chrisvoncsefalvay/vaers-outcomes huggingface dataset:
34 patients received only two doses of HPV vaccine; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to 34 female patients of an unknown age. No information regarding patients' pertinent medical history, drug reactions or allergies and concomitant medications was reported. The patients took part in Home Human Papillomaviruses (HPV) or Pap Examination study from March 2012 to December 2014.  On an unknown dates, the patients were vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (exact dose, route of administration, lot# and expiration date were not provided) for prophylaxis or with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (exact dose, route of administration, lot# and expiration date were not provided) for prophylaxis. On an unknown dates, the patients were vaccinated with the second dose of suspect vaccine. They received only two doses regimen of the suspect vaccine (considered as inappropriate schedule of vaccine administration).  A copy of the published article is attached as further documentation of the patients' experience.   This is one of two reports derived from the same literature article (cross referenced with MARRS# 1908USA000166).; Sender's Comments:  US-009507513-1908USA000166:
Patient states she has had pain (achy) and swelling in her left arm (injection arm, NOT injection site) since the shot. Painful after shot and states pain/swelling down whole arm ever since.
Left arm muscle of injection site started twitching/spasming every 4 to 15 seconds. Continued 24 hours a day for 7 days and then stopped. Arm swollen and bruised looking. Arm still has visible lump 3 weeks after injection.
vaccination with the one dose Covid-19 vaccin Johnson & Johnson at 11:40am. Around 6pm patient began having headaches and a bit of fever.  By 9pm patient had high fever, body aches, nausea, head spinning, bad headaches, and very fatigued. Mother gave her some pain and fever medicine.  By 10pm she began complaining her chest felt like being squeezed. Mother applied some camphor essential oil on her chest. Seemed to bring a bit of comfort. Mother prepared her few bottles to drink throughout the night. Next morning 6am, patient still had a high fever throughout the day and evening, nausea, headaches, body pains but no more chest squeezing! Friday morning: patient's fever is gone. Yet she still has head aches and tired.New symptoms are sore throat and a blue toenail! Saturday morning: still some headache, sore throat, a bit of pain in the chest between the breasts, her arm where the injection took place is swollen as big as a grapefruit and painful to the touch as well as warm. You can clearly see the spot where the neddle was inserted.
This spontaneous report as received from a consumer refers to currently 6 years old son with gluten allergy and yeast allergy. In October 2007 (reported as when he was born in the hospital) the patient was vaccinated with RECOMBIVAX HB (lot/batch was not reported). In January 2009 (reported as 15 months age) the patient was vaccinated with (Oka/Merck) VARIVAX and MMR II. In April 2009 (reported as 18 months age) the patient was vaccinated with hepatitis A vaccine (manufacturer unknown) and DTP (manufacturer unknown). It was reported that since birth, her son has always suffered from what she thought was yeast on his bottom. On unknown date the patient took unspecified amoxicillin for a double ear infection. After that the patient was diagnosed with thrush which was transmitted to his mother via breastfeeding. The yeast was later diagnosed as psoriasis, which was exacerbated by the intake of gluten products. Mother also reported that he son was also "always sick", usually with upper respiratory infections and ear infections. It was also reported that in March 2010 her son was diagnosed with Autism (also reported as pertinent medical history). The patient was non verbal, suffering from apraxia. On unknown date the patient began treatment with "CHOLESTEROL", a product that provides the body with cholesterol to enhance brain development). It was reported that since beginning this product, the patient was verbal and had better communication and social skills. The patient received all age appropriate vaccines until he was of age of five. Causality and outcome for all events were unknown, only outcome for dyspraxia was recovering. Additional information has been requested.
totally numb right foot. I sat up, shook it and no feeling came back for about 10 minutes.; plus tingling lasted for about an hour; It still feels a bit strange; This is a spontaneous report from a contactable consumer (patient).  A 68-years-old female non pregnant patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 08Feb2021 10:00 (at the age of 68-years-old)(Lot Number: EL3249) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included high blood pressure but normal under my medication and slight arthritis in back and knees. Concomitant medication included ibuprofen (ADVIL [IBUPROFEN]), tramadol, citalopram, olmesartan medoxomil (BENICAR), nicotinic acid (NIASPAN) all were taken for an unspecified indication, start and stop date were not reported. It was reported that patient woke up at 5 am the morning (09FEB2021) following my 1st vaccination by a totally numb right foot. she sat up, shook it and no feeling came back for about 10 minutes. she almost never have a foot fall asleep at night and i was lying totally float when I woke up. And if some limb falls asleep it comes right back after shaking it. Not this time plus tingling lasted for about an hour. It still feels a bit strange. Her right foot was totally numb. Perhaps it was everything below the knee. It scared the heck out of her. She had never had anything fall asleep like this. She was laying totally flat with nothing on her leg. She shook it and it took about 15 minutes and it slowly started to come back. She reported this online. She had tingling that lasted for hours. It still feels a bit strange. She called her doctor and was told to take Tylenol. It still feels weird and tingly. It is in the back of her foot and big toe. When reporting online she may have left out the specifics about the tingling. After an hour most of the tingling went away. patient still have some tingling.  The only testing she has had was a mammogram 2-3 months ago. post vaccination Patient did not test Covid. Patient has no allergy. Outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Administrative error found, notified in regards to the event. Advised no complications, but needed documentation on form as an admin error.
No Adverse Event; HBP reporting that PROQUAD was administered after it experienced a supported temperature excursion. No side effects reported from healthcare professional.         ?    Names of vaccines involved (including lot/exp): PROQUAD, Lot: W036940, Expiration: 4/15/2024; This spontaneous report was received from an administrator refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-JUL-2023, the patient was vaccinated with the second dose of improper storage measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin), (PROQUAD) lot # W036940, expiration date: 19-MAY-2024, 0.5 milliliter (route of administration and anatomical location were not reported) for prophylaxis, dissolvent with sterile diluent.  Administered dose of vaccine was exposed to the temperature excursion of -8.6 degree Celsius for 51 minutes. The previous temperature excursion of -11.5 degree Celsius for 1 hour and 16 minutes (product storage error). There were no additional adverse events reported (no adverse event).
got a flu shot and came down with the flu badly; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 06-Dec-2020.  This case involved unknown demographic patient who got a flu shot and came down with the flu badly (influenza) while received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect Influenza Vaccine (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported].   On an unknown date, unspecified time after receiving the vaccine, it was reported that patient got a flu shot and came down with the flu badly (influenza)  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.
Rash. Red, raised and itchy. About the size of baseball. Consulted MD. No action given.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: This was the day my tech immunizer was practicing with me so im not sure who gave this vaccine.  (either case I would have drawn up the vaccine - either I gave the vaccine or my technician)
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-JAN-2016 at 03:34, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.6 and 8.0 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Patient reported large red area and hot to touch. Patient had pain for 1 week before syptoms stopped.
Extreme pain in joints, legs, arms. Could barely move my left arm for over 24 hours. Low grade fever, chills and body ache
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified date, the patients may have received improperly stored doses of VAQTA intramuscularly (dose and lot number were not reported). The vaccines were improperly exposed to 48.5F for 5 hours 49 minutes (on 01-FEB-2015), and to 48.5F for 9 hours 44 minutes (on 02-FEB-2015), and to room temperatures <77F for 31 minutes (on 24-FEB-2015) for 16 minutes (on 16-FEB-2015) for 15 minutes (on 09-FEB-2015) for 15 minutes (on 06-FEB-2015) for 24 minutes (on 30-JAN-2015) for 31 minutes (on 27-JAN-2015) for 40 minutes (on 15-JAN-2015) for 16 minutes (on 06-JAN-2015) and for 54 minutes (on 30-DEC-2014). There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse event but patient did receive the wrong vaccine that what was ordered. In March 2023 the Public Health portal for ordering additional doses of COVID19 vaccine was down. Pharmacy called Public Health and placed a verbal order for monovalent vaccines for 12 and over. On 3/22/2023 the Public Health COVID19 vaccine order was received but it was the bivalent adult vaccine (Lot Number GJ3270).  Three orders were placed for monovalent but bivalent dispensed (Dates: 4/4, 4/21, and 4/22). Two patient received bivalent when monovalent was ordered.  On 4/18, the FDA issued the news release to simplify vaccines to bivalent; monovalent no longer authorized for use.  Both data and the data have been corrected. No Adverse Reactions noted.
Pt. received an injection in her LT arm. The area quarter size sore, red yesterday. She applied ice. Now the whole LT arm red, warm to touch and very sore. The redness size is now orange.
Pain in upper arm, radiating to top of shoulder, collar bone, and just below neck. Vaccine was administered in left deltoid. Pain is on the left side.
Patient started having symptoms like a cold on January 1, 2021. She attributed them to having had the vaccine 3 days prior. Her husband started getting sick a couple days later and was sent home from work to be tested for COVID. When he went, she went as well to be checked out. She tested positive on January 6,2021.
Long splotchy rash on the underside of both arms.; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 15May2021 at 12:00 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. The patient had no known medical history. Concomitant medications were not reported. 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 vaccine. On 15May2021 at 13:00 the patient experienced long splotchy rash on the underside of both arms. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the event long splotchy rash on the underside of both arms was not recovered at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Patient reported confusion, soreness in arm, bad headache and twitching, feeling hot and clammy. All symptoms resolved by morning. Patient requested that this reaction be reported. Did not occur with dose #1.
Information has been received from a nurse practitioner concerning an 18 year old white female who on 11-APR-2007 at 15:00 was vaccinated, intramuscularly in the right deltoid, with a first 0.5 ml dose of Gardasil (Lot #655324/0089U).  Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA) and metronidazole (FLAGYL).  On 11-APR-2007, several hours after the vaccination, the patient developed a blister-like reaction at the injection site and at 15:00 experienced prolonged injection site pain (for three weeks).  At the time of this report the patient's outcome for blister-like reaction at injection site was unknown.  No product quality complaint was involved.  Additional information is not expected.
swollen and sore lymph nodes in armpits - neck and groin area.   not resolved at this time
Arm hurt as soon as I got the injection. The next day and every since. I have headaches. Awful neck pain,weakness,tired, coughing, pain in back. Using Tylenol doesn't help much..I will feel fine for a day then it comes back
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 76-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date January 2019). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site bruising, injection site rash and injection site pain. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site bruising, injection site rash and injection site pain were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site bruising, injection site rash and injection site pain to be related to SHINGRIX. Additional information was received as follows: The patient received a dose of SHINGRIX in the left deltoid. After receiving the vaccine, the patient experienced rash, bruising, pain and swelling about the size of her palm a couple inches below the injection site. These symptoms resolved after 3 days.
Headache, Fever, BODYACHE, CHILS, FATIGUE Narrative:
Patient initially had soreness in the arm but 5/14 a rash was discovered on the same side as the vaccine.
2/8/03 2 hrs post Anthrax vax PT experienced headache accompanied by poor appetite, blurry vision. 2/9/03 PT couldn't get out of bed, temp, chills, and migraine. 2/10/03 Fever fluctuating, migraine dizziness. 2/11/03 Took Dayquil went to work condition worsened fever, stomach cramps, nausea, difficulty breathing, tightness in chest, no appetite, blacked out. Questionable convulsions. Called ER transferred to a hospital. Was in ER for 7.5 hrs. 2/12/03 stayed in bed poor appetite. 2/13/03 felt better, low grade fever, went back to work.
This is a spontaneous report from a contactable other health professional.  A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EV0140, via an unspecified route of administration in the left arm on 03Jan2021 13:00 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. Patient was not pregnant at vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication included Simvastatin, Gabapentin, Flonase, Claritin and multi (not specified). The patient previously took codeine and experienced allergy. Within two days (on 05Jan2021), patient experienced headaches, body aches, fatigue, nasal congestion. Strength not yet fully recovered ten days out. The outcome of events was recovering. Patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
I tested positive for COVID-19. I thought I had a common cold. I had chest congestion, tightness, running nose and a headache. I had trouble sleeping and I did not have a fever until the second day for 24 hours. Then I had nasal congestion once my fever broke. I talked to telehealth they gave me antibiotic in case it was something else because I kept testing negative for COVID-19 then, I finally tested positive for COVID-19.  I ended up not taking the antibiotic. I started taking Tylenol instead. My symptoms lasted for 2 weeks.
"covid vaccine arm" beginning 8 days after injection -- itching and redness/pinkness, along with warmth and a lump under the skin. The redness appears to be only below where the injection was given (I am heavily tattooed, and cannot tell whether the pink coloring extends further, but can see some of it approximately two inches below the injection site). It's not painful. I am also tired, and have a headache, much like I did in the 24-36 hours after the vaccine.
a Vaccine injury; Initial information received on 23-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.   This case involves a 54 years old female patient who experienced a vaccine injury, while she received vaccine INFLUENZA VACCINE (QUADRIVALENT).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Jan-2017, the patient received a dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer (lot UT568MA and expiry date 30-Jun-2017) via unknown route in unknown administration site.  The patient developed a non-serious a vaccine injury (vaccination complication) <<Unknown latency>> following the administration of INFLUENZA VACCINE (QUADRIVALENT).  (Other relevant tests included No lab data reported.)  Final diagnosis was a vaccine injury.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for a vaccine injury.
Patient called  Health Dept. requesting 2nd dose of Pfizer vaccine to be administered in home due to disability. Pt states received 1st dose on 8/14/2021 @ Rehabilitation Center. No records found in Tenniis. Later that same day, RN drove pt. Pt unable to locate vaccine card upon arrival. RN administerd Pfizer vaccine in left deltoid. New vaccine card made. Before leaving home, pt found vaccine card which states received Moderna on 8/17/2021.
This spontaneous report was received from the patient's mother refers to her son a 18 month old male patient. Patient with no drug reactions, allergies or pertinent medical history. On an unknown date (several years ago) the patient was vaccinated with the first dose of MMR II (route, lot number and expiration date not reported). There was no concomitant medication reported. Patient's mother reported that when the patient received MMR II he experienced fever and was lethargic on an unknown date. Patient sought for medical attention: unspecified contact. No lab diagnostic studies were performed. These symptoms lasted for about a week and then recovered on an unknown date. It was reported that events occurred several years ago when family was living in another city. It was also reported that the patient had not received dose 2 of MMR II. This is one of two reports from the same source (sibling MARRS # 1406USA005661). Additional information is not expected.
Bronchitus.  I don?t think this is related to Covid shot.  I was exposed to someone with bronchitis.
I was fine after my shot, but at 3:00pm I started having chills  muscle aches and severe nausea. I also have a headache and fever. While driving home my muscles seem to shut down. My face was numb I couldn?t move my hands or my legs to drive. I had to pull over on the highway for 20min until my hands legs and face regained mobility.
After needle was retracted following vaccination, the needle broke away from the hub and a drop of vaccine fell on the patient.  It was determined that a sufficient dose was given and the patient was released to home.
"herpes outbreak was starting to develop just below the center of lower lip. it has developed into a rather large multi-blister outbreak"; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 07Apr2021 at 12:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis. The patient did not receive any medication within two weeks of vaccination. The patient previously took Ibuprofen and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 18Mar2021 at 12:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021, On the evening of the second day after the second vaccination, the patient noticed that a herpes outbreak had started to develop just below the center of her lower lip. Two days later, it had developed into large multi-blister outbreak- the worst that she had ever experienced. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event "herpes outbreak was starting to develop just below the center of lower lip and it developed into a rather large multi blister outbreak" was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.