chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified medical assistant (CMA) for GARDASIL, a Pregnancy Registry Product, concerning a 23 year old female patient who on 17-AUG-2011 was vaccinated with her final dose of GARDASIL (dose, route, site and lot number not reported). The CMA said that the patient called the office on 20-AUG-2011 to report that she just found out that she was pregnant. The patient had not yet missed her period. There was no adverse effect reported. Patient's last menstrual period and expected date of delivery were not reported. Follow up information of the prospective pregnancy report as received from the physician refers to the 23 year old female patient. On 17-AUG-2011, the patient was vaccinated with her second dose of (initial reported as final dose) GARDASIL (lot #, expiry date, dose, strength, route and indication not reported). The reporter stated that the patient just found out that she was pregnant. The patient stated that she had not yet missed her period when she called the office on 20-AUG-2011. The patient became pregnant with last menstrual period (LMP) of an unspecified date in 2011. The patient did not seek medical attention. The estimated date of conception (EDC) and estimated date of delivery (EDD) were unknown. Follow up information was received from the MA who reported that the baby was fine. The reporter stated that the baby was born full term and was normal and healthy with no problems and no congenital anomalies. No further information is available. Additional information is not expected.
First dose given 12/24/2020 injection site pain developed 12 hours after vaccine given and resolved by 24 hours post vaccination.  Trunk rash developed 48 hours after vaccine and resolved within hours.  Twelve hours after second dose on 1/14/2021, developed chills, aches, burning neuropathic pain all over, temperature of 101 degrees F.  After 5 hours took 600 mg ibuprofen with relief and required another dose at noon the day after vaccination.  Symptoms resolved within 24 hours.  Developed pruritic trunk rash that lessened within hours but took > 2 weeks to resolve.
pt recv vax; fever to 104;inc irritability x several hr; apap & children motrin given;
Information has been received from a licensed practical nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history. Concomitant therapies included sterile diluent (MRK). On an unknown date, the patient received an improperly stored dose of VARIVAX for prophylaxis, lot # M024683 and expiry date 18-MAY-2018 (anatomical location, dose and route of administration were not reported). No adverse effects reported. It was reported that on an unspecified date, the vaccine was exposed to a temperature between -9° Celsius (C) and 8° C for 2 hours and 31 minutes. The medical assistant reported that there was no previous temperature excursion. The call was not placed because of a Digital Data logger report.
Information has been received from a physician concerning a female who on 22-JAN-2008, who was supposed to have received zoster vaccine live (Oka/Merck), was inadvertently vaccinated with varicella virus vaccine live (Oka/Merck). The patient was not experiencing any known symptoms. It was indicated that the incident was due to human error. A product quality complaint was not reported. Additional information has been requested.
Left arm became slightly itchy and a little red at injection site approximately 7 days after injection.  At 10 days, larger portion of left arm at injection site is red and slightly swollen and hot. I am currently 10 weeks 3 days pregnant with an estimated due date of 08/22/21.  I have one living child (2 years old) and three miscarriages since then to date.
This spontaneous report was received from a medical assistant and refers to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ, (dosing details unknown) (lot # M019707 with expiry date 25-OCT-2017; lot # M014755 with expiry date 30-OCT-2017; lot # M041814 with expiry date 27-JUL-2018) orally for prophylaxis. Medical assistant did not know which of the vaccine lot numbers were administered. The administered doses of ROTATEQ experienced a temperature excursion of 47 degree Fahrenheit(F) to 77 degree Fahrenheit(F) for a time frame of 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. No additional information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA001442: Original Case : 1706USA001442
On Wednesday, 01/17/01, the patient's left arm ached from the site where the shot was given down her hand. Thursday,01/18/01, the pain was better but still sore at the injection site. Friday, 01/19/01, having numbness on the left arm down to the hand. Feels tired all over with dizziness.
PATIENT COMPLAINT ABOUT HAVING A THIRD BREAST UNDER THE ARM PIT. UPON RESEARCH IT WAS TOLD THAT IT COULD BE SWOLLEN LYMPH NODES DUE TO PFIZER VACCINE BUT SHE SHOULD GET IT CHECKED BY HER DOCOTR TO RULE OUT CANCER IF THE ISSUE IS NOT RESOLVED IN 7 DAYS. SHE WAS RECOMMENDED TO APPLY COLD COMPRESS.
This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 25-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, which had a lot # of L016428 and an expiration date of 30-AUG-2017 (dose, dosage number, route of administration and anatomical location were not reported). It was stated that the temperature excursion was 28.9 F for a time frame of 7 hours. This excursion was found due to a data logger. Additionally, it was stated that no previous temperature excursions had occurred.  This is one of the several cases received from the same reporter. Additional information has ben requested.
Under injection site, large circle shape about 2 inches wide. Red in color and swollen. Painful and hot to the touch, appeared the next day after the shot. Over the counter medicine not helpful. Seeing Dr. in a few days.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M010440, expiration date: 09-DEC-2018) (dose and route of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursions of 9.5 degrees for 1 hour and 10 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Change in gait, loss of balance, inability to complete balance test (self administered) weakness in legs, exacerbated by: length of time standing, lateness in the day, hot weather
the strangest feeling washed over me/strange sensation; a really rapid heartbeat for about a minute; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 07:00 (Lot number: ER2613, Expiration Date: 31Jul2021) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism", start date: 1999 (unspecified if ongoing), notes: diagnosed when she was 44, which was 22 years ago. She says it is an autoimmune thyroid condition.; "a-fib" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing), notes: Caller says this was diagnosed 10 years ago. There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious) with onset 22Mar2021, outcome "recovered", described as "the strangest feeling washed over me"; HEART RATE INCREASED (non-serious) with onset 22Mar2021, outcome "recovered", described as "a really rapid heartbeat for about a minute". Relevant laboratory tests and procedures are available in the appropriate section. She says after about 10 minutes after vaccination, the strangest sensation washed over her and she had a rapid heart beat of about 100 beats for about 60 seconds that went away. She says that she was concerned about when she gets her next shot what may happen. She said that the strange sensation went away after about 60 seconds, it was very fast, she felt like she could feel the vaccine spread through her whole body, it was a really strange sensation. She says she would like to know if this is normal, they waited 5 more minutes before they left and it has been 4.5 hours and she is fine now. She says that her main concern is for the next shot, what will likely happen. She says she guesses that was an adverse effect.  No follow-up attempts are possible. No further information is expected.
Rash; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH (Rash) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 24-Dec-2020, the patient experienced RASH (Rash). On 25-Dec-2020, RASH (Rash) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Approximately 2 weeks after my 2nd booster shot (Dose 4) I experienced the following symptoms: Runny nose, sore throat, coughing, body aches, low grade fever. I took Tylenol and ibuprofen. As of today I have not recovered from the symptoms and it's been ongoing ever since.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-MAY-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5 ml) (lot #: L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer) (R/F) for each time were 384, 34 and R; 72, 31 and R. The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
Vomited within 3 hrs post vaccination, limp, pale, unconscious. Contacted 911 and within minutes vital signs stabolized.
Patient has pain in right shoulder and has trouble lifting arm 2 months after injection. Patient claims to have had adverse reaction 12/28/15 but did not report until 2/18/16.
Patient fainted minutes after administration of the vaccine, and emergency services were called. He mentioned a tendency to faint with "shots" to the adminstering pharmacist as the vaccine was being given. Emergency services arrived within 15 minutes and the patient was alert enough to converse with them.
Information has been received from a medical assistant concerning an 11 year old female who on 09-APR-2007 was vaccinated intramuscularly with a first dose of Gardasil vaccine (lot #659435/1265U). On 09-OCT-2007, the patient was vaccinated with a third dose of Gardasil vaccine. Concomitant vaccination on the same day included Havrix. On 09-OCT-2007, when the patient was coming out of the room she bumped into the wall, her eyes were open, face was very pale, skin was cold and clammy. The patient's mother caught her and assisted her to the floor. The patient was given candy and a drink. The patient rested in the office and was then fine. The office staff does not believe she fainted or loss consciousness. At the time of the report the patient was doing fine. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. Initial and follow-up information has been received from a medical assistant concerning an 11 year old female who on 09-APR-2007 was vaccinated intramuscularly with a first dose of GARDASIL vaccine. On 09-OCT-2007 the patient was vaccinated into the left arm with a third dose of GARDASIL (Lot #659402/1265U). Concomitant vaccination on the same day included HAVRIX vaccine. On 09-OCT-2007 when the patient was coming out of the room she bumped into the wall, her eyes were open, face was very pale, skin was cold and clammy and the patient passed out. The patient's mother caught her and assisted her to the floor. The patient was given candy and a drink. The patient rested in the office and was then fine. The office staff does not believe she fainted or lost consciousness. At the time of the report the patient was doing fine. Additional information is not expected.
Pt developed low grade fever followed by dizziness which led to a fall and hematoma on left forearm.
Rec'd 5yr shots in office on 7/26/16. Seen 7/27/16 for c/o redness to Rt deltoid (5x6cm) and 4x3 cm to Lt deltoid. Both with warmth and c/p discomfort and pruritis. Afebrile. (No Hx RXN). TX with cold packs; Ibuprofen. To return if S/S increase.
Parsonage Turners Syndrome right arm. Guillain Barre. Symptoms began Feb/8/19, right arm first, followed by numbness, etc. Ongoing through today - 5/19/13. Being treated by multiple doctors.
Left lymph nodes behind the sternocleidomastoid at the base of the neck swollen to size of pennies, tender, and hard.    Tinnitus in the left ear followed by complete hearing loss in the left ear with lots of pain.
After 1st Vaccine (8/11/21): - starting 6 hours after the shot (approx. 8 pm): full body weakness - During the night (approx. 15 hours after the shot): tightness in left chest/heart area; difficulty breathing deeply - 2 days later, 8/13, afternoon (i.e. 48-52 hours later): re-occurrence of tightness in left chest/heart area; difficulty breathing deeply.
body unnaturally warm; fever blisters around her mouth; muscle ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (body unnaturally warm), ORAL HERPES (fever blisters around her mouth), MYALGIA (muscle ache) and HEADACHE (headache) 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 FEELING HOT (body unnaturally warm), ORAL HERPES (fever blisters around her mouth), MYALGIA (muscle ache) and HEADACHE (headache). At the time of the report, FEELING HOT (body unnaturally warm), ORAL HERPES (fever blisters around her mouth), MYALGIA (muscle ache) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
I was diagnosed with upper respiratory infection on March 15, 2023 I was prescribed medication for my symptoms.
achiness at the injection site; Injection site knot; injection site turned red in a small spot /She developed a knot,; whole muscle from the elbow up  to her shoulder got sore; she got warm, like a fever just at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shoulder replacement. Previously administered products included Shingles vaccine (received shingles vaccine a year ago before reporting date).   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain, injection site lump, injection site warmth, injection site erythema and muscle soreness. On an unknown date, the outcome of the injection site pain, injection site lump, injection site warmth, injection site erythema and muscle soreness were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site lump, injection site warmth, injection site erythema and muscle soreness to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient after vaccination started having achiness at the injection site. The patient developed a knot, as big the palm of her hand, at the injection site.  The patient got warm like a fever just at the injection site. The knot at the injection site turned red in a small spot, next  the whole muscle from the elbow up  to her shoulder got sore. The patient stated that it would not be sore if she is standing up, but when she rolled over or moved it. The reporter consented to follow up.
The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On or about 20-JAN-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 01-FEB-2012, patient was treated by a healthcare provider for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. She was prescribed ibuprofen and valacyclovir hydrochloride (VALTREX) for management of her painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
Severe back pain, between shoulder blades; difficulty breathing; Dose Number 4: 02Apr2022/ Dose Number 3: 02Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 02Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ADAIR; SINGULAIR; VITAMIN B COMPLEX; VITAMIN D [COLECALCIFEROL]. Past drug history included: Composine, reaction(s): "Known allergies: Composine"; Keflex, reaction(s): "Known allergie: Keflex". Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: EXTRA DOSE ADMINISTERED (non-serious) with onset 02Apr2022, outcome "unknown", described as "Dose Number 4: 02Apr2022/ Dose Number 3: 02Apr2022"; BACK PAIN (hospitalization) with onset 02Apr2022 at 16:00, outcome "recovered" (2022), described as "Severe back pain, between shoulder blades"; DYSPNOEA (hospitalization) with onset 02Apr2022 at 16:00, outcome "recovered" (2022), described as "difficulty breathing". The patient was hospitalized for back pain, dyspnoea (hospitalization duration: 1 day(s)). The events "severe back pain, between shoulder blades" and "difficulty breathing" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Apr2022) Negative. Therapeutic measures were taken as a result of back pain, dyspnoea. Clinical course: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included prebiotic and citruce. Several breathing treatments and pain medication were received as a treatment of events dyspnoea and back pain. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient developed COVID symptoms including stomach ache, vomiting, diarrhea, headache, and fatigue on 4/18/2021. Patient did have exposure to a COVID-positive person on 4/16/2021.
temperature excursion which was administered to multiple patients.; No additional AE's reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's historical drugs or reactions, pertinent medical history and concomitant medications.  On 06-APR-2021 the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX)  with dose reported as 1 administered subcutaneously (lot number T028303 and expiration date 20-AUG-2022) for prophylaxis (vaccination scheme frequency and anatomical location were not reported). It was stated that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of minus 11.5 degree Celsius. This excursion had a time frame reported of 25 minutes. No previous excursions were reported, and information was provided via data logger. No additional adverse event was reported and patient was asymptomatic.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA002751:
Patient received 2nd dose of vaccine too early. First dose was administered on 10/1/2021. No adverse reactions to vaccine noted. Patient to receive repeat dose of vaccine at 6 month interval of invalid dose.