chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6/23/08 FINE RED RASH, SLIGHTLY ELEVATED ON BOTH CHEEKS,NECK AND STARTING AT R ANTECUBITAL SPACE.  MILD EDEMA R EYELID. 3RD dose IMMOVAX given with 50mg BENADRYL at 1305.  6/24/08 presents with angioedema face, lips, genitalia; rash spreading on trunk, itching increased. Pt instructed to continue 50 mg qid PO. COUNTY  PUBLIC HEALTH notified who contacted state PUBLIC HEALTH  and the CDC.  Around 1450 pt phoned dr office to report increased edema labial area. SHE was concerned of inability to urinate and sent to the ER.  7/4/08 Reviewed ER medical records of 6/16/08 FINAL DX: acute angioedema & urticaria s/p rabies vaccine Records reveal patient experienced bat bites on her face.  Had received 3rd shot in rabies series.  After 2nd shot had developed a rash which resolved.  After 3rd shot, developed frank angioedema, hives, facial edema, diarrhea, swollen throat & genital edema.  Tx w/steroids, improved & d/c to home.
Extreme chills, worst in my life. Finally had to take ibuprofen which took them away about 4 hours in. Had them and a mild form of them for almost 26 hours. No other symptoms.
Sore back and neck; Sore back and neck; night sweats; Booster; fever; insomnia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "had COVID", start date: 2021, stop date: 2021, notes: I had COVID 3 and a half months ago. The patient's concomitant medications were not reported. Past drug history included: Monoclonal antibodies. Vaccination history included: Covid-19 vaccine (Dose number unknown, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021, outcome "unknown", described as "Booster"; NECK PAIN (non-serious), BACK PAIN (non-serious) all with onset 28Dec2021, outcome "unknown" and all described as "Sore back and neck"; PYREXIA (non-serious) with onset 27Dec2021, outcome "recovered" (28Dec2021), described as "fever"; INSOMNIA (non-serious) with onset 27Dec2021, outcome "unknown", described as "insomnia"; NIGHT SWEATS (non-serious) with onset 28Dec2021, outcome "unknown", described as "night sweats". Additional Information: Booster COVID vaccine shot received on 27Dec2021 within 12 hours had fever, insomnia. Fever lasted over 30 hours. Also had night sweats & insomnia on second night. Sore back and neck.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Fever and nausea developed each afternoon for 4 days vaccination. Extreme tiredness for 5 days vaccination each afternoon. Left arm sore for 4 days & red for days 2-4. I took care of symptoms myself, with Acetaminophen, ginger ale, and going to bed early.
Developed painful red rash one day following vaccine., about 4cm in diameter. It gradually expanded while becoming less bright red, and then became itchy and then went away within 3 days total.
Dizziness, Headache, Myalgia, Arthralgia & Diarrhea
fever & rash started 24hr p/vax;beet red around eye-spotted rash all over 101.7 R-very irritable;allergic rxn;no more pertussis vax;
This spontaneous report was received from a physician concerning a 23 year old medical assistant female patient in her office. The patient's medical history included varicella. The patient's pertinent drug reactions/allergies were unknown. Seven dates ago, on 11-OCT-2013 the patient was preparing a dose of ZOSTAVAX (lot number and expiration date were not provided) when it splashed in her eye. Co-suspect therapies and concomitant medications were not provided. On 18-OCT-2013, 8 days after ZOSTAVAX was splashed in her eye (also reported as 19-OCT-2013), the patient began to experience mild itching and redness in the conjunctiva/mild erythema of the part of conjunctiva (no scleral, corneal or visual changes). It was reported that she did not irrigate the eye. At the time of the report, the patient had not recovered from the event. The relatedness between the events and suspect therapy was unknown. Additional information has been requested.
Pt became dizzy, felt balance was "off", complained of feeling "drunk". Symptoms persisted throughout the weekend and on Tuesday, 4/6/10, she reported she still felt dizzy and that she was not thinking clearly. When I saw her on 04/06/2010, her blood pressure was 120/80, no rash observed, breathing normal. No ataxia noted. Pt. states that her granddaughter developed similar symptoms after recieving Varicella vaccine when she was a child. Pt. has made an appt. to see her physician on Friday, April 9th.  Pt. states no alcohol consumed since the vaccination. No immediate side effects after vaccination. Pt is unsure events are connected to Zostavax administration. Patient's physician had recommended that she get the vaccine if it was available.
Information has been received from a registered pharmacist via a company representative referring to a patient of unknown age and gender. There was no information about concurrent condition, concomitant medication and medical history. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, route, dose and unit unknown). On an unknown date, the patient began experiencing "swelling from shoulder middle forearm on the arm the dose was administered". The patient was diagnosed with "over stimulation from the vaccine" by the physician. The outcome of the event was unknown. Additional information has been requested.
Vomiting, Headache, Stomach Cramps and Low Grade Fever all lasting three days.
approx 3 hrs p/vax pt became hypotonic & hyporesponsive; APAP given following vaax;
liver disease; pain; swelling; fever; tiredness; This case was reported by a consumer via call center representative and described the occurrence of hepatic disease in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included nephrolithiasis (of kidney stones, so she saw her urologist).   On 22nd February 2019, the patient received the 1st dose of Shingrix (intramuscular). In February 2019, less than a month after receiving Shingrix, the patient experienced fever and tiredness. On 4th March 2019, the patient experienced hepatic disease, pain and swelling. On an unknown date, the outcome of the hepatic disease, pain and swelling were not recovered/not resolved and the outcome of the fever and tiredness were recovered/resolved.   It was unknown if the reporter considered the hepatic disease, pain, swelling, fever and tiredness to be related to Shingrix.  Additional details were provided as follows: The caller reported that the patient received Shingrix and afterwards she had common side effects like fever and tiredness that lasted about 1 week and she started having pain and swelling on her left side. The patient has a history of kidney stones, so she saw her urologist, but an ultrasound did not show any kidney stones. She had a CT scan it showed what could be liver disease. She was referred to a gastroenterologist and was going to have a nuclear scan next week.  Emergency room visit was required.  The reporter consented to follow up.
Clinician inadvertently gave monovalent covid vaccine when patient was due for and was expecting the bivalent booster
injection site pain; tiredness; fever; nausea; joint and muscle pain; muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the left arm on 30Mar2021 at 15:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the left arm on 09Mar2021 at 15:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient previously received pethidine hydrochloride (DEMEROL), cefaclor (CECLOR) and amoxicillin, clavulanate potassium (AUGMENTIN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 31Mar2021 at 09:00, the patient had injection site pain, tiredness, fever, nausea, joint and muscle pain. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events injection site pain, tiredness, fever, nausea, joint and muscle pain. The clinical outcomes of the events injection site pain, tiredness, fever, nausea, joint and muscle pain were resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
VERY BAD JOINT PAIN,CANT SLEEP GOOD,TOES NUMB AND BURNING
This spontaneous case was reported by an other and describes the occurrence of ASTHENIA (weak), FATIGUE (fatigue), MYALGIA (couldn't get out of bed with body aches) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.  No Medical History information was reported. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weak), FATIGUE (fatigue), MYALGIA (couldn't get out of bed with body aches) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (weak), FATIGUE (fatigue), MYALGIA (couldn't get out of bed with body aches) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication details was reported. Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24/05/2021 Contains  No New Significant  Information. Patient denied further follow up.
Day 12 I also got a rash on my stomach in one area &some spots on my legs.; 10 days after shot "I" developed a rash on the inside of "my" left forearm. Day 11 it spread further up my arm and also on my right arm. Day 12 "I" also got a rash on my stomach in one area and some spots on "my" legs; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 10:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome and known allergies to latex and wool. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT) and omeprazole (PRILOSEC); both from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 20:00, 10 days after shot, the patient experienced a rash on the inside of left forearm. On 18Apr2021, on day 11, the rash spread further up her arm and also on her right arm. On 19Apr2021, on day 12, the patient also got a rash on her stomach in one area and some spots on her legs. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash on the inside of left forearm, on day 11 it spread further up her arm and also on her right arm, on day 12 she also got a rash on her stomach in one area and some spots on her legs were resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shortly after receiving the flu vaccine on 12/30/19 she experienced seeing white spots and then feeling like she was going to pass out.  She experienced a frontal headache after.  Later on in the evening she verbalized passing out at the dinner table.  She developed an urticarial rash on her upper back on 12/31/19.  She had several episodes of syncope on 12/31, each lasting a few minutes 9am, 1:30pm and 3:30pm.  After those episodes she sought medical evaluation.  Unsure if these events were caused by influenza vaccination or was triggered by influenza vaccination but felt the need to report.
head rush; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "head rush". Therapeutic measures were taken as a result of headache.  Additional information: The patient did not experience side effects from the vaccines just a head rush after the first one but was extremely poorly with covid and was on a virtual ward and needed an inhaler.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
V-Safe rep said I should report these to you although there is not a definitive link to the vaccines given my health history and medications.  To my knowledge, I have never had COVID. However, I experienced a noticeable (and ongoing) noticeable downgrade in health beginning in July 2022, shortly after starting a new immunosuppressant, Enbrel. Switched to Humira (which I'd had no major issues with in the past) in October 2022. All of the following conditions have either worsened or appeared as new in the time since starting the COVID vaccine series (3 Pfizer, followed by 2 Moderna, including the bivalent on 9/16/22),   - Worsened psoriasis - non-responsive (for the first time) to treatment - Buzzing and internal tremors in forearms; weakness; clumsiness - GERD/forceful burping, stomach pain, intestinal pain, nausea - Periodic loss of bladder control - Significant downturn in eyesight, including rapid onset changes in distance vision (street signs all of a sudden becoming blurry) - confirmed inflammation, repeated conjunctivitis (viral like) and eyelid swelling/styes  - New kind of psoriasis (guttate) - Muscle and connective tissue stiffening (tin man like feeling) in thighs, upper arms - Inflamed sinuses without corresponding congestion - Increased food sensitivities, including sugar and alcohol intolerance  This is not an exhaustive list, but the most prominent and still lingering issues.
12 hours following 2002 flu shot, extreme body pain, chills, 102 fever. 36 hours 100 degree fever. Next 2 days, headache, body aches.
allergic reaction; This is a spontaneous report from a non-contactable consumer received from Pfizer-sponsored program.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced allergic reaction to the vaccine on an unspecified date with outcome of unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
My menstrual period began 3+ weeks early, beginning 51 hours after I received the Moderna booster. This period is extremely heavy, with a volume I have not experienced in 15+ years. It is wildly different from periods I have experienced since I birthed my only child nearly 12 years ago. I experienced a similar ultra-early period after my initial Pfizer vaccine on April 3, 2021, although it was not as heavy as that seen with the Moderna booster two days ago. I have not yet phoned my physician, but I will be calling my OB/GYN if the heavy period continues beyond my normal flow length.
6 days after vaccine student developed pain at injection site - no redness, (+) warmth. Day 7 follow up - pain, small area of redness and (+) warmth to area continues.
Information has been received from a registered nurse, via a company representative, concerning a female patient who was vaccinated (date unspecified) with the first dose of Gardasil. Following the vaccination (duration of time not specified), the patient developed swollen lymph nodes in her neck. At the time of this report, it was unknown if the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
FACIAL RASH WHICH STARTED AFTRE THE FIRST ANTHRAX SHOT jUN 13, 2003.
Patient c/o nausea, Vital signs BP 140/81, RR 16, HR 99, spO2 97%. Patient felt anxiety after 2nd dose of vaccine. Physical exam unremarkable. Patient felt better and able to go home.
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 62-year-old male patient received BNT162b2 (BNT162B2), on 14Aug2021 as dose 2 (booster), single (Lot number: FC3180), in right arm, on 11Feb2022 as dose 3 (booster), single (Lot number: FM0698), in left arm and on 13Jun2022 as dose 4 (booster), single (Lot number: FJY991) at the age of 61 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 10Mar2021 as dose 1, single (Lot number: 1805025), in right arm for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing), notes: other medical history: RA; "Interchange of vaccine product" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Rituxin, notes: other medical history: Taking Rituxin twice a year. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jul2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jul2022) Positive, notes: Tested positive 09Jul2022; (16Jul2022) Negative, notes: Tested negative 16Jul2022; (21Jul2022) Positive, notes: tested positive 21Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Tested positive 09Jul2022 started Paxlovid 10Jul2022 am. Tested negative 16Jul2022. Symptoms returned 21Jul2022 tested positive 21Jul2022. There was no other medication taken in 2 weeks. There were no known allergies  No follow-up attempts are possible. No further information is expected.
One week after the first dose of the Moderna COVID-19  vaccine, I developed a 3-inch red patch around the injection site. This was not noticeable at all before day #8. I also had a small cluster of tiny welts (about 1/2 inch or smaller) on my right forearm that developed on day #8 as well. Those were red and itchy.  I applied Cortizone to both sites. In about 48 hours, the injection site red patch was gone. The small patch of welts is almost gone. Not red or itchy anymore.
This case was reported by a healthcare professional and described the occurrence of pruritus all over body in a 53-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included ZYRTEC, ACTONEL, Multivitamin and LUNESTA. On 18 September 2012 the subject received unspecified dose of FLULAVAL (.5 unknown, unknown, right arm). On 18 September 2012, less than one day after vaccination with FLULAVAL, the subject experienced redness, swelling and itching all over their body and pharmaceutical product complaint. On 19 September 2012, the events were resolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. This is the second of three reports made by the healthcare professional, please also see A0995170A and A0995174A. On 09 October 2012, follow-up information was received from the healthcare professional. It was reported that the redness, swelling and itching all over their body had resolved. The reporter considered that the events were not serious. It was also reported that the immunization series with FLULAVAL was discontinued and was not delayed. According to product complaint investigation results reported by GSK Biologicals quality assurance on 09 October 2012, the product complain was assessed to be unsubstantiated.
DIFFICULTY IN BREATHING; PAIN IN BREATHING; DIFFICULTY SPEAKING; TEMPERATURE 39 DEGREE CELCIUS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-JUL-2021, the subject experienced difficulty in breathing. On 12-JUL-2021, the subject experienced pain in breathing. On 12-JUL-2021, the subject experienced difficulty speaking. On 12-JUL-2021, the subject experienced temperature 39 degree celcius. Laboratory data included: Body temperature (NR: not provided) 39 degree celcius. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty in breathing, pain in breathing, and difficulty speaking, and the outcome of temperature 39 degree celcius was not reported. This report was non-serious.
This spontaneous report was received from a pharmacist refers to a 40 year old male patient. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose not specified) subcutaneously for an unknown indication. On an unknown date, the patient experienced headache and numbness of face after administration with ZOSTAVAX. The patient went to see pharmacist to seek medical attention. The outcome of numbness of face and headache was reported as recovered/resolved. Additional information has been requested.
This is in follow-up to report (s) previously submitted on 6/14/2007.  Information has been received from a registered nurse concerning a 24 year old female teacher (weight 133#, height 62") who on 23-APR-2007 was vaccinated with the first dose (also reported as the second dose) of GARDASIL (lot #657617/0384U), IM in the deltoid.  Concomitant medication was not reported.  On 23-APR-2007 approximately 5 minutes after vaccine was administered, the patient fainted.  The patient was treated with a cold pack to her head and she was instructed to lie down.  The patient's blood pressure was 130/70.  Subsequently that same day, the patient recovered from fainting and left the physicians office unassisted.  Additional information has been requested.