouth has painful bumps), SWOLLEN TONGUE (her tongue is swollen and painfu) and GLOSSODYNIA (her tongue is swollen and painfu). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 07-Apr-2021, MOUTH SWELLING (roof of mouth is swollen), ORAL DISORDER (roof of mouth has painful bumps), SWOLLEN TONGUE (her tongue is swollen and painfu) and GLOSSODYNIA (her tongue is swollen and painfu) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported by HCP  that patient was not recommended to take second dose of COVID-19 Vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Added Patient demographics and medical history . Added Concomitant medications and changed outcome of the events from unknown to recovered
swelling of the tongue; This is a spontaneous report from a contactable physician via Pfizer sales representative. A 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history included a very similar event (unspecified) following a presumed COVID-19 infection about 6 weeks prior. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced swelling of the tongue on an unspecified date a few days following the second dose of the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
vomited; chills; headache; had some itching, ongoing soreness and lump at site; had some itching, ongoing soreness and lump at site; had some itching, ongoing soreness and lump at site; nauseous; This is a spontaneous report from a contactable consumer (patient).  A 65-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL9262), via an unspecified route of administration in the left arm on 22Jan2021 19:00 at a single dose for COVID-19 immunization. She takes thyroid daily (as reported) as it was removed when she was 20.  The patient was not pregnant at the time of vaccination. The patient had no COVID prior to vaccination. The patient had not been tested for COVID post vaccination. The patient has not received any vaccine in 4 weeks. Concomitant medication included teriparatide (FORTEO) daily injection, diphenhydramine hydrochloride (BENADRYL). The patient previously took codeine and experienced allergies: codeine. The patient reported that no one knew if she should inject with teriparatide. On 22Jan2021, she received teriparatide at 4pm and bnt162b2 at 7pm. She took a diphenhydramine and had some itching, ongoing soreness and lump at site. She took teriparatide at 3:30pm at about 7pm she was nauseous and vomited. She had chills but felt better afterwards. She went to bed and have headache, not sure if she should discontinue teriparatide or discontinue before next shot. According to the reporter, the events started on 23Jan2021 19:00; vomited started on 23Jan2021 21:00. The outcome of the event was recovering.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 76-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Aug2023 at 15:00 as dose 5 (booster), single (Lot number: GK0928) at the age of 76 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Benign prostatic hyperplasia" (unspecified if ongoing); "diverticulitis" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN, start date: 01Jan2018; CLIMAX, start date: 01Jan2018. Past drug history included: Nsaids, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective. Therapeutic measures were taken as a result of covid-19, drug ineffective, the patient received paxlovid from 27Sep2023 to 01Oct2023.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 cannot be completely excluded.
02/12/2021- 12:36am woke up with chills that went on for about 1 hour. About 7am woke up went to the restroom and almost fainted (lightheaded, nausea, black vision, cold sweat). Blood pressure was 84 over 44. In the afternoon had muscular pain and a low grade fever of 100F for about 2 hours. A little sore at the injection site but all symptoms disappeared on day two  03/13/2021
Red, hot, sore left deltoid. Given Tevaquin for 3 days then Keflex for 5 days.
After the second dose of the injection site on 02;09/21 on 02/17/21 about 10:30pm injection site started itching then on 02/19/21 around noon I looked at the site and it?s red puffy and a little swollen with  a little heat
Congested with thick mucus; itchiness on back; swelling on nose; out of breath; dizziness; sinus infection; rash from buttocks to waist; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congested with thick mucus), PRURITUS (itchiness on back), NASAL INFLAMMATION (swelling on nose), DYSPNOEA (out of breath) and DIZZINESS (dizziness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced NASAL CONGESTION (Congested with thick mucus), PRURITUS (itchiness on back), NASAL INFLAMMATION (swelling on nose), DYSPNOEA (out of breath), DIZZINESS (dizziness), SINUSITIS (sinus infection) and RASH (rash from buttocks to waist). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency and CETHROMYCIN at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (Congested with thick mucus), PRURITUS (itchiness on back), NASAL INFLAMMATION (swelling on nose), DYSPNOEA (out of breath), DIZZINESS (dizziness), SINUSITIS (sinus infection) and RASH (rash from buttocks to waist) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, COVID-19: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       HCP said she might have a sinus infection.  No concomitant information was reported.
Pt presented to the ER with her mother on 3/23/21 c/o sudden swelling and redness that morning of the l upper arm at the site of injection of her 2nd moderna covid 19 vaccination on 3/19/2021.  Pt also reported pain at the site. She had no reaction to the first vaccine on 2/19/2021. On exam the L upper ext showed an erythemetous patch over the upper ext which appeared warm, tender and reddened.  She was prescribed Doxycycline.
Delayed onset chest tightness with SOB - took own albuterol 2 puffs with resolution. No airway involvement. Normal pulse, oxygen and BP
This is a spontaneous report from a contactable office manager (non-HCP).  A 71-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot S15227, Expiration Date 01Feb2018, NDC number 0005-1971-02) intramuscular in right deltoid on 27Feb2017 13:30 at 0.5 ml, single for immunisation . The patient medical history was not reported. Concomitant medication included fluticasone, lisinopril, xantofyl (LUTEIN), ascorbic acid (VITAMIN C), ergocalciferol (VITAMIN D) , fish oil, tocopherol (OMEGA 3), ascorbic acid, biotin, calcium, calcium pantothenate, colecalciferol, copper, cupric oxide, cyanocobalamin, dl-alpha tocopheryl acetate, ergocalciferol, ferrous fumarate, folic acid, iodine, iron, magnesium, magnesium oxide, manganese, manganese sulfate, nicotinamide, pantothenic acid, phosphorus, potassium, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, zinc, zinc sulfate (CENTRUM), ubidecarenone (COQ-10), carbidopa, levodopa (SINEMET), tocopherol (VITAMIN E). The patient experienced muscle ache in her thighs, her back and her upper arms (both arms) and she felt like she had weights on her thighs on an unspecified date.  Therapeutic measures as a result of muscle ache in her thighs, her back and her upper arms (both arms) included taking some ADVIL. The outcome of the events was unknown.
6:00 am client noticied 2 blister type bumps on right side of chin area, then Saturday morning there was 12 more blister type bumps, c/o itiching and tightness in the chin.
cold; unable to sleep; severe body ache; arm soreness; nausea; headache; chills; This spontaneous case was reported by a physician and describes the occurrence of FEELING COLD (cold), INSOMNIA (unable to sleep), PAIN (severe body ache), PAIN IN EXTREMITY (arm soreness) and NAUSEA (nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 010821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy (allergy to codeine), Drug allergy (allergy to keflex) and Migraine. Concomitant products included NARATRIPTAN HYDROCHLORIDE (AMERGE) for Migraine.   On 11-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced FEELING COLD (cold), INSOMNIA (unable to sleep), PAIN (severe body ache), PAIN IN EXTREMITY (arm soreness), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills). At the time of the report, FEELING COLD (cold), INSOMNIA (unable to sleep), PAIN (severe body ache), PAIN IN EXTREMITY (arm soreness), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.Action taken with mRNA-1273 in response to the events was not applicable.
initially, nausea and dizziness, followed by feeling that throat was closing. Self administered Epipen. Taken to Hospital, given 50mg Benadryl and 10mg Decadron IV en route. Hands and feet turning purple, patient c/o being very cold. In ED, met by MDs, given another dose of Benadry and Decadron and pepcid. She started to have difficulty breathing and they stopped the IV meds, bolused her with fluids and she responded well. Additionally, she was put in sitting position and chest and back were massaged.
Started feeling hot about 19 hours later 07/15/21 around 2:30pm, then both forearms and hands felt tingly/numb sensation on and off for about 7 hours. Started feeling confusion in the brain with stuttering lightly, trouble concentrating, inside brain kept feeling not as aware around 4:30PM for 2 hours,  then started feeling like throwing up lightly around 6:30PM on and off for 3 hours, body ached all over starting at 8:30PM for about 4 hours towards end of night. I took 2 aspirin and 4 Tylenol around 10:00PM, then felt better at 3:30am.
Hot to touch, reddening (about size of softball(, hard, very painful. No treatment.
Intense itching at injection site and along arm in which injection was given. Some pain, redness and swelling. Itching, redness and swelling are continuing two days after injection.
This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Persistent but sporadic cough), DYSPNOEA (Unable to hold the air), DIZZINESS (Dizzy), MYALGIA (Pain in the arm /muscle aches) and FATIGUE (Tired/ fatigued) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced MYALGIA (Pain in the arm /muscle aches). On 13-May-2021, the patient experienced DIZZINESS (Dizzy). On 14-May-2021, the patient experienced FATIGUE (Tired/ fatigued). In May 2021, the patient experienced COUGH (Persistent but sporadic cough), DYSPNOEA (Unable to hold the air) and HEADACHE (Headaches). On 14-May-2021, MYALGIA (Pain in the arm /muscle aches) had resolved. On 15-May-2021, DIZZINESS (Dizzy) had resolved, HEADACHE (Headaches) had resolved. On 16-May-2021, FATIGUE (Tired/ fatigued) had resolved. At the time of the report, COUGH (Persistent but sporadic cough) and DYSPNOEA (Unable to hold the air) had not 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. Concomitant product use was not provided by the reporter. No treatment information was provided.  Reporter did not allow further contact.
Bilateral Ovarian Cysts, Prolonged HA (10 days), (Nausea 10 days), rash Left arm
Symptoms started about 9:30 p.m. Wednesday night Sept 20. 2" welt on left upper arm where shot was given. Arm sore to touch. Pain running down to fingertips thru this date Sept 23. When shot was first given I felt a pain behind my left knee in the crease at outer side. I had a Benadryl Sept 21 at 9:30 and pain subsided some by next day but is still there today. Causing a lack of sleep.
p/vax pt devel chickenpox;no prescription drug treatment was required;pt recovered;
Headache and fatigue. Pausing during speech. Difficulty recalling words. Using incorrect words.  Slurred and /or garbled speech.
Twinrix (#1) administered 7/16/04 approximately 9:00 AM. Client's husband reported on 7/19/04 that client broke out on 7/19/04 with hives on arms and legs.
Headache, dizziness, arm soreness all started around 6:15pm on the same day; and chest pain while taking deep breaths started 09/10/2022 morning.
Joint pain, stiffness & swelling in both feet & hands for approximately 5 days-now resolved. However, residual & persisting symptoms include parasthesia, numbness, tingling in thumbs & fingers both hands. Also diminished tactile sensation & dexterity in both hands.
Information had been received on 18-JAN-2017 from a nurse practitioner who reported that female patient (age unknown) received an expired dose of VAQTA (lot# L042039, expiration 14-JAN-2017) 50/1.0 U/ml intramuscularly in right deltoid on 18-JAN-2017. The patient has not reported an adverse effect. No additional information was provided. Additional information has been requested.
Rash and itching around neck and arms. Fever and swelling of tongue. Headache.
pt recv vax 13AUG97 & exp nausea, chills & vomited twice;on the morning of 14AUG97 pt exp constant diarrhea, w/no vomiting, fever, h/a or muscle joint aches;15AUG97 diarrhea cont but 16AUG97 sx subsided & pt recovered;
Rash white bumps over face for 2 days then resolved. Weakness, tingling, pain in right arm for past three weeks.
This spontaneous report as received from a female patient of unknown age via company representative refers to herself. The patient pertinent medical history was not provided. On an unspecified date in 2009 (also reported as sometime in 2009), the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On an unknown date, when the patient went to get her annual influenza virus vaccine inactivated (unspecified) (also reported as flu shot) from her pharmacist, she was also given the ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported), despite she had already been given ZOSTAVAX. The patient was not experiencing an adverse reactions. There was no treatment given for adverse event. The patient did not sought medical attention. Additional information has been requested.
Allergic reaction; Tightness in chest; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 9AB33, expiry date 6th December 2021) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE HIGH DOSE) for prophylaxis.   Concurrent medical conditions included shellfish allergy (reaction to allergies for shellfish and peanuts) and peanut allergy.   On 16th September 2019, the patient received Shingrix (intramuscular) and FLUZONE HIGH DOSE. In September 2019, less than a week after receiving Shingrix, the patient experienced allergic reaction and chest tightness. On an unknown date, the outcome of the allergic reaction and chest tightness were recovered/resolved.   It was unknown if the reporter considered the allergic reaction and chest tightness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix along with Fluzone High Dose flu shot. The patient described she as an allergic reaction that included tightness in her chest like her reaction to allergies for shellfish and peanuts.   The Caller reports patient went to the hospital and issue has resolved. The emergency room visit was required.
pericarditis; pericardial effusions; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jun2021 (Lot number: EW0179) at the age of 45 years as dose 2, single for covid-19 immunisation. There was no other vaccine in the 4 weeks prior. Relevant medical history included: "Asthma" (unspecified if ongoing); "shellfish allergy" (unspecified if ongoing). She had not had COVID prior to vaccination. Concomitant medication(s) included: NASACORT and daily multivitamin. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0179, Location of injection: Arm Left), administration date: 21May2021, for Covid-19 Immunization. The following information was reported: PERICARDITIS (medically significant) with onset 27Jun2021 13:15, outcome "recovering", described as "pericarditis"; PERICARDIAL EFFUSION (medically significant) with onset 27Jun2021 13:15, outcome "recovering", described as "pericardial effusions". On 27Jun2021 experienced chest pain, radiated to neck and jaw. Then had persistent neck pressure afterwards. The events "pericarditis" and "pericardial effusions" were evaluated at the physician office visit; patient saw PCP (primary care physician), and was referred to GI and ENT, urgent care at one point. The patient underwent the following laboratory tests and procedures: chest x-ray: normal; colonoscopy: unknown result; echocardiogram: pericardial effusions; endoscopy: unknown result; thyroid function test: normal; x-ray (soft tissue neck): normal. Multiple meds to treat GERD. Finally has echo and had pericardial effusions. She saw cardiologist "last week" (as of 07Feb2022) who confirmed pericarditis. She was still having intermittent chest pain. She had not been Covid tested post-vaccination.; Sender's Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of "pericarditis" and "pericardial effusions"  cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient received vaccine at 0920, stayed for observation.  At 0932 presented with c/o difficulty swallowing, dry mouth.  MD on site noted erythematous rash around injection site and on chest.  BP 201/116, HR 134, O2 98%.  Epi-pen administered at 0933.  Patient reported no change in symptoms after 5 minutes, 911 called.  At 0938, BP 117/110, HR 118, O2 100%.  Second epi-pen administered at 0938.  Care transferred to EMT by Dr. at 0940.
My wife and I met some friends who were not boosted and 24 hours later they informed us that one of them had tested positive for Covid. Subsequently, my wife and I then began to experience symptoms. I developed a moderate headache and myalgias symptoms around 48 hours after the initial exposure. We both tested positive around 3 days after that on 5/7. I called my doctor's office the following Monday, but it had already been 6 days or so and I was relatively asymptomatic so they advised that I just monitor symptoms and since then I have been fine.
Directly after receiving the vaccination the patient felt lightheaded and then 'blacked out' for a couple of seconds. He was sitting in a chair and slowly slid down the chair to the floor, but he did not hit his head; his head was supported by the vaccinator. The episode was witnessed and no seizure activity or signs of anaphylaxis were present. Patient appeared to have a short syncopal episode. The patient was placed on the floor with his legs up by me, and the patient states he felt much improved in that position. The patient reports that he did not eat or drink anything that day and that he had been working outside until the time of his vaccination. The patient was given Gatorade here to rehydrate; within a couple minutes the patient states that he felt completely normal. EMS was not called. Patient will follow-up with is PCP and has a ride from his mother who was present during the event.
Positive redness and swelling of right anterior and lateral thigh with prolonged crying, but less than 2 hours. Cool compresses and Motrin used to treat symptoms. Pain decreased next day but redness and swelling persists.