chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 9 year and 8 month old female who on 14-JUN-2010 was vaccinated with the first dose of GARDASIL. Concomitant therapy included hepatitis A vaccine (manufacturer unknown) on 14-JUN-2010 in the other arm and had had no symptom in that arm. The physician reported that on 14-JUN-2010, later that night the area of the patient's deltoid was slightly irritated. This resolved. The patient was seen in the office on 07-JUL-2010 for another issue but expressed no complaints from the injection. On 08-JUL-2010 the patient's mother called stating her daughter had an area on her arm that was red, swollen and she was unable to move her arm. She would be seen in the office later on 09-JUL-2010. On 09-JUL-2010, the physician stated that the patient was seen in the office and only had a "knot' at the injection site, and no other problems. The physician stated after speaking to the patient's mother she found out that a knot was usually left behind when a child got an injection. The physician did not know if these symptom were related to GARDASIL. Follow up information has been received from the physician who reported that the patient with no illness at time of vaccination and no pre-existing allergies who was vaccinated with the first dose of GARDASIL, in right deltoid. On 08-JUL-2010 (previously reported as "09-JUL-2010"), the patient developed 0.25 cm area of induration in site of injection. No erythema, no warmth. The patient had visited the physician office. On 09-JUL-2010, the patient had recovered from the event. Additional information is not expected.
Patient received 2nd dose of COVID vaccine series Pfizer infant 6 mo to 4 yr maroon cap lot FT9142 on 8/1/2022 while being 5 years old at the time of vaccination. No harm to patient or monitoring provided. Per CDC guidelines, Pfizer manufacturer has been contacted for information on the efficacy of the vaccine and whether the dose needs to be repeated. The patient will be contacted for follow-up once this information is available.
Severe body chills, nausea and puking for 2-3 hours, severe body aches in arm, neck, back, and torso, occipital headache for 3 days
sick; Initial information was received on 17-Jan-2021 regarding an unsolicited valid non-serious from a consumer/ non-heath care professional.  This case involves a patient of unknown age who got sick (illness), while being received INFLUENZA VACCINE.  Past medical history, medical treatment(s), past vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (batch number and other dosing details were not reported) at an unknown dose via unknown route and unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after receiving the suspect vaccine, patient was sick (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  Outcome of the event was reported as unknown.  There will be no information available regarding batch number in this case.
1) Received MMR/IPV/DTAP at 12:30PM left office within 10 minutes of receiving vaccine. 2) returned to office approximately 30 minutes later with itchy hives-no wheezing or trouble breathing.  Benadryl 12.5mg per mouth with good response monitored for approximately 1 hour left office doing much better.
had a reaction to his 1st Covid dose with ringing in the ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "had a reaction to his 1st Covid dose with ringing in the ears".  Additional information: The patient informed that the ringing was really loud and he does not want it with dose 2. The patient wanted to know if he can skip dose 2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt complained of dizziness, nausea, blurred vision, SOB. Fainted 3 times for 5-10 seconds at each time. EMS called for unresolved SOB. Oxygen by mask given during wait for EMS.
could feel heat from both legs; hands freezing; soft bowl movements; fever of 101f; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (could feel heat from both legs), PERIPHERAL COLDNESS (hands freezing), DIARRHOEA (soft bowl movements), PYREXIA (fever of 101f) and FATIGUE (fatigued) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced FEELING HOT (could feel heat from both legs), PERIPHERAL COLDNESS (hands freezing), DIARRHOEA (soft bowl movements), PYREXIA (fever of 101f) and FATIGUE (fatigued). At the time of the report, FEELING HOT (could feel heat from both legs), PERIPHERAL COLDNESS (hands freezing), DIARRHOEA (soft bowl movements), PYREXIA (fever of 101f) and FATIGUE (fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Pyrexia: fever of 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
Pt. received FLUMIST on 9-10-14. Has had dysphonia since.
3 days of fever,  6 days chills, pain in the eyes, weakness in the body and a massive breakout of cold sores inside and just below the nose.  Asthma flare up.
blood clot in abdomen 2 surgeries removal of blood clot and 4/5 of small intestine
Worsened redness/ worsened swelling and worsened really itchy, has now worsened to the size of a palm of hand; concern these symptoms are an allergic reaction; Where I got the shot is really tender with pain; where I got the shot is really icthy; Where I got the shot' is breaking out in hives; Starting to swell; where I got the shot is really red; Where I got the shot is really tender with pain; Left upper arm was just sore for 5-7 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left upper arm was just sore for 5-7 days), CONDITION AGGRAVATED (Worsened redness/ worsened swelling and worsened really itchy, has now worsened to the size of a palm of hand), HYPERSENSITIVITY (concern these symptoms are an allergic reaction), the first episode of VACCINATION SITE PAIN (Where I got the shot is really tender with pain) and VACCINATION SITE PRURITUS (where I got the shot is really icthy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left upper arm was just sore for 5-7 days). On 28-Apr-2021, the patient experienced CONDITION AGGRAVATED (Worsened redness/ worsened swelling and worsened really itchy, has now worsened to the size of a palm of hand), HYPERSENSITIVITY (concern these symptoms are an allergic reaction), the first episode of VACCINATION SITE PAIN (Where I got the shot is really tender with pain), VACCINATION SITE PRURITUS (where I got the shot is really icthy), VACCINATION SITE URTICARIA (Where I got the shot' is breaking out in hives), VACCINATION SITE SWELLING (Starting to swell), VACCINATION SITE ERYTHEMA (where I got the shot is really red) and the second episode of VACCINATION SITE PAIN (Where I got the shot is really tender with pain). At the time of the report, PAIN IN EXTREMITY (Left upper arm was just sore for 5-7 days) had resolved and CONDITION AGGRAVATED (Worsened redness/ worsened swelling and worsened really itchy, has now worsened to the size of a palm of hand), HYPERSENSITIVITY (concern these symptoms are an allergic reaction), VACCINATION SITE PRURITUS (where I got the shot is really icthy), VACCINATION SITE URTICARIA (Where I got the shot' is breaking out in hives), VACCINATION SITE SWELLING (Starting to swell), VACCINATION SITE ERYTHEMA (where I got the shot is really red) and the last episode of VACCINATION SITE PAIN (Where I got the shot is really tender with pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included one dose of Tylenol on 17 Apr 2021. No lab data has been provided by the reporter.
04/18/2022 Vaccination 06/08/2022 Low hemoglobin presented when giving blood.  07/05/2022 I started to get a sore throat, one side. I thought maybe allergies as  post nasal drip. I started to get achy and headache as day went on and I did a COVID test; POSITIVE.  07/06/2022 Contacted PCM 07/07/2022 Went to Urgent Care. They prescribed Plaxovid.  07/19/2022 I am feeling fine now. I had a cold virus immediately following COVID-19. It took 10 days before I tested negative.
Dizziness, lost time (blackout???), fever, headache, chewed on the inside of my mouth during lost time. Extreme nerve pain and weakness in left arm for minimum of 48 hours.  It is ongoing still.
pt recvd vax;devel a persistent erythematous, edematous,urticarial rash rxn coincident w/ adm of vax;pred given;pt devel local rxn at the inject site characterized by erythema & swelling,also exp "throat swelling" 10 days p/vax;cont on pred
Patient received ZOSTAVAX vaccine on 8/15/11. She developed symptoms of shingles around 7 days later. She was diagnosed with shingles on 8/25/11. Her symptoms do include pain!
Pounding/raising heart, heart felt like it could beat out of my chest, numbness in right hand, numbness/heaviness in right arm up to elbow, diarrhea, dizziness, body trembling, felt uneasy, all of sudden was extremely tired.
inj site red, swollen, & tender rt upper thigh for 8-10cm diameter most of anterior thigh;cold compresses & DPH;
Like prior Pfizer covid immunizations,  I had flu like symptoms (aches, chills, headache) and a deep dry barking cough, which resolved in a day.  This time, I was also dizzy, nauseaus, very weak, and the dry barkinguncontrollable cough didn't resolve and got worse, with airway restriction that continued over the course of a month.  During this time period, inhalers (albuterol and qvar) and prednisone were prescribed and used.  At one point, a 5-day antibiotic z pak was thrown for good measure "in case of atypical pneumonia".  Prednisone and inhalers helped with airway restriction.  The dry barking cough and airway restriction has improved a little bit each day, very slowly.
Night of the vaccine, arm hurt at the injection site, very slight raised area about the size of my palm. I woke up with my left pointer finger and thumb side of my hand starting to swell.  Pain at the injection site (slight) when my arm is not in motion and when my arm is in motion. 9:45 am the swelling was continuing and I felt strange all over, head felt cloudy, so I took Benadryl. 10:27 am hand swelling is reduced, but head and body still feel strange. Some acid-reflux type feeling happening Generally feeling off today.
Pt exp a rash w/1st dose of Engerix-B; pt recovered;
On the evening of the receiving the first dose of the Moderna vaccine (05/03/2021), the patient states the injection site felt a little sore. Over time, she noticed a small, red area (about the size of a dime) and over the next few days the size of the redness increased to the size of a quarter. The site is warm to touch and feels itchy/irritated only on occasion. She states she does not feel like she has a fever, but has not checked her temperature. About a week after the injection was given, she thought the redness was going away, but when she observed the area on 05/11/2021, the red area had increased to the size of a tennis ball. Patient has not tried taking any OTC medications to alleviate symptoms.
Fever of 101 by temple for over 24 hours.  Temp at site of injection 102.9.  Muscle aches, neck pain, pressure behind eyes, severe fatigue. Oliguria (I was drinking ice water regularly and it took about 12 hours for my urine stream to return to normal)
Itching, redness and inflammation at the injection site (left forearm). Started approximately 16 hours after injection and started to improve after 48 hours
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Pt was 54 years of age, with a PMH significant for t2dm, AF, CHf, gout, HTN, hyperlipidemia, ckd, and polyclonal hypergammaglobulinemia. Patient presented to outside facility on 4/20/21 with a chief complaint of cardiac arrest. No cause of death noted.
he can't walk; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT INABILITY (non-serious), outcome "unknown", described as "he can't walk". Additional information: It was reported that the patients daughter (name withheld) called for assistance with colestipol. She stated "my mom has C diff and she's taking colestipol hydrochloride but at this point my dad is in the living room in a hospital bed because he cant walk since covid even though he got all 3 of your vaccines and than she yeah he's a whole another ball game but meanwhile my mom has C diff and colestipol the only thing stopping it and we can't afford to buy it anymore." Advised we help with the Colestid (name withheld) stated mother is taking colestipol hydrochloride greenstone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I got a headache in eye; This is a spontaneous report from a non-contactable consumer (patient). This consumer reported similar events for two patients. This is the 2nd of of two reports.  A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got a headache in eye on an unspecified date the moment she had vaccine but it went away. Outcome of the event was recovered. The event was assessed as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021021969 same drug/similar events, different patients
Information regarding Prevnar was received from healthcare professional regarding a male patient who experienced redness and swelling of the arm, had not eat on two days and redness and swelling of the arm. The patient received vaccine. Relevant medical history was not provided. Concomitant medications were not reported. The patient experienced redness and swelling of the arm and had not eaten in two days. Outcome was unknown. No additional information was available at the time of this report.
This spontaneous report was received from a registerd nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # M022924 with expiration date of 24-JAN-2018 and lot # M047658 with expiration date of 28-OCT-2017) (strength, dosage schedule, route of administration and anatomical location were not reported) for prophylaxis. No adverse effects were reported. The reporter stated that the doses of the vaccine (lot # M022924) experienced a temperature excursion between >8 degrees Celsius but <25 degrees Celsius for 40 Hours 25 minutes and the doses of the vaccine (lot # M022924 and lot # M047658) also experienced a temperature excursion between 0 degrees Celsius to 2 degrees Celsius for 4.5 hours. There were no previous excursions reported. The aforementioned temperature was identified due to a data logger. There were no previous excursions. Furthermore, no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000930: US-009507513-1702USA000929: US-009507513-1702USA000927: US-009507513-1702USA000928.
Initial misuse report received from a healthcare professional on 29 JULY 2013. It was reported that, a 5-year-old male patient had received ADACEL instead of DAPTTACEL. No adverse event was reported. List of documents held by sender: none.
achey; This case was reported by a consumer via sales rep and described the occurrence of pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR197019   Additional Information: GSK Receipt date: 29-Dec-2022 Reporter's Comment: The patient was reporter's friend's husband. Reporter stated that the patient had any issues with first dose but thought he mentioned he was achy. The reporter was not sure when patient received first dose. Additional Supportive Information: For the tolerance of 2nd dose refer case US2022AMR197019, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR197019:Same reporter
Patient complained of severe pain to bicep area; radiated to front shoulder. Pain level 3/10. No fever noted, but did experience chills, fatigue. No swelling to arm, but sensitive to touch to area. Patient complained of sore throat. Patient states she took advil by Sat 09/28/2013 all symptoms subsided.
I got a fever, chills, and was very fatigued. I rested, took Advil after about 2 hours had passed with the fever, and worked from home. After about 2 days I felt better.
8yr old patient was given adult booster dose instead of 5-*11 booster dose.
Left thumb numbness with wrist droop started 8 days after injection. Went to ED and saw neurology who thought could be related and dx as radial nerve palsy. On prednisone taper and seeing PT after EMG next week.
Suspected Vaccination failure / After vaccine, got shingles a year later / I got the vaccine and a year later got shingles again; After vaccine, got shingles a year later / I got the vaccine and a year later got shingles again; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (2 times before the vaccine).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself.  The age at vaccination was not reported. The patient got shingles a year later after vaccination and it did not work for him/her. The reporter mentioned that, it was worse then the 2 previous times, he/she had it before the vaccine. The reporter just pray that he/she did not get them again and asked what was shingle gel. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible, as no contact details were available.
Vasovagal syncope with unconsciousness; Vasovagal syncope with unconsciousness; Ongoing Light headedness; nausea; Headaches; This is a spontaneous report from a contactable consumer. A 45-year-old non pregnant female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EW0178), via an unspecified route of administration, administered in Arm Left on 09Jun2021 10:00 (at the age of 45-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two 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. The patient historical vaccine includes BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EW0179), via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for covid-19 immunisation and did not experience any reaction. On 11Jun2021 19:00, patient experienced vasovagal syncope with unconsciousness, ongoing light headedness, nausea, headaches. The patient underwent lab tests and procedures which included laboratory test: normal on an unknown date in 2021. The events resulted in emergency room visit. No treatment was taken as a result of events. The reporter assessed the events as non-serious. The outcome of the events were not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Fever, chills, fatigue and local pain, redness and swelling at the site of injection.
Patient described feeling dizzy/light-headed almost immediately following vaccine administration. EMS assessment onsite: BP=106/59 and P=64 (SpO2=96) at 2:17pm. Patient discharged from clinic recovered.