chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Booster; My armpit are swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 17Nov2021 (Lot number: FF8839) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; SWELLING (non-serious) with onset 17Nov2021, outcome "unknown", described as "My armpit are swollen". Additional information: When the agent asked the patient to spell the first and last name, patient stated that she just had the same conversation with the other agent. The patient said the agent just cut off phone with someone else and took my all the information filed type of report was transferring me to someone back who can answer my medical question. The patient was enquiring if there was any way the agent can see that because patient just did it like.  The patient stated that the agent was trying to transfer me to medical professional that can answer my question because the patient mentioning that she just got the Pfizer booster shot and her armpit are swollen, so the asked the agent if this was one of the side effects of if the event was normal. The patient concern that she should be worried, and the agent said she couldn't answer that question. But one of the medical people could and gave the patient a number which was the same number the patient called then. The patient said that if the agent was going to give the number, she has the same number. The patient was informed by the agent that after dialing Pfizer Medical information contact, press option 3 and timings are 8 am to 8 pm as per EST from Monday to Friday. In response the patient stated, it didn't give her option 3, she press option 3 when the recording says please listen to all the options because our main option was change right. It listed 1, listed 2, listed 3, the patient pressed option 3. When she pressed option 3 you came on the line. When the agent enquired about LOT#, NDC#, UPC# and expiration date, the patient stated that she gave that to agent already, the agent had all the details of the patient. The patient was informed about to transfer the call in Pfizer Medical Information, the patient stated that it would be better if she just call back in the morning.  Further probing could not be done as the patient was not willing to share the information. Hence, limited information available over the call.  No follow-up attempts are possible. No further information is expected.
all over body aches, chills, soreness (flu-like symptoms). symptoms ended approximately 24 hours later
sz, t103-100.4 rectal;pt had cough 4 days, poor appetite, rash;
Once the shot was given my arm swelled then after 2 weeks my arm had pains, redness and skin peeling. Later in January both hands and fingers swelled and terrible pains were in almost every part of my body, I have been referred to see a specialist (Rheumatologist) by my primary doctor.
Swelling, redness and itching started March1st, 2021. Mild symptoms, still present
Took Typhoid vaccine in a capsule at 8 am on 6-9-06. By mid day had a headache, lay down to rest. Experienced hallucinations which continued. Taken to Hospital where they dissapated. Discharged by 6pm.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot # L042257, expiration date reported as 17-AUG-2018 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 56.8 degrees Fahrenheit for 12 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports from the same reporter. Additional information has been requested.
CLT FELT LIGHT HEADED.  BP 127/67.  CLT MOVED TO A COT AND LAYED FOR 15 MINUTES WHEN SHE FELT BETTER
Starting at 9pm, I experienced chills, shaking, headache, wide spread muscle soreness, fast heart rate, and nausea. My temperature was 99.5 consistently throughout the night but did not exceed this number. I took Advil twice throughout the night which relieved some of the headache. My symptoms stopped about 12/13 hours later.  Symptoms felt very similar to the flu.
Patient was given two doses of Polio one dose in the combo vaccine Pentacle and a separate dose of just polio. The staff member didn't realize that polio was included in the combo vaccine.
pt recvd vax; vomited several times for 3 days p/ vax; t 105; laid around & cried & was like a "cabbage doll" when picked up; limp;
Lost appetite; Chills; Fatigue; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lost appetite), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 043B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.".  The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE and POTASSIUM for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced DECREASED APPETITE (Lost appetite), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, DECREASED APPETITE (Lost appetite), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a nurse practitioner concerning a 22 week male who on 31-JAN-2007 was vaccinated with a first dose of ROTATEQ (lot # 654664/0726F) via oral administration and on 23-APR-2007 and 21-MAY-2007 was respectively vaccinated with a second and third dose of ROTATEQ (lot #s were both 656191/1365F). Concomitant therapy included DTAP (unspecified), PREVNAR, HIB (unspecified carrier) and IPOL. On 21-APR-2009, the patient experienced intussusceptions and was hospitalized for four days. On 25-APR-2009, the patient recovered from intussusceptions. Additional information has been requested.  7/13/09 Hospital records received DOS 4/20/09 to 4/23/09. Assessment: Intussusception of Intestine. Patient presents with intermittent abdominal pain, periumbilical and associated with paleness. Intermittent crying. One BM w/o blood. Has eaten only a few 'goldfish' and 2 ozs pedialyte. Abdominal guarding. Enema administration.  7/10/09 Received ICD9 codes: 560.0 intussusception.
Immediately after injecting IM in patient's left deltoid, a slightly purplish bump appeared at the injection site. I applied ice to the area, and the swelling was slightly improved. I expensed an instant ice pack and directed her to apply 15 minutes on and 15 minutes off. This was an employee, so before she left at 3:00 pm, I checked with her, and she said the swelling was gone. We did let her know to contact a physician if the swelling did not improve or returned.
12/15/2020 First Pfizer Covid Vaccine EH9899 RT arm 4pm 1/8/2021 Second Pfizer Covid Vaccine EL3246 RT arm 4pm 5/19 Daughter tested positive for covid 5/19 Employee tested Neg 5/24 Employee became ill 5/25 Employee tested positive for covid 6/4 potential to return to work
This is a spontaneous report from a contactable Physician via Pfizer Sales Representative. An over 65-years-old female patient of unknown race received PREVNAR 13 on an unknown date in May2013 (elaborated as 4 days ago) at single dose once as pneumonia vaccine. Relevant medical history and concomitant medications were unknown. It was reported that on an unknown date in May2013 (4 days ago) patient experienced red sore which were swollen in touch, spot size of an orange at the site of injection and on 17May2013 patient experienced red sore which was swollen in touch spot 2-3 inches lower than the initial spot size of a lemon. Relevant lab details were unknown. Therapeutic measures taken in response to the reported events were unknown. The consumer had not recovered from the reported events at the time report. Follow-up (22-JUN-2013): Follow-up attempts completed. No further information expected.
Given after being punctured for 28 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given after being punctured for 28 hours) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022 at 2:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given after being punctured for 28 hours). On 13-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Given after being punctured for 28 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. It was reported that the vial was  initially punctured on 12JAN2022 at 8:55 AM and administered at 2:30 PM on 13JAN2022 and not reported any symptoms. Date on which the vial was initially stored in the refrigerator 10 Jan 2022 and the total amount of time the vial was exposed to room temperature range from  12JAN2022 8:55 AM to 13JAN2022 2:30 PM .
Patient had redness, swelling, and tenderness. Patient also experienced fever and required time off from work.
Rash with pruritis on both legs, behind knee and behind upper thigh.  Onset was 4 days after injection. Nausea all day, onset was 1 week after injection. Depression, irritability, poor mood, onset was 1 week after injection.
No known adverse reactions-Patient received adult Hepatitis A dose instead of pediatric dose of Hepatitis A.
Started getting hives for no apparent reason. They last for about 15 minutes and disappear. They reappear again later. This has been on-going for 4 days now. We have not changed anything else and he is not allergic to eggs.
Syncope, fear of needles, hadn't eaten meal. BP 70/37 (pulse 60), 100% O2 sat.  Final BP 111/72 (pulse 82), O2 sat 100%.
Temp over 102 first night, over 100 second night, chills third night. Malaise, fatigue, difficulty concentrating Large muscle aches, pain in both sides of my  neck Left arm red, hot, bruised Feels like the flu after 4 days
Needle stick was painful and actual injection caused pain.  Arm ached that day.  Next morning I had increasing pain in the shoulder.  Noticed restriction in movement and increasing soreness by the next day.  Progressed to shoulder impingement syndrome.  Underwent 5 weeks of PT.  Improvement seen in first 2-3 weeks, then plateaued.  Had an ultrasound and x-rays (which were normal) followed by a cortisone injection on 11/21/12.  Immediate pain relief.  However, pain came back less than 2 weeks later.
Shortly after receiving the vaccine patient fainted, then woke up, then fainted again. Patient was sitting the entire time. Patient did NOT hit their head. Patient was laid down and gatorade and soda crackers were given. About 5 to 8 minutes after the second episode the patient fainted a third time while still sitting down, he did NOT hit his head. Patient immediately revived. Patient was kept laying down for over an hour. Vitals were taken, blood pressure was low, 108/49. After monitoring for over an hour blood pressure was retaken and was 118/79. Patient was carefully walked with someone next to him. He did fine. Patient chatted with the clinic PA but he declined an exam as he said he was feeling much better. Patient was counseled to follow up if things recurred. Patient felt fine upon leaving. Patient had stated he hadn't had breakfast this morning and was maybe a little dehydrated.
Within 10 minutes of leaving pharmacy, patient experienced tingling/burning/irritation near right breast.  Patient thought it was an underwire in her bra and dismissed it.  By the next day, the irritation was way worse and felt like it was "on fire".  Even clothes touching the spot was extremely painful.  There was no rash at the time and no rash ever appeared.  She also experienced increased temperature for a few days.  She says the pain is still present but is less than it was the first few days.  Patient spoke with doctor by phone but she  did not have a rash and didn't see point of going in.
1st dose 11/13, 2nd dose 12/8. On 12/31 we noticed small bald spot on patients head. On 1/25/22 Dr. advised it appears to be alopecia. Patient has no previous history of alopecia. Dr. advised we see a specialist and could not rule out this is a side effect of the vaccine.
Systemic: Body Aches Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: PATIENT HAD NECK PAIN AFTER THE INJECTION/ AND ELEVATED BLOOD PRESSURE-Mild, Systemic: Hypertension-Mild, Additional Details: PT WAS FEELING ANXIOUS IN THE BEGINNING TO GET THE VACCINE SINCE SHE HAD A REACTION TO TETANUS VACCINE PREVIOUSLY. PT WAS COUNSELED AND EXPLAINED ALL THE SIDE EFFECTS AND POSSIBLE ALLERGIC REACTIONS. PT WAS ASKED TO SIT 30 MINUTES DUE TO HER REACTION TO A VACCINE PREVIOUSLY. AFTER 20 MIN PT STATED SHE WAS FEELING NECK PAIN/LIGHTHEADED. PATIENT'S BP WAS TAKEN WHICH WAS ELEVATED SO SHE WAS ASKED TO SIT FOR 5-10 MIN SO I COULD DO A RECHECK. PT'S BP WENT DOWN/SYMPTOMS HAD RESOLVED AFTER 20 MORE MIN.
Knee, pain, thigh edema onset 24' post injection. (L) thigh CBC normal. Pt was started on Cephalexin & Benadryl q6h. Resolution
patient felt a little dizzy after receiving her injection- gave patient a sucker (tends to help people to keep from fainting in certain conditions), cold paks to put on her neck and hands, a fan on her and for air circulation, a bottle of water...patient felt fine within a short time and rested for at least 30 minutes if not longer before leaving , said she was felt fine and was ready to leave
Pt and mother presented to immunization clinic on 9/13/06 for second set of shots, noted on form a history of adverse reaction to Prev vaccine given on 8/2/06, mother states baby turned blue and had trouble breathing approx 5 hour after vaccine, then fine no medical f/u.
1st Dose Pfizer on 05/01/2021 2nd dose Moderna given on 05/29/2021
?Moderna COVID-19 Vaccine EUA Starting 2 weeks after receiving my Moderna vaccine, my bowel movements began floating and I've had constipation which has never been an issue in my life (my diet and liquid intake have not changed at all).  I've also noticed hair loss that I've never had in 52 years. Starting approximately 14 days after the vaccine, small clumps of hair have been coming out in the shower and there is much more hair on my hair brushes. I've noticed in the past week though, that the hair loss has decreased a little.
Information was received on 19-APR-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 19-DEC-2013, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-JUN-2015, the patient was seen at a family medicine clinic for a painful rash that was diagnosed as shingles. On or about the dates of 22-JUN-2015, 02-JUL-2015, 07-JUL-2015, 17-JUL-2015 and 06-AUG-2015 the patient was treated at the same facility for additional outbreaks of shingles. On or about the dates of 23-JUL-2015; 30-JUL-2015; 31-JUL-2015; 06-AUG-2015;  29-AUG-2015; 14-SEP-2015; 08-OCT-2015; 13-OCT-2015; 19-NOV-2015; 05-DEC-2015; 22-DEC-2015; 29-FEB-2016; 11-MAR-2016; 05-APR-2016 and 07-JUN-2016 the patient had encounters with her medical team at a family health clinic for treatment of postherpetic neuralgia, a painful and chronic condition caused by the residual nerve damage after the contracting shingles. Postherpetic neuralgia is an incurable condition, but the patient has been prescribed valacyclovir and valacyclovir hydrochloride (VALTREX) to manage her ongoing symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Fatigue and sore injection site evening of Day #1 also sweats at night, Days #2-4 continued fatigue, mild malaise. Days 4-6 worsening URI and mild flu-like symptoms the worst being coughing especially at night Day #7, symptoms appear to be improving. No fever, no aches, self-started Rx with Azithromycin pack on Day #5 as well as cough suppressants and expectorant (OTC DELSYM, NYQUIL).
COVID-19 Pfizer Updated Booster 12+ given to patient. Adult Booster was intended for mom but went to patient in error.   Patient's arm was sore starting at 8:00pm and lasted until the next night.
This is a spontaneous report from a contactable physician based on information received by Pfizer from Novartis Pharmaceuticals Corporation (Novartis reference #: PUS2014US106950). A 15 month-old female patient of an unspecified ethnicity  received PREVNAR13, MMR, and varicella virus vaccine, live all via unspecified routes of administration on 05AUG2014 at single doses to an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced fever. The clinical outcome of the event, fever, was unknown. Follow-up (12NOV2014): Follow-up attempts completed. No further information expected.
At time of injection- immediate warm sensation in stomach, neck and face. Slight flush color in face. Itching in  face and forehead however NO signs of hives or labored breathing. Intake if fluids. No Benadryl or Epi-pen required. Symptoms diminished and left facility in 10-15 minutes.   2-3 hours later- body aches,  mild nausea and mild headache. NO Tylenol 1 am- woke from sleep- Headache . Took 2 Tylenol. Went to sleep.  Woke at 6 am- string body aches, nausea, and very sore arm. NO headache. Took Tylenol. Stated in bed with fluids until 2 pm.  Little appetite.  Slight headache in evening. Achey feeling subsided . Next day - Mild body aches  and nausea. Took one Tylenol. No appetite.
This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 80-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be possibly related to SHINGRIX. Additional details were reported as follows: This case was reported by the other healthcare professional for himself. The age at vaccination was not reported, however it could be 79 or 80 years. The only side effect the patient had was a sore arm for a couple of days. The patient did not feel any other side effects. The patient did feel it could be attributed to the vaccine. The reporter did not agree to follow-up. The vaccination date, lot number and date of birth of patient were unknown.
experienced shingles; only received the first dose; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In April 2021, the patient received COVID 19 VACCINE. On an unknown date, between 6 and 8 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows:  This case was reported by patient himself. The age at vaccination was not reported for 1st dose of Shingrix and Covid 19 vaccine and was not applicable for the 2nd dose of Shingrix. The patient received 1st dose of Shingrix and 4 weeks before reporting date, the patient received the covid vaccine and Less than 4 weeks after receiving dose of Covid 19 Vaccine, the patient experienced shingles. The patient was late for the 2nd dose and till the time of reporting, patient did not receive 2nd dose, which led to incomplete course of vaccination. It was unknown if the reporter considered the shingles to be related to Covid 19 Vaccine. The reporter did not consent to follow up. No further information was reported.
Patient is a 19 y.o. male with PMH significant for anxiety and ADHD who presents with chest pain and palpitations.  He was woken up this morning by chest pain described as sharp, midsternal, 7/10, radiating down right arm, with no exacerbating or alleviating factors.  He also reports chest pressure.  During episode of chest pain he felt his heart was beating fast.  He felt nauseous and vomited once.  He received his 2nd Pfizer COVID vaccine 4 days ago.  He states that he felt fatigue and aching for a day following the vaccine.
Pt called 7 days later and was still shaking, tremoring, had pain in the vaccinated arm and felt anxious. She had unbearable head aches for 3 days and just felt foggy and sick. She was weak and feverish for the first 48 hrs. No treatment given.
This case was reported by a nurse and described the occurrence of intramuscular formulation administered by other route in a patient who received INFANRIX. Co-suspect products included KINRIX, PEDIARIX, HAVRIX, ENGERIX B, BOOSTRIX, FLUARIX and FLULVAL. On an unknown date, the patient received INFANRIX at an unknown dose, KINRIX at an unknown dose, PEDIARIX at an unknown dose, HAVRIX at an unknown dose, ENGERIX at an unknown dose, BOOSTRIX at an unknown dose, FLUARIX at an unknown dose and FLULAVAL at an unknown dose. On an unknown date, an unknown time after receiving INFANRIX, KINRIX, PEDIARIX, HAVRIX, ENGERIX B, BOOSTRIX, FLUARIX and FLULAVAL, the patient experienced intramuscular formulation administered by other route and wrong injection technique. On an unknown date, the outcome of the intramuscular formulation administered by other route and wrong injection technique were unknown. Additional information received: INFANRIX, KINRIX, PEDIARIX, HAVRIX, ENGERIX B, BOOSTRIX, FLUARIX, FLULAVAL may have been injected SC vs IM, or using insufficient length of needles in several pediatric patients. No patient details available.