chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain near elbow through forearm; Tingling near elbow through forearm, tingling had increased and spread down to hand and up through shoulder and upper back on the left side; Pain, discomfort, and tingling have increased and spread down to hand now and up through shoulder and upper back on the left side.; Felt like arm was partially asleep, but no amount of movement; This is a spontaneous report from a contactable healthcare professional. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0179) via an unspecified route of administration in the arm left on 02Aug2021 at 16:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine and chronic diarrhea. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B-12), ascorbic acid (VITAMIN C), zinc (MANUFACTURER UNKNOWN) and loratadine (MANUFACTURER UNKNOWN). 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. On 04Aug2021, 2 days after vaccine, the patient began noticing pain and tingling near elbow through forearm. Pain, discomfort, and tingling had increased and spread down to hand and up through shoulder and upper back on the left side. Felt like arm was partially asleep, but no amount of movement, stretching, repositioning reliefs the discomfort of these symptoms. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the events pain, discomfort and tingling near elbow through forearm and felt like arm was partially asleep were not resolved at the time of this report.
Vaccine with different color administered/opaque vaccine administered/yellowish vaccine administered; Vaccine with different color administered/opaque vaccine administered/yellowish vaccine administered; Injection area swelled up; Little bubble in the injection area; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT COLOUR ISSUE (Vaccine with different color administered/opaque vaccine administered/yellowish vaccine administered), PRODUCT CONTAMINATION (Vaccine with different color administered/opaque vaccine administered/yellowish vaccine administered), VACCINATION SITE SWELLING (Injection area swelled up) and VACCINATION SITE MASS (Little bubble in the injection area) 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 20-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, the patient experienced PRODUCT COLOUR ISSUE (Vaccine with different color administered/opaque vaccine administered/yellowish vaccine administered), PRODUCT CONTAMINATION (Vaccine with different color administered/opaque vaccine administered/yellowish vaccine administered), VACCINATION SITE SWELLING (Injection area swelled up) and VACCINATION SITE MASS (Little bubble in the injection area). At the time of the report, PRODUCT COLOUR ISSUE (Vaccine with different color administered/opaque vaccine administered/yellowish vaccine administered), PRODUCT CONTAMINATION (Vaccine with different color administered/opaque vaccine administered/yellowish vaccine administered), VACCINATION SITE SWELLING (Injection area swelled up) and VACCINATION SITE MASS (Little bubble in the injection area) 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.   It was reported that the color of the vials that they received were different than usual. The reporter mentioned that the color was not white, but opaquer and more yellowish. It was also reported that color was not only seen in the vial, but in the product inside as well. It was further mentioned that when the vaccine poured into a syringe, the color of the vaccine looked normal inside the syringe, and that the discoloration was only seen in the vial.  No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
*Fever of 103 beginning the night of the vaccination (approximately 7 hours later on Friday 2/5) through the early morning of Sunday 2/7. *Chills during entire time of fever. *Body aches during entire time of fever. *Extreme headache 2 days after vaccine on Sunday 2/7 until Monday 2/8 (24 hours). *"Covid arm"- large red patch at site of injection approximately 2.5-3 inches in diameter; red patch was itchy and sore
Intense itching under injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included pruritus. Concomitant products included COVID-19 VACCINE (COVID 19 BOOSTER).   In November 2022, the patient received Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced injection site itching. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site itching was not recovered/not resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Nov-2022 Reporter's Comments:  The reporter stated that the patient said she had the shingrix vaccine a week ago and now has a intense itching under the injection site on her arm.  The reporter said the patient had itching profusely.  She said the benadryl she put on her arm did not really help. The reporter mentioned patient experienced some itching for a few days after she got her covid booster last month. No other information was reported to the agent by the patient. The reporter did not consent to follow-up. Note: As per source document the patient received Covid booster a month ago hence captured as concomitant medication.
Patient came in 10 days after her vaccination complaining of ongoing pain in her arm. She stated that she had severe pain at times that radiated up to her neck. She had taken ibuprofen in the night when the pain had gotten worse.  She had not yet seen a doctor, but planned too.
Patient described a small "pimple like white head" to the injection site, and then having "uncontrolled shaking" for approximately 4 hours that he thought was a "mild seizure."  Patient never lost consciousness, did not lose control of his bowel/bladder, did not have a post ictal period, and was "aware" of his shaking for the entire 4 hour period.  He also reported that his "excessive" sweat on his pillow smelled like "vinegar."
Rash just below injection site. So far not itchy but still present on day 15.
Information has been received from a health professional concerning an 11 year old male who on 10/27/95 was vaccinated with 1 dose of varicella virus vaccine live (site unk) (lot 609293/0436B). Subsequently, it was reported that in 6/01, the pt was dx'd with "a mild case of chicken pox". Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. The reporter also indicated that the vaccine was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently, the pt recovered. No further information is available.
Pt's left upper arm was red, swollen, and warm to touch and tender. Pt was prescribed cephalexin 500mg 1 capsule 3 times daily.
Cough, nasal congestion, rhinorrhea started on Saturday, improving after tylenol.
Nausea, vomiting, headache. Symptoms improved with medication (ondansetron). Headache and mild fatigue continued through 1/4/2021.
This case was reported by a pharmacist and described the occurrence of swelling injection site in a 54-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included a 1st dose of TWINRIX (GlaxoSmithKline) given on 20 July 2012. Concurrent medications included Multivitamin. On 20 July 2012 at 10:30 the subject received a dose of BOOSTRIX at 0.5 ml in the right arm. On 20 July 2012 (in the PM), less than one day after vaccination with BOOSTRIX, the subject experienced a large, red, swelling of the right arm (swelling injection site and injection site redness). At the time of reporting the events were improved. The pharmacist considered the events were probably related to vaccination with BOOSTRIX. It was noted by the reporter that the subject might seek medical treatment if the events did not clear up. The dose of TWINRIX administered was not considered to be suspect as it was administered into a different, unspecified site. It was reported that the subject had not had a BOOSTRIX vaccination since childhood.
scars from the blisters; The patient received PNEUMOVAX 23 on 8/17/2018 and developed blisters on his skin later that evening or the next day. The blisters were large in size and filled with liquid.; This spontaneous report was received from patient's mother and refers to a 51-year-old male patient. The patient's medical history was not reported. His concurrent conditions included cerebral palsy and intellectual disability. Concomitant medications included buspirone hydrochloride (BUSPAR), atorvastatin (ATORVASTATIN), gabapentin (GABAPENTIN), and water pill.   On 17-AUG-2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, valid lot #R006466, expiration date: 24-OCT-2019, administered for prophylaxis (dose, frequency, strength, anatomical location, and route of administration were not provided).  On the same date (also reported as later that evening or the next day), the patient developed blisters on his skin. The blisters were large in size and filled with liquid. He went to the emergency room where the blisters were cleaned with betadine, and he was given a prescription medication. The caller reported that it took the patient around 6 months to heal from this and that he still had scars from the blisters.  The causal relationship between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sense of panic, couldn't sleep, dizzy, nauseous, chest pain with shortness of breath (lasted 2 days), chills started at around 10 PM, then switched to body feeling very very hot, profuse sweating and feeling like body was burning without a fever (started at ~12am and lasted about 10 hours, it was about 50 F that night, so it wasn't the temperature)
PATIENT HAS NO SYMPTOMS OR ADVERSE REACTION /I CALLE D  PATIENT TOLD ME NO PROBLEM
patient receiving an expired dose of menactra, with no AE (adverse event); Initial information received on 05-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who received an expired dose of menactra, with no ae (adverse event) while receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV vaccine.  On 03-May-2022, the patient received a 0.5ml dose of suspect meningococcal a-c-y-w135 (d conj) vaccine unknown formulation and strength lot U6919AB via intramuscular route in the left deltoid for prophylactic vaccination.  Same day, the patient received an expired dose of menactra, with no ae (expired product administered).  Action taken: Not applicable   Corrective treatment: Not reported   Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient arrives to ED by POV on 06/22/2017. Chief Complaint: UPPER EXTREMITY PAIN and SWELLING. This started 06/21/2017 and persisted the following day (began 2 hours after pneumonia immunization in left arm). The quality is noted to be "pain". It is described as radiating (left neck, left pectoral region, left trapezius). Symptoms located in the area of the left shoulder and left arm. No difficulty breathing, sensory loss or motor loss. She has had redness and swelling. (No reaction in the past to PNEUMOVAX. Fever 101 06/21/2017. No chest pressure (pain when palpate left pectoralis or moves left arm). No antipyretics taken).
Fever starting around 11 hours after injection. Fever for 36 hrs after onset. Flu like symptoms; sore muscles and joints, headache; increased pulse rate and blood pressure after onset of fever.
Child developed rash RLE approximately 38 days post vaccines including VARIVAX - seen by pediatric dermatologist and lab testing confirmed varicella. Unable to reach parents for completion of form, client new to current pediatrician.
The same day I had the second dose of the vaccine I had severe swelling of my left arm at the injection site along with pain, redness, and warm to touch. I also experienced a fever, muscle and joint pain, and extreme fatigue which caused me to miss a day of work. The swelling ended up lasting multiple days. After contacting the department they told me they weren't sure what I should do. After 3-4 days I ended up taking Benadryl to see if that would help the swelling, which it did. A little while after I started experiencing consistent extreme fatigue along with heart palpitations and very low blood pressure.
Information has been received from a nurse practitioner, concerning a 22 year old female patient who on 29-MAR-2010, was vaccinated with the first dose of GARDASIL. In the evening of 29-MAR-2010, the patient began to experience a mild generalized rash on the trunk, chest and neck. The rash was treated with BENADRYL, 50 mg, three times a day. It was reported that the patient did not report to the physician's office until 06-APR-2010. On an unknown date, the patient stopped the series of GARDASIL. The patient's outcome was unknown at the time of reporting. The patient sought medical attention via office visit. Additional information has been requested.
Child receive 15mcg dose instead of 10mcg dose.  Father reports fatigue, muscle aches, low grade fever, decreased appetite x2 days
Patient alerted clinic worker that she wasn't feeling well. Reported scratchy throat, not feeling herself, and potential tongue swelling. Called 911 at 1357. Arrived at 1402. Patient left with EMS at 1410. Patient talking and alert upon departure with EMS.
Patient left arm still sore.  Hard to grasp or lift heavy objects.  Vaccine given on 12-4-08.  No treatment given at this time.
Pt. developed diffuse itchy red macular rash over arms - legs - scalp - face - neck - shoulders- upper chest and back. Within 72 hours of receiving the influenza vaccine.
had gotten it back by the end of OCT and right now patient still has it.; lost her menstrual cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11May2021 (Lot number: EW0173) at the age of 16 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, lot number of EW0151, Date: 20Apr2021), administration date: 20Apr2021, when the patient was 16 years old, for COVID-19 Immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset Jul2021, outcome "unknown", described as "lost her menstrual cycle"; OLIGOMENORRHOEA (non-serious) with onset Oct2021, outcome "not recovered", described as "had gotten it back by the end of OCT and right now patient still has it.". The events "lost her menstrual cycle" and "had gotten it back by the end of oct and right now patient still has it." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had no issues besides being tired. Caller declines to make a report. It is unknown if the patient had medical history including any illness at the time of vaccination. Patients regular doctor suggested the labs and they didn't find any problems and the next step is birth control to get patient back regulated.  No follow-up attempts are possible. No further information is expected.
pt recvd vax & 21 days p/vax c/o lightheadedness, epigastric & lt chest pain upon deep breathing, pain behind the rt ear; dx benign postural vertigo; dose 2 given 15JUN93 w/no problems; MD noted that did not feel pt's sx were related to vax
Got very sick; Initial information received on 04-Nov-2021regarding an unsolicited valid social media non-serious case received from a consumer or non-healthcare professional via social media via Digital Media.  This case involves adult patient (unknown demographic) who had got very sick (Illness) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious got very sick (Illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  It was reported "Got one once. got very sick. never again."  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
At approximately 3:30 a.m. on 04/19 I experienced strong pain in the chest, armpit, and upper back/shoulders accompanied by discomfort breathing that lasted 2.5 to 3 hours. These symptoms faded and altogether went away between 6:30 and 7:00 a.m. At 9:00 a.m. I went into prompt care and had the following tests and procedures as described in Item 19.
Information about concomitant therapy, concurrent condition, drug reactions/allergies and medical history was not provided. On an unspecified date, the patient was vaccinated with the first dose of GARDASIL (strength, dose, route, lot # and expiration date were unknown) for prophylaxis and a second dose (lot # and expiration date unknown) on another unspecified date. On another unspecified date, the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, route, lot # and expiration date were unknown) for prophylaxis (interchange of vaccine products). No adverse effect was reported.   Additional information has been requested.
Delayed 2nd dose later took after 4 weeks and no symptoms but sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing), notes: Hashimoto's but Thyroid was in rage during a this event. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, lot number- EN6206, administration time-10:00, vaccine location: Left arm), administration date: 08Mar2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "Face numbness", "Feeling of blood moving in arms/legs with cold sensation", "SOB", "Events of low blood sugar (not diabetic)", "Dizziness", "Clammy feet", "Very scary", "Thyroid was in rage during this event". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Delayed 2nd dose later took after 4 weeks and no symptoms but sore arm". The event "delayed 2nd dose later took after 4 weeks and no symptoms but sore arm" was evaluated at the physician office visit and emergency room visit.  Additional information: The patient had no known allergies. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient had not COVID prior vaccination. The patient had no COVID teste post vaccination. The patient reported that delayed 2nd dose later took after 4 weeks and no symptoms but sore arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021415529 similar report from same reporter
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 15-month old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 06-DEC-2022, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in left thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009088: US-009507513-2301USA009112: US-009507513-2301USA009113: US-009507513-2301USA009927: US-009507513-2302USA000401: US-009507513-2302USA000400:
pt recv vax 01dec95; 18jan97, pt devel chickenpox; lesions heaviest on her abdomen & back, pt devel a handful on her face, legs & arms; chicken pox were described as a medium case;
Body ache 9/1, vomited 9/1, diarrhea 9/2.
Frequent (since second dose): Wake up with sharp pain in left arm around injection site whenever sleeping on left side for prolonged period of time. Pain is relieved by reducing pressure on arm (e.g. switching sleeping position). Pregnancy: First pregnancy, first dose at 9+4 weeks, second dose at 12+4 weeks, estimated delivery date: Nov 23, 2021; complications: PPROM at 15+3 weeks (pregnancy ongoing as of 17+2 weeks).
The recipient was vaccinated at 1:09pm on 07/22/2021 with Pfizer vaccine  ( first dose). While waiting in the observation patient walked to the window and said he felt dizzy. As the nurse walked about 3 feet to attempt to escort him to sit back down he fell to his back hitting his head. He was clamy, cool , sweating  but alert to person, place and situation.