chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a female who on 01 Sep 2006 was vaccinated intramuscularly with HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653650/0702P).  The nurse reported that she was very unhappy with the syringe.  The nurse reported that she "had received no instructions, and upon using the syringe for the first time, the safety device activated as soon as she pushed all the way down on the plunger, and it hit the patient in the arm".  The nurse also reported that she had not read the product insert prior to administering the vaccine, as it was not available in the carton, and as soon as she administered the full dose of vaccine, she immediately let go of the plunger.  She also reported that "it was loud, which scared the patient, and the needle coil sprang out and hurt the patient.  The patient was kept in the office longer than normal since the coil hit the patient against her arm and hurt her.  Unspecified medical attention was sought.  The nurse was able to administer the entire dose of vaccine.  On 05-Sep-2006 the patient had recovered.
lethargic; muscle aches; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24Mar2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and pollen allergy. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. Concomitant medications included atorvastatin calcium (LIPITOR), lisinopril (MANUFACTURER UNKNOWN) and vitamins (MANUFACTURER UNKNOWN), all for unknown indications on unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 05Apr2021 at 10:30, the patient experienced muscle aches and was lethargic. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lethargic and muscle aches was resolved on an unknown date in Apr2021.The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12Apr2021 at 10:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This is a spontaneous report received from contactable consumer (patient). An 86-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, intramuscular, administered in arm right on 12Apr2021 13:00 (Batch/Lot Number: AW0158) as single dose for COVID-19 immunization. Medical history included chromosomal abnormalities, diabetes, obesity, migraines, sinus during spring, allergies, compromised immune status, respiratory illness, endocrine abnormalities, headaches and acidity. Concomitant medication included acetylsalicylic acid (ASPIRIN (E.C.)); amlodipine besilate (NORVASC) taken for acidity; and tamsulosin hydrochloride (FLOMAX RELIEF) taken for acidity and one medication for acid for his stomach every day. He has been these taking for years along with a Vitamin D. He was taking all prior to getting the vaccine. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6207), at 86 years old age, Injected in left arm in the muscle on 23Mar2021 for covid-19 immunisation and experienced joint pain. The patient had been experiencing some pretty good amounts of joint pain on his knees, ankles, and lower back. Patient was getting concerned because his joints were bothering him and are painful in his knees and lower back. He also got a headache. Headache started after second shot. He had allergies and sometimes he got headaches. He had a sinus problem and in the spring he got migraines. This was a different type of headache and was a dull headache. The outcomes of events were not recovered. No follow-up attempts are needed. No further information is expected.
Fluttering in chest, got checked out and there are multiple misfires in my heart.  Never had heart issues before the vaccine.
This spontaneous report as received from a physician refers to a 2 months old female patient. The patient was vaccinated with dose 1, 2 ml ROTATEQ on 27-SEP-2012 (Lot # not reported). No other co-suspects were reported. Concomitant medications included PENTACEL, PREVNAR 13 and vitamin D (unspecified). No allergies were reported. On an unknown date in 2012 the patient experienced black tongue. The physician stated that he knows that pink colored liquids can sometimes cause a black tongue. No treatment information was reported. The outcome of black tongue was reported as not recovered/not resolved. The relatedness for black tongue was unknown for ROTATEQ. Additional information has been requested.
Received 1/2 of the adult formulation; 2nd dose received on 29-Apr-2022 and 3rd dose Engerix B adult received on 29-Aug-2022; second Hepatitis B injection given late; This case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 2-month-old male patient who received HBV (Engerix B adult) (batch number AC397, expiry date 8th August 2023) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B vaccine (1st dose received on 21 February 2022).   On 29th August 2022, the patient received the 3rd dose of Engerix B adult (intramuscular). On 29th April 2022, the patient received the 2nd dose of Hepatitis B vaccine. On 29th April 2022, not applicable after receiving Engerix B adult and unknown after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long. On 29th August 2022, the patient experienced adult product administered to child and drug dose administration interval too short. On an unknown date, the outcome of the adult product administered to child, drug dose administration interval too short and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the 6 month old child patient received Engerix B adult vaccine. The reporter stated that the patient received second dose of Hepatitis B vaccine On 29 April 2022 after 2 months of received first dose of Hepatitis B vaccine. The reporter did consent to follow up. Additional supportive information: The child patient was administered a 1/2 of the formulation(0.5ml) of adult dose of Engerix B on 29th August 2022, which led to adult product administered to child  The patient received 2nd dose of Hepatitis B vaccine late than recommended time frame, which led to which led to lengthening of vaccination schedule. The patient received 3rd dose of Engerix B adult vaccine early than recommended time frame, which led to which led to shortening of vaccination schedule.
Dizzy, anxious and flushed.  Observed for 26 minutes and patient wished to go to the ED. BP at 0638: 187/95; HR 115.  Pulse ox 99%.  at 0650 BP 181/89, HR 106.  PUlse ox 100%.  Felt the same as before - no oimprovement.  Asked to go to the ED.  At 0658 BP 190/84 and HR 109.  Escorted to the ED.  Seen in the ED for hypertension.    No signs of allergy.  Observed and felt better. BP improved on recheck and will follow-up as an outpatient.
Pain all over the body! Swelling in both feet ankles, fever, stomach pain, fatigue, chest pain and phlegm! Extreme tiredness, pain and swelling in the vaccinated arm, swollen of the shoulder of the vaccinated arm, severe headache
Flu-like symptoms began the night of the vaccine. Extreme cold, shivers, lymphadenopathy, joint pain, fogginess. Fogginess and extreme fatigue continues today.
Five minutes after administering the vaccine, the patient complained that her body felt hot, nausea, and  her face looked pale.   After 15 minutes, she was okay.
She ended up getting Covid in Aug2021; found out that the vaccine was not effective because of kesimpta; This is a spontaneous report received from contactable reporter. The reporter is the patient. Other Case identifier(s): NVSC2020US302184.  A 51 year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; Kesimpta (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset Aug2021, outcome unknown, described as She ended up getting Covid in Aug2021; DRUG INEFFECTIVE (medically significant) with onset Aug2021, outcome unknown, described as found out that the vaccine was not effective because of kesimpta. She had COVID again about 2 weeks ago. The action taken for Kesimpta was unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Received 2nd Moderna shot at a drive through facility around 4:00 PM. Was warned that 2nd shot could cause flu like symptoms and make my arm sore more than 1st shot. Later that evening around 9:00 I began to experience moderate pain at the injection site. I went to bed shortly thereafter. Around 2:00 AM I was suddenly awoken by extreme pain at the injection site. So much so I sat up in bed. It felt like I was being repeatably stabbed with a pair of scissors. It finally subsided and I went back to sleep. When I woke up the next morning my left shoulder was very sore and stiff. Over the next week this condition persisted and eventually affected my entire left arm and hand. I then began to experience this pain and stiffness in my right shoulder and arm as well. This limited my ability to move or extend my arms. Within another 2 weeks it had extended to my inner thighs making it impossible to continue my daily walks. On the morning of 07/17/2021 I awoke in extreme pain and I found myself unable to roll over or get out of bed. Fortunately I was laying close to the edge and after laying there for about 45 minutes was able to get my right leg over the edge. I could not however raise or extend my arms which prevented me from dressing myself. As the day progressed It became less difficult to move and later that evening I went an urgent care center. There they examined me, drew blood for labs and prescribed steroids. I was diagnosed with systemic inflammation response. I was seen by a rheumatologist on 06/17/2021 who ordered numerous blood and urine tests which indicated the inflammation was still present. I was given an injection of Kenalog and continued with the oral steroids. I then began to experience peripheral neuropathy and weakness in my hands, forearms and feet. I've lost a significant amount of hair due to possible telegon effluvium. Other treatment medications included methotrexate a leflunomide. As of 02/21/2022 still on steriods, gabapentin, ARB and statin. Was prescribed toxilixumab but insurance denied the treatment. Still unable to see neurologist because of false information provided by insurance co.  Participated in program. Tested positive for S Protein antibodies but negative for N Protein indicating that the S Protein antibodies produced were vaccine induced.   06/17/2021 1. Possible new onset inflammatory polyarthropathy. 2. Previous history of biopsy-proven idiopathic glomerulonephritis treated with chlorambucil and Cytoxan. 3. Post viral syndrome following a donor vaccine. 4. Elevated CRP.
Broke out on arms with a rash then it eventually went to chest back & legs.  Very very itchy!!
Developed sore arm on 8th day after shot around injection site and 2 rashes have developed at shot site and and below shot site.
6/9/00 Diagnosed with diabetes; insulin dependent. Per 60 day follow up; for the missing vaccine information they say "Would the Dr. give this info without causing a problem?" The pt did not recover. Diabetes. There was another child diagnosed the week before about the same age who was a pt of Dr.  60-day follow up on 11/20/2003: "Vaccine recipient did not recover from the adverse events that were reported for this vaccination.  Diabetes Type I, insulin dependent the rest of his life.  Is there any other reports of diabetes from vaccines?"
patient experienced side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (patient experienced side effects) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.   On 16-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (patient experienced side effects). At the time of the report, IMMUNISATION REACTION (patient experienced side effects) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment drugs were reported.   Reporter did not allow further contact
Pain 24/7. Limited movement of right arm. Follow-up: R arm pain and weakness.
pt was given immunizations at aprox. 11:30am showed up to emergency room at aprox noon with anaphylaxis treatment administered by emergency department.
Early morning Friday 01/08/21, moderate pain at injection site, PO Tylenol 1000mg, @ 0615, heading into work. Then @ 1030 feeling tired, neck & shoulder pain, chills, headache, right ear pain, slight sore throat, PO Motrin, 400mg moderate relief. Total of 30 hrs of recurring symptoms, alternating Tylenol & Motrin throughout. Started to feel better Saturday afternoon 4-4:30p
Vomiting, Diarrhea, high fever, aches, abdominal pain, upper respiratory last from 10:00 pm on 10/23 to 6:00 am on 10/25. Only treatment was Tylenol and Mucinex.
This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age and gender. Initially reported as RECOMBIVAX HB, (lot # J009374, expiration: 11-JUN-2016) and GARDASIL vial wet SD 120 Y (lot # K005083; expiration 04-NOV-2016) were improperly exposed to 31 Fahrenheit (F) for 48  hours on an unspecified date, and to several other unspecified temperature excursions on unspecified dates. An unspecified number of patients received at least one of these vaccines on unspecified dates. Further it was reported that RECOMBIVAX HB,(lot # j0009374; expiration: 11-JUN-2016) and GARDASIL (lot # K005083; expiration: 04-NOV-2016) were exposed to 31F for 15 days (360 hours). However later it was confirmed that GARDASIL was not administered to anyone. On 20-SEP-2014, the patients were vaccinated with improperly exposed RECOMBIVAX HB vial SD, intramuscularly (lot # J009374, expiry date 11-JUN-2106.  Later it was confirmed with the reporter that RECOMBIVAX HB were improperly exposed to 33F for 96  hours from 04-SEP-2014 to 08-SEP-2014, and to 34F for 48 hours from 09-SEP-2014 to 11-SEP-2014, and to 34F for 72 hours from 12-SEP-2014 to 15-SEP-2014, and to 33F for 168 hours from 15-SEP-2014 to 22-SEP-2014, and to 31F for 240 hours from 26-SEP-2014 to 06-OCT-2014. No adverse effects reports. Outcome of events was unknown. No product quality complaint (PQC) was involved. No further information reported. This is one of several reports received from the same reporter. Additional information has been requested.
Passed out; vomit; nauseous / Nausea worse; dizzy; shortness of breath; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fish allergy.   On 20th November 2019, the patient received Shingrix. In November 2019, 10 hrs after receiving Shingrix, the patient experienced nausea, dizziness and shortness of breath. On 21st November 2019, the patient experienced passed out (serious criteria GSK medically significant) and vomiting. On an unknown date, the outcome of the passed out, shortness of breath and vomiting were unknown and the outcome of the nausea and dizziness were recovered/resolved.   It was unknown if the reporter considered the passed out, nausea, dizziness, shortness of breath and vomiting to be related to Shingrix.  Additional case details were reported as follows: The patient was excellent in health and very allergic to shell fish. The patient received vaccine at about 3:00 pm. About 10 hours later, patient felt nauseous, dizzy and experienced shortness of breath. The next morning, 1 day after vaccination patient became much more nauseous and dizzy. The patient passed out and his wife had to call 911. The nausea got worse and patient began to vomit (not food but both dry heaves and green bile). The hospital performed various tests (ekg, ct scans, xrays, etc). The patient did not have a heart attack, a stoke, and that his lungs, brain and blood pressure were normal.  After follow up with doctor a week later also found no abnormalities. The nausea went away but the dizziness persisted for a few days and was gone now. The patient asked whether it was possible that what he experienced was a severe side effect. The reporter requesting consent to follow up.      Lab Comments: on an unknown date lab test was performed.
I had some eye pain; light sensitivity after my second dose of the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (I had some eye pain) and PHOTOPHOBIA (light sensitivity after my second dose of the Moderna vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EYE PAIN (I had some eye pain) and PHOTOPHOBIA (light sensitivity after my second dose of the Moderna vaccine). At the time of the report, EYE PAIN (I had some eye pain) and PHOTOPHOBIA (light sensitivity after my second dose of the Moderna vaccine) outcome was unknown.            No concomitant medication was provided  Treatment medication was not provided
I got my 1st vaccine and April and noticed a really heavy period afterward but nothing to alarming. I track my cycle month and it's always very consistent and it follows an app on my phone. After I got my next vaccine  in May my following period came when it normally does but lasted 15 days straight instead of the usual 6. After 25 days it stopped for 4 days and then started up for another 4 days.  It wasn't spotting it was a full period. So the month of June I had a  19 days period. Next cycle came in July and it was normal
The evening of the vaccine, my left deltoid we sore.  It stayed sore for 5 days and also was red and swollen.  On the 5th day I developed a red, itchy rash over my anterior neck X 2 days.  The next day my eyelids were swollen and I had a red rash on my face.    I saw Dr. on Nov 17th and she felt this was an allergic reaction to the Prevnar 20.  The face and neck rash were gone on that date, but the arm rash was still present, although faint, and resolved by the next day.  I took pictures and showed the rash pictures to Dr.
11-6-09 - Had vacular lesions & purpura on thigs-then arms-lots of lesions. 11-9-09 - Swelling of joints of lower extremities, foot - painful. Saw Dr. 11-16-09 - Saw NP - pain worse - referred to rheumatoid specialist. 11/30/09 Saw Dr. (rheumatoid specialist). Saw Dr. (dermatologist) and lesions biopsied and specimens sent. Was put on prednisone x2 months. Dx: Vasculitis. Reactionary inflammation related to exposure to something. Inflammatory response. Lesions - granulomatous inflammation. Sed rate during this time 92. Today: Status - finishing prednisone - returns to dermatologist 1/21. Lesions gone. Pain started to resolve 5 days after starting prednisone - and could then also start wearing shoes again. Still has some weakness in left foot.
This spontaneous report as received from a consumer refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneous for prophylaxis. On 18-MAY-2017, the patient experienced varicella. On an unknown date, the patient experienced hypersensitivity. The outcome of hypersensitivity and varicella was reported as not recovered/not resolved.
Syncope. Fainted standing up and fell backwards, hit back of head on floor. Pt felt lightheaded after shot. Water, juice given. Minimal pain. Stable and released. NP recommend ER visit if any headache, lightheadedness, vision changes.
Ten 10 days after receiving PCV 13 vaccine, pt was playing outside w/mother when he became stiff, eyes rolled to back of head, became unresponsive and started shaking. Lasted approx. 30-60 seconds, and then sluggish for 5-10 min.
Large red spot; Warm to the touch; This is a spontaneous report from a contactable other healthcare professional, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 29Mar2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included addison's disease. The patient had no allergies to medications, food, or other products. Concomitant medication included hydrocortisone (MANUFACTURER UNKOWN) for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 08Mar2021 at 13:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 17:00, the patient experienced large red spot which was warm to the touch. The patient did not receive any treatment for the reported adverse events. The clinical outcome of the event large red spot which was warm to the touch was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
10 min post vaccine began c/o tingling in  lips and tongue.  stated felt like her throat was  like a balloon  being blown up.  mild anxiety, no sob or diff breathing.  no diff swallowing.  brought from  lobby to exam room.  VS  taken.  25mg of po benedryl given and  0.3mg epi  given  SQ  at approx  09:20 sat with patient and monitored VS frequently  approx q 10m  for  60m.  oxygen sats remained 98-99% on RA, resp were  20 ( initially with anxiousness down to  14 by discharge.  P ave 80s  BP ave 130/70s symptoms  began to resolve by  30min and  were resolved  at 60min and pt was  release d home  pt  called when she  returned home  ( 1hr drive ) and was feeling well with  mild tongue  thickness sensation . advised to repeat  25mg  of  benedryl po at  3pm and 9pm  today advised to call Emergency Services for any return of sob  diff breathing  swallowing or sense of airway closing