chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Salt water taste in mouth, lasted strongly 5 min immediately after injection. Got less strong as time went on for approx 45 min after injection; Dry mouth with lasted an addition 30 min; This is a spontaneous report from a contactable consumer (patient himself).  This 19-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via an unknown route, on 05Jan2011 at 13:30 at single dose for COVID-19 immunisation. Vaccine location was arm left. Relevant medical history included asthma. No relevant concomitant medications were provided. The patient was vaccinated at hospital, age at vaccination was 19-year-old. No known allergies. No other vaccine was received in four weeks. Post-vaccination COVID test was not performed. The patient had salt water taste in mouth, lasted strongly 5 minutes immediately after injection. Got less strong as time went on for approx 45 minutes after injection. This was followed with dry mouth with lasted an addition 30 minutes. The onset date of the events 05Jan2021 at 13:45 (as reported). The patient was not treated for the events. The patient recovered from the events on 05Jan2021.
Oct 9-11: runny nose and cough begins and still continues today (Nov 7) Oct 12-14: cough continues; lost my voice completely during this period  Oct 15-23: cough continues runny nose returns Oct 24-26: I seemed to feel a bit better; symptoms lessen Oct 27-31: feel worse; cough, aches, fever Nov 1-5: antibiotic, steroid, cough med; dr thinks it is bronchitis  Nov 6 to nw: meds help a bit but still coughing; very rattly cough and chest when I exhale
Achy; stiff neck; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) and MUSCULOSKELETAL STIFFNESS (stiff neck) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN (Achy) and MUSCULOSKELETAL STIFFNESS (stiff neck). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 31-Mar-2021, PAIN (Achy) and MUSCULOSKELETAL STIFFNESS (stiff neck) had resolved.            Concomitant product details was not provided by the reporter.   This case was linked to MOD21-066816 (Patient Link).
over about an hour increasingly achy, arm pain, fever, nausea, high blood pressure, lower lip numb (sometimes a sign of a TIA), some confusion (sometimes the sign of a TIA) The severe nausea came in waves, lasted a couple of hours and cleared by Midnight before she went to sleep.
Mother called and states that client has rash over his whole body. Some of the spots are quite big and red.  Fever last night was 104 degrees and he has been throwing up.  Mother states that the family has been sick with stomach virus and high fever.
It started with extreme fatigue, shortness of breath, stabbing pains in his chest. It was severe so he wasn't moving or doing anything and was very lethargic and couldn't do anything or move without severe pain. We went to the ER the first night and they didn't really diagnosis him them said it could be either pericarditis or myocarditis and to come back if it got worse. 2 days later, it got worse and we went back to the ER and the doctor could hear rubbing on the scope so it helped him diagnose pericarditis and to not do activities till it got better and take Tylenol. We followed up with our regular doctor and she said the same thing and did another ekg which looked normal but the pain persisted and just last week (6monts later) he did an echocardiogram and that all looked normal but he still has pain when he does physical active though it's gotten better. Doctor said same thing that it was pericarditis.
Follow-up information received 1/26/10. No adverse events. Pt simply go a second season flu vaccine. Vaccine was given 12-2-09 at about 10:15 am.
Case number PHEH2013US020959 is an initial spontaneous report received from the medical assistant on 04 OCT 2013 with a follow-up information received from the medical assistant on 05 NOV 2013. This report refers to male child patient whose age was about 11-12 years. He did not have any history of recent injury or illness or allergies. His concomitant medications were not reported. His vaccination history included administration of IPV (manufacturer and batch number not reported) in 22 DEC 2001, DTap (other manufacturer, batch number not reported) in 23 FEB 2002, MMR (other manufacturer, batch number, not reported), IPV (manufacturer and batch number not reported), DTaP (other manufacturer, batch number, not reported) and hepatitis B and HIB (other manufacturer, batch number: not reported) in 21 MAR 2003, Varicella  in 05 SEP 2003, seasonal influenza in 12 NOV 2005, MMR (other manufacturer, batch number not reported), IPV (manufacturer and batch number not reported), DTaP (other manufacturer, batch number, not reported) in 28 AUG 2007 and hepatitis A (manufacturer and batch number not reported) in 18 FEB 2008. He was vaccinated with 0.5 ml of MENVEO (batch number A12114, expiry date 31 AUG 2014) on 03 OCT 2013. ON an unknown date after vaccination, he experienced paleness and severe generalized diffuse abdominal pain for about 30 minutes, nausea, decreased appetite and was light headed. He was afebrile. His vital signs were normal. Physicol examinations were done and were normal. He denied fever, chills malaise, weight loss or gain and he was sleeping well. There were no red eyes, eye drainage, runny nose, nasal congestion, sore throat, post nasal drip, ear pain, mouth ulcers, swallowing difficulty, day time or night tine cough, sleep disturbance, chest pain, vomiting, cramping, diarrhea, heart burn, radiating pain to shoulder or back, joint pain, swelling, redness, rashes and dry skin. There were no signs of appendicitis or obstruction. He was prescribed ZOFRAN 4 mg thrice daily on 04 OCT 2013. He was also advised to increase fluids, avoid spicy foods and to call if the symptoms would not get better. The events outcome was reported as complete recovery. The seriousness and causality were not reported. No additional information was available.   Follow up information received on 05 NOV 2013. Updated vaccination history, suspect drug, site of vaccination, events (nausea, decreased appetite and lightheadedness), physical examination details, treatment and outcome of the event.
The vaccine was given 8/24/2021 and the following month I experienced a big delay in menstruation. I am currently experiencing  a delay in menstruation as well.  My cycle is always on time and it has been many years since I experienced a delay in menstruation.  I was completely unaware of this possible side effect until a relative mentioned it.
Pt recvd 1 dose of Engerix-B & devel rt sided pain in the neck, shoulder & arm which persisted for 3 wks; pt had residual discomfort;
Patient is experiencing redness, itching, swelling, and heat in her left upper arm. It started the day after her vaccine.
Received hep B #1 on 03/14/02. Reports that on 03/22/02 developed a flu-like illness (temp, sore throat, achiness). PCP dx as viral illness. On 03/23/02 developed hives (PCP attributed to recent use of Zithromax or codeine in cough med). A few days later developed swelling of eyes and lips. Seen at ER and Rx for allergic reaction. Hives came and went for 1 1/2 weeks. MD thought possibly etiology was post-viral. She reports that she asked 2 MD's if they thought it was related to hep B vaccine and she reports they did not feel vaccine connected. Approx 4/15/02 experienced tightening through shoulder blades, PCP thought possibly connected to Prevacol (had recently increased dose, and previously had a problem with Lipitor). Had other symptoms that had come and gone: Right arm and hand swelling, ache in knees, toes and fingers. Had experience a flat pink to red blotchy rash that starts 2 inches above elbows and extends down ventral side of arms. Rash seems to come and go, more apparent after showering. 06/15/02 experienced "total numbness from back to arms and legs" was seen at ER, currently experiencing a "crawling" sensation under her skin that comes and goes, and also reports periodically experiencing a numbness on the left side of face along jawline. At time of 04/24/02 hep B #2 vacicnation, she circled "NO" to screening questions regarding medical or allergy changes or problems with previous hep B dose. Case has had various diagnostics done and she reports everything (including Lyme Disease) came up negative. She is scheduled for an MRI of the brain and neck 06/28/02. After researching her symptoms on the internet, she has found several reports that list some of her symptoms as possible reactions to hepatitis vaccine, and she is concerned that the symptoms she is experiencing could be long term effects from the hepatitis vaccine. She reports that after her second hep b immunization on 04/24/02, she did not recognize any significant increase or change in symptoms.
04/19/2022, I came down with symptoms of COVID-19. The weekend prior we were traveling, and pressure in my ears never went back to normal and the next day, I had a runny nose and pain. Then I woke up 04/19/2022 with a sore throat, aches and pain, and took a test and got a positive test. My ears were also still feeling pressurized. I called my doctor due to ear draining finally and I had an ear infection in both ears and was given antibiotics for both and I was also given a prescription for Paxlovid for a full course. I felt that the COVID-19 went away pretty quickly and tested negative on day 6 and I still had congestion in my ears 3 weeks later. However, all my other symptoms are still gone.
eyes swollen & puffy, itching, welts, redness;tx @ ER w/adrenaline & 2 kinds of antihistamine on 5/9/99;
severe back pain on following day.   Went to emergency room and was admitted to Hospital with fluid on right lung after Xray. Chest tube inserted and fluid was drained.
Headache, Fever, NauseaVomiting,  fatigue, chils, myalgias
Numbness from ring to pinky finger of left arm travelling up to shoulder. Heaviness in lower left arm. These symptoms started 1 day after vaccination on 01/15/2021 and have persisted until now. Patient reports worsening symptoms in the last 1-2 days.
Pt received meningococcal and tetanus shots on 9/11 she developed itchiness after vaccines were given, Ha started on 9/13 had a temp of 100.9 and chills had numbness of feet since 9/13/2006. 02/20/2007-records received and reviewed for DOS 09/20-09/26/06.Complained of chills, nausea and numbness in feet no trouble ambulating, complained of headache and migraine headache. Continues to have numbness  and feels weak but doing better as of 9/22/06. 9/23/06 numbness decreasing, less tired from the Atarax, 9/25/06 feeling better parent unable to bring patient in for labs. To see neurologist is no improvement.
Pt had vaccines 11/21 and 11/22 an noted to have quarter sized redness of deltoid area. No warmth or tenderness, 1 cm of induration. Pt well acting.
One of nine cases: An event of Expired Drug Administered occurred in a nine-year-old male.  The report was received from a registered nurse.  No medical or drug history was reported for this child.  The child received a one-time dose of FluMist intranasally on 15-Jan-2008.  On 15-Jan-2008 the child received FluMist, which had an expiration date of 19-Dec-2007.  The reporter stated this is one of nine children that was vaccinated on the same date.  In discussing the error with two reporters from the site they both indicated that the front of the FluMist box states "For the 2007/2008 Season", there is an expiration date on the side of the box.  The reporter indicated they also administered a competitor's product which is good for the entire season and does not expire until May/June time frame.  One reporter also stated many of the vaccines they give do no have an expiration date.  She also indicated they do look for expiration dates but it was confusing to have the front of the box indicate the vaccine was "For the 2007/2008 Season".  The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with product that was to expire in less than three weeks.  Outcome: the child had no ill effects, the site has not had any contact from the child's family.  Further dosing with FluMist is not indicated.  Causality assessment is not applicable for this vaccination error.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Painful lump at injection site starting one week after injection. Area is warm, red, and achy. Hurts to be touched.
severe Pericarditis - started May 2, 2021 and is ongoing! Still taking  Indomethacin and  Colchicine
Patient was waiting in a chair in front of pharmacy for the required 15 minutes.  Told his wife he needed some water.  Then passed out hitting his head on the floor.  Ran out to him and he was already coming out of it.  Ambulance came and cleared him to go.  He said he was dehydrated.
bad bowel movements; Stomach cramps; Stomach Bleeds; stomach bloating; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4296720-00 (Agency).  A 79 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 24Nov2021 (Batch/Lot number: unknown) at the age of 79 years as dose 3 (booster), single, intramuscular, administration date 26May2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 05May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg (cf (40 mg,1 in 2 wk)) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GASTRIC HAEMORRHAGE (medically significant) with onset 2021, outcome "unknown", described as "Stomach Bleeds"; ABDOMINAL PAIN UPPER (medically significant) with onset 25Nov2021, outcome "unknown", described as "Stomach cramps"; DEFAECATION DISORDER (medically significant), outcome "unknown", described as "bad bowel movements"; ABDOMINAL DISTENSION (medically significant) with onset 2021, outcome "unknown", described as "stomach bloating". The action taken for adalimumab was unknown.  Causality for Pfizer Biontech COVID-19 vaccine (TOZINAMERAN): The dechallenge was N/A, action taken with drug was unknown, causality as per reporter (drug/vaccine) was possible for the events defaecation disorder, stomach cramps (abdominal pain upper), disorder abdominal bloating (abdominal distension), stomach haemorrhage (gastric hemorrhage). Causality for Humira: The causality for the events stomach haemorrhage (gastric haemorrhage), stomach cramps (abdominal pain upper), disorder abdominal bloating (abdominal distension), stomach haemorrhage (gastric haemorrhage). the action(s) taken with drug was unknown causality as per reporter (drug/vaccine) was not reported, causality as per MFR. (drug/vaccine) was not assessable. Causality for SKYRIZI (RISANKIZUMAB): The reporter's causality for the event(s) of psoriasis flare ups with SKYRIZI (RISANKIZUMAB) was a reasonable possibility. The reporter's causality for the event(s) of patient took skeptical of booster and had a temperature was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Rash has had throat infect & saw MD on 15JUN91; Has rash on face, chest, back, leg & buttocks, t103 on 15JUN91 on Ceclor 150mg q8hrs;
Starting last night around 10 pm. I developed a cough. Today I have a fever max of 100.6. I have no know direct contacts with covid + persons. I got vaccinated through my job. Employee health referred me to get tested for covid, which I did today and am waiting results.
Information has been received from a medical assistant concerning a 6 year old Caucasian female with no past medical history and NKDA who on 11/14/96 was vaccinated with the first dose of varicella virus vaccine live (site unknown) and the first dose of MMRII. There was no concomitant medications. On the night of 11/05/01, the child developed a mild case of chicken pox with an itchy rash, red lesions with white centers on her arms, legs, abdomen and back. The pt was afebrile. It was noted that four children in the patient's class had varicella . It was reported that the pt recovered after 8 days.  No further information is expected.
Redness at injection going up towards shoulder joint; Aching all over; Chills; Fever of 100.2; Felt tired; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness at injection going up towards shoulder joint), PAIN (Aching all over), CHILLS (Chills), PYREXIA (Fever of 100.2) and FATIGUE (Felt tired) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness at injection going up towards shoulder joint), PAIN (Aching all over), CHILLS (Chills), PYREXIA (Fever of 100.2), FATIGUE (Felt tired) and INJECTION SITE SWELLING (Swelling at injection site). At the time of the report, ERYTHEMA (Redness at injection going up towards shoulder joint), PAIN (Aching all over), CHILLS (Chills), PYREXIA (Fever of 100.2), FATIGUE (Felt tired) and INJECTION SITE SWELLING (Swelling at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (High) fever of 100.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received and contain non significant information.
28OCT95 day of vax deltoid swollen tender;29OCT96 lt shoulder ache x 1day;
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 79 years old female patient who experienced left arm swollen and hot to the touch, it felt like a heat pad, while she received vaccine FLUZONE QUADRIVALENT. The patients past medical history included Hypersensitivity (allergic to penicillins, myacins and sulfur). The patients past vaccination(s) included influenza vaccination (Flu shot) from 20-22 years. Concomitant medications included PREVNAR 13 for Immunization. On an unknown date in Sep 2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT6290NA and Exp. Date 30 Jun 2019) via unknown route in the left arm. On an unknown date, her left arm swollen and hot to the touch, 3 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that it felt like a heat pad. Details of lab data not provided. Final diagnosis was left arm swollen and hot to the touch, It felt like a heat pad. No information about corrective treatment reported. On an unknown date the patient was recovered from events. List of documents held by sender: none.
Patient did not receive the injection at this facility, but presented with symptoms.  Had vaccine 10/18/2021 and developed redness, pain, swelling, warmth to injection site, but not until 12 days post injection.
Client called into report complication after receiving the Pfizer COVID 19 booster vaccine on 11/16/2021. Per Client, about nine hours after receiving vaccine booster, started having "Arthritis flare up in right middle finger knuckle. Per Client, has underlying medical condition, and about several years ago had complication with arthritis in right hand. Client had no other symptoms concerns. No MD follow up for C/O Arthritis flare-up and Client did take Naproxen for pain and swelling. Per Client, still having mild symptoms of the pain and swelling in right middle finger knuckle. Client reported being a Doctor, and will not be follow up, just report his reaction to vaccine booster.  Per Client received Moderna shot 1
Skin rash/blisters on buttocks; 100 degree fever; muscle aches; nerve pain in thigh and near tailbone.  Doctor prescribed anti-viral medication for a period of 7 days.
Severe fever, body aches, chills, pain, and fatigue - lasted 3 days
Muscle aches, general malaise, severe itchy rash - like a giant hive - at the upper arm where shot was given - plus swelling. Took a week to get better.
pt started screaming p/vax & mom said all way home 1/2hr drive;tx w/APAP @ home;fever up to 104.7 w/APAP;mom called MD who brushed off & told to double up on doses to reduce fever;terrible rash, lethargic, listless, no appetite or smiling;
Pt fully vaccinated for COVID-19. Unknown manufacturer and dates. Pt hospitalized on 1/8/2022 after experiencing dyspnea and falling at home. Pt Expired 1/9/2022.
My menstrual period had terminated on the previous Saturday. On the day of the vaccine (Tuesday) 3/4 hours after the vaccine I started spotting. This then transformed into moderate vaginal bleeding which lasted for about 4 days. I had no other symptoms and this was very unusual and scary. I had a vaginal ultrasound 2 days after the bleeding started and no abnornalities were found. My pap smear is also clear.
raised, itching rash x 48 hrs on trunks self treated w/DPH;
105 degree temp 10 hrs after injection. Extreme arm pain for 96 hrs.   Fever/temp, controlled over 24 hrs.  Nurse advice line said to go in if it stayed over 104 for more than 2 hrs and to control with Motrin.   Peak of 105, then hovered around 100-103 over 12 hrs.   Out of work for 4 days.
Day after shot of Johnson & Johnson I had to stay in bed all day too tired and didn't eat all day.
(L) upper lateral arm with 4 x 8cm erythema and induration.
Patient presented for evaluation of 5 days of epigastric pain. Etiology possible medication side effect from newly started Invokana versus lisinopril. Patient symptomatically improved throughout hospitalization. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Persistent crying lasting longer than or greater than 3hours within 48 hours of vaccine being given.