chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 2, single (Lot number: Ff2593), in left arm and on 04Apr2022 as dose 3 (booster), single (Lot number: Fk9895) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 09Mar2021 as dose 1, single (Lot number: 1805031), in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: Positive, notes: Covid rebound. Therapeutic measures were not taken as a result of drug ineffective. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Rapid Heartbeats 5 minutes after 1st dose high blood pressure. High Blood Pressure after 2nd dose and still having it,
pt recvd opv & spit it in RN's eye; RN exp burning in eye p/ she rinsed it out w/ tap water;
Had ROTATEQ vaccine 4-14-09. Developed vomiting on 4-17-09 - lasting 24 hours then had 4 days of watery diarrhea. No fever. Sibling then developed same symptoms on 4-21-09. He sibling also had fever. Both children fully recovered.
severe arm swelling; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient (demographics unknown) who experienced severe arm swelling (peripheral swelling), when received vaccines PNEUMOCOCCAL VACCINE POLYSACCH 23V [PNEUMOVAX] and INFLUENZA VACCINE (QUADRIVALENT).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect PNEUMOCOCCAL VACCINE POLYSACCH 23V [PNEUMOVAX] not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious severe arm swelling (peripheral swelling) (Unknown latency) following the administration of INFLUENZA VACCINE (QUADRIVALENT) and PNEUMOCOCCAL VACCINE POLYSACCH 23V [PNEUMOVAX].  (Other relevant tests included no lab data.)  Final diagnosis was severe arm swelling.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for severe arm swelling.  Information on the batch number was requested.  List of documents held by sender: none.
Pt recvd MMR vax then watched younger sibling recvd 2 inject, sibling crying & resisting; Pt turned pale & fainted; VS monitored; BP 90/58, P84, BP 102/60, p80, BP 99/58, p84;
I started experiencing extreme lethargy, I started having a hardy time breathing, dizziness and feeling very horrible. I called to make an appointment with my doctor. Once I was in for the appointment, she ran bloodwork it came back negative for any thyroid issues, I did a Pulmonary breathing function test that came back showing that I have COPD. I am now awaiting a doctor's appointment to check the lump that in my throat. I am awaiting an appointment with a heart specialist, it felt as if I was having a heart attack a few days ago.
Dizziness, Fever, NauseaVomiting, c/o chills. Told to see primary are physician if no improvement. Narrative:
Per patient, had rash of little red dots running up and down both arms, feeling very sick for a few days after
Coinciding with vaccination timing, severe acid reflux was triggered; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 24Feb2021 at 15:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included no evidence of disease (NED) for ovarian cancer and allergies to nuts and kiwi. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included vitamin D (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. On 25Feb2021, coinciding with vaccination timing, severe acid reflux was triggered in the patient and it was unclear that vaccine was the cause but primary care physician indicated to report this in case others experienced the same. The reflux was still ongoing 1.5 weeks post the first dose of vaccine (at the time of this report). The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with proton pump inhibitors (PPI's) awaiting issue resolution. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe acid reflux triggered was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
chills; headache; tiredness; cold like this; The initial case was missing the following minimum criteria: [no adverse event]. Upon receipt of follow-up information on 06May2022 this case now contains all required information to be considered valid.   This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold like this".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
We got the vaccine early in the morning. By noon, I was really tired, so I took a nap on the couch. I woke up because my entire body was vibrating. It lasted on and off for a little over a month. The fatigue went away the day after the shot.
Client phoned 2 weeks after receiving vaccine c/o pain in both arms. No fever no swelling no redness just pain. Client will contact us if persists. Client returns from trip and reports pain continues left arm is worse than right arm. Unable to life anything or cross arm over her chest client is going to ER for evaluation.
Raised lump , sore , quite warm, rash at injection site, itchy,  very lathargic,  headache, sore muscles,  cold,  Occurred next day early afternoon
This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 21-FEB-2018, the patient was vaccinated with an improperly stored dose M-M-R II, lot # N025889, expiration date 18-APR-2019, 0.5 ml, subcutaneous for prophylaxis. The M-M-R II was reconstituted with an improperly stored sterile diluent, lot # N026287, expiration date 07-FEB-2020. No adverse effects were reported. Names of vaccines involved: M-M-R II. Temperature/Time frame: 9-25 Celsius degrees for 8 hours 42 minutes, and 9-25 Celsius degrees for 2 hours 50 minutes. Previous temperature excursion? NO. Was call because of a "data logger"? YES.
Nausea; Chills; Feelings of being "rundown"; Headache; Increased body temperature; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the right arm on 26Apr2021 at 14:45(at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 11:00,   roughly 20 hours after the first vaccine, the patient experienced feelings of being rundown, headache and increased body temperature. Later in the night, roughly 30 hours after the vaccine, the patient experienced a sense of nausea, chills and still had an intense headache at the time of reporting. Therapeutic measures were not taken as a result of these events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event feelings of being "rundown", headache, increased body temperature, nausea and chills was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Dizziness; Ears fullness and achy; Rash extended towards elbow; Swollen lymph node under right arm; Soreness at injection site; Developed a big rash in the injection arm; Nausea; Headache; Fatigue; Fevers up to 103; Body chills; Achy body; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), EAR PAIN (Ears fullness and achy), RASH (Rash extended towards elbow), LYMPHADENOPATHY (Swollen lymph node under right arm) and VACCINATION SITE PAIN (Soreness at injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Percocet) and IBD (Microscopic Colitis) since 01-Jan-2020. Concomitant products included BIFIDOBACTERIUM INFANTIS (ALIGN) for Colitis, ATORVASTATIN for Hypercholesterolaemia, VITAMIN D3 for Supplementation therapy, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) for Vertigo.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced DIZZINESS (Dizziness), EAR PAIN (Ears fullness and achy), RASH (Rash extended towards elbow), LYMPHADENOPATHY (Swollen lymph node under right arm), VACCINATION SITE PAIN (Soreness at injection site), VACCINATION SITE RASH (Developed a big rash in the injection arm), NAUSEA (Nausea), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fevers up to 103) and MYALGIA (Achy body). 16-Apr-2021, the patient experienced CHILLS (Body chills). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) (oral) from 16-Apr-2021 to 19-Apr-2021 for Fever, at a dose of 500 mg and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. On 19-Apr-2021, DIZZINESS (Dizziness), EAR PAIN (Ears fullness and achy), RASH (Rash extended towards elbow), LYMPHADENOPATHY (Swollen lymph node under right arm), VACCINATION SITE PAIN (Soreness at injection site), VACCINATION SITE RASH (Developed a big rash in the injection arm), NAUSEA (Nausea), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fevers up to 103), CHILLS (Body chills) and MYALGIA (Achy body) had resolved.      This case was linked to MOD-2021-089677 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Added - patient demographics, medical history, 1st and 2nd dose vaccine information, concomitant medications, treatment medication, new events (rash starting at injection site, rash extended towards elbow, dizziness, nausea, fatigue, fevers, swollen lymph node under right arm, ears fullness and achy, body chills, achy body). The outcome of the events changed (from unknown to resolved). On 30-Jul-2021: Follow up received on 30-Jul-2021 and contains no new information.
No adverse event; one dose of an improperly stored vaccine, VARIVAX, was administered to one patient; assistant confirmed route of administration was intramuscular; This spontaneous report has been received from a Medical assistant, referring to male patient of unknown age and gender. Information about current conditions, concomitant medications, pertinent medical history and previous drugs reactions and allergies were not provided.  On 12-SEP-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0,5 milliliter, once, lot number S002877 and expiration date reported as 23-AUG-2021, but upon internal validation established as 29-JAN-2121) for prophylaxis: by intramuscular administration (Incorrect route of product administration) (strength and concentration were not provided). The vaccine was reconstituted with properly stored sterile diluent (lot number S000130 and expiration date 23-AUG-2021).  The varicella virus vaccine live (oka/merck) (VARIVAX) was stored at a temperature of 8.1 degrees Fahrenheit for the time frame of 20 minutes with a previous temperature excursion of 8.1 degrees Fahrenheit for a time frame of 17 minutes and a temperature of 9.5 degrees Fahrenheit for the time frame of 21 minutes. It was reported that call was due to Data logger. No adverse effects reported.  It was unknown if the patient received treatment or if the patient sought for medical attention. It was unknown if any laboratory diagnostics or studies were performed.
5 hours post injection - violent chills, shortness of breath, elevated heart rate (100+), temperature went from 98.1 to 101.3 in less than 30 mins, weakness, severe full body muscle pain.  Unable to sleep, rest or eat.  Day 2 - intense, severe full body muscle pain, temperature 101.7 even with tylenol taken ever 4-6 hours, severe headache and light sensitivity, nausea, unable to eat and unable to sleep.  Day 3 - ongoing headache and light sensitivity.  Vomited stomach acid.   Day 3 around 5pm went to Immediate Care - covid test negative; was referred to Emergency Room and eventually admitted to inpatient floor.  ER tests showed - 2 bags of fluid given.  Admitted as inpatient, 1 additional bag fluid.
got my first severe migraine; nauseous; headache; difficulty speaking; difficulty standing; severe aura; ringing in ears; dizziness; extreme confusion; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm right on 03Sep2021 at 18:30 (Batch/Lot number was not reported) as dose 1, single (at the age of 28 years old) for COVID-19 immunization. Medical history included complex migraine in 2017. No known allergies. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. It was reported that the patient had no side effects first 48 hours after the shot. On 06Sep2021, she felt nauseous and got her first severe migraine that would go on daily for 15 days. That day of the report was the first day she only had a headache and no migraine. Migraines were debilitating 90% of the time difficulty speaking, difficulty standing, severe aura, ringing in ears, dizziness, extreme confusion. She had a history of less than 5 severe migraines, one in which she went to ER for in 2017 but had not experienced severe migraine since then. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown if patient had COVID prior vaccination and was tested post vaccination. The patient underwent lab tests and procedures which included covid test: negative on 09Sep2021 via nasal swab. Therapeutic measures were taken as result of the events, ae treatment Inhaler, migraine prescription. The outcome of the events was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
I am a recovering long covid patient (since March 2020). I improved greatly around December 2020. After the vaccine, my symptoms returned. Sinus tachycardia, brain fog, extreme fatigue, sleeping 20 hours a day, vomiting, diarrhea and constipation, SOB, joint and muscle pain, ocular changes. In addition, I started having terrible headaches, pain at injection site (left arm was virtually unusable for 3 weeks), and tinnitus. No menstruation since vaccination (2 confirmed negative pregnancy tests, and I was supposed to have my period right around the time I was vaccinated), intermittent uterine pain. Went to the ER and had 160 resting HR, and plan to go back on a beta blocker. Symptoms have waned somewhat, but I am still nowhere near where I was before the vaccine.
Visible swelling over lower abdominal region for 1 week that started about 1 day after vaccine. Pain over ovaries/uterus lasting for 1 week starting 1 day after vaccine.  On 4/14 I began my first menstrual cycle after the vaccine. On 4/17 I experienced heavier than normal bleeding, bloating and cramping. With this was extreme abnormal mood swings, severe depression, suicidal ideation, anxiety, insomnia lasting severely for 3 days. I called my psychologist, spoke to the nurse at my clinic and many others because it was too much to handle. I have never experienced this to this degree in my life. Since 4/19 the mood swings and mood changes have mellowed but are still present today along with low back pain, cramping, bleeding and extreme exhaustion. I have been bleeding for 12 days. I usually bleed for 6-8 days. I usually only experience PMS for 1-2 days.
Information has been received from an RN concerning a male who on 4/22/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 640744/0994L). Subsequently, the pt developed redness at the injection site. The pt sought unspecified medical attention. The reporter that the lot be checked. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.  Follow up on 07/01/2003: "Information has been received from a registered nurse concerning a 71 year old male (also reported as 74 year old) who on 04/22/2002 at 10:00am was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 640744/0994L) (IM), in the left deltoid "with usual aseptic technique."  there was no illness at the time of vaccination.  On 04/22/2002, the patient developed redness at the injection site.  On 04/23/2002 the patient presented to the doctor's office and was diagnosed with "cellulitis that involved his whole left arm."  The patient was treated ceftriaxone sodium (Rocephin)(IM) and ciprofloxacin HCl (Cipro) (500mg) (BID).  On 04/26/2002 the patient was seen again in the office and "the cellulitis site appeared to be larger" (the patient was also reported as "better").   The patient was treated again with deftriaxone sodium (Rocephin)(IM) and was given cetirizine (Zyrtec).  On 04/28/2002 (also reported as 05/01/2002) the patient recovered.  The reporter requested that the lot be checked.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  The reporter considered cellulitis to be an other important medical event (OMIC).  Additional information is not expected."
Fever a few hours after receiving vaccination. 99.5 after taking ibuprofen. felt flushed and red in the face.
patient claims she developed a blood clot approximately one week after receiving her first dose of the Pfizer Covid-19 vaccine.
dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants products were reported. No treatment information  was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: TCR- received on 24-apr-2021. Outcome of the event updated from unknown to not recovered/not resolved.
Woke up with Right Arm Pain and SEVERE Body aches.  Took long hot shower, 600mg Motrin.
Vaccine administered at 12:15 pm on 9/10/2021 Approximately around 12:30 pm patient felt stinging sensation in arm at injection site.  Had a  feeling of being flushed. and warm.  Went home : About 2 hours later- felt faint and arm started to burn even more. Looked like her arm was scorched color of red apple  and swollen the size of baseball.  Swelling and redness lasted 10 days in left arm.  That evening- felt dizzy, weak, nausea, headache. Did not sleep all night.  On Saturday, attended son's (coach) high school football game.  At game, she felt faint and then fainted on the bleachers.  Banged hand on bleachers.   Paramedics were called and found that your Blood Pressure was 100/60 and then dropped to 100/58.  Blood Sugar okay,  Pulse was weak/slow. Paramedics  monitored for 45 minutes+  on the field sidelines.  Completed Portable EKG.  Nothing was found.  Patient went home and to bed and rested/feeling ill for 3 days. Then symptoms improved except for left arm which stayed swollen for 10 days.  Patient states the injection was given very low in her arm.  About 3 inches above the elbow. Different from previous two doses.
4 WEEKS AFTER RECEIVING THE ABOVE VACCINES/INJECTIONS, PATIENT DEVELOPED FATIGUE, WEAKNESS OF LOWER EXTREMITIES FOLLOWED BY WEAKNESS OF UPPER EXTREMITIES 2 DAYS LATER. PATIENT WAS ADMITTED AT MEDICAL CENTER AND CURRENTLY BEING SEEN BY NEUROLOGY SERVICE.
I began to feel a cold feeling in my fingers immediately after injection, and then in my back about 2-3 days later. I began to develop a big red spot on the site of injection. When I went to the doctors they sent me to get an x-ray that came back clear. Bloodwork was ordered and showed low platelet count. I still currently have numbness in my back however no pain.