chrisvoncsefalvay/vaers-outcomes huggingface dataset:
throwing up; off balance; dizzy; falling; he got really sick; feeling sick to stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Nov2021 (Lot number: 32030BD) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sick to his stomach" (unspecified if ongoing), notes: Stated that he has been getting sick to his stomach for the last 40 years.; "lost some weight" (unspecified if ongoing), notes: Stated that he lost some weight. Stated that he gradually lost weight before the Covid vaccine. There were no concomitant medications. The following information was reported: ILLNESS (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "he got really sick"; ABDOMINAL DISCOMFORT (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "feeling sick to stomach"; VOMITING (non-serious) with onset 05Nov2021, outcome "recovered" (Nov2021), described as "throwing up"; BALANCE DISORDER (non-serious) with onset 05Nov2021, outcome "recovered" (2021), described as "off balance"; DIZZINESS (non-serious) with onset 05Nov2021, outcome "recovered" (Nov2021), described as "dizzy"; FALL (non-serious) with onset 05Nov2021, outcome "unknown", described as "falling". Therapeutic measures were not taken as a result of illness, abdominal discomfort, vomiting, balance disorder, dizziness, fall.  Additional information: Patient was Stated he had the first dose of the pfizer covid vaccine on 03Nov. Reports 1-2 days after his first shot, he got really sick. Reports feeling sick to stomach; throwing up; dizzy ; off balance. He was scheduled for his 2nd shot on 24Nov but cancelled as he did not want to be sick for holiday. wanting to reschedule his appt/find out where he can. Stated that he cancelled it because it was the day before holiday and he did not know if he would get sick or not. Stated that some of his friends got sick off the first and second shots. Stated that they got sick to their stomach and nauseated. Declined to complete reports at this time. Stated that he lost some weight. Stated that he gradually lost weight before the Covid vaccine. Wanted to know if it would be safe to get the second shot. Patient was stated that 1-2 days after the shot that he got sick to his stomach for about two days. Recovered completely. Stated that he has been getting sick to his stomach for the last 40 years. Stated that two days after the shot that he was throwing up for about 2-3 days. Recovered completely. Stated that he was dizzy and off balance two days after the shot. Stated that every now and then that he will raise out of bed and like he was falling.   Follow-up attempts are completed. No further information is expected.
Starting approximately 6-8 hours following second dose of Moderna on 3/12/21,  patient reported angioedema/peeling lips, rash on both arms, tingling in both legs, body aches and fever as high as 104F. All symptoms have resolved except for angioedema and peeling/irritation of lips.
A dose of TWINRIX was administered to a 15 year old instead of separate Hep A and Hep B for a pediatric age range. TWINRIX is indicated for 18 years and up.
Flu like symptoms and muscle pain at the injection site starting approx 6 hours after vaccine.   48 hours after vaccine, there was itching near the injection site. A few hours later the upper arm become warm  and a  very red, large welt appeared on the arm, not at the injection site but below the site approx 6? long by 3? wide. Puffy swelling of the area followed  It looks almost like a very large hive with some additional swelling.
This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (gastrointestinal issues, diarrhea), DIARRHOEA (gastrointestinal issues, diarrhea) and COLITIS (Colitis) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040AZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021 at 3:00 AM, the patient experienced ABDOMINAL DISCOMFORT (gastrointestinal issues, diarrhea) and DIARRHOEA (gastrointestinal issues, diarrhea). On an unknown date, the patient experienced COLITIS (Colitis). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (gastrointestinal issues, diarrhea) and DIARRHOEA (gastrointestinal issues, diarrhea) had not resolved and COLITIS (Colitis) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Patient ended up with CDiff.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow-up received on 25-may-2021 included reporter email address. On 05-Aug-2021: Follow up received contains significant information: Events added: Colitis, CDiff
on 4/15  red itchy rash appeared on my forearms, the next day also on my stomach and left hip area approx.  6 inches in length--12 days later I still have this extremely itch rash.  also had a bit of poisen ivy on my hands--but this rash on my body, was different. I went to the urgent care after a week of this and using everything to help with rash, using aloe vera, epson salts, calamine lotion, antihistimine. etcs.  NOTHING helped.  Was given a steroid shot and a  prescription for refillable  steroid cream  to apply. Those actually did nothing to help the itching either--I also have a compromised auto-immune issues--and suffer from vitiligo which  has gotten much worse since the vaccine--its like this vaccine has fired up all my cylinders,  and not in a good way...my stenosis from neck arthritis is much worse as well...my feet and legs tingling is constant now where as before vaccine, was more sporadic. Frankly, I am very nervous about getting my 2nd dose.
This spontaneous report was received from a medical assistant and refers 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 does of GARDASIL 9 (lot # L023230, expiration date 28-JUL-2017) (exact dose and route of administration were not reported). There was no adverse effect reported. Administered doses experienced the temperature excursion of 48.7 degrees Fahrenheit for 24 hours. There was no previous temperature excursions. A date logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Patient presented complaining of nausea, vomiting X 1, headache, weakness, dizziness ~3 hrs after receiving H1N1 vaccine. Vital signs were taken BP: 119/77, P: 86, T: 99.7.  Member was sent to ER for treatment/follow-up.
Red lump approx. 3-4in in diameter appeared near injection site 8 days after vaccine. Pain, redness, swelling, and heat present. Itching or hives NOT present. Diphenhydramine 50mg taken once, approx 6 hours after lump appeared. Lump persisted for three days before resolving. Second dose of Moderna COVID vaccine administered to right arm (opposite arm from first vaccine) on 02/03/2021 at 1200. No cutaneous adverse effects noted related to this injection as of 02/06/2021.
patient complained about soar arms, swelling and inflammation at the site of injection . she has trouble moving her arm .
Parent called the office 2 days later, states that sx started same day between the hours of 5pm -7pm. Face flushed and then later hives. Used BENADRYL with relief. Sx reoccurring on face. Today states hives on face, neck, chest and both arms. BENADRYL still helps sx.
Fever, chills joint aches, headache, fatigue for approx 12 hrs. When seen only residual fatigue.
Break-through infection. Believe obtained in public setting Oct 9, 2021 ( >10 people present) even though fully masked and using sanitizer. Only contact that weekend (grocery store, diner, and fundraising dinner). Symptoms first appeared Oct 11 pm as irritated throat. Tested by Clinic Oct 13 (PCR test). Positive test result returned Oct 14. ordered a 10 day quarantine from symptom onset to Oct 21. Symptoms included Allergy like symptoms Oct 12...runny nose (clear mucus), irritated throat (not sore) nasal drip cough - not chest cough, Low grade fever (99.7) started Oct 13. Fever broke overnight Oct 13. Loss of taste and smell Oct 14.  Retested using PCR test Oct 25. Results returned Oct 27 as positive for Covid. As I report this Oct 27, sense of smell and taste is returning. Other symptoms improved though Oct 23, then disappeared by Oct 25.
Abdominal pain; nausea; vomiting; metallic taste in mouth; This is a spontaneous report from a contactable consumer (patient). A 22-years-old male patient received BNT162B2, dose 2 via an unspecified route of administration, administered in left arm on 06Mar2021 (Lot Number: EN6205) as single dose for COVID-19 immunisation. Medical history included microscopic colitis. No known allergies. No Covid prior vaccination. The patient previously received first dose (lot number: 8982) of BNT162B2 at the age of 21-year-old, in right arm on 13Feb2021 at 12:00 AM for COVID-19 immunisation. Concomitant medications included valproate semisodium (DEPAKOTE), mesalazine (LIALDA), budesonide, bupropion hydrochloride (WELLBUTRIN), dicycloverine hydrochloride (BENTYL). The patient experienced abdominal pain, nausea, vomiting and metallic taste in mouth on 07Mar2021 12:00 AM. Required hospitalization. The patient was hospitalized for the events for 3 days. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. Treatment was received for the events which included IV fluids, anti nausea medicine pain medication. The patient underwent lab tests and procedures which included Nasal Swab: negative on 12Mar2021. The outcome of the events was recovering.
vomiting; headache; stomachache; heartburn-like sensation; diarrhea; generalized pain across the body; Nausea; This is a spontaneous report from a contactable consumer (patient's Mother). A 29-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration, administered in left arm on 09Apr2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. They are scheduled to get the second dose in 2 weeks. On unknown date the patient experienced, Caller mentions that she and her daughter got the first dose of the Pfizer covid vaccine past Friday (8 days ago) and since then they had vomiting, headache, stomachache and heartburn-like sensation, diarrhea and generalized pain across the body. Diarrhea started today for her and for her daughter yesterday, as well for the heartburn-like sensation. She would like to know if the heartburn-like sensation is normal and that is what worries them most. The outcome of the event was unknown.  Case AER#2021422771 is for caller self (Mother) and split into AER#2021428556 for daughter.  No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021422771 same reporter/SD/AE, different patients.
The side effect or adverse event was a seizure in the middle of the night.  I woke up paralysed from my neck down, felt my spine had contracted and I couldn't move for what seemed like 2 minutes.  Very scary losing control of your body and I wondered if I was going to die?  Then it let go and I relaxed, cried, and got out of bed slowly to stretch out my neck and back and legs, slowly. The next day I told my roommate my emergency contacts in case that happened again. I believe I did mention this incident on my next visit to my PCP and it was just documented. Not thrilled with her and fired her later. I called my family members and let them know what had happened too.
Pt with 4 grand mal/tonic clonic seizures and fever to tmax of 104.
Departed Emergency Room Hospital 11/07/18 8:23 PM 11/07/18 9:40 PM MD. Office visit on 11/08/2018: The patient presents with diarrhea. These symptoms began 3 days ago. He is not having fever or vomiting. Other comments include: decreased urine output. Had ROTATEQ on Mon. and Sx started on Tue. Yesterday w/6 episodes of bloody mucousy stools, today 3 episodes since 4 AM. Some spitting up. Dec. intake of ENF, only 1-3 oz/feeding, Q2-3HR. Voided 3-4x yesterday. Today voided 2x. Crying more freq, not typical.
Information has been received from a nurse concerning a patient who in 2007 was vaccinated with a dose of MMR II, RECOMBIVAX HB (MSD) (lot # 625096/1367E and lot # 626441/0600H), VARIVAX (Merck) (MSD) (lot # 628036/1251H). The patient developed an unknown adverse experience after received the vaccines. The patient sought medical attention. Additional information has been requested.
arm got bright red from elbow to shoulder; arm got warm from elbow to shoulder; arm got itchy from elbow to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm got bright red from elbow to shoulder), INJECTION SITE WARMTH (arm got warm from elbow to shoulder) and PRURITUS (arm got itchy from elbow to shoulder) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced ERYTHEMA (arm got bright red from elbow to shoulder), INJECTION SITE WARMTH (arm got warm from elbow to shoulder) and PRURITUS (arm got itchy from elbow to shoulder). At the time of the report, ERYTHEMA (arm got bright red from elbow to shoulder), INJECTION SITE WARMTH (arm got warm from elbow to shoulder) and PRURITUS (arm got itchy from elbow to shoulder) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include alcohol and skin lotion.
(11/11/2021) Experienced break-thru COVID. Not sure what variant but had recovered in about 2 weeks. Verified by home test. Went in to  Urgent Care on 11/16 to verify.  Was advised to get an appointment at another center for a monoclonal IV infusion on 11/18. I was feeling somewhat better after 48hrs and after that it took about a week to recover. No additional issues arises.
Facial Itching; My tongue has been swollen; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 26-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: FJ6369), in left arm for COVID-19 immunization; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Facial Itching"; SWOLLEN TONGUE (non-serious), outcome "unknown", described as "My tongue has been swollen". The patient underwent the following laboratory tests and procedures: Protein albumin ratio: Normal, notes: I did have a lab test to look at my blood protein values to test for allergic reaction and that all back normal; Troponin: Unknown Results.Therapeutic measures were taken as a result of pruritus, swollen tongue.  Additional information: Patient reported of taking Pfizer COVID vaccine on January 18. The side effect that patient had were facial itching which started immediately after reporter got the vaccine and also had tongue swelling ever since got the vaccine. Patient got it on January 18 and tongue has been swollen a couple of time a week ever since then. Expiration date was not written on patient's card. Patient did not have any other medical conditions and medications. Whenever the tongue swelling started doctor prescribed hydroxyzine hcl to help with the swelling (Later clarified as treatment). Patient saw an allergist as well but they did not find anything in the test. Patient never did see an allergist as well but they did not find anything in the test. Patient never had any other side effect from any other vaccine. Had Flu vaccine(confirmed later as Influenza vaccine, Unknown manufacturer and captured) a few days before I got the Pfizer vaccine.
no record of a second dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 20th August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: This case was reported by the physician's assistant (PA). The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter had no record of a second dose. The patient vaccination history was unknown. The reporter consented to follow up.
Fatigue, body aches 1/12-13/21 and extreme nausea on 1/14/21.
rash on top or rt shoulder-folds of arms, legs & buttocks;now spread to back of thighs etc;on ATB now for ear infect;rash lasted 4 days;rash very itchy;mom gave DPH;
4 1/2" X 4" local reaction which mom noticed on 5/23/01 at 08:30.
pt recvd vax; lab eval showed 4 wks later that pt failed to seroconvert
Participant c/o of HA, dizziness and left side jaw numbness prior to exiting covid monitoring area; est. about 20 minutes post Pfizer Covid vaccine 1st injection. 1313 Escorted to covid monitoring cot and placed in semi - reclined position. 1317 BP 148 /88, P 79, R 18, 62; denies medical hx and allergy to any meds / foods. 1319 O2 sat 98% and participant voiced decrease in HA with no jaw numbness or feeling of heart pounding; denies numbness to upper extrems. 1324 BP 151/92, P 82, R 18, O2 sat 97% with participant voicing "it's all related to anxiety due to lots too for the day". 1332 Call 911 to site for response. Participant aware of call at time. 1337 Bp 176/102, P 82 and sitting on sit of cot. 1332 EMS on scene and assessment begun. 1345 Participant declined EMS support / transport to hospital. 1348 Ambulated to restroom with assist with no c/o; voiced "feels much better at time". 1350 Provided education on s/s to call 911 for immediate f/u and encouraged to notify PCP of event post vaccination. Participant voiced understanding and shared is scheduled to see PCP on 03/24. Discharged from site into self care with ambulation to car.
Fever, chills, migraine, vomiting, nausea, dizziness, fatigue
Patient received 1st dose of Pfizer Covid vaccine 03/03/2021 and tested positive for COVID-19 03/21/2021. Patient currently admitted to hospital for COVID-19 infection.
painful arm-triceps arm RA; red & swollen-warm to touch x 20 mins; t99.3 orally, tired-dec energy;
third vaccine (booster); Headache; Mild body aches; This is a spontaneous report from a contactable consumer (patient) via a sales representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient previously received dose 1 and dose 2 bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Numbers: not reported), both via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache for 2-3 days post administration of third vaccine and mild body aches on an unspecified date. The outcome of headache was recovered, the outcome of mild body aches was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Missed menstruation following receipt of the first vaccine dose.  I?ve never missed a period previous to this.
rash; A spontaneous report  was received from a consumer concerning a 86years old male patient who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced events(rash).  The patient's medical history was not provided. Relevant concomitant medication was reported i.e., heart failure medication.  On 20jan2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot/batch: unknown) intramuscularly in the anatomical location for prophylaxis of COVID-19 infection.  Laboratory details not provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was resolved.
On Monday, 11/8, I developed hives on my arms, which have continued and expanded. I am now covered head-to-toe in hives. It is has continued to get worse. treated with over the counter cortisone cream Monday 11/15, primary care visit, with resulting prednisone treated--4 days at 40 mg--hives are continuing, although less itchy
same side effects; Platelets were up; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (same side effects) and PLATELET COUNT INCREASED (Platelets were up) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced ADVERSE EVENT (same side effects) and PLATELET COUNT INCREASED (Platelets were up). At the time of the report, ADVERSE EVENT (same side effects) and PLATELET COUNT INCREASED (Platelets were up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) blood work was unusually good. In 2021, Platelet count: high (High) platelets were up.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     .   This case was linked to MOD-2021-054300 (Patient Link).   Reporter did not allow further contact