chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse who was reporting regarding her 25 year old daughter. Patient's concurrent conditions included drug reactions/allergies to amoxicillin and penicillin. The patient's medical history included hypothyroidism. On an unknown date (reported as in 2005 or 2006) the patient was vaccinated with GARDASIL (lot number, dose and frequency unspecified) (all three shots of the series according to the normal dosing schedule) (route: injection) for routine vaccination. Concomitant medications were not reported. The reporter stated that the patient began experiencing adverse effects (adverse event) right away after receiving GARDASIL when the patient was 14 or 15 years of age in 2005 or 2006. On unspecified dates, the patient experienced hormones which were out of balance, menstrual cycle irregularities, fainting at school, having no cramps but instead huge blood clots during menstrual bleeding, hemorrhagic, losing so much blood during menstrual bleeding, anemia, low energy level, and suspected sterility. The patient also has psychological side effects because of the adverse effects and the possible sterility. The reporter stated that the patient always dreamt of having children and cries as she now may not be able to. The side effects appear to be severe and long term. The patient's first sexual intercourse was at age 21. The patient experienced various different unspecified side effects which had onsets in the years following vaccination including at age 15, 16, 17, 18, and 19 years. The patient switched physicians from the time of having received GARDASIL. The patient had the same unspecified physician from birth through the time of having been recommended GARDASIL and receiving GARDASIL. The patient has to have unspecified long-term medical treatments for complex adverse effect issues. The patient has undergone many unspecified lab tests of which none were reported. The patient sought medical attention by visiting many physicians. The outcome of the events was reported as not recovered/not resolved. The causality of the events with GARDASIL was not reported. Additional information has been requested.
NONE. Asked us to fill out for 12th dose given via IPOL vial. Telehealth done for child after noticed extra  dose was from vial. Child ok. No issues.
Morning after vaccination, noted a 1x1 inch lump just under injection site with a 2x2 ring of red, raised, itching bumps surrounding needle injection site. Performed no treatments. Denies any other symptoms or abnormal signs.
ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 12/23/2021  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Fever of 100.0 lasting approximately 12 hours. Slight body aches, lack of energy lasting through 2/13/2021. Largely resolved, by 2/14/2021 a.m.. Pain at the left arm injection site continuing through 2/14/2021. Treated with acetaminophen, 200mg three times daily. Discontinued 2/14/2021 a.m.
The patient went home after her well child exam and several hours later she developed a welt where her injection was given and a rash that extended up her arm and back. Mom was advised to give BENADRYL according to age and weight and apply ice to her injection site. I called the patient back 2 hours after her initial call and the mom stated the rash had resolved.
Received first dose of Engerix-B 1 mL IM, Lt deltoid.  Immediately became weak and lightheaded.  No LOC.  Placed head between knees, BP 110/69.  Placed in supine position, 86/55 P 60 bpm, 90/50, 109/62.  Entire episode lasted approx 10 minutes.  No further side effects. Contributed to having not eaten that day.
Hospitalized 2/24/22-3/7/22 UTI, kidney stone, bladder stone with ureter obstruction
lump; lymph nodes swelling on neck; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump), LYMPHADENOPATHY (lymph nodes swelling on neck) and VACCINATION SITE ERYTHEMA (redness at injection site) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (lump), LYMPHADENOPATHY (lymph nodes swelling on neck) and VACCINATION SITE ERYTHEMA (redness at injection site). At the time of the report, VACCINATION SITE MASS (lump) and LYMPHADENOPATHY (lymph nodes swelling on neck) outcome was unknown and VACCINATION SITE ERYTHEMA (redness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. No treatment medication were provided.   This case was linked to MOD-2021-306401 (Patient Link).
About 24 hour after he felt burning, tingling and itching on his chest. Hours later turned to blisters. Called urgent care and they confirmed he had shingles on video phone call.
Pt presented with redness, itching  and warmth to the touch. Locations of vaccination were raised. Pt denied any other system reactions or breathing complications. Pt denies prior vaccine reactions. Dose #3 of TWINRIX and dose 1 of HPV 9 but prior dose of HPV4 received. Seen by medical director and prescribed medication to assist reaction. Pt informed to report to the ER is any breathing concerns present or if symptoms worsen and immunization is not open.
Day after the vaccine- extremely lethargic; chills; flu-like symptoms; headache. Those symptoms lasted 24 hours. On the 14th of October, my wife and child were diagnosed, and I went and got tested on the 15th. I had mild symptoms - sniffles for two days and then I was fine. I started getting a lot of earwax around the 12th of October. It got really bad on the 2nd of November my ears were blocked. On the 3rd of November, I was diagnosed with Ear Infection at Urgent Care. They gave me ear drop antibiotic with combination steroid for the inflammation. The ear infection is still ongoing. I got my flu vaccine maybe about 2 weeks before the dose 3 of COVID-19 vaccine - at the same pharmacy where I got the booster. That was my left arm. On the 8th of September 2021 I got my tetanus shot - I got that at Internal Medicine as part of my physical exam. Left arm.
Lips tingling, shortness of breath, severe body aches, runny nose, headache, pain near kidneys, fever
pt recv vax 28FEB96 & 28FEB97 pt devel over 200 lesions on body & in the throat;
Initial unsolicited report received from a non-healthcare professional  on 22 September 2015. This case involves a 72 years male patient who was vaccinated with an intramuscular second dose (previously received one dose) of FLUZONE HD (batch number UI457AA, expiration date 22 April 2016) in left deltoid on 22 September 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. Concomitant medications were not reported. On 22 September 2015, same day following the vaccination, the patient experienced pin prick of blood in left deltoid and a dime size diameter of swelling 2-3mm height. Lab data and corrective treatments were not reported. The patient was recovered from the event in three minutes. List of documents held by sender: none.
Currently breastfeeding. 45 min after dose started feeling pain in right breast/nipple.  Upon returning  home it?s been very painful nursing on right side.   Significant pain in left arm at injection site
Information has been received from a MA concerning a 18 month old white female with allergies to eggs, nuts, milk, soy and wheat who on 04/30/03 was vaccinated in the left arm with a first dose of varicella virus vaccine live (Lot # 641787/0758M). There was no illnesses at the time of vaccination. In September 2003, the pt developed a very mild case of chickenpox.  No medical attention was sought. No diagnostic lab studies were performed.  It was also reported that in September 2003 there was an outbreak of chickenpox "in daycare". In October 2003 the pt recovered. No further information is expected.
This spontaneous report was received from a licensed practitioner nurse referring to a 15 month-old child of unknown gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 23-JUL-2015, the patient was administered an improperly stored dose of LIQUID PEDVAXHIB injection (lot # K026533, with expiration date: 07-AUG-2017; dose, frequency and route were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
I had pain on the interior side of my upper arm like nerve pain that went from my elbow up to almost my underarm area about 10 days after my first shot (4/7/21); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 07Apr2021 (Batch/Lot number: unknown) at the age of 48 years as 1st dose, single dose for covid-19 immunisation. Relevant medical history included: "Constipation chronic" (unspecified if ongoing), notes: chronic constipation with silent reflux; "silent reflux" (unspecified if ongoing), notes: chronic constipation with silent reflux; "Irritable bowel syndrome" (unspecified if ongoing), notes: IBS; "several antibiotics- sulfa" (unspecified if ongoing), notes: several antibiotics- sulfa, doxycycline, macrobid, and erythromycin. The patient's concomitant medications were not reported. Past drug history included: Erythromycin, notes: several antibiotics- sulfa, doxycycline, macrobid, and erythromycin.; Doxycycline, notes: several antibiotics- sulfa, doxycycline, macrobid, and erythromycin.  The following information was reported: PAIN IN EXTREMITY (non-serious onset 07Apr2021), outcome "not recovered", described as "I had pain on the interior side of my upper arm like nerve pain that went from my elbow up to almost my underarm area about 10 days after my first shot (4/7/21)".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given Moderna monovalent as a booster dose instead of the bivalent vaccine.
Stinging, burning at site. Welt the size of golf ball by evening. Went to urgent care. No treatment given except ice pack and ibuprofen. Painful at site, numbness at site slightly improved.
Sick; This case was reported by a other health professional via sales rep and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (received 1st dose on unknown date, refer case US2019AMR068777).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received 2nd dose of Shingrix and was sick.
Pharmacist injected vaccine from the vial that was punctured 23 hours ago and was at room temperature about 75 degrees for 23 hours 20 minutes
he has flu and cough; he has flu and cough; he does not want to go out because although he does not feel dizzy and has smell he has little cough and phlegm; he does not want to go out because although he does not feel dizzy and has smell he has little cough and phlegm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE Batch/Lot number was not reported) via an unspecified route of administration on 30Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced he has flu and cough, he does not want to go out because although he does not feel dizzy and has smell he has little cough and phlegm. The clinical course reported as follows, caller received the first dose of the Pfizer Covid-19 vaccine on 30Jul2021, his appointment for the second dose is scheduled tomorrow 20Aug2021, but he will not assist because he has flu and cough, he does not want to go out because although he does not feel dizzy and has smell he has little cough and phlegm. He would like to know how to change his appointment for the second dose of the vaccine as he recovers. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
headache; chills; fever 100.6; tired; Slept afternoon into next morning; achy all over; This is a spontaneous report from a contactable consumer. This 54-Year-Old female patient (non pregnant) reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: EW0183), via an unspecified route of administration, in left upper arm on 19May2021, at 15:30, as DOSE 2, SINGLE for covid-19 immunization (age at vaccination: 54-years-old). 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 was not tested for COVID-19. The patient concomitant medications included Probiotic, fermented ginseng, multivitamin and menopa within 2 weeks of vaccination. She reported allergy to Sulfur based ointments. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number:  ER8736), via an unspecified route of administration, in left upper arm on 28Apr2021 16:10, as DOSE 1, SINGLE for covid-19 immunization. On 20May2021, at 07:00, patient was achy all over. By 14:30, she had headache, chills with fever 100.6, and was tired. She Slept in afternoon till next morning and when she woke up her all symptoms were gone. The patient did not receive any treatment for the events. The outcome of the events was recovered in May2021.  Follow-up attempts are completed. No further information is expected.
Inability to get a full breath; shortness of breath; difficulty breathing and trying to move about.  Condition slightly improved but continues.
Fever for three days (104 f) then measles like rash beginning 3/2/2013.
Sore arm, fever (101.4 at peak), body aches, chills, headache Did not take medications. Slept/rested
p/ pt recv vax approx 1mo later pt broke out w/vesicles on neck, arms & temp 102/104, exp rash appearing as pustules/vesicles. subsequently exp herpes zoster. treated w/acyclovir
24 hours after 2nd dose had 103 fever, swollen lymph node, lethargy for 48 hours.  almost 3 months subsequent to 2nd dose, developed Bell's Palsey on left side of face (5/18/21)
She was given the vaccine at 12:00. At 12:07 she  (she is an RN employee here at the hospital) reported feeling as if she had lump in her throat and asked for some benadryl.  Rapid response team was called at 12:08 as she became diaphoretic, flushed and reported blurred vision. MD ordered an IV to be started and a NS bolus x 1 liter.   She broke out in hives on bilateral upper extremities.   Benadryl, solumedrol, albuterol inhaler, zofran, scopolamine patch were all ordered and given to the patient. She reported that she felt some better and was transferred to the ER at 1245 for further monitoring.
experienced swelling/Patient is still swollen on left breast/swelling on breast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "both breasts removed" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BREAST SWELLING (non-serious), outcome "unknown", described as "experienced swelling/Patient is still swollen on left breast/swelling on breast".  Additional Information: Proprietary medicinal product name was Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent. It was reported that the Patient had both breasts removed, and experienced swelling after the vaccine. Other Conditions, other products and investigations were not provided. COVID-19 vaccine manufacturer was unspecified. NDC number and Expiry Date of COVID-19 vaccine was unknown. Reason for no lot number of COVID-19 vaccine was Complainant does not have the product with them at the time of call. The patient that reporter mentioned was not a blood relative, but a family member and had swelling on breast on the side where the shot was given, but that was not reporter, reporter had no swelling. Thought patient was a year older than reporter, so patient should be 79 years old. Patient was told not to get any more of the vaccine in the arm, was told to get things in the hip, hard time getting someone to give vaccines in hip. Patient found someone to give vaccines in patient's hip. Should everyone be getting vaccines in hip. Patient never had cancer of breasts, nothing, just a low thing, patient just had BRCA in the family. Patient was still swollen on left breast, got shot on left side. Hard for patient to wear clothes. Confirmed patient had breasts removed prior to receiving the vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever and chills off and on for 8 days so far. Temps 99.6 to 101.
Narrative: 4/29/22: Pt reports received COVID Booster #2 Pfizer 3pm yesterday; recalls lips and arm swelled when previously vaccinated Pfizer. Lip swelling onset last night, went to bed midnight grossly fatigued, but denies pulm sxs or tongue/throat swelling. This AM both lips swollen, unusually fatigued, "very thirsty". Able to take AM meds but "choked and gagged" when subsequently tried to drink water. Pt on lisinopril. During our conversation pt "sleepy" but denies tongue/throat swelling or pulm sxs; managing secretions normally. Advised given constellation of current sxs she needs ED eval now: she concurs. Pt summoned EMS via G911 pendant. I phoned her back and she was not in distress, reports EMS coming promptly. She reports no one in her complex to summon and sit with her while awaiting EMS. No Epipen in home. Has Benadryl but I did not advise her to take given "choking" on water. ER report not available as patient was seen outside the facility. On 5/3 phone follow up with provider patient reported: The lip swelling had resolved prior to ER, Worse symptom was migraine HA has finally resolved, feeling better today. Pt reported toradol was given at the ER and she went home with an RX for Zofran but didn't need to take it.
Psoriasis appeared on my scalp in several areas.A dermatologist was consulted and diagnosed this..; This is a spontaneous report from a contactable Consumer. A 78 -year-old non pregnant female consumer received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered in Left arm on 13Jan2021 10:00 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. On 18Jan2021, the patient had experienced Psoriasis appeared on scalp in several areas. A dermatologist was consulted and diagnosed this. Betamethasone dipropionate lotion was received in response to the adverse events. On 04 Feb2021, patient had other vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. At the time of reporting, the event was resolving.
Mom called office 3/28/2006 stated child's left arm with red bump, warm, tender to touch.
pt recv vax & devel an inj site rxn characterized by swelling, redness, warmth, & pain as well as fever;
"Shaking" - vertigo starting 13 Sept 2011 - Rx'd ANTIVERT - vomiting - quarters. Pt to call nurse this afternoon.
3:05pm client began to complain of experiencing shortness of breath, lightheaded, dizziness,  and feeling faint,  she complain of feeling nausea, mouth tingling, and flush. She verbalized "it feels like my throat is shutting". Client diaphoretic, flush ,skin clammy, and she began to dry heave and than began to vomit. Epipen 0.3mg administered in left leg. Pulse-120 respiration-24. She said she felt like she was going to faint.  EMT present and on site and quickly responded. Client transported to ER via EMS at 3:10pm
Development of chickenpox despite previous IZ. Pt had a red rash begin; 1 noted on 11/19/01; 3 noted on 11/20/01 and numerous over body on 11/23/01 with blisters starting and itching. Mother states exposure at school.
Elevated liver numbers. Enlarged liver and throwing up blood. Sweating high fever headache  severe abdominal pain
Left breast swollen, painful, & had red lines across outer aspect of breast. Became less tender by day 5, still slightly swollen.
INSOMNIA; ITCHY BUMP; ONE INCH OF REDNESS ON STOMACH/GENERAL REDNESS THROUGHOUT THE BODY/HARD TO TOUCH BUMPS THROUGHOUT THE BODY; 4-5 INCHES OF INFLAMMATION ON  NECK; This spontaneous report received from a patient concerned a 74 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206a21s, and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride. On 04-MAY-2021, the subject experienced 4-5 inches of inflammation on neck. On 04-MAY-2021, the subject experienced itchy bump. On 04-MAY-2021, the subject experienced one inch of redness on stomach/general redness throughout the body/hard to touch bumps throughout the body. On 09-MAY-2021, the subject experienced insomnia. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from itchy bump, one inch of redness on stomach/general redness throughout the body/hard to touch bumps throughout the body, insomnia, and 4-5 inches of inflammation on neck. This report was non-serious.
Pt got shot on Wednesday 7/6/11 at 2:15pm & it started red, hot, swollen 7/7/11 & had fever, aches & diarrhea. She called PCP and was told to take TYLENOL. Kept getting bigger and warmer. On 7/8 called pharmacy and we told her to take BENADRYL & cold compress & draw line around redness, no fever 7/9 and it's not as hot or swollen but the redness is spreading.
Vomiting and diarrhea severely. Was taken to hospital for IV hydration and monitoring x2 days.
About 24 hours after recieving Hep A/B, Polio Booster, Tetnas and Diptheria, patient expericenced severe vertigo and loss of hearing in left ear.  Is being treated with Prednisone
Received the Arexvy RSV vaccine from the pharmacy. Injection went well with a slight soreness at injection site. In the middle of the night, woke up with chills especially my feet felt very cold. Wrapped up in a blanket but didn't get up to take my temperature to see if I had a fever. Next morning woke up with a headache and extreme tiredness. By the following day was feeling much better. Over a week later and still some soreness in my arm by the injection site and still have a bruise.