chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came to several clinics for Moderna COVID vaccines even though the patient had already received second primary dose or completed series at another clinic and did not require or meet the criteria for any more COVID vaccinations. It is assumed that the patient's parents/ guardians took advantage gift card incentive program for patients that receive COVID vaccines. Pt was given unnecessary Moderna COVID vaccine and was asked to wait the required 15 minute wait period, after the 15 minute wait period patient's parents stated that the patient was doing fine and did not complain of any effects from vaccine prior to leaving clinic.
Excessive thirst and blurred vision started on 2/2/19. At the emergency room on 2/4/19 patient had an elevated blood sugar and was treated with IV fluids and Sub Q insulin. Patient was discharged to follow up with an endocrinologist for new onset diabetes.
injection site reaction, erythema/swelling/pain/induration started 12/23/22, peaked over 12/25/22, now resolving 12/27/22
Pt vaccinated with DT c/o muscle pain injection site lt deltoid on 20NOV90 pain persists; Increased severity with prolonged use. Pain radiates to lt shoulder - no redness, no swelling. Relieved with rest.
After receiving first dose vaccine in left deltoid had left elbow pain; This is a spontaneous report received from a contactable Other HCP. This Other HCP reported for a patient (young individual).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in deltoid left (Batch/Lot number: unknown) as dose 1, single and administered in arm right (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "After receiving first dose vaccine in left deltoid had left elbow pain".  Additional information: After receiving first dose vaccine in left deltoid had left elbow pain: The caller is a Nurse Practitioner and reporting a young individual came in after receiving the first dose Pfizer Covid 19 Vaccine in the left deltoid and had left elbow pain.The left elbow pain is persisting for the patient. The patient subsequently received the second dose Pfizer Covid 19 Vaccine in the right arm and had no complications. The patient continues to have left elbow pain. The caller asks is there any way to make the patients feel better? Is the caller the only person reporting this event after receiving the Pfizer Covid 19 Vaccine? Caller states this is the reason she is really calling Pfizer and the caller would prefer to be transferred to USMI. No further information provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received pneumococcal Immunization 10/10/06 left arm 10/12/06 c/o 3 red spots on left deltoid. States sore touch. No treatment. Resolved 10/14/2006.
Upon administering the last vaccine the patient was pale with a noticeable change in her body language.  Her head was relaxed and loose.  At that moment, the nurse checked patients vital signs.  Blood pressure 122/68, pulse 82, temp 98.3.   We monitored the patient and assess her mental status by asking simple questions. The patient responded correctly.  While sitting down the patient threw up.  Approximately 15 min later the patient regained her composure and stated she felt good enough to leave.
Almost immediately  got 'woozy' and fell off the chair onto the floor. His eyes were glassy and his hands and arms were jerking.  He was able to get back up on  the chair and said that he was ok, but he looked pale and felt a little clammy. He sat on the chair and drank some water while we were waiting for the EMS. He said that he had breakfast but no lunch. While he was sitting on the chair his eyes glassed over again and he made some grunting sounds.  EMS came checked him out and said that his vitals where  okay, and he wanted to drive home which was 15 miles away.  The EMS  gave him a report as to what happened and his vitals incase  he needed to seek further medical attention.
3 weeks later the muscle at the 1st injection site still hurts. In a curve from the sight around toward the fatty area near my arm pit. But not all the way to the arm pit. I feel it when I reach, lift my arm or tighten my arm muscle.
I took the vaccine dose at 1030 a.m, I started feeling chills and fever by 9 pm same day, still  having low grade fever and some cough and not too much chills. I am taking Advil two tablets OTC.
Client described onset of general malaise 24 hrs later with left arm/side tenderness and an episode of tachycardia. Has a HX of tachycardia and this episode resolved without incident. Soreness/malaise resolved in 24 hrs.
Suspected vaccination failure; Got the shingles shot & booster. It keeps trying to come back but the next day or two, it's gone; Itching; Burning; Got the 2nd one (booster) 21 days after the 1st shot; This case was reported by a consumer via media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient had shingles boils in past).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus, burning sensation and drug dose administration interval too short. On an unknown date, the outcome of the vaccination failure and drug dose administration interval too short were unknown and the outcome of the shingles, pruritus and burning sensation were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and burning sensation to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient had received the shingles shot a year before the date of reporting and had the second dose (booster) 21 days or 2 weeks after the 1st shot. The patient states that shingles (itching and burning) keeps trying to come back, but then it goes away after a day or two and felt that it was crazy. The itching and burning goes away in a day or two. The patient did not want the shingles boils ever again. The reporter was thankful that they got the shingles shot.  Note: Discrepancy is noted in the interval of 1st and 2nd dose and narrative states 21 days and 2 weeks as gap in two different statements, events has been coded considering more precise value (21 days) and both information is captured in narrative conservatively as no follow-up is possible.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-MAY-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL (strength: 0.5 ml) lot # L020162 and expiration date: 23-JUL-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 120 hours, with the highest recorded temperature of 53 degrees Fahrenheit (11.66 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
numbness; tingling; dizziness; grain like headache; Spinal pain; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 05Feb2021 10:30 (age at the vaccination 68-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included gastrointestinal issues and mild wheat allergy (causes some congestion). Concomitant medications included calcium carbonate (TUMS), acetylsalicylic acid (ALKA SELTZER), calcium and joint supp taken for an unspecified indication, start and stop date were not reported. The patient previously took vicodin and experienced allergy (Known allergies: Vicodin, mild wheat allergy (causes some congestion). Patient received vaccine in four weeks that Shingles, other vaccine dose number 2 via unspecified route Left arm on 21Jan2021. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. Patient experienced severe morning grain like headache with spinal pain, numbness and tingling, accompanied by dizziness on 07Feb2021 06:00 PM. Patient had beaches like this before, but they last for a day or two at the most. After the shot, he his came on two days later and patient still have it 10 days later. Patient did not received treatment for the adverse events. The outcome of the events was not recovered.  Information about Lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Arrived with weakness, tested + for COVID in ER. Completed vaccine 3/2021. Given 1 unit plasma, steroids, vit-c, vit-d, zinc and singulair, lovenox. No pna. Never requried O2. Discharged home.
Information has been received from a licensed practical nurse concerning a 17 year old female with penicillin allergy and drug hypersensitivity to CECLOR who on 28-JUL-2008 was vaccinated with the first dose of GARDASIL (lot # 660553/0070X). Concomitant therapy included MENACTRA. "A couple weeks ago" the patient developed swollen ankles, rash on her legs and arms and night time fevers after her first dose of GARDASIL. Her ankles were swollen to the size of grapefruit. She also had an unproductive cough for 2 weeks and general malaise. The patient was seen in the office. At the time of reporting a chest X-ray and a blood tests were performed but results were pending. At the time of reporting the patient had not recovered from swollen ankles, rash on her legs and arms and night time fevers. Additional information has been requested.  3/27/09 Received PCP vaccine & medical records of 12/21/2006-2/26/2009. FINAL DX: none provided Records reveal paitent experienced general good health on 7/28/08 & also received MCV4 same day.  Ongoing psych counseling for eating disorder.  RTC 9/11/08 for rash, fever, cough x 2 wk, bilateral ankle swelling w/pain x 4 days, eczema flareup & fatigue.  RTC 1/12/09 w/intermittent abdominal pain.  Dx w/UTI & tx w/antibiotics.  RTC 2/26/09 w/migraine HA x 4 days w/phonophobia, photophobia, N/V & had missed school.  Tx w/meds. This is in follow-up to report (s) previously submitted on 10/14/2008. Follow up information was received on 23-Dec-2008, patient weights 141 pounds and is 5 feet 11 inches tall. GARDASIL (lot # 660551/0070X) was received on the left deltoid at 3:00 pm. On 07-Sep-2008 patietn experienced fatigue, ankle pain, swelling and joint arthralgias. Follow-up information received on 18-Feb-2009 from a liscensed practical nurse who reported that it was determined by the doctor that the patient's symptoms were not related to GARDASIL but rather were a result of other medical condition. GARDASIL is not considered to be suspect. No futher information is available.
Pt developed severe erythema, induration and local itching from elbow to neck on left deltoid. He is using Benadryl, Tylenol and ice packs. Infection was ruled out. He is recovering.
Increased temp 101, 48 hours later. Vomited 1 time.
rights  side  of neck and throat sore  felt like punched  sore to swallow
Very severe lower back and abdominal pain with constant left sided (upper and lower extremities) weakness, numbness, tingling, burning sensation and  pain on cuff muscles that started on day 2 after receiving the vaccine.- still persists as of 9/21/21 but decreased symptoms after taking steroids.  Accompanied by dizziness , headache or heavy headedness (feeling like I am about to black out)- Very mild and occasional.
Out for a run that evening (8 hours after shot) after about 12-15 minutes of running I stopped to walk and started sneezing a lot, about 8 - 10 times. Then my nose started to run, eyes started to water a little followed by tingling & itching on the back of my tongue and throat, then swelling on the back of my tongue. I felt a little light headed a few minutes later, I slowed to an even slower walking pace. The swelling did not get worse. Blood pressure was fine when checked at home about 30 minutes after the start of the episode, a little high for me if anything, but normal. My nose become fully congested which was the only  side effect that lasted for a couple of hours.  Yes, it is spring here but I do not have allergic reactions beyond a few sneezes and slight runny nose to spring pollen. This was much more intense and I have never experienced tongue and throat swelling.
Three days after vaccination redness & slight swelling in vac. area. In the following week both increased in area. In second week rash appeared on both thighs then in next 3 days spread to lower legs and both arms. BENADRYL did not help. A Z-pack from the doctor cleared everything up within a week.
I had nasal congestion, not like my usual sinus symptoms. My temperature was 98.3 degrees. I felt body aches and headache. My temperature went up to 98.6 degrees and then I did the home test and it was positive. I messaged the doctor and the nurse called me back and I had the telehealth with the doctor who prescribed PAXLOVID.
CLIENT RECIEVED FIRST BOOSTER DOSE 12 DAYS TOO EARLY. (6 MONTHS) CLIENT DENIES ANY ADVERSE EFFECTS FROM VACCINATION.
swelling on neck & lt side w/soreness;no SOB;tx w/APAP PM;
Information has been received from a registered nurse concerning her grandson a 12 month old male with no known medical history or allergies who on 5/26/2005 was vaccinated IM in the groin area of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently, on 5/26/2005, the patient was described as miserable and did not sleep during the night. Unspecified medical attention was sought. No laboratory diagnostic test were preformed. On 5/27/2005, the patient was much better and considered to be recovered. Additional information has been requested.
Woke up this morning (one week after first dose) with a  big red mark on my upper bicep that was warm to the touch. The area was swollen, as well as the under arm (lymph node?). Red mark has gotten larger over the course of the day, still swollen, tender, and hot to the touch. No other side effects, other than neck and hip pain the Monday after, but I am unsure it is related. The neck pain limited movement when trying to turn my chin over my right shoulder. The joint pain has gone away.
Patient received monovalent PFizer Covid vaccine instead of bivalent booster. Patient will not be eligible to receive bivalent booster until at least 8 weeks.
Vomiting, arching of back, pale, clammy and cool extremities, not 100% responsive and has a distant gaze.
This is a spontaneous report from a non-contactable nurse received via a sales representative. A patient of unspecified age, race and gender received TRUMENBA, via an unspecified route of administration at single dose in Apr2012 (first dose) and in Jul2013 (second dose) for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fatigue, chills, fever and headache for two days after shots. The final outcome was unknown.   No follow-up attempts possible. No further information expected.
Severe diarrhea the next day after the first dose, continuing up to this day.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), on 07Mar2021 at 15:00 as dose 1, single (Lot number: EN6206) at the age of 83 years, in left arm and on 27Mar2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "CVD" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "bladder cancer" (unspecified if ongoing). Concomitant medication(s) included: PLAVIX; HYDROCHLOROTHIAZIDE; ATENOLOL; ISOSORBIDE. Past drug history included: Statins, reaction(s): "Known allergies: statins". The following information was reported: DIARRHOEA (non-serious) with onset 08Mar2021 at 08:00, outcome "not recovered", described as "Severe diarrhea the next day after the first dose, continuing up to this day.". The event "severe diarrhea the next day after the first dose, continuing up to this day." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea. Additional Information: 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 vaccination. Facility type vaccine was Administration facility. Ae treatment was RX Dicyclomine 10mg. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sore neck - mild, 12 hours, no treatment injection site reaction similar to bee sting, benadryl, 2 tablets daily for 4 days, triamcinolon 0.1% twice daily for 4 days
This spontaneous report as received from a pharmacist refers to a 69 year old female patient. The patient had no pertinent medical history or drug allergies. On 06-MAY-2014, the patient was vaccinated with single dose of ZOSTAVAX lot # J013452, exp# 24-JAN-2015, subcutaneous. No concomitant medications were reported. On 15-MAY-2014, 10 days after onset of therapy the patient was diagnosed with shingles by an unspecified physician. The patient sought medical attention by calling the pharmacy. The patient was treated with unspecified medication. The outcome of shingles was reported as not resolved. The causality was unknown. Additional information has been requested.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a other manufacturer Pfizer concerned a 46 year old male. Initial information was processed with the additional information received on 14-JUN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total, administered on unspecified date in APR-2021 on left arm for prophylactic vaccination. Age at time of vaccination 45 years old. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total, administered on unspecified date in NOV-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 46 years old. No concomitant medications were reported.  On 27-MAY-2022, patient was first tested positive for covid-19 and hence confirmed covid-19 infection and had confirmed clinical vaccination failure (Dose number in series 2). On same day, patient administered non company suspect drug: Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, last administered on 31-MAY-2022 for covid-19. Patient's first negative test came on 31-MAY-2022, with additional negative test on 01-JUN-2022 and 02-JUN-2022. On 03-JUN-2022, at 06:30, patient again tested positive (twice) for covid-19. Patient also, reported he do not had any symptoms at time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and treatment with paxlovid was withdrawn on 31-MAY-2022. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000235726.; Sender's Comments: V0:20220627527-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Day of injection c/o slightly swollen arm, pain with movement, cannot raise arm over head. Increased pain with turning arm outward. No tingling or numbness.
"EOHD Note 12/29 EE states she recieved the COVID19 vaccine (first dose) 12/28 at 7 pm at the Metro EOHD location. She stayed 15 minutes for observation and was feeling fine, however 30 minutes after vaccine administration started feeling her left upper lip was swollen and tip of her tongue felt thick. When she looked in the mirror her lip and tongue appeared normal, but she had the sensation they were swollen. She then took 50 mg of PO Benadryl and about 4 hours later felt swelling had resolved. Today, feels normal. Pt denies hx of allergies but her mother has a hx of anaphylaxis with IV contrast. EE denies throat tightness, SOB, wheezing. Numbness on left leg.  Advised EE to go to ER if she experiences throat tightness and itchyness, SOB, or wheezing. Advised pt that she should consult her PCP to decide whether or not the benefits of recieving the second dose of the vaccine outweigh the risks and if she should pre-medicate with benadryl for the second dose if she choses to recieve it. "
Headache, malaise, numbness, itching at injection site started approximately 36 hours post vaccination.
Vaccine given 02/10/04.  On 02/12/04, pt noted arm was swollen, erythematous.  On 02/24/04, shot site burst open and drained brown secretions and blood.  Site is now open hole.  Appointment made for surgery clinic on 02/27/04.  Keflex 500mg per mouth 3 times a day for 10 days prescribed.
PERSISTENT PAIN IN LEFT DELTOID. NO LUMP, REDNESS OR SWELLING. FIRST SOUGHT TREATMENT 5/26/2009.  RECOMMENDED HEAT, IBUPROFEN.  FOLOW UP IN 2-4 WEEKS IF NOT IMPROVING.
Optical migraine began about 24 hours after completion of second vaccine.  Optical effects lasted about 20 minutes.  Headache continued most of day.