chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HIGH BLOOD PRESSURE; HOT FLASHES; PAIN IN THE BACK OF HER EYES; INTERCRANIAL HYPERTENSION; This spontaneous report received from a consumer concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: cherries allergy (Gets a rash), and alcohol user (occasionally), and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 27-SEP-2021 for covid-19 prophylaxis. Age at time of vaccination 42 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced brain fog, hot flashes, pain in the back of her eyes, headaches, blurriness and high blood pressure. Laboratory data (dates unspecified) included: Blood pressure high. On 23-SEP-2022, the patient visited a physician and underwent MRI (Magnetic resonance imaging) scan which showed in intercranial hypertension. On 05-OCT-2022, MRV (magnetic resonance venography) had been scheduled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from hot flashes, and had not recovered from high blood pressure, pain in the back of her eyes, and intercranial hypertension. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220952025-covid-19 vaccine ad26.cov2.s-intercranial hypertension. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Ringing in ears started at 8 AM on the day after the booster shot. It comes and goes. It depends on the position of my head.
Pt describes continued pain in injected arm as beginning just below injection site (left deltoid) and radiating to just above the elbow.  She states it feels like a bruise.  The is no physical apparent evidence.  She states the pain began around the time of injection and describes it as being of normal intensity for receiving a vaccine.  However the pain has continued and spread somewhat since the injection for approximately 3 months and counting.  I advised patient to discuss with her primary care physician.
I was on a trip 24MAR2023 on the morning 25MAR2023 I had a severe ear each that lasted twenty four hours I had congestion coughing sinuses drainage What I noticed every couple of hours I has to blow my nose gong through boxes of Kleenex. I had severe wheezing as well I took ALEVE to try and help my symptoms. I continued to cough up mucous and blow it out my nose, very severe symptoms. I was in a colder environment, on 31MAR2023 I began my trip home and took a ZYRTEC from a friend. I used a inhaler every four hours a lot of coughing and wheezing. I started using my nebulizer upon getting home, albuterol 205mg/3ml and my rescue inhaler every four hours this continued until Tuesday when I went to the urgent care. A PCR was negative as was the chest x-ray.
covid vaccine breakthrough case  dose 1 Pfizer 3/11/21  EN6207 dose 2 Pfizer 4/1/21  ER8730 dose 3 Pfizer 10/28/21  EW0164
Freezer vaccine had been stored in had been unplugged and temperature monitoring of the vaccine was not done prior to administering to the patient.
Significant pain in injection site. I was unable to sleep on that side for 2 nights. I felt foggy and very goofy, almost like I was high or something for the 5-7 hours after getting the shot. Throat felt like I was having massive allergies (not closing but thick? and itchy) Random sweats 5-7 hours after the shot. Mild headache for a day after. Exhaustion for a day after. My lymph node in my left arm pit is hurting today (day 6?).  5-10 random bumps on both arms within 3-4 days. They itched and looked more like acne than hives.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Freezing/I'm cold all the time), TREMOR (Shaking), DECREASED APPETITE (No appetite), ABDOMINAL DISCOMFORT (my stomach's upset) and DYSPNOEA (Short of breath) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Acid reflux (esophageal), Allergy to antibiotic (Tetracycline) and Drug allergy (Aspirin). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal).    On 30-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced SLEEP DISORDER (Woke up in the middle of night). On 31-Mar-2022, the patient experienced FEELING COLD (Freezing/I'm cold all the time), TREMOR (Shaking), DECREASED APPETITE (No appetite), VOMITING (I vomited) and FATIGUE (So  tired). On 05-Apr-2022, the patient experienced ABDOMINAL DISCOMFORT (my stomach's upset), DYSPNOEA (Short of breath), CHEST PAIN (Pain in my chest) and NAUSEA (Nausea). At the time of the report, FEELING COLD (Freezing/I'm cold all the time), TREMOR (Shaking) and ABDOMINAL DISCOMFORT (my stomach's upset) had not resolved, DECREASED APPETITE (No appetite), DYSPNOEA (Short of breath), CHEST PAIN (Pain in my chest), SLEEP DISORDER (Woke up in the middle of night), VOMITING (I vomited) and FATIGUE (So  tired) outcome was unknown and NAUSEA (Nausea) was resolving.            The patient reported patient woke up in the middle of the night & was freezing & shaking, then vomited. Patient went back to bed, but patients body was shaking for 1 hr before patient fell back asleep. Patient woke up so tired and had no appetite. The patient ate chicken soup. On 05 Apr 2022 the patient felt better but still had some nausea & stomach's upset. When  the patient went for walk she was short of breath. Patient reported that she was not sick with the other shots of vaccine. The patient had never tested positive for COVID-19. It was unknown if the patient experienced all the events in the past. All the events dose not caused the patient to seek medical care and it was reported that on 5 April 2022 symptoms were ongoing but improved. The patient Denied the history of cardiac issues.  No treatment information was reported.   This case was linked to MOD-2022-533446 (Patient Link).
There is some pain at the injection site.  The day after I got the shot I was very tired.  Later that night I started to get a headache and realized I had a low temp fever.  My daughter had the same symptoms as I did.  She received the shot right before me so the lot number is the same as mine.  This is 3 days later and I am ok except my arm is still a little sore.
Got phone call from patient, states right upper arm at site of injection Friday 05/09 redness, injection on Sunday 05/11/2003, site became red, raised and hot to touch.  Patient started Advil II tabs Q10, Benadryl 50mg, applied cold compresses to area.  Patient seen in office on 05/13/2003 by MD.  Td injection site had 3 x 4 cm pale red indurated rash.  Patient to continue Benadryl 50mg, 3-4 times per day and Advil 2 tabs 2 times a day.  patient to follow up per PRN.
four patients who present with symptoms of hyperthyroidism after receiving SARS-CoV-2 mRNA vaccine; This is report for the following source(s): "Thyroid Adverse Events after SARS-CoV-2 Vaccination".  An adult female patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTHYROIDISM (medically significant), outcome "unknown", described as "four patients who present with symptoms of hyperthyroidism after receiving SARS-CoV-2 mRNA vaccine". The patient underwent the following laboratory tests and procedures: Thyroid stimulating immunoglobulin (6.21-11.87): positive.  Clinical course: It was described as four patients who present with symptoms of hyperthyroidism after receiving SARS-CoV-2 mRNA vaccine. All were females, median age 49 (range 44-59). Two patients presented with de novo (starting from the beginning) hyperthyroidism 25-29 days following SARS-CoV-2 mRNA vaccine. All four patients had TSH receptor antibodies positive (range 6.21-11.87IU/L); Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (HYPERTHYROIDISM ) and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300081270 Same article/drug/event and different patient;
all four got flu.; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves four-patients (unknown demographics) who all got flu (influenza), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the all patients got flu. (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Fever of 102 (axillary temp).  Red flat rash on stomach, back and forehead.  Mother to continue to observe.  To give Tylenol as occasion requires fever and to call office back if worsening.
T99 on 7AUG91; Thurs evening temp 102.3 given APAP; Betwen 9 & 930 pt had a convuls;
Adverse Event: Severe headache (HA), chills, nausea, vomiting, lightheadedness. Slight headache began around 7pm, HA worsened in severity within an hour, chills started around 7:30pm. I then took my temperature  at home (96.5F). After getting my temperature, I took 2 Tylenol at 7:45pm, dry heaved at 8pm. My HA was refractory to Tylenol and continued to worsen. I went to the Emergency Department at Hospital where I reported pain as a 10/10.  I then vomited in the waiting room. I was brought back to a room, gave  a urine sample and gave blood for testing.  I was then given IV fluids and later given a CT scan. Test results are below in Item 19.  Treatment: IV fluids (2 bags), rest, oral hydration and food. Outcome: Within minutes of vomiting, pain went down to 4/10. With in the hour, I had fully recovered.
Bumps in stomach, legs, in hair exposed to chicken pox baseball team, treatment: Zovirax.
Pt received his first dose of the Pedi Pfizer covid19 vaccine however the vaccinator did not catch that the pt was 12yo and therefore should have received the regular dosed Pfizer vaccine instead.   Parent was informed by health director and the pt's mother was advised to get the regular dose for dose #2.
Inappropriate Schedule of Vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of Vaccine administered) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Smoker in 2013 and COVID-19 on 15-Jan-2021. Concurrent medical conditions included Depression since 01-Jun-2000, Anxiety since 01-Jun-2000, Hypertension since 01-Jan-2005, Atherosclerosis since 01-Jan-2013, Penicillin allergy and Fish allergy. Concomitant products included CLONAZEPAM from 01-Jan-2013 to an unknown date for Anxiety, ACETYLSALICYLIC ACID (ASPIRIN 81) from 01-Jan-2005 to an unknown date for Cardiovascular disease, unspecified, AMLODIPINE from 01-Jan-2016 to an unknown date for Hypertension, VITAMINS NOS from 01-Jan-1980 to an unknown date for Supplementation therapy.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of Vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of Vaccine administered) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: postive (Positive) Positive. On 19-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. On 07-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. On 16-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative.         The patient stated that he received first dose of Moderna 13 January 2021 and second dose on 20 April 2021.  The patient stated that he got COVID-19 after first dose on 15 January 2021 and experienced cough for 7 days, chills for 3 days, myalgia for 3 days, and fever for 3 days with temperature 100.5 fahrenheit. The patient also stated that he used Bamlanivimab IV on 22 Jan 2021 and Ibuprofen, 400 mg, TID, oral from 15 Jan 2021 to 19 Jan 2021 during COVID-19.   This case was linked to MOD-2021-010840 (Patient Link).
I experienced a headache at 03:00AM and I couldn't go back to sleep. The headache pain was concentrated in the back of my head and neck. I did take Excedrin migraine. It took some of the edge off but the headache was still. By 09:00AM I did have bouts of diarrhea. I took Imodium and that helped the diarrhea. I went to bed that night at about 07:00PM, but I had woken up in the middle of the night with the headache again. I took my temp and it was 98.8. but the walls felt like I was vibrating. I took an oral temp 103.3. I went to urgent care and I was prescribed Paxlovid. For the next 5-6 days I was so fatigue and sick feeling I couldn't even lift my head. The following week I went back to work and I was wearing a mask. When I came home I had a 101 temp. I had a fever for the next 3 days. I was taking Tylenol and Ibuprofen. I did go back to the doctor for my annual bloodwork and they found that my liver enzymes are high. I was told to stop taking the Tylenol and my blood pressure medication. As of today, I still have a cough, congestion and sinus drainage.
Site: Pain at Injection Site-Mild, Systemic: Chills-Medium, Systemic: pt says now has a facial tick on right side - happens 50 times a day-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: pt said chills nausea all day the day after lasting about 12hrs.  says he now has facial tick on right side,  happening about 50 times a day.  He called his MD (Dr with the Admin) and was not given a treatment plan.  Md told him to call the pharmacy where he was vaccinated or the Reporting site.  - pt sasy it is a continuing issue.
Received vaccine on Saturday Oct 30,  2022 at 10 am.  Woke up  the next morning with significant tinnitus, which sounded like bees buzzing.    The tinnitus subsided during the day.    I continue to experience tinnitus when I wake up in the morning.   The level of tinnitus is variable, some days it is worse than others.
was vaccinated six days before she should have received her second dose. Her first dose of Moderna was administered on May 13, 2021 and her second dose was administered on June 4, 2021. Her second dose was administered on Day 22.
At 9:30 pm, my husband began to feel cold and started shivering..  These symptoms increased and he developed a fever of 101.0 by midnight.  I gave him 2 extra strength Tylenol at 12:18 am.  By 1:45, the shivering stopped and fever was down to 100.2.  By 8 am, all symptoms were gone.
Initial unsolicited report received from a pharmacist on 15 October 2015. This case is linked with case 2015SA164326 (same events and different patients). This case involves three patients (age and gender not reported) those were vaccinated with a dose of MENACTRA and a dose of GARDASIL (manufacturer other) (batch number, dose, route and site of administration was not reported for both vaccines) on an unspecified date last month. All patients' medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, all patients experienced lower leg paralysis, decreased sensation below knees, felt a burning sensation all over body, had air hunger, O2 WNL (within normal limits) and tinnitus. Lab data and corrective treatments were not reported. Outcome of events was unknown. Upon internal review, the company decided to consider the case serious because of important medical event: lower leg paralysis and decreased sensation below knees. List of documents held by sender: none.
Pt vaccinated with DTP/OPV/HIB experienced high pitched shrieking less than 3 hrs at one time.
pt reports experienceing the following sx @ approx 6PM on the evening of the same day of inject; sl rash w/itching @ the site of inject (lt deltoid); lt sided neck, shoulder & upper back pain; severe h/a lasting all noc; nausea;
muscle pain; fever; chills; brain fog; massive headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (brain fog), MYALGIA (muscle pain), PYREXIA (fever), CHILLS (chills) and HEADACHE (massive headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07M20A) for COVID-19 vaccination.     Family history included Migraine.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (massive headache). On 21-Feb-2021, the patient experienced FEELING ABNORMAL (brain fog). On an unknown date, the patient experienced MYALGIA (muscle pain), PYREXIA (fever) and CHILLS (chills). The patient was treated with ACETAMINOPHEN for Headache, at a dose of 325 mg twice a day. At the time of the report, FEELING ABNORMAL (brain fog), MYALGIA (muscle pain), PYREXIA (fever) and CHILLS (chills) outcome was unknown and HEADACHE (massive headache) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to MOD-2021-073383 (Patient Link).
Pt recvd vax & 2 wks following vax devel Hep B; No further details were provided;
(L) thigh red, swollen with heat. Warm moist compress 4x a day.
Dizzy, poor mobility, ringing in the ears, tremors, raised injection site with warmth, sleep w/o medication and vivid dreams. NDC: 59267100001.
Received shot around 12pm Sunday, woke up at 7 am Monday with ?head feeling heavy?. Developed a fever by the afternoon, lethargy, low appetite. Slept for 14 hours Monday night and woke up Tuesday feeling better. Fever seems to be broken and appetite is returning.
Normally consistent low normal blood pressure has been consistently rising since immunization. Average normal 96/74 before vaccine has now gone to 156/95 resting. Shortness of breath with mild activity. Migraines that were under control with medications prior to vaccine now occurring regularly on average 2-3x/week with nausea and sensitivity to light and sound making normal activity impossible. Constant fatigue.
On 10/20/2022 we ordered what we thought was the Moderna Bivalent. It was listed as booster dose. At that time it was our understanding that the only booster dose was the new Bivalent vaccine.. When we scanned the QR code on box info for the bivalent vaccine came up. We started using thinking it was the new bivalent vaccine. On 10/27 we called Moderna to ask a question about the vaccine. They were given the lot number. On 10/31/2022 they called us back to answer our initial question, but also informed us that the vaccine was not the bivalent vaccine.  16 patients were involved and all have been notified of error. All understood and no one had an adverse effect.
Information has been received from a healthcare worker, certificated medical assistant  (CMA) who reported that multiple unspecified patients received doses of improperly stored oral, ROTATEQ (lot # K010224 expiration date 13-MAY-2016, dose, frequency and route were not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
p/vax pt exp inj site rxn 3 inches in diameter w/swelling, redness & warmth;
the site is a little sore; pain in her left wrist/pain to right shoulder; pain to right shoulder and believes it is from either the fall, or torn rotator cuff; dry mouth; pain to right shoulder and believes it is from either the fall, or torn rotator cuff; This is a spontaneous report from a contactable consumer and other hcp received from. An 88-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 88-years-old via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.   Medical history included bypass graft in 2016 (five years ago), pacemaker placed in 2021 (about a month and a half ago). The patient's concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (lot number not reported) for covid-19 immunisation. The patient reported having pain in her left wrist, wears a band, and feels safe while performing activities. She further reported having pain to right shoulder and believes it is from either the fall, or torn rotator cuff. She had the vaccine on 01Apr2021 and reported that the site is a little sore. She further reported due to having dry mouth she was already drinking water all the time. The events occurred on an unspecified date in Apr2021. Patient reported placing ice pack to site, and taking tylenol. She also reported having various blood readings, and have shared readings with MD staff. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Severe throat problems, headache lasted over a month, muscle weakness, fatigue, fever. I?ve been on antibiotics since the vaccine.
Excessive sleepiness; Difficulty to arouse for 7 days p/immun; Mom spoke to MD in Feb @ well baby ck-up & was advised to get DT;
I noticed approximately 20 ant bite appearing red bumps on his legs and arms 4-5 days after he received the Chicken Pox/MMR vaccine.  Four to five days after noticing the red bumps a hard scab-like area was noticed in the center of each red bump.
2 days after my right lymph node became very swollen and uncomfortable the next day I started presenting with a painful rash across my right breast under my armpit and onto my upper back that has started presenting with fluid filled blisters and I have extreme nerve pain through out my entire body.