chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information has been received from a physician and a registered nurse for the Pregnancy Registry for GARDASIL concerning a 20 year old female (demographics not reported) with migraines (also reported as headaches), a sinus disorder, and a history of an abnormal pap (CIN I) who on 28-MAR-2007 was vaccinated intramuscularly with the first dose of GARDASIL (Lot 656049/0187U; site not reported). On 29-MAY-2007, the patient was vaccinated intramuscularly with the second dose of GARDASIL (Lot 657622/0388U). Concomitant therapy included montelukast sodium (MSD), AVIANE, and albuterol inhaler (manufacturer unspecified) and ibuprofen (manufacturer unspecified). On 09-SEP-2007, the patient had a positive home pregnancy test, and on 10-SEP-2007, a quantitative HCG blood test confirmed the pregnancy. On 20-Sep-2007, the patient sought unspecified medical attention in the office. On 04-DEC-2007, the patient has an ultrasound for history of prominent fetal stomach (not further specified). On 03-JAN-2008 the patient had a ultrasound which was normal. The patient was treated with an iron supplement for 2 weeks and prenatal vitamins (not further specified). On 26-APR-2008, the patient gave birth to a normal, healthy male infant (8 lb. oz; 22 in). The baby had an Apgar score of 9/9. The infant had no congenital anomalies, complications or abnormalities. There were no complications during pregnancy or during labor and delivery. Additional information is not expected.
she kept having chills and a mild fever; she kept having chills and a mild fever; really bad headaches; She hasn't been able to sleep because of feel warm yet cold and her body aches.; She hasn't been able to sleep because of feel warm yet cold and her body aches.; She hasn't been able to sleep because of feel warm yet cold and her body aches.; She hasn't been able to sleep because of feel warm yet cold and her body aches.; This is a spontaneous report from a contactable healthcare professional. A 28-year-old female patient received BNT162B2 (Lot# EH9899) via intramuscular on 20Dec2020 08:00 AM (anatomical location: arm left, dose number: 1) at single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient did not have allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and did not have any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. It was reported that at around 17:00 on 20Dec2020, patient started having really bad headaches. She took a two-hour nap and when she woke up she kept having chills and a mild fever (on 20Dec2020 19:00). She hasn't been able to sleep because of feel warm yet cold and her body aches. No treatment received for the adverse events. Outcome of events was not recovered.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no pertinent medical history, drug reactions or allergies and concomitant therapies reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (Lot number L003775 and expiry date 04-FEB-2017) (dose and route were unknown). There were no adverse effects reported. Lot number L003775 with expiry date 04-FEB-2017 has been verified to be a valid lot number for (Oka/Merck) VARIVAX. Follow-up information was received on 03-AUG-2015 and 05-AUG-2015. The reporting certified medical assistant would have to search the request made for patients' identifiers, lot number and expiration dates and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 1 year old patient of unknown gender. On 30-JUL-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot # L003775). This is one of several reports received from the same source. Additional information has been requested. Patient's details, event information and narrative were updated.
Moderna COVID-19 Vaccine EUA I had a fast heartbeat about a couple minutes after the vaccine, then shortness of breath, dizziness and shakiness. I received Epinephrine then I had some itching and received Benadryl.
iNJECTION SITE SWOLLEN, HOT AND PAINFUL EXTENDING TO ELBOW. DEVELOPED PAIN IN BACK, JOINTS AND MUSCLES. FEVER  VARIED FROM 100.3 TO 103.1 (PATIENT BASAL TEMP 97.1). LOSS OF APPETITE, HEADACHE AND GENERALIZED MALAISE. SYMPTOMS PERSISTED FOR 48 HOURS. RESOLVED FOLLOWING ABDOMINAL CRAMPING AND BOWEL MOVEMENT.
Had 3 x 4-5" red, warm area around injection area. Also itched. Treatment: DEPO-MEDROL injection and KEFLEX for 10 days.
Administer vaccine on 05/09/08 - patient being having symptoms on 05/10/08 around 2:00pm.  Had fever, body aches and local reaction at injection site.  Red and swelling at injection site and painful.  9 1/2 cm x 10 cm.
arm was quite sore; headache; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and headache. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingles vaccine.     Additional Information: GSK receipt date : 11-SEP-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received shingrix vaccine and experienced quite sore arm and headache for 24 hrs Additional Supportive information:The duration of the headache was 24 hrs hence outcome captured as recovered/resolved
My lymph nodes under my right arm swelled up a lot, then a week or two later what I believe to be my lymph nodes in my chest on the right side swelled to a pretty big lump.
I had a known exposure during the end of November, two family members tested positive before I left. On 11/29/22, I had a scratchy raw throat, I used a home COVID-19 test that came back negative, I took a test on 11/30/22 and this time it came back positive. I called my doctor and had a telehealth visit, we discussed my symptoms, was prescribed the PAXLOVID. Started it that evening and was feeling better before I finished the PAXLOVID. I feel that I had a very mild case, low grade fever. By seven days I was feeling really good.
CDC reports: 5 mo developed apnea @ 530PM & fever to 103.5, pt had neurologic sx - hypotonia, shock; tx CPR, oxygen & heart monitor. Hospitalized 1 day for observation.
I was scheduled to get 2nd dose on 3/13/2.; Hemorrhagic stroke on 3/4/21; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGIC STROKE (Hemorrhagic stroke on 3/4/21) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced HAEMORRHAGIC STROKE (Hemorrhagic stroke on 3/4/21) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I was scheduled to get 2nd dose on 3/13/2.). At the time of the report, HAEMORRHAGIC STROKE (Hemorrhagic stroke on 3/4/21) and PRODUCT DOSE OMISSION ISSUE (I was scheduled to get 2nd dose on 3/13/2.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Treatment information was not provided.  Patient reported that experienced hemorrhagic stroke on 14-Mar-2021, and physician advised to him to not get 2nd dose vaccine.  Based on the current available information and temporal association between the use of the product and the start date of the event Hemorrhagic stroke, a causal relationship cannot be excluded. This report refers to a case of Product dose omission issue for mRNA-1273.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event Hemorrhagic stroke, a causal relationship cannot be excluded. This report refers to a case of Product dose omission issue for mRNA-1273.
Woke up Friday morning around 5:30am and had significant fever and chills (100.8F). In the morning fever, during the day increased heart rate. Took tylenol about 3 times a day. Felt burning up all day. Felt like I was on fire. In the evening about 6PM very nauseous, muscle aches, laying down uncovered and I felt like I was burning up. Went to bed early. No taste in the evening. This morning I feel pretty good other than no taste and a little bit of nausea.
Left leg cellulitis 7.6 cm AUGMENTIN ES-600 PO BID.
stated she had developed hives and blisters to bilateral inner extremities.  also reported that she developed blisters inside of her mouth. Generalized weakness and an elevated temperature were accompanying symptoms. Symptoms began on 04/13/2021 approximately around 11:30am.
pt recvd vax;devel rash on lt arm;pt had rxn to contact lens solution therefore for MD thought it may be a reaction to preservative;pt discharged w/ order of dph;
On 1/27/21, resident experienced shortness of breath and felt some pressure on her chest. Systolic Blood Pressure was in the 200's and Diastolic Blood Pressure was in the 100's, HR 117. She was sent to Hospital and diagnosed with: St Elevation Myocardial Infarction due to occlusion of circumflex coronary artery, Acute Systolic Heart Failure, and Aspiration Pneumonia.
I had a subdural hematoma which resulted in emergency surgery at facility on April 26th, followed by an emergency craniectomy on April 28th.
First, fatique then heart palpitations, then headache, then not muscle aches and pains like with the flu, but like I was being hit, radomly. Dizzy and lighheaded.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted after receiving vaccine
This spontaneous report as received from a pharmacist refers to an unspecified number of patiens of unkonwn ages and genders. On an unknown date, the patients were vaccinated with M-M-R II (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a consumer concerning his son who at age of 16 weeks was vaccinated with the first dose of ROTATEQ and at 6 months was vaccinated with the second dose of ROTATEQ.  Subsequently, the child had been "clogged and congested" for 4 months.  The parent did not know if the vaccination was rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) or rotavirus G1 P1 vaccine live (89-12).  The patient did not seek medical attention.  As of 10-FEB-2009, the adverse event persisted.  No further information is available.
Extreme fatigue, Headaches, Body aches, Nausea, Injection site pain; began about 12 hours after shot; was severe from roughly hour 12 through hour 36; moderate, mostly headache and injection site pain, from hour 36 through hour 48
April 24, 2007 patient was treated for intersusseption records received 5/15/07-intussusception. exploratory laparotomy.
After the second shot, my resting heart rate went up and I started experiencing symptoms of hyperthyroid.  At my June checkup, my thyroid levels were all high, including thyroid antibodies. I quit my medications and the thyroid level went down slightly but remained above normal levels.  In October 2021 I was diagnosed with Graves disease.
Pt received #3Hep B mid day on 04/05/2002. Mom called at 4:15pm stating that pt had fever, elevated heart rate, dizziness and flushed face. Mom states had just been sick prior to vaccine administration.
This spontaneous report was received from a nurse practitioner referring to anonymous patients. On an unknown date, anonymous patients were vaccinated with VARIVAX (Merck) that was exposed to a post temperature excursion (lot# K016128; Expiration date 23-SEP-2016) and (lot# K007979; Expiration date 03-JUN-2016) dose and route of vaccination were unknown. No adverse effects noted by any patients. Additional information has been requested.
I have been having some problems with kidney stones; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age (Age: 61; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient has been having some problems with kidney stones on an unspecified date. The event was assessed as serious (medically significant). The patient asked what happens if she can't get the second dose? Second dose was scheduled on 15Apr2021. The outcome of the event was unknown.  No follow-up attempts are completed; information about batch/lot cannot be obtained.
Patient has hemophilia with inhibitor. Vaccine administered IM as per CDC guidelines for vaccination administration in patients with bleeding disorders. Patient experienced hematoma at site of injection that required administration of bypassing factor NovoSeven x 6 to treat bleed. It should be noted that patient is also currently receiving immune tolerance induction therapy with Alphanate. His prophylactic factor is novoseven daily and he also uses Novoseven for on demand treatment of bleeds as his bypassing agent.
Normal arm soreness abated after a few days. Replaced by extreme tenderness within arm muscle. Tenderness slightly better as of 11/27/2017.
HEAD ACHE, MUSCLE TIGHTNESS BETWEEN THE SHOULDER BLADES ALONG THE SPINE FROM MIDDLE BACK TO THE MIDDLE NECK.
This spontaneous report as received from a Licensed Practical Nurse, via a company representative, refers to a 23 year old female patient. The patient's medical history and concurrent conditions were not reported. On an unspecified date approximately in 1993 (reported as: "At one year of age"), the patient was vaccinated with a dose of MMR II (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. The reporter stated that the patient was vaccinated again at kindergarten age on an unknown date. Subsequently antibody titers were drawn on an unspecified date, and the patient failed to seroconvert. The patient was recently revaccinated with a dose of MMR II, and other antibody test was drawn, and this time the patient failed to seroconvert the rubella portion of the vaccine, the measles and mumps titers were high. The patient contacted the doctors office on an unknown date in regards to this problem. The outcome of the events was reported as not recovered. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of a 64-year-old male subject not responding to therapy following vaccination with TWINRIX for prophylaxis. Concurrent medications included Cyclosporin, Azathioprine, Lotrel, Atenolo, Sulphasalazine and Alendronate sodium. On 26 April 2007 the subject received 1st dose of TWINRIX at 1 ml in an unknown arm. On 26 June 2007, after the 1st vaccination with TWINRIX, hepatitis A and B surface antibody levels were drawn, and on 11 July 2007, the levels were both reported at negative. The subject had not responed to therapy. On either 20 July 2007 or 30 July 2007 (date not clear), the subject received his 2nd dose of 1 ml TWINRIX in the left arm. The third dose of 1ml TWINRIX was administered to the subject on 12 December 2007. This was considered to be an inappropriate schedule of drug administration as the 3rd dose of TWINRIX was administrated too close to the 2nd. On 17 December 2007, just five days following administration of the 3rd and final dose of TWINRIX, hepatitis B surface antibody levels were drawn and were found to be less than 5. This was considered to be a low hepatitis B surface antibody level. Hepatitis B antibody levels were drawn too close to the 3rd dose of TWINRIX. The subject experienced a systemic reaction. No additional adverse events were reported. At the time of reporting the outcome the not responding to therapy was unresolved and the outcome of the negative hepatitis B and A antibody level and the low hepatitis B antibody level were all unknown.
Reportedly about one two weeks after vax the pt developed rotating myalgia.  Follow up on 02/12/2003: "It was reported that a female patient received a TD Adult vaccination and a PPD Tubersol skin test on 06/29/2000.  Reportedly about one-two weeks after injections the patient developed rotating myalgia.  Further information requested.  Follow up #1: As of 05/08/2001, no further information has been received from the reporting facility.  Several attempts have been made to obtain further information for this case and all attempts have been unsuccessful.  Therefore this patient is lost to followup and this case is closed."
Client states right shoulder pain  MD and MRI obtained   injection into tendon  complains unable to use   had physical therapy and steroidal injections   much better now
Extreme pain in upper left arm where vaccine was given. Can barely move left arm. Has been 24 hours and still extremely painful.
Developed high fever (104 +), very cranky, developed rash on chest and back 3 days after fever started.  Fever lasted 3 days.  Crankiness started 04/29/2003.
Ringing in my ears. Right ear was and still is extreme and left ear is little lower. Right after my first does I got tinnitus and still have it . Been over 6 months now. Lately it has spiked up.  I am still suffering from tinnitus.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 04-DEC-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # K007797 and expiry date: 29-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Expired dose given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30-APR-2023) for prophylaxis.   On 04-MAY-2023, the patient received Menveo. On 04-MAY-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date 11-MAY-2023 The patient reported of receiving an expired dose of Menveo. The reporter wanted stability information and needed information for repetition of vaccine. The medical Safety staff member did not provide any additional details and medical information submitting all details as provided on web form. The reporter consented to follow up. Patient received a dose of Menveo on 4th May 2023 which was expired on  30th April 2023, which led to expired vaccine used.
trouble in breathing; congestion; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble in breathing) and NASAL CONGESTION (congestion) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Bronchitis and Shortness of breath (SOB). Concurrent medical conditions included Chronic obstructive pulmonary disease (COPD) and Smoker.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date (reported as few days after vaccination), the patient experienced DYSPNOEA (trouble in breathing) (seriousness criterion medically significant) and NASAL CONGESTION (congestion) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (trouble in breathing) and NASAL CONGESTION (congestion) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The treatment information included inhaler.   Reporter did not allow further contact.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.  However, patient's prior SOB, being a smoker and underlying bronchitis and COPD may have been contributory.
2 weeks and I still have ?Covid arm?. Red itchy knot at injection site.
Anaphylaxis, Tachycardia, Lightheaded, Injection site swelling and redness Narrative: Went to ER in community-IV benadryl and IV decadron and 3 epi-pens
about 10 minutes after  receiving vaccine pt said she felt light headed. We gave her some water to drink and she sat for about 30 additional minutes and said she felt fine
Mild dizziness started within 5 minutes. Within 20 minutes my tongue started to swell, but only the front to middle part, not the back part. I was still able to breathe. After 25 minutes, I was unable to stand and nearly passed out twice trying to get to some place safe.  I could not verbally communicate and was lacked strength to move. I started drinking as many fluids as possible with the assistance of family. Symptoms began to subside after 3 hrs. After 4 hrs, I regained strength and was not dizzy if I stayed in place. I continued to push fluids and rested. I needed to be careful not to drink anything too cold as i would develop the chills. The next day, there was no dizziness but I was very groggy. I continued to push fluids. I would develop a headache if I did not drink at 16 oz every hour. The following day, I was still groggy, but was functional and felt okay to drive.
On the morning of 3/31/2021 patient had chills, she seemed to develop a cold, she was achy and not wanting to eat.  She was very sleepy and by 6:00 P.M. she passed away.
Left leg issues, fever on and off, rash on abdominal area, hives, fever, rash, eyes puffy and swollen, loss of appetite, lethargic
Patient given Fluzone High Dose indicated for 65 and older.  Patient is 59 yo.
This spontaneous report was received from a 65 year old male consumer who was reporting on himself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced sharp pain in his shoulder and in his chest. The outcome of the adverse events was unknown. The relatedness between adverse events and the therapy with ZOSTAVAX was not reported. Additional information is not expected as there are no contact details.