chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from   a contactable pharmacist via a physician and via a consumer (patient mother) and then the contractable physician. A 19-year-old female patient received TRUMENBA (lot number J29203, expiration date JUN2016) at 0.5 ml single dose intramuscular in the left deltoid on 23FEB2015 at 15:20. Relevant medical history was not reported. The patient had no illness at time of vaccination. Concomitant medications included ongoing methylphenidate ER 36mg once daily since 23FEB2015, ongoing methylphenidate 5mg tablet since 23FEB2015 and ongoing citalopram 20mg at 1.5 DF daily since 24FEB2015. On 24FEB2015, 24 hours after vaccination, the patient experienced blinding headache (reported as headache by the pharmacist) and fever (>101F>24hr). On 25FEB2015, 48 hours after vaccination, the patient experienced joints/muscles neck spine shoulders hurt. Additional the pharmacist reported that the patient had muscle pain all over on unspecified date in FEB2015. According to the reporting physician blinding headache and fever recovered 24 hr after onset on 25FEB2015, joints/muscles neck spine shoulders hurt recovered 48  hrs after onset on 27FEB2015. Outcome of the event muscle pain all over was unknown. No specified tests or treatment were required. The physician considered there a reasonable possibility that the events were related to TRUMENBA. Follow-up (20MAR2015): New information received from a cont actable physician includes: gender, causality assessment, product details, new events (fever and joints/muscles neck spine shoulders hurt), updated event description( (from headache to blinding headache), concomitant medications, info on treatment/tests, outcome. Follow-up (27APR2015): This is a spontaneous report from the non-clinical study program"IBCC (Inbound Call Center for HCP's)". No additional information was obtained.  Follow up attempts completed. No further information expected.
Suspected Neoplasm of brain causing mass effect on adjacent structures. , atypical metastasis, and less likely infectious process.  Patient was evaluated by neurosurgery who recommended dexamethasone and Keppra and follow-up at neurosurgery for further management of her brain mass. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Pt here with body aches, fever, chills, chest pain, treating for suspected pericarditis,
Vaccine was administered very high, presumably in the joint space, rather than the deltoid. Patient experienced intense pain in the entire shoulder area for 24 hours following administration. After initial 24 hours, pain remained more localized in the joint itself. Pain is intensified when moving out of the neutral position.
On 7/3 pt. noted redness, swelling and pain at site of injection on Rt. deltoid.  Also noted headache, nausea and loss of appetite.  On 7/4 pt. noted a slight acne-like rash on the left side of her face and approx. 5 flat reddened spots on her abdomen that were not itchy or sore.  She has reported having diarrhea and being more tired then normal.
About 7-10 minutes after receiving the shot, patient started to feel extremely shaky and warm. Her face turned red and hands were shaking. Patient felt her heart skipping with irregular heart beats. The nurse measured the patient's blood pressure and it was 183/95 with a pulse of 104. The patient was observed for an hour.
redness and raised temperature at injection site.  Recommended ice pack and tylenol as needed.
15cm Blood clot in left leg - lower calf.; Superficial vein prominence; This is a spontaneous report from a contactable consumer (patient herself).  This 50-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER8732), via an unknown route in the left arm, on 27Mar2021 at 14:45 (at the age of 50-year-old) at single dose for COVID-19 immunisation, administered at hospital. Relevant medical history included Factor V Leiden and varicose veins. The patient did not have allergies. The patient did not have COVID-19 before vaccination. Relevant concomitant medications included acetylsalicylic acid (ASPIRIN), levothyroxine sodium and Women's multivitamin (unspecified). On 07Apr2021, the patient presented 15 cm blood clot in the left leg-lower calf and superficial vein prominence. The events required a physician office visit. An ultrasound was done but results were not provided. Therapeutic measures taken as result of the events included enoxaparin sodium (LOVENOX) injections for 14 days. Post-vaccination COVID test was not performed. The patient was recovering from the events.
Patient called pharmacy the week after his flu shot and stated he felt dizzy/light headed the day after receiving his vaccine. Patient stated that he had his shot Friday 8/28/20  and the incident happened Saturday 8/29/2020 - flu shot was actually administered on 8/27/2020. Patient stated that he passed out and hit his head, which required a visit to an emergency room. Patient stated that he received several stitches to his head. I asked the patient if the hospital made any mention what the cause of the dizziness/fall was (did the mention the flu shot?) and patient said they did not. Patient seemed unclear on many of the details. I told the patient to follow up with us if he had any more information or concerns. Patient stated he would be returning to doctor for a follow-up visit to have the sutures removed.
pt recvd vax & w/in 4hrs p/vax exp pain & stiffness;pt was seen by MD who treated w/APAP #3;w/in 24hrs p/vax pt exp hives;reporter did not know whether or not the hives were d/t APAP #3 or the vax
Patient's voice became hoarse and she felt likt her throat was swelling.  Upon exam:  no shortness of breath, no wheezing, no swollen lips/tongue.  Patient reported same symptoms when she received the flu shot this year.
intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; redness in face and eyes; redness in face and eyes; feels warm; This is a spontaneous report from a contactable consumer (patient is girlfriend). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EKH176), via an unspecified route of administration on 12Jan2021 morning at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on unspecified date for covid-19 immunization. The patient medical history was none. There were no concomitant medications. The patient was currently having side effects, stated she was having on and off, intermittent, sharp pain in her left arm, left chest and left shoulder blade, feeling the pain all on her left side on 13Jan2021. The reporter stated the patient looked worse than she did 2 hours ago, that her face was turning red and her eyes were turning red and she felt a little warm on 12Jan2021. The reporter wants to know when she should take the patient to the hospital. The reporter was encouraged to reach out to a health care provider. The outcome of events was not recovered.
Information has been received from a consumer concerning her son with no known drug reactions/allergies and medical history who "when about 18 months old, was vaccinated with both recommended 0.5 ml doses of MMR II (approximately in May-2002) (route and lot number unspecified). Concomitant therapy included Poliovirus vaccine (date, route and lot number unspecified). It was reported that "blood work" (date unspecified) was performed (results not reported). The mother stated her son received both recommended doses of the vaccine and soon after he would not make eye contact and the mother noticed "off the wall changes", "about 3-4 years ago" (approximately in 2005). The patient was diagnosed with autism, attention deficit hyperactivity disorder (ADHD), Bipolar, oppositional defiant disorder (ODD) and obsessive compulsive disorder (OCD). The patient was taking Focalin XR (Novartis) tablets 10 mg, Focalin (Novartis) tablets 2.5 mg, Oxcarbazepine (manufacturer unknown) tablet 300 mg/twice daily, Guacince HCL (manufacturer unknown) tablets 1mg/ twice daily Mirtazapine (manufacturer unknown) tablet 7.5 mg. The mother stated the patient stopped therapy "when about 18 months old". The outcome of the patient was not recovered. The patient sought medical attention. Upon internal review, autism was determined to be an other important medical event. Additional information has been requested.
I had a slight fever and whole body ache after 7-8 hrs post vaccine administration.  The fever sustained for 20 -24hrs, took  Tylenol during this feverish time period.    Especially after my third dose i.e 29th Oct 2021, nearly after a week or so, I was thirsty and started drinking lukewarm water (~ 1.5 ltrs) every day.  Also started noticing., while driving my car in the dark, traffic lights was visible "like a flower shape", instead circular shape. Felt really something not correct and before I could get Primary Care Appointment and Eye examined, I went to meet my family abroad. There, incidentally, I found out that I have been going through type2-diabetics.   Since, January 2022, I've started taken medications for type-2 Diabetics, after consulting my MD.
Mild fever,   increased pain in my neck and shoulder that were previously a bit sore from an old injury, my hand felt "tight and sore" and so did the "bones in my head".  I do suffer from that when we have a storm and one was on the way, but it was more intense than normal. I had 4 bouts of very urgent needs to urinate that is not normal for me and the urine was very dark, not the typical light yellow.  I was not otherwise ill or dehydrated that perhaps would've caused that to happen.
Fever; Achyness; Vomiting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever), MYALGIA (Achyness) and VOMITING (Vomiting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), MYALGIA (Achyness) and VOMITING (Vomiting). At the time of the report, PYREXIA (Fever), MYALGIA (Achyness) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.   Reporter did not allow further contact
Severe Chest Pains and numbness in checks.  Irritation in the throat and dry cough
Booster vaccine was provided by EMTs via a homebound visit. Client states five minutes after the vaccination he begin experiencing sharp, "needle-like" pain in his chest.  He was sweaty and "burning up".  His blood pressure was taken and he was told it was high.  Onsite EMTs called another ambulance to transport client to local emergency room for evaluation and observation.   Client states an Xray was done and he was provided medication, Nitroglycerin.  Client states he experienced this 3 months ago,
Has the shots, has shingles now/Suspected vaccination failure; Shingles outbreak; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Has the shots, has shingles now/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles outbreak). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-MAR-2023 The case was received from the patient's friend interactive digital media. The patient had Shingles shots and now had severe outbreak of shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Swelling, itching at the injection site 1 week after injection. Swelling and soreness of the underarm/armpit of the injection site arm
Hospitalized for newly diagnosed anemia (Hgb 5.8) found to be positive for COVID 19 fatigued and dyspneic.
One episode of apnea 8/23/13 at 2335 and one episode apnea 8/24/13 at 0215.
has only had 1 dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 8th March 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has only had 1 dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-OCT-2023 The pharmacist reported a 72 year old male patient states insisted he had only had 1st dose of Shingrix, but his pharmacy had record of 2 doses being administered.  The doses were on record as being given on 08th March 2023 and 20 July 2023.  The patient was disputing that he received the 2nd dose and wanted to receive another dose, but this had not been administered at the time of call. The consumer reported only received 1st dose, which led to incomplete course of vaccination. The reporter consented to follow up.
patient fainted in aisle after having shot.  Was alert while pharmacist spoke with him.  Patient felt dizzy and had blurred vision, but was able to see clearly right away.   Paramedics cleared him.
Patient stated that 3 days after her vaccination she had increased pain, swelling and redness at the injection site that grew and became larger now extending all the way to her elbow. She went to see a doctor and was diagnosed with cellulitis and prescribed dicloxacillin 250 mg  q 6 hours x 7 days. Patient just started taking medication today on 7/17/21
Received 3 doses of shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The pharmacist reported that a patient received 3 doses of Shingrix, which led to extra dose administration. The reporter consented to follow up. The patient did not receive the 3rd dose at the reporters pharmacy so no lot number or expiry date.
Day two- small red bump, skin painful to light touch and then subsided over the next few days. Day 9 red bump appeared and gradually grew larger, lump felt under the skin, itchy rash around red bump.
blood pressure (125-1.30); fast heart beat, heart is pretty fast; not sleeping well; had discomfort and not able to rest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE ABNORMAL (blood pressure (125-1.30)), TACHYCARDIA (fast heart beat, heart is pretty fast), POOR QUALITY SLEEP (not sleeping well) and DISCOMFORT (had discomfort and not able to rest) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced BLOOD PRESSURE ABNORMAL (blood pressure (125-1.30)), TACHYCARDIA (fast heart beat, heart is pretty fast), POOR QUALITY SLEEP (not sleeping well) and DISCOMFORT (had discomfort and not able to rest). At the time of the report, BLOOD PRESSURE ABNORMAL (blood pressure (125-1.30)), TACHYCARDIA (fast heart beat, heart is pretty fast), POOR QUALITY SLEEP (not sleeping well) and DISCOMFORT (had discomfort and not able to rest) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Blood pressure measurement: 125-130 (abnormal) abnormal.         No concomitant medications reported.  No treatment medications provided by the reporter.   This case was linked to MOD-2021-078012 (Patient Link).
Elevated temperature; Extreme Fatigue; Pain at injection site; Deep productive cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101107725 (Pfizer).  A 79 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 23Aug2021 14:00 (Lot number: FC3182) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Heart Disease" (unspecified if ongoing); "Bee venom" (unspecified if ongoing). Concomitant medication(s) included: IGG. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 23Aug2021 14:30, outcome "recovered" (Aug2021), described as "Elevated temperature"; FATIGUE (non-serious) with onset 23Aug2021 14:30, outcome "recovered" (Aug2021), described as "Extreme Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 23Aug2021 14:30, outcome "recovered" (Aug2021), described as "Pain at injection site"; PRODUCTIVE COUGH (non-serious) with onset 23Aug2021 14:30, outcome "recovered" (Aug2021), described as "Deep productive cough". Therapeutic measures were not taken as a result of body temperature increased, fatigue, vaccination site pain, productive cough.  Follow-up attempts completed. No further information expected.
Patient started with itching all over. Redness and hives on chest. "Itchy throat" with frequent clearing of throat observed. Bilateral breath sounds were clear and equal. No angioedema noted. Vital sings were monitored.  Pulse was 98-99% on room air. Later felt a headache and felt jittery. Benadryl 50 mg PO was administered.  Within 20 minutes of Benadryl symptoms improved. Prior to discharge the patient was no longer clearing her throat. Patient states she felt better. Husband reports chest and hive are basically gone. Patient remained alert and oriented x4 the entire visit. Reviewed to continue with over the counter Benadryl and take per directions on bottle. Husband reported he would stop and get Pepcid to take with Benadryl. Patient ambulates out of clinic without problems. 4:28 pm  161/88  89  16  97% 4:36 pm  149/82  79  17  99%. 4:43 pm 142/66  71    17   99%. 5:00 pm  124/ 83   72   15   98%.
Headache, Arthralgia, Fever, CoughWheeze, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE,  LOSS OF TASTE AND SMELL Narrative:
Everything tastes like onions.  car exhaust smells like onions.  fresh brewed coffee smells like onions.  fruit tastes like onions
Patient felt lightheaded a couple of minutes after receiving vaccine.  HR and BP reported to be low. Patient recovered spontaneously and without intervention.  En route home in car, patient had a witnessed, brief syncopal episode.
Client awoke on the day after vaccines given, 3/21/01, to find his left upper arm, outer aspect, to be inflammed and slightly tender distally to inflammed site. Client assessed at health dept by PHN on 3/22/01 at 10:00. Left upper outer arm noted to have a warm erythematous site measuring 8cm noted. Recommend warm and moist packs alternated with cold packs every 1/2 hour, 4 X a day until improved. OK to use topical hydrocortisone 1% cream. Child's mother was instructed to call PMD if worse or not improving.
pt exp temp & fussiness-starting 3JAN96 pt started having sz in form of infantile spasms;speech & devel language delays by 6 to 8mo;
Patient said she was "tired, [nauseous], and couldn't eat for 3 days" after 1st dose.  Then, a  week later she had "chicken bites" on her arms and legs.  All of the symptoms have been resolved.    No sign & symptoms of anaphylaxis after 2nd dose.
10 minutes after administration patient began to have a burning sensation in her nostrils, itching in her throat, and nausea/vomiting. 50 mg of PO benadryl  with water. INitial VS as follows: BP was 122/80, HR 102, and O2 was 98%. VS remained stable . Patient was monitored for an additional 40 minutes after the reaction.  Patient was advised to go to the ER if symptoms return.
Excessive bruising, nosebleeds, petechia. Platelet Count 11,000 upon entering hospital. After 2 rounds of IVIG, platelet count 4000 - 6000. Oral prednisone therapy started after discharge home. Count rebounded to 28,000 after 14 days of prednisone. Returned to low normal range (150,000) in Feb. of 2008, 12 months after onset.  8/15/08 Reviewed PCP medical records of 1/2007-1/2008. FINAL DX: none provided Records reveal patient adoped from out of country at 8.5 mo.  Patient was in good health on 1/18/07 day of vaccination.  Returned to PCP on 2/24/07 for bruises, nosebleeds & bleeding gums intermittently x 1 week.  At that time, reported cold s/s x 1 mo of congestion & wet cough.  Admitted to hospital based on labs.  Returned to PCP s/p hospitalization 2/27/07.  8/26/08 Reviewed hospital medical records of 2/24-2/26/2007. FINAL DX: idiopathic thrombocytopenic purpura Records reveal patient experienced bruising x 1 week and bleeding, nosebleed & bleeding gums x 1 day.  Had been seen in PCP office on day of admit & noted to have petechiae on cheeks.  Peds hematology consult done.  Tx w/IVIG.  D/C to home to f/u w/PCP next day for serial labs.
Since getting ZOSTAVAX, patient started getting a headache daily starting the day after getting the vaccination. She uses OTC medication to treat the headaches. Still having them 5 days after.
PATIENT CAME UP TO PHARMACY COUNTER AFTER ABOUT 10 MINS POST VACCINATION SAYING SHE FELT DIZZY WITH RACING HEART.  I IMMEDIATELY TOOK HER TO A ROOM AT OUR CLINIC WHERE SHE COULD RECLINE. SHE PROGRESSED TO HAVING TINGLING IN HER FACE AND LEFT ARM AND  HOARSENESS SO I ADMINISTERED, WITH HER CONSENT, 25 MG ORAL BENADRYL LIQUID. I TOOK HER BP AND IT WAS NORMAL AS WELL AS HER PULSE OX (99 - 100%). SHE SAID SHE STARTED TO FEEL SOME BETTER, BUT STILL HAD THE TINGLY FEELING IN HER FACE AND ARM SO I ADVISED AT THAT POINT, AFTER BENADRYL NOT HELPING, TO SEEK EMERGENT CARE AT ER.  SHE REPORTED TO HER MD AND WAS GIVEN STEROIDS.