chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tingling; numbness in arms which resolved on it's own; Left arm injection site pain; Slight headache; I felt pretty tired after both doses; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling), HYPOAESTHESIA (numbness in arms which resolved on it's own), VACCINATION SITE PAIN (Left arm injection site pain), HEADACHE (Slight headache) and FATIGUE (I felt pretty tired after both doses) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TRAZODONE, OMEPRAZOLE, BISOPROLOL, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ASPIRIN [ACETYLSALICYLIC ACID], SERTRALINE HYDROCHLORIDE (ZOLOFT), VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) and UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PARAESTHESIA (tingling), HYPOAESTHESIA (numbness in arms which resolved on it's own), VACCINATION SITE PAIN (Left arm injection site pain), HEADACHE (Slight headache) and FATIGUE (I felt pretty tired after both doses). In 2021, PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness in arms which resolved on it's own) had resolved. At the time of the report, VACCINATION SITE PAIN (Left arm injection site pain) and HEADACHE (Slight headache) had not resolved and FATIGUE (I felt pretty tired after both doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-344194 (Patient Link).
This is a spontaneous report from a contactable pharmacist received via a sales representative. This pharmacist reported same events for two patients. This is the first of 2 reports. An elderly female patient (over 65) received PREVNAR 13 (lot number and expiry date were not reported), 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 patient experienced red arms for 3 days on an unspecified date. The patient used cold compresses, but did not require medical treatment. Outcome of the event was unknown. Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018500271 same reporter/different patient/same drug/same event.
Breakthrough COVID-19 case with symptom onset 5/20/2021: Runny Nose/Congestion, Shortness of breath/difficulty breathing, Fatigue or tiredness, Cough. Hospitalized 5/24/2021-5/26/2021: presented to the ED with S0B and productive cough, found to have diffuse expiratory wheezing, admitted for exacerbation of unspecified reactive airway disease. Positive COVID-19 TEST. She was discharged home in good condition.
NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) Non-ST elevation (NSTEMI) myocardial infarction Acute kidney failure, unspecified
Pt developed severe headache on day 0, on day 1 developed fever and vomiting.
Jerking. Muscle Spasms. Falling over. Briefly holding breath while tense. Swelling of injection site. Irritated injection site. Fussy behavior. Loss of appetite.
Information has been received from a licensed visiting nurse concerning a 9 year old white male who on 11/24/1999 was vaccinated SC with the first dose of varicella virus vaccine live.  The LVN reported that on 02/23/2005 the patient was diagnosed with chickenpox characterized by 20-30 scattered red lesions.  The LVN also indicated that the patient also had lesions in his scalp. Unspecified medical attention was sought.  On 02/28/2005, the patient recovered from the chickenpox.  Additional information is not expected.
Chronic Spontaneous Urticaria (hives); hive outbreaks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 15:00 (Lot number: EP7533) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies : Sulfa ACE inhibitors" (unspecified if ongoing), notes: known allergies : Sulfa ACE inhibitors. Concomitant medication(s) included: SIMVASTATIN; HYDROCHLOROTHIAZIDE; AMLODIPINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 11Mar2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: CHRONIC SPONTANEOUS URTICARIA (non-serious) with onset 15May2021, outcome "not recovered", described as "Chronic Spontaneous Urticaria (hives)"; URTICARIA (non-serious) with onset 15May2021, outcome "not recovered", described as "hive outbreaks". The events "chronic spontaneous urticaria (hives)" and "hive outbreaks" were evaluated at the physician office visit. Therapeutic measures were taken as a result of chronic spontaneous urticaria, urticaria.  Additional information: Most received facility of Covid-19 vaccine administration was reported as Public Health Clinic/Veterans. Patient was neither diagnosed with COVID-19 prior to vaccination and nor tested since the vaccination. The patient had not received any other vaccine within 4 weeks. The patient mentioned that he never had hives before the covid vaccine and had been having hive outbreaks ever since the covid vaccine. The treatment received for the adverse event includes Cortisone Shots (3 rounds) Pepcid and 4x antihistamines daily. Device Date: 03Jan2022.
Patient received injection at 1045 to left deltoid. At approx. 1053, patient noted to be clearing throat and claims "it feels difficult to swallow". Patient assessed and lips noted to be slightly swollen and diaphoretic. No SOB or difficulty with speech at this time and patient remains A&0x4. Patient placed into wheelchair and escorted to ED immediately with proper precautions in place.
Pt vax w/ 3 doses hepta B. in 86 or 87.  lab tests revealed modest elevations of GGT, SGOT, + serum alk phosphatase, borderline HBsAG, anti-HBs antibodies neg + anti-HBs antibodies pos.
was seen in clinic r/o pertussis;pt given Doxycycline;lt deltoid area red edematous, hard, hot; c/o severe pain @ inj site
idiopathic intercranial hypertension or psuedotumore cerebri; chills; myalgia; Headache; vision impairment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 10:45 (Lot number: F38757) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "avocado" (unspecified if ongoing), notes: known allergies: avocado; "raw spanish" (unspecified if ongoing), notes: known allergies: raw spinach; "melon/cantelope" (unspecified if ongoing), notes: known allergies: melon/cantelope; "eggplant" (unspecified if ongoing), notes: known allergies: eggplant; "zucchini" (unspecified if ongoing), notes: known allergies: zucchini; "dill" (unspecified if ongoing), notes: known allergies: dill. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8721, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 19Mar2021, when the patient was 49 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN0158, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 07Apr2021, for covid-19 immunization, reaction(s): "headache". The following information was reported: IDIOPATHIC INTRACRANIAL HYPERTENSION (medically significant) with onset 2021, outcome "unknown", described as "idiopathic intercranial hypertension or psuedotumore cerebri"; CHILLS (non-serious) with onset 2021, outcome "recovered", described as "chills"; MYALGIA (non-serious) with onset 2021, outcome "recovered", described as "myalgia"; HEADACHE (non-serious) with onset 2021, outcome "recovered", described as "Headache"; VISUAL IMPAIRMENT (non-serious) with onset 2021, outcome "unknown", described as "vision impairment". The events "idiopathic intercranial hypertension or psuedotumore cerebri", "chills", "myalgia", "headache" and "vision impairment" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of idiopathic intracranial hypertension, chills, myalgia, headache, visual impairment.  Clinical Course: It was reported that, the patient had continued headaches after dose 2 and the booster dose and then after 4 weeks, had vision impairment in left eye which had been diagnosed as IIHT (idiopathic intercranial hypertension or pseudotumor cerebri). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient had been tested for COVID-19.
Severe stomach pain...diarrhea bad, headaches, chills, itching on top of head, left side of back and right arm. Began after shot which was given in AM Oct 29th (Monday) and Wednesday 31st at 4:30 AM was woken with severe stomach pain and severe diarrhea. Pain lessened each hour and gone in 8 hours. As each day passed and it is NOW day 31.....the itching is not as bad ...seldom headaches. Diarrhea stopped but because I stopped my vitamins 30 days ago and have not been able to eat the normal meals have become packed and went to Hospital on 21 October for a MRI of gastro test/shows packing.
on 09/14/2022  Patient's mother reported swollen area "size of lemon" at injection site on left thigh. Reported area was hot and red.  Client's mother reports that client was seen by a physician who did not diagnose infection.  On 10/28/2022 mother reported that client was still having problems with injection site. She reports a "rubbery" appearing area at site. She feels like this area may be on the right thigh.
After immunizations were given patient was crying and upset. About 5-10 seconds after that patient started drooling was leaning back and hit head on mirror. Turned pale. had a partially chewed tootsie roll in her mouth, easily removed. Dr checked patient. P 108 Sao2 97% BP 90/58. Patient was kept for 20 min for observation. Dr said patient was feeling better and could go home.
Pt started having new onset of left hand swelling of medial pal, and forearm. PT also had weakness, tremors and high blood pressure (159/98). Pt blood sugar was in the 330s; decrease cap refill. Pt states she did not ear or drink much this morning. EMS assist was called. Pt was transferred to Emergency Room
54 year old male received 2 doses of FLUZONE QUADRIVALENT/ no AE; Initial information was received on 17-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 54 years old male patient who received two doses (0.5 mL) of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Suspension for injection, lot UT7006JA, expiration date: 30-Jun-2021) first dose via intramuscular route in the right deltoid and second dose via intramuscular left deltoid for prophylactic vaccination (extra dose administered) on 16-Sep-2020.  Medical history, past medical treatments, past vaccination and family history were not provided.  No concomitant medications were given to the patient.  This was actual medication error due to extra dose administered (on same day).  It was not reported whether the patient experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recvd vax & exp burning & swelling @ the inject site which required tx w/ice; w/in several hrs of vax sx subsided; The nurse then switched to a different lot# of vax & the sx did not recure; No further details were provided;
ACUTE PULMONARY EMBOLISM 12/28/2022 ADENOCARCINOMA METASTATIC TO LEFT KIDNEY ACUTE PULMONARY EMBOLISM 12/28/2022 HYPOKALEMIA ACUTE PULMONARY EMBOLISM 12/28/2022 HYPOTENSION
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 05May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 27Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ALLEGRA, start date: 01Dec2020, stop date: 03Aug2022; NASONEX, start date: 01Dec2020, stop date: 03Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Aug2022, outcome "unknown", COVID-19 (medically significant) with onset Aug2022, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19 and included treatment with nirmatrelvir;ritonavir (PAXLOVID) from 04Aug2022 to 08Aug2022. Clinical course: When the patient finished her five day course of nirmatrelvir;ritonavir, she felt so much better. For two days, the patient felt really good. Now, the patient have rebounded and have symptoms again. Today is day 12 of having COVID and still feel rotten.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swelling, redness, & tenderness @ site of DTP vax; Onset 7 days p/vax; dx cellulitis, pyogenic abscess; epi-linked w/8 other cases;
Pt received vaccines on 3/10/14 and by the next day arm was swollen from shoulder to elbow on the right side. Skin blanched red and white. Warm to touch.
This spontaneous report was received from a Licensed Practical Nurse concerning a patient of unknown age and gender. The concurrent conditions and medical history were not reported. The reporter stated that on an unknown date in December 2015 at the approximately age of 9 months old, the patient who was three months younger that the minimum age indicated for VAQTA immunization was administered an unknown dose number of the mentioned vaccine (given dose and route of administration were not reported) lot # L039659, expiration date 15-MAR-2017. It was also reported that the nurse noted that several months later (on an unknown date in 2016) the patient was diagnosed with an ear infection, there was not treatment specified. The outcome of ear infection was unknown. The causal relationship was not reported. It was reported that there was not a product quality complaint involved. Additional information has been requested.
5 hours after vaccine, began experiencing severe chills, fever, and muscle pains all over body. Fever reached 101F with ibuprofen taken every 6 hours. Fever, chills, and muscle pain continued for entirety of following day. Numbness in legs and arms on and off for hours for 4 days after vaccination. Pain/headache behind eyes for 24 hrs after vaccination.
c/o pain to site along tingling from site to hand and numbness from forearm to hand and intermittent pain upon of grabbing times.  Employee was referred to her employer for follow up
I still had asthma from the first dose, a week after getting the second dose, I started getting a painful cough and running fevers. The fevers were from 100-103. I was a having a much harder time breathing and still using my inhalers, I was getting dizzy from climbing the stairs at home. I waited for about a month to go to the hospital, I was coughing up stuff. At the urgent care in the hospital in June I was diagnosed with bronchitis and was put on a Z-pak antibiotic and steroids for a few days. Since then, I have been back to the ER 2 other times. I have been diagnosed with bronchitis 2 more times, still running fevers off and on up to 102F. I am now using a nebulizer four times per day and I am on steroids all the time. In a week I am getting a pulmonary function test and seeing a pulmonologist in September.
Pfizer-BioNTech COVID-19 Vaccine Patient received COVID-19 vaccine on 12/30/2020 at 7:21am  and about 3 minutes later, experienced nausea, dizziness and weakness. Patient was brought to ED to be evaluated @ 07:35 am.  Ondansetron  4mg inj was given at 8:29am and NS 1000 mL was given over 2 hrs at 8:30am.  Patient felt better and tolerating oral at 09:19 am and discharged at 9:25am.
Information has been received from a medical assistant concerning a female in her 20's, who in December 2008, was vaccinated with the first dose of GARDASIL 0.5 mL, I.M. After the patient received the vaccine, experienced seizure like symptoms that lasted couple of seconds. The patient was apprehensive and nervous before getting the shot. The patient has since received the second dose of GARDASIL without any problems. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Pt right deltoid muscle extremely sore at site of injection, with blotches surrounding site. Red streaks also visible toward armpit. Warm to touch. Also, achy, tired and chills.
Fever >101 for 24 hours, chills, body aches for 24 hours, pain at injection site
Information has been received from a physician concerning an approximately 6 month old female infant with lymph system disorder affecting her breathing and requiring a G-tube, gastrostomy tube who in approximately August 2010 "2 to 3 months ago", was vaccinated orally with a first dose of ROTATEQ (dose and lot # not reported). In the week of 22-NOV-2010 the patient was vaccinated orally with a second dose of ROTATEQ (dose and lot # not reported) and immediately vomited the majority of the suspension. The patient usually took minimal amounts of fluid orally. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
pt recv vax; c/o muscle soreness; 12jun95 area itching & edema, warm to touch; no tx;
Developed COVID arm; Red area at injection site that grew bigger for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Developed COVID arm) and VACCINATION SITE ERYTHEMA (Red area at injection site that grew bigger for 3 days) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M2CA and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (codeine). Concomitant products included MILK THISTLE [SILYBUM MARIANUM], SPIRONOLACTONE and IRON for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE REACTION (Developed COVID arm) and VACCINATION SITE ERYTHEMA (Red area at injection site that grew bigger for 3 days). On 20-Mar-2021, VACCINATION SITE ERYTHEMA (Red area at injection site that grew bigger for 3 days) had resolved. At the time of the report, VACCINATION SITE REACTION (Developed COVID arm) had not resolved.            The patient reported there was still a shadow at the infection site.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Updated patient demographics, medical history, added concomitant medicines, added new event -vaccination site erythema.
It was Thursday December 29, 2022 at 02:00AM when I woke up with my left side paralyzed. I didn't do anything until 02:00PM in the afternoon because I thought it would go away. At 2PM, I went to the hospital and I knew it was a stroke. They took over and took a CT scan and confirmed the stroke. I was in the emergency room for 2 days, and we were waiting for the MRI to confirm what my brain was like in regard to where the clot would have occurred. I didn't have the MRI until the 12/31/2022, then after that, they prescribed losartan, aspirin, atorvastatin, and clopidogrel. I started taking those on 12/31/2022 and I've continued that. Each of those is once daily. They started me on physical therapy as well. It was a mild stroke so it went well. I was released on 01/02/2022 from the hospital. I am currently walking with a limp, but it's getting better every day. My arm is doing well. I used to run every day, but right now, I'm still unable to at this time.
12/29/2020 (date of injection) soreness at injection site, Headache & increased Heart Rate.  12/30/2020 Headache, Chills, Body Aches, Fatigue.  12/31/2020 Headache, increased Chills, increased Body Aches, increased Fatigue, feeling Feverish (not able to do ADL's).  1/1/2021 Headache, increased Chills, increased Body Aches, increased Fatigue,  feeling Feverish (not able to do ADL's).  1/2/2021 All symptoms are getting better, still slightly there.
Severe swollen gums. First left side (Jan 9th), then two days later right side (Jan 11th). Regular dentist patient, have cleanings every six months.
The medical assistant administered the wrong formulation to the patient. He was due for the bivalent booster and was given the monovalent booster (also meant for 6-11 year olds) instead.
when I received 2nd dose I have I slept for 10 hours,its very unusual; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (when I received 2nd dose I have I slept for 10 hours,its very unusual) in an 82-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (when I received 2nd dose I have I slept for 10 hours,its very unusual). At the time of the report, SOMNOLENCE (when I received 2nd dose I have I slept for 10 hours,its very unusual) outcome was unknown. Not Provided          No concomitant medications were mentioned. No treatment drugs were reported   This case was linked to MOD-2021-018827, MOD-2021-018827 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI
Expired Moderna Booster administered on 4/19/22. Patient without adverse effects. We will repeat the vaccines at the patients earliest convenience.
This is a spontaneous report from a contactable consumer via Pfizer sales representative. A patient of an unspecified ethnicity and gender in his/her 50s, received PREVNAR 13, via an unspecified route of administration in Apr2017 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient was not feeling well, feeling "crummy" 48 hours after administration. Patient had also experienced dizziness since administration. No follow-up attempts are possible. No further information is expected.
1 week after I received my Covid-19 Vaccine a rash around the vaccination area started to show. The area is also a little warmer than the rest of my arm and it itches.