chrisvoncsefalvay/vaers-outcomes huggingface dataset:
throat was closing up; fatigue; headache; muscle pains; chills; fever; tired; had to make herself vomit; throat feels rough; felt like throat was tight; feeling sick; throat swelled up; felt like she could not breathe; is scared of eating things after that; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (feeling sick), PHARYNGEAL SWELLING (throat swelled up), DYSPNOEA (felt like she could not breathe), FEAR OF EATING (is scared of eating things after that) and SELF-INDUCED VOMITING (had to make herself vomit) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included DVT. Concurrent medical conditions included Drug hypersensitivity, Drug hypersensitivity, Drug hypersensitivity (most severe reaction she ever had.), Drug hypersensitivity, Drug hypersensitivity, Drug hypersensitivity, Drug allergy, Drug allergy, Drug allergy (made her hair fall out), Drug allergy (Heart raced.), Drug allergy (Heart raced.), Drug allergy, Drug allergy (Had DVT when got it.), Drug allergy (mess with her lung.) and Drug allergy. Concomitant products included PREDNISONE and HYDROXYCHLOROQUINE SULFATE for Arthritis, MACROGOL 400, PROPYLENE GLYCOL (SYSTANE) for Dry eyes, METOPROLOL, CALCIUM, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ACETAMINOPHEN and WARFARIN for an unknown indication.   On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced MALAISE (feeling sick), PHARYNGEAL SWELLING (throat swelled up), DYSPNOEA (felt like she could not breathe), FEAR OF EATING (is scared of eating things after that) and THROAT TIGHTNESS (felt like throat was tight). On an unknown date, the patient experienced SELF-INDUCED VOMITING (had to make herself vomit), THROAT IRRITATION (throat feels rough), THROAT TIGHTNESS (throat was closing up), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pains), CHILLS (chills), PYREXIA (fever) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, MALAISE (feeling sick), PHARYNGEAL SWELLING (throat swelled up), DYSPNOEA (felt like she could not breathe), FEAR OF EATING (is scared of eating things after that), SELF-INDUCED VOMITING (had to make herself vomit), THROAT IRRITATION (throat feels rough), THROAT TIGHTNESS (felt like throat was tight), THROAT TIGHTNESS (throat was closing up), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pains), CHILLS (chills), PYREXIA (fever) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable
Precipitation of an inflammatory arthritis, affecting post surgical knee joints (LEFT more than RIGHT), and RIGHT shoulder (native) joint
Patient states that about 12 hours after receiving vaccine she began feeling ill with swollen glands in neck, fatigue, muscle aches, and fever.  States she felt perfectly healthy prior to vaccine, and when she returned to relate this information two and a half days after receiving vaccine she said she still felt ill.
PT RECEIVED EXPIRED FLUMIST LOT 500548P EXP DATE 12/18/2008.  NO REPORTED ADVERSE EVENTS TO DATE OF COMPLETING REPORT.
Moderna COVID-19 Vaccine EUA Swelling on hands, arms and feet---How likely am I to have swelling with the second shot?? Many, many strong heart palpitations fatigue!! Body aches Low stamina Chills Sore arm Occasional headache
Cataracts in both eyes; Arm was a little sore after the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Lot number: EW0162 or EWD162) at the age of 60 years as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: for approximately 10 years; "Diabetes" (unspecified if ongoing), notes: for approximately 10 years; "Bifocals eyeglass wearer" (ongoing). Family history included: "Cataracts run in her family" (unspecified if ongoing). There were no concomitant medications. The following information was reported: CATARACT (medically significant) with onset 2021, outcome "not recovered", described as "Cataracts in both eyes"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Arm was a little sore after the vaccine". Therapeutic measures were not taken as a result of vaccination site pain. Clinical course: The patient's arm was a little sore after the vaccine but she didn't need to take anything. After the patient got the vaccines, she felt like she had cataracts and really noticed them at that time. The patient doesn't think her cataracts were related to the vaccine, as they run in her family and she knew she would have them. The patient stated that she knew her eyes were getting worse. She was wearing her bifocals and thought she needed stronger ones however she was diagnosed with cataracts. The doctor said her eyes were really bad.  She has cataracts in both eyes and needed to have cataract surgery. She was scheduled to have cataract surgery on 25Jan2022, and they won't do it unless she gets the booster shot. The patient received 2 doses of the Pfizer COVID-19 vaccine and she was seeking out the booster dose. She lost her vaccination card and the vaccination sites are refusing to vaccinate her with the booster because she lost her vaccine card. It was also reported that the patient received her vaccine on "20Oct2021" (not further specified).    The reporter considered "cataract" not related to bnt162b2. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known disease pathophysiology, the event of cataract is assessed as not related to BNT162B2, and more likely due to factors like familial history .
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient received vaccine with mother - no issue at first but according to RPh, they returned and she had hives all over her hands. no sequelae known to have occur since as of today 8/24/21
Patient stated that the vaccine hurt very badly when given. It is 7 weeks later and she reports she still has pain in her arm and has shooting pain that travels to her elbow and upper arm.
She has a first seizure the night of August 10, 2018. 3 days after her 6 month vaccinations. She started crying, her eyes were dazed and zoned out and she was unresponsive. Her body and jaw were stiff and she was grunting loudly. She had a 2nd seizure one month later on September 10, 2018. She was playing and suddenly the expression on her face changed. She started moaning and crying, she was very pale and sweating a lot, her head was flexed,she was zoned out, unresponsive, grunting and she was trying to catch her breath. Also, she had stiffness of her upper and lower extremities. ?She had her first flu shot 5 days before? She had a 3rd seizure on September 12, 2018. Again, she started crying and then grunting very loudly, while she was looking around. She had a 4th seizure on October 9, 2018 at which time her medicine dosage was increased.
Has a small, walnut sized lump on her left arm where the injection was; having increased arthritis pain; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (lot EL3247) via an unspecified route of administration in the left arm on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included Covid prior to getting the first shot (has had Covid). Concomitant medications were not reported. It was reported that the patient has a small, walnut sized lump on her left arm where the injection was on Jan2021 that has been there for about a week. She wanted to know what to do about the lump and if she should get the second shot. It was also reported that she's having increased arthritis pain on 2021. She's going to a state on 28Feb2021 and would have second shot on 23Feb2021 and she needed a negative Covid test 72 hours prior to going. She wanted to know how would she get a negative Covid test. The outcome of the events was unknown.
Narrative: COVID infection following COVID vaccine series 08/16, Pfizer, dose #1 09/07, Pfizer, dose #2 1/1 COVID swab, result: detected 1/1 pt cc: fever, myalgias exposure: unknown 1/1 pt admit to ED cc: cough/congestion/body aches dx: Coronavirus LOS: 1 day 1/1 TROPONIN I: <0.016
pt recv vax 15NOV93 & 22NOV93 pt exp a fever of up to 105, OM, a rash on face & was seen by MD;dx allerg to eggs;tx w/meds;lab eval on 22NOV93 revealed a hematocrit of 39.3;
PATIENT SAID THAT THE INJECTION SITE WAS RED, SWELLED AND ITCHING AND THAT GETTING GROWING. WHEN PATIENT CALLED TO PHARMACY A WEEK LATER, THE SITE WAS AROUND 4 SQUARE INCHES.
Since my first vaccine , I have had sudden sharp left temple pain lasting 5-10 seconds. I have never in my life had this type pain .  No rhyme or reason to when it happens . It became progressively more frequent slowly over next 4 months .     I went to see my PCP on May 11 because I could not ignore this any longer because was happening now multiple times per day .    Pcp believes it is either temporal arteries or trigeminal nerve irritation.  Since it is sudden sharp pain ...they are treating me with gabapentin  for 1 month to see if it is resolved .     It is helping .     Only have pain now 2-3 times per week which is so much better .   My concern is I have never had this before and started after vaccine for covid .   I have had both vaccines now because I am an RN .
The evening of the vaccine,  I had a heightened reaction to celery.   While I do have an oral allergy to celery if eaten directly,  I have never had an issue with it blended into smoothies, cooked,  etc.  I drink a smoothie almost daily with celery without any issue.   Around 730pm, I drank my smoothie and within 10 minutes,  my throat and chest tightened significantly, similar to my rxn to nuts.  I took a zyrtec and it resolved after an hr.
hospitalized for 1 week and had to be intubated due to aspiration; unresponsive. I did come and go speaking but made very little sense; inflammation of my heart; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female non-pregnancy patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Left upper arm on 28Apr2021 14:00 (Batch/Lot number was not reported, at age of 43 years old) as single dose for COVID-19 immunisation. Medical history included peripheral nueropathy and bipolar 2 and connective tissue disorder. The patient previously took amoxicillin and experienced drug allergies. Concomitant medications included unspecified medication received in two weeks. The patient was hospitalized for 1 week and had to be intubated due to aspiration. The patient's husband found her 4 days after her 2nd shot unresponsive. The patient did come and go speaking but made very little sense. Many tests were run with nothing found to explain and she also had an echo that confirmed inflammation of her heart. Event onset date reported as 02May2021 08:00 AM. Events resulted in Hospitalization, Life threatening illness (immediate risk of death from the event), hospitalisation 7 days. The patient received treatment as Intibated, echo, O2, heart medication. The outcome of events was recovered with lasting effects.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Low energy; Leg problem; Pain in their left legs/leg pain; Feeling Fatigue; Cramps in their left legs; 3 weeks sick after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps in their left legs), ILLNESS (3 weeks sick after 2nd shot), ASTHENIA (Low energy), LIMB DISCOMFORT (Leg problem) and PAIN IN EXTREMITY (Pain in their left legs/leg pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Cholesterol since 1978. Concomitant products included LOSARTAN and ATENOLOL for Blood pressure high, SIMVASTATIN for Cholesterol, VITAMIN D NOS for Vitamin supplementation.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced ILLNESS (3 weeks sick after 2nd shot). On an unknown date, the patient experienced MUSCLE SPASMS (Cramps in their left legs), ASTHENIA (Low energy), LIMB DISCOMFORT (Leg problem), PAIN IN EXTREMITY (Pain in their left legs/leg pain) and FATIGUE (Feeling Fatigue). At the time of the report, MUSCLE SPASMS (Cramps in their left legs), ILLNESS (3 weeks sick after 2nd shot), ASTHENIA (Low energy), LIMB DISCOMFORT (Leg problem) and FATIGUE (Feeling Fatigue) had not resolved and PAIN IN EXTREMITY (Pain in their left legs/leg pain) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up information received contains patient initials and details,current conditions, suspect drug(dose 1 and 2 details),concomitant drugs and events(3 weeks sick after second shot, feeling fatigue, low energy and leg pain) added.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A female patient received unknown dose number of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced pain (body pain), with outcome of unknown. Additional information: Reporter mentioned she experienced light side effects of the Pfizer COVID-19 vaccine. She asked if it's okay to take Tylenol for her body pain. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Swollen, painful lymph node in the left axilla and an erythematous, macular rash with distinct borders on the left deltoid, where the injection was given.
PATIENT REPORTED A FEW DAYS AFTER RECEIVING MODERNA VACCINE SHE GOT A ITCHY, RED RASH ON UPPER ARM WHERE VACCINE WAS GIVEN.
vaccination was done on 7/11. pt reports after developing leg swelling of both legs. his wife told him his arms possibly swollen as well. he was seen in office on 7/14 - noted to have moderate pitting edema bilaterally of lower legs from ankles to mid lower leg. he stated the swelling was already going down.
Rash, swollen, red area warm & Hot to touch, tenderness in Arm, chills, fever.
This spontaneous report as received from a medical assistant refers to a currently  5 years old male patient. On an unknown date, when the patient ws 15 months old, the patient was vaccinated with M-M-R II INJ (albumin status unknown) dose 1 (route, dosage, and lot number unknown). The medical assistant reports that the patient received his second dose of M-M-R II (albumin status unknown) when he was 2 years old on an unspecified date. No adverse events were reported. Additional information has been requested.
Case of misuse was received from a healthcare professional on 08 October 2013. A patient of unspecified gender and age received a dose of MENOMUNE (manufacturer not reported, lot-no not reported) on an unspecified date. The patient received IM and then saw that it was to given SC. Do they had to call the patient back to repeat. Advised per Q and A: "Response to vaccines recommended by the subcutaneous route probably will not be affected if the vaccines are administered by the intramuscular rather than subcutaneous route. Repeating doses of vaccine administered by the intramuscular route rather than subcutaneous route is not necessary." No information regarding an adverse event was given at the time of this report.
Approx. 2 hours after receiving HPV vaccine pt. developed tingling in left arm (vaccine given in left arm) and then in left leg. At times both extremities felt slight "weak". Pt developed severe right sided headache with nausea and photophobia
Injection site reaction, red, warm to touch and swollen. Told pt. to take BENADRYL and IBU and ice.
pt recvd vax 14OCT95 & exp soreness in lt arm for a wk;stated on the morning of 21OCT95 noticed a red streak 9approx 6" x 2") on upper lt arm extending to elbow;felt a knot in the area & upper lt arm hot & red;seen in ER 21OCT95
Moderna COVID-19 Vaccine Chills, Aching all over, fever 99.9, fatigue, itching below injections site (still itching on 2/13/21) 6"x3", slight nausea and no appetite. Took Extra Strength Tylenol (2) every 6 hrs. Temp went to 102.3 several times on 2/10/21, slept most of the day.  On 2/11/21 still had fever (99.7-99.6) and took Tylenol but feeling better, stomach still not right. On 2/12/21 Fever gone but stomach still not right and feeling better. Itching continues.
Rash on left upper extremity (site of vaccination).  It was not raised, no welts and no itching.  Four days later, it is still there but is fading.  Other symptoms included just general feeling of muscle aches and headache.
3 inch red, raised area at injection site. Started the following day & increased from 2.5 inches to 3 inches in diameter overnight. Painful to pt with pressure Applied.
This spontaneous report as received from a pharmacist revers to a 60 year old adult non pregnant female patient. No information about medical history, concurrent conditions was reported for the patient. Approximately on 18-MAY-2015 (reported as 3 weeks ago) the patient was vaccinated with ZOSTAVAX dose 0.65 ml, subcutaneously, lot # K024031, expiration date 20-FEB-2016 for shingles prevention. No concomitant therapy was reported. The reporter stated that approximately on 25-MAY-2015 (reported as 1 week later from the date of vaccination) the patient experienced shingles-like rash, two on her left leg, one on her neck and one on her lip post vaccination with ZOSTAVAX. The patient also complained of pain associated with the rash. The patient was not treated for the events reported. The outcome of events was reported as not recovered/not resolved. The patient had not sought medical attention. No product quality complaint was involved. Pharmacist declined Varicella Zoster Virus Identification (VZVIP). Additional information has been requested.
Vaccine was expired on 12/2 but administered on 12/3. Writer called Pfizer and was told no adverse outcome expected and dose still valid due to stability testing completed.
This spontaneous report as received from a physician via company representative refers to a 65 year old female patient. The patient's medical history included diabetes. In approximately February 2013 (also reported as about a year and a half ago) the patient was vaccinated with ZOSTAVAX (dose, lot # unknown) via injection. No concomitant medication was reported. In August 2014 (also reported as in the last week and a half) the patient experienced shingles. The patient sought medical attention. The patient was treated with Acyclovir antiviral. The physician reported there was no progression and deemed it a mile case. The outcome of shingles was reported as recovering. There was no intervention to prevent serious criteria. Product quality complaint was not reported. Causality of shingles with ZOSTAVAX was unknown. Additional information has been requested.
PATIENT RETURNED 2 DAYS AFTER IMMUNIZATION WITH 7CMX7.5 CM CELLULITIS OF LEFT THIGH WHERE IMMUNIZATIONS WERE GIVEN.  STARTED KEFLEX 35 MG TIBX72.
Itching all over my body and lip swelling at 12:00a.m. on 2/19/21
6 days later pain in chest, next day went to lung, called the Ambulance. Admitted to the hospital, on 2nd day transferred to another hospital 4th day, went to arm.  Released from the hospital after 7 days in the hospital. Still have numbness tingling and pain in the right arm. Going to have EMG today.
After receiving LymeRix Vaccine, I first had flu like symptoms, then I was affected neurologically and hospitalized for a week.  Then arthritis set in with extreme fatigue and weakness.  Periodic swollen glands and always feeling ill, as though I never got over the flu. Then, my heart started to beat irregularly.  I was diagnosed with heart block and eventually had to have a permanent pace maker.   Every symptom I got was the same as though I had lymes disease, without having the disease it self.  I feel the Lymerix vaccine caused all these symptoms.  I still suffer with arthritis, especially in my knees, and the fact that my heart is now damaged has me very concerned. Per 60 day follow up: Pt has not recovered. Now have a permanent heart block, pace maker implant and has developed mytral vavle regurgatation. Pt may possibly need a vavle replacement in the future.
Patient called and stated she has been having problems lifting arm where vaccine was given. No swelling itching or redness at sight of injection.
Sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An elderly 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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick".  Additional information: The first booster made her sick.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
approximately 5 minutes after injection, patient became dizzy while sitting in chair and felt like she was going to pass out.   Pt was laid down on yoga mat with legs elevated.  BP and pulse monitored.  Water given to drink.  Pt states she had not eaten since breakfast.  After approximately 5 minutes.  Pt was feeling better able to sit up and drink water.   After approximately 10 min she was able to stand and leave with mother
13 minutes after received vaccine felt like hair ball was stuck in throat, feet and hands were cold, face and body was hot, also labored breathing was going on *forcing self to breathe, rash broken out on face and arms, difficulties swallowing, Benadryl in left arm with iv and epi iv in right arm, in ambulance she vomited, emt said throat was closing and almost touching, painful leg and arm twitching, after getting discharged had a pokey tongue, headache, dry mouth. allergic to vaccine.
Hives- used benadryl PO, & hydrocortisone cream with no relief; Hives still present