chrisvoncsefalvay/vaers-outcomes huggingface dataset:
woke up cramping in the middle of the night/stomach with cramps; upset stomach/misery stomach/had to go running to the bathroom; diarrhea; soreness in the arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (woke up cramping in the middle of the night/stomach with cramps), ABDOMINAL DISCOMFORT (upset stomach/misery stomach/had to go running to the bathroom), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (soreness in the arm) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 009C21A, 009C21A and 012H21B) for COVID-19 vaccination.     Previously administered products included for Urinary tract infection: Macrobid. Past adverse reactions to the above products included No adverse event with Macrobid. Concurrent medical conditions included Urinary tract infection, Sulfonamide allergy and Allergy to antibiotic. Concomitant products included MIRABEGRON (MYRBETRIQ), PREDNISONE and GLYCOPYRRONIUM BROMIDE (ROBINUL) for an unknown indication.   On 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 06-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 06-Apr-2022, the patient experienced ABDOMINAL PAIN (woke up cramping in the middle of the night/stomach with cramps), ABDOMINAL DISCOMFORT (upset stomach/misery stomach/had to go running to the bathroom), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (soreness in the arm) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN (woke up cramping in the middle of the night/stomach with cramps) had resolved, ABDOMINAL DISCOMFORT (upset stomach/misery stomach/had to go running to the bathroom), DIARRHOEA (diarrhea) and HEADACHE (headache) outcome was unknown and PAIN IN EXTREMITY (soreness in the arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No-Negative.         In last night she woke up cramping in the middle of the night and had to go running to the bathroom. She could get back to sleep after going to the bathroom.  patient taking Blood pressure medicine, Medicines for endoscopy. treatment medication included Drink liquids and Stay rested.   This case was linked to MOD-2022-535527, MOD-2022-535529, MOD-2022-535530 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow up document contain reporter information updated, batch no and dose details were added.
Patient received the vaccine and fainted within 5 minutes after receiving the vaccine. He fell and hit his head and had a nose bleed. He was put in the Trendelenburg position and recovered immediately. The EMT was called and provided care to the patient. Checked on patient and patient said he was able to walk home on his own.
pt recvd vax & 24 to 48 hrs later pt devel soreness, swelling & redness @ the inject site that was more severe than usual;
Red sploge of the size of my hand; Arm is slightly swollen; Red sploge is extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red sploge of the size of my hand), PERIPHERAL SWELLING (Arm is slightly swollen) and PRURITUS (Red sploge is extremely itchy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced ERYTHEMA (Red sploge of the size of my hand), PERIPHERAL SWELLING (Arm is slightly swollen) and PRURITUS (Red sploge is extremely itchy). At the time of the report, ERYTHEMA (Red sploge of the size of my hand), PERIPHERAL SWELLING (Arm is slightly swollen) and PRURITUS (Red sploge is extremely itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Vaccine given in LUE. Soon after became swollen from shoulder to elbow, warm and painful.
great deal of pain under her arm, and down her side; This is a spontaneous report from a contactable healthcare professional. A 73-year-old female patient started to receive pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (lot number and expiration date unknown) at a single dose for immunisation. Medical history and concomitant medications were not reported. The patient received the updated pneumonia vaccine. She stated that she was expecting the injection site to be sore, but she had unusual reaction -- great deal of pain under her arm, and down her side. It  started the day after and lasted few days. There was no rash/redness. The MD was not aware. The outcome of the event was recovered.
Headache and dizziness s/p Tdap and HPV #3.  Immunization given at 1515, gradual onset of headache over course of the day. Patient to ED at 2205  6/8/09 Received ER medical records 6/2/2009. FINAL DX: Headache & dizziness Records reveal patient experienced HA, lightheadedness, feeling like going to pass out approx 4 hrs s/p vaccination.  Improved while in ER w/o treatment & d/c to home.
itchy, then 2 days later broke out in hives on head, neck and face off and on for 2-3 days. took Benadryl2-3 times per day starting 4/30/21
This spontaneous report was received from a registered nurse refers to 15 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 23-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: M020103, dose, frequency, expiry date were not reported) for prophylaxis. The patient was vaccinated under Vaccines for Children Program (VCF). The vaccines underwent a temperature excursion of -0.3 C for 22 hours. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. Digital data logger was involved. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Fever, then 6" x 4" patch of redness with tenderness and left arm became so sore by the following morning could barely move arm.
Second vaccine administered on 2-24-2021 at 4:45 appointment. Woke up during early morning hours drenched in sweat. On 2-25-2021 started to feel very tired by noon. Developed chills. At 4pm took temp and it was 100.5. Chills and temp that night. 2-26 felt tired and run down . Evening of 2-26 developed stomach issues and diarrhea that lasted thru 2-27-2021. Tired and run down 2-25 through 2-27-2021.
Low grade fever about 6 hours after vaccine. Rash appeared about 18 hours after vaccine.
day after injection bruise at injection sight and red raised heated rash below a circle about 3 inches in diameter. It lasted a few days, then 7 days after injection the red raised heated rash re-appeared
Narrative:  92 y/o male with past medical history of CAD, Afib, CHF, COPD, CKD, hypothyroidism, and T2DM. Patient recently diagnosed with bladder cancer associated with significant weight loss of ~23lb over 1 year. Per palliative care consult, prognosis was poor, and patient met hospice criteria. Patient denied hospice care and was not a candidate for surgery, chemo, or radiation therapy due to his other comorbidities. Patient received the Moderna COVID-19 vaccine at agency MC on 2/4/21. Per patient's wife, the patient experienced progressive shortness of breath, weakness, and swelling of extremities days after receiving the vaccination. On 2/10/21, the patient was weak, did not feel well, and his wife was directed to call the ambulance by a nurse. She reports that the patient passed away before the ambulance arrived.
Redness and hot to the touch around the site, HA, and feeling of malaise off/on X 4 days.
Shots given 8/16/2012 - in ER 8/18/2012 with fever, headache, body aches, forehead swollen, right arm, forearm, and shoulder swollen.  Client received steroids and antibiotic Benadryl.
My heart was healthy after my surgeries years ago, 3 days after vaccination of my 2nd dose of Pfizer I was hospitalized with suspected myocarditis, I was put on a halter monitor which revealed I had developed Trigiminy, Yesterday 8/20/21 I was givin a cardiac MRI to further investigate damage to my heart, You may contact me in a week for results on that if need be. Current symptoms Chest pain Fluttering of chest - Heart triple beating PVC's New Cough - likely related to PVC's Trouble Lying flat - Cannot be pericarditis as I have no pericardium
pt recvd vax & the same noc felt bad, devel flu like sx & cough; pt got progressively worse w/sore throat & gasping for air; treated w/Erythromycin for sore throat; still has cough & SOB;
This spontaneous report was received from a female patient of unknown age via Biogen (other company number: 20168100214172) refers to herself. Concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (route, dose, lot# and expiration data were not reported). On an unknown date the patient experienced allergies to sulfamethoxazole, BACTRIM. Action taken with sulfamethoxazole, BACTRIM, outcome of the event and the causality between the event and ZOSTAVAX were not reported. Additional information has been requested.
Patient presented with community acquired pneumonia with complain of SOB, cough, and chills. Pt. was treated with supplemental O2 and remdesivir, steroids, and albuterol.
mild rash on both thighs post vax;no fever no other problems;rash resolved p/wk;visited hlth clinic;
Itchy eyes; Red owl eyes; Wrists and chin were itchy; Wrists and chin were red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE PRURITUS (Itchy eyes), OCULAR HYPERAEMIA (Red owl eyes), PRURITUS (Wrists and chin were itchy) and ERYTHEMA (Wrists and chin were red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (Patient reported unspecified allergies. Probably, pollen season related.).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced EYE PRURITUS (Itchy eyes), OCULAR HYPERAEMIA (Red owl eyes), PRURITUS (Wrists and chin were itchy) and ERYTHEMA (Wrists and chin were red). At the time of the report, EYE PRURITUS (Itchy eyes), OCULAR HYPERAEMIA (Red owl eyes), PRURITUS (Wrists and chin were itchy) and ERYTHEMA (Wrists and chin were red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The Treatment information included prednisone 1% cream, since 19 Jan 2021. No relevant concomitant medications were provided.
Extreme bleeding; Cramping; Tightness in chest; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 23Jun2021 (at the age of 18-year-old) at dose 1, single for covid-19 immunisation. Medical history included acne. Family medical history relevant to adverse event was none. Patient did not administer additional vaccines on same date of the Pfizer Suspect. History of all previous immunization with the Pfizer vaccine was not considered as suspect. Patient did not have adverse event following prior vaccinations. Patient did not have prior vaccinations within 4 weeks. Concomitant medication included trimethoprim (TRIMETHOPRIM) at 100mg taken for acne from an unspecified date in Dec2019 and ongoing (Trimethoprim: Patient has been taking this medication for over a year and never had any issues with it. She started it and stopped it and then they had her start it again. It has been sporadic based on her acne). The patient experienced extreme bleeding, cramping, tightness in chest on 24Jun2021 08:00. Patient had an adverse reaction. Patient stated that she had extreme bleeding, cramping and tightness in her chest. Another person came on the line and stated that patient had these symptoms last night and was on the way to the doctor now. Clarified with patient that she was on the way to the hospital. Did not think patient will be receiving the second shot. That person stated that the date of onset of the adverse events was last night, but patient clarified onset date for each event as 24Jun2021. Relevant tests were none. Outcome of the events was not resolved.  Information about lot/batch number has been requested.
This case was reported by a consumer and described the occurrence of heavy breathing in a 47-year-old male patient who received ADVAIR multi dose powder inhaler for chronic obstructive pulmonary disease and flu vaccine (unspecified manufacturer). A physician or other health care professional has not verified this report. The patient's past medical history included fall off roof. Concurrent medical conditions included anxiety disorder, back pain, brain swelling, bronchitis, chronic obstructive pulmonary disease, gout, hypercholesterolemia, increased excretion of mucus, lower leg pain, meningitis, pneumonia, rhinitis, sciatic nerve pain, seizure, spinal disorder and type 2 diabetes. Co-suspect medication included Flu vaccine. Concurrent medications included COMBIVENT, PRO-AIR, SOMA, HYDROCODONE, DUONEB, ASTELIN, XANAX, GABAPENTIN, ALLOPURINOL, LIPITOR, TRICOR, COLCHICINE, LORATADINE and Diabetes medication. It was reported that the subject did not have any adverse events following previous vaccinations; however, it was also reported that the subject previously experienced diarrhea, vomiting and headache following a flu shot (unspecified manufacturer). On an unknown date, in approximately 2006 or 2007, the patient started Fluticasone propionate+salmeterol xinafoate (inhaled) at 1 puff (s) twice per day. On an unspecified date (the subject thinks it was in September 2008), the subject received flu vaccine (left arm). On 29 October 2008, the patient experienced heavy breathing, possible influenza, vomiting, headache, diarrhea and product complaint. On 31 October 2008, the patient took an extra dose of ADVAIR. Treatment with Fluticasone propionate+salmeterol xinafoate was continued. At the time of reporting, the events were improved. This caller states he forgot he took his dose of ADVAIR dose this morning (31 October 2008) and took a second dose 10-20 minutes later. He states approximately 30 minutes after taking the dose he experienced heavy breathing but he thinks he has the flu, clarified as he had a flu shot (could not provide a date but he thinks it was in September 2008) and on 29 October 2008 he started vomiting, got a headache, and had diarrhea. He attributed this to the flu vaccine. The headaches were reported as "nasty headaches". The diarrhea and vomiting resolved on 31Oct2008. The headache continues. Strongly advised caller to contact his physician, however he stated his doctor is going to tell him to go to the hospital and he has recently been there and does not want to go back. He thinks he has been taking ADVAIR for about 1.5-2 years. QA analysis results were received on 21 January 2009. QA analysis revealed that there was no lot number or sample received. Therefore, this product complaint as determined to be inconclusive.
Please help me and let me know if anyone else has complained about severe arm pain that has persisted over a month after receiving the flu vaccine.  Hours after I got the shot (back in November, the week before Thanksgiving) my arm started to hurt and got progressively worse until I could barely use it.  I can barely pick things up or reach with the arm that I was vaccinated in.  My doctor told me that it was tendonitis, but I never had this prior to getting the flu shot.  I had a flu shot last year and had no problems.  I called the Health Department and they said they had received 2 other complaints like mine.  I have sat in the whirlpool and soaked my arm in warm water, taken motrin, and slept with a heating pad around it. PLEASE LET ME KNOW WHAT I SHOULD DO.  I HAVE BEEN SUFFERING WITH LIMITED USE OF MY LEFT ARM FOR GOING ON 2 MONTHS NOW.  PLEASE HELP ME.  THANK YOU.
Vision problems, seeing double, starting on Thursday 10/13/16. Hoping it would clear up waited until Sunday 10/17/16 to go to ER where it was diagnosed as Sixth Cell Palsy. I have never had anything like this before. All tests were normal. I still have this and was advised it could be viral but is unknown. May or may not clear up in 6 weeks. If not will need to see neurologist.
Patient having extreme chills starting at 6am. She took anti-inflammatory and came to work. Temp 97.8
Approximately 6 hrs. after administration of shingles vaccine (after store closing) - severe headache, swollen arm & disorientation for about 24 hrs.
Woke next day with area around site swollen, red and warm. Red area increased in size for next 2 days-9 1/2" long on 11/21. Occasionally itchy. Benadryl starting 11/21 which decreased symptoms.
Contracted Covid 19; Contracted Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Contracted Covid 19". Clinical course: Patient sister called and told me she contracted COVID. She was fully vaccinated with Comirnaty.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The symptoms started on Tuesday, 12/27/2022. I was feeling miserable with sinus drainage and coughing. When I still had symptoms the next morning, I used a home test and I was positive. I scheduled the Telehealth visit and my goal was to get PAXLOVID. The nurse practitioner agreed and after examining me over the telehealth and looking at my throat, she prescribed my PAXLOVID that day and within a couple days I was feeling a lot better. I never had a fever. I was given the expectation that I would have gotten a metallic taste, but it was really just a bad taste in the mouth. I was more tired than usual and that lasted longer than the other symptoms. Others I've talked to noted to continue to rest and they were correct. I had a get together for Christmas Eve, and after I tested positive, I contacted everyone that was there to inform them. Only one other person had noted they were positive 12 to 24 hours after I tested. I am unsure of who I was infected by, but they may have been asymptomatic. My wife did not get sick.
About ten minutes after vaccine he became diaphoretic, dizzy, had a numb face and blurred vision. His legs were lifted, ice applied to neck. He was at that time taken to treatment and report handed off.
Initial information received on 14-Mar-2019 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 10 years old patient who accidentally received an expired 0.5 ml dose of FLUZONE QUADRIVALENT (lot UT5911KA and Exp. Date 30-Jun-2018) via unknown route in the left deltoid, on 13-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included BOOSTRIX for Immunisation; and MENVEO for Immunisation. It was a case of actual medication error due to expired vaccine used. It was reported that MA accidentally gave an FLUZONE QD 0.5 ml pre-filled syringes to a patient yesterday with the expiration date of 2018.It was in the box that had an expiration date of 2019. (Carton Lot UT6375JA exp date: 30-JUN-2019). No adverse reactions reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
This evening about 6 I became aware that I had not sense of taste. Other than that I feel fine.
Incorrect mRNA COVID-19 vaccine product administered for second dose in two dose series.  Patient did not report any symptoms or adverse reactions.
Narrative: Dose 1 was 2/4. 1 week later developed urticarial rash under axiallae. Persisted. Got dose 3 moderna 3/4 and rash got more intense, now also on abdomen. No systemic symptoms.