chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After 1 hr of getting the fist dose of covid19, I experienced a migraine, chills, fever, fatigue, followed by dizzy spells a couple of days later and this was reported to through my daily check-ins app.   After the 2nd shot, I experienced joint pain muscle aches,  no migraine, the dizzy spells continued and now I  suffering of blurred vision, dizziness that feels like I am going to faint,  hearing loss, chest pain.
Rashes that looked like mosquito bites; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes that looked like mosquito bites) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rashes that looked like mosquito bites). At the time of the report, RASH (Rashes that looked like mosquito bites) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment information not reported.   This case was linked to MOD-2021-247929, MOD-2021-247929, MOD-2021-236284 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Reporter stated that she received Pfizer vaccine not a daughter.
Pt incurred scratch to leg with administration of vaccine. Upon returning to clinic one week later, pt presents with redness at site of injection as well as red scratch to side of injection site which now has small vesicles lateral to scratch. Both site and scratch appear to be painful to touch. Pt has been afebrile per pt parents report. Pt is being treated with oral KEFLEX and will return to clinic for f/u in one week.
was already opened and stored at 51.2F for 1 hour and 16 minutes with no AE; Initial information received on 21-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA237576 and 2019SA237575 (same reporter).  This case involves a patient of unknown age who received vaccine IPV (VERO) [IPOL] and reported that vaccine was already opened and stored at 51.2f for 1 hour and 16 minutes with no AE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL).  On 20-Aug-2019, the patient received 4th dose of suspect IPV (VERO) lot P1A242M and expiry date: 26-Apr-2020 via unknown route in the left thigh.  It was a case of actual medication error due to incorrect product storage.  No adverse event was 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.
After receiving the vaccine patient presented for routine lab draw and evaluation of her ascites.  She was found to have Acute kidney injury in the setting of chronic kidney disease, thought to be unrelated to the vaccine, but related to recent diarrheal illness one week prior.
I have always had elevated hemoglobin and am an active blood donor because of that. I was suffering lack of energy and fatigue but didn't attribute it to the vaccine until I was denied a donation after my second shot because my Hgb had dropped to 11.2. Subsequent tests showed iron deficiency anemia for which iron supplements and treatment is still in progress.
Miscarriage at 16 weeks was found on 05/13/2021. Due date was 10/31/2021. Ultrasound at 16 weeks showed baby with no heartbeat at approximately 12-13 weeks growth.
Detectable visual issues starting 3-4 weeks after COVID-19 booster (3) dose, leading up to nearly loss of vision in the one eye a week later. Diagnosed as CRVO. Now 2 months after detectable onset of event, majority of vision (75%) returned on its own and treatment with anti-VEGF injections to be started.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) had not resolved.            No concomitant medications were reported.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The patient experienced the event headache for three days and it subsided for a while. Three weeks later, she experienced headache daily. She never had headaches before vaccination.
New Onset Graves Disease diagnosis Covid Vaccine Dose #1 on 12/29/20; Dose #2 on 1/19/21 Routine Labs on 2/8/21 indicated TSH value undetectable; additional workup identified Positive Antibodies for Graves' Disease.
A healthcare professional reported that a pt inadvertently received an intradermal injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated on 07/15/2001. The pt subsequently experrienced an injection site reaction characterized by redness and swelling. Additional reports will be generated when information is provided.
Vomited approximately half an hour after taking Vivotif; Spontaneous report received on 24FEB2020.  A physician reported that a male consumer vomited approximately half an hour after taking Vivotif (PT: Vomiting). He was receiving Vivotif for immunisation. The consumer took his first three doses of Vivotif as per schedule. On 22FEB2020, he took his last dose of Vivotif and vomited approximately half an hour after taking the dose. He had only one episode of vomiting. He did not receive any treatment for vomiting. Action taken with Vivotif with respect to the reported event was not applicable. The consumer had recovered from the reported event.  Company Comment: A consumer vomited approximately half an hour after taking last dose of Vivotif (Vomiting). This patient had only one episode of vomiting and the event was resolved without any treatment. Considering the potential of Vivotif to cause vomiting and the case information, the causality of vomiting is assessed as possible with Vivotif.; Sender's Comments: A consumer vomited approximately half an hour after taking last dose of Vivotif (Vomiting). This patient had only one episode of vomiting and the event was resolved without any treatment. Considering the potential of Vivotif to cause vomiting and the case information, the causality of vomiting is assessed as possible with Vivotif.
Itching on injection site within 4 hours, 24 hours fever 100, swelling at injection site, elevated pulse, 100 bpm (normal 80bpm). Fever continuing at 6 days, swelling continues, about 4" x 8" welt, hot to touch, itchy.
Case fully vaccinated with Pfizer. Tested positive for COVID 19 @ 9/15/2021. Admitted on 9/15/2021 and expired on 9/20/2021 while still hospitalized.
6cmx6cm massively indurated, erythematous less than 1 hour post vaccine. No fever. Benadryl IBP 1.5 tsp every 6 hours.
An hour after receiving the vaccination, patient complained of symptoms.  Patient felt dizzy.  Tongue felt heavy and throat swollen a little.  She went to clinic where she received a benadryl shot and steroid shot.
pt called an hour after the shot and said she started to experience blurry vision about a half hour after returning home. the blurry vision goes away when she closes her eyes. She stated no other side effects.
LIGHT HEADEDNESS; BRAIN FOG; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced light headedness, and brain fog. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light headedness and brain fog was not reported. This report was non-serious.
about 12 hours later w/ PAIN ON RT ARM , SWELLING OF left THIGH WITH PAIN
Severe delayed cutaneous hypersensitivity. beginning late on day six (6) post vaccination.   Red rash, swelling, pain, severe itching, hot to the touch from shoulder to elbow in arm where received vaccination.  This is day four (4) post onset of symptoms and it's worse than previous three days.  Rash covers bigger area every day.  Swollen lymph node under arm.
Client reports on 8/22/18 to RN " right arm has been hurting, tender, and can't hardly move it ever since I got those shots in it back on 08/08/18."
Information has been received from a physician concerning a patient who in the fall of 2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). "Very recently," in approximately May 2008, the patient experienced shingles. Additional information has been requested.
I broke out in hives from head to toe, couldn't breathe, fainted, couldn't walk or move. Went to ER, BP was 60/40. Was given epi shot and Benadryl and some other meds I don't have the names of.
First dose received Moderna vaccination; second dose received Pfizer. Joint swelling, joint pain, rash, fatigue, Covid symptoms, blood clot formed in leg.
Conceived on August 20th. Had Vaccine 8/25/2021. Had a miscarriage at 8 weeks (October 7th) that was a Blighted Miscarriage. EDD was May 2021. G1P0.
Patient received the flu vaccine in November 2015. Immediately had pain. Tenderness did not resolve. Reported pain in January. MRI of upper left arm demonstrated findings suggestive of bursitis or myositis which the radiologist suggested could be infectious in etiology.
Fatigue, heavy chest congestion, cough since receiving a flu shot 1/04. Blood in sputum two times; cultured for Serratia Marcescens for several months. Given Levaquin. Medical records state blood in sputum. msv
Three x Two inch swelling in right deltoid area. Red, warm to touch vax. Treatment: Omnicef 250 mg daily for five days. Soreness at site day of vax. Redness and swelling noted on 04/22 when child awoke.
Terrible headache, chills to the point I?m shaking, upset stomach, body aches, fever 100.2, runny nose, sore throat
DVELOPED FEVER EVERY ATFERNOON AND EVENING UNTIL 2/18 & 2/19 WHEN HAD FEVER ALL DAY. HIGHEST FEVER RECORDED WAS 103.1 AXILLARY. FEVER LOWEST ON 2/20, BUT TOOK CHILD TO HEALTH CARE PROVIDER THAT DAY. NO TREATMENT PRESCRIBED. NO RASH NOTED BY MOTHER.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: I gave vaccine and watched for 15 minutes. Patient was wearing a mask so couldnt see but later she came back in like 30 minutes and showed me her swollen tongue. I gave her immediately 2 benadryls and water and she came back before she left store to show me swelling went down. shw was with a friend and counseled her not to drive because drowsiness from benadryl. she was ok before she left.
Joint pain (knees - primarily right) began approximately 4 weeks prior to this writing. Ibuprofen as needed. Vaccine administered 2/12/03.
Dizziness, Tachycardia, PATIENT REPORTED 'ROOM SPINNING, LIGHT HEADEDNESS, SWEATING, CLAMMY FEELING' Narrative:  PATIENT WAS AT THE END OF HER 15 MINUTE OBSERVATION TIME (APPROX 8:01AM) WHEN SHE REPORTED SHE FELT LIKE THE ROOM WAS SPINNING. SHE COMPLAINED OF A  SWEATY/CLAMMY FEELING AND LIGHTHEADED/DIZZINESS. PATIENT WAS MONITORED UNTIL APPROX 8:35AM WHEN SHE FELT WELL ENOUGH TO AMBULATE STEADILY ON HER OWN. PATIENT STATED SHE WAS FEELING BETTER PRIOR TO LEAVING THE CLINIC. VITALS WERE AS FOLLOWS. 8:05AM 135/91 97% 100P 8:10 AM 127/92 98% 99P
This is a spontaneous report from a physician and from a 59 year old male pt who, on 3/2/99, received his 1st dose of Lymerix and 1 day later, he experienced a stiff neck, which resolved in 1 week. On 5/11/99, the pt received the 2nd dose of Lymerix, and 1 day later, he experienced a stiff neck, neck pain and tingling from ear lobe to his chin. He was treated with NSAIDS (nos). The most recent information, received on 9/10/99, reports the condition of the pt as unknown.
swollen lymph nodes (under arm), fever; Md said it was just a side effect & to take ASA;
Client 45 at time of Dose #1 ofGardisil .... Missed #2 and #3---now 46; Client 45 at time of Dose #1 ofGardisil .... Missed #2 and #3---now 46; This spontaneous report was received from a nurse and refers to a 46-year-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On an unknown date, reported as when the patient was 45 years old, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, lot number and expiration date were not provided) for prophylaxis.  On unknown dates, the patient missed the second and third dose of the suspect vaccine.
Has Cancer; itching on his lower back/hip area which has been getting worse/entire chest is red and itchy; low BP.; Serious headaches; Rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEOPLASM MALIGNANT (Has Cancer) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced NEOPLASM MALIGNANT (Has Cancer) (seriousness criterion medically significant), PRURITUS (itching on his lower back/hip area which has been getting worse/entire chest is red and itchy), HYPOTENSION (low BP.), HEADACHE (Serious headaches) and RASH (Rash). At the time of the report, NEOPLASM MALIGNANT (Has Cancer), PRURITUS (itching on his lower back/hip area which has been getting worse/entire chest is red and itchy), HYPOTENSION (low BP.), HEADACHE (Serious headaches) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included chemotherapy.  Based on the current information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. There is very little information regarding the event of Neoplasm Malignant and additional information has been requested.; Sender's Comments: Based on the current information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. There is very little information regarding the event of Neoplasm Malignant and additional information has been requested.
Systemic: Blood Disorder  (diagnosed by MD)-Severe, Systemic: Hospitalized with PE per family member-Severe
Soreness at injection site was possible. That happened last night. It did not hurt as much as the step 1 vaccine but took a little longer to manifest; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: EL3248; expiration date: Apr2021), via an unspecified route of administration on 01Feb2021 as 2nd dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included levothyroxine sodium (LEVOXYL); atorvastatin calcium (ATORVASTIN); and montelukast at daily frequency for an unspecified indication. The patient received first dose of BNT162B2 on an unspecified date for covid-19 immunisation. The patient previously took Shingrix vaccine and it hurt. The clinical course of the event was reported as: the patient got step 2 of the COVID-19 vaccine and had local soreness at injection site was possible. That happened last night. It did not hurt as much as the step 1 vaccine but took a little longer to manifest. Neither hurt as much as the Shingrix vaccine got in the fall. The outcome of the event was unknown.  Information on about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
First night started to feel tired and went to bed early  Next morning about 20 hours after vaccine I was very exhausted and stayed home from work. That night I had leg aches throughout the night and took Tylenol. The next day still very exhausted and had headaches. By day 4/17/21 morning I was feeling better and able to get out and do things. No fever at all. The side effects are worth the end result of protection though! Just thought I should share. Thank you
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). In July 2010 the subject received 1st dose of BOOSTRIX (details unknown). In July 2010, "soon" after vaccination with BOOSTRIX, the subject experienced swelling injection site, injection site redness, body temperature increased, muscular rigidity, shortness of breath and panic attack. The healthcare professional considered the events were disabling. Relevant test results included the subject's body temperature increased from normal to 100 degrees Fahrenheit to 102. 4 degrees Fahrenheit. At the time of reporting the events were improved. The healthcare professional reported that the subject was vaccinated with BOOSTRIX in the last few days prior to reporting. Injection site swelling and redness started soon after the vaccination shot with the subject's temperature going from normal to 100F to 102.4F and complaint of muscle rigidity, shortness of breath and a panic attack lasting about 3 to 4 hours. The healthcare professional reported the onset date of the events as being in the last few days prior to reporting, and that the events lasted 3 to 4 hours. Due to HIPAA laws, the healthcare professional did not provide any further information.
This spontaneous report was received from a certified medical assistant, referring to a patient of unknown age and gender. The patient concurrent condition and medical history were unknown. On 20-NOV-2015 the patient was vaccinated with an improperly stored dose of MMR II (Lot # 1003855, expiration date 05-FEB-2017) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Rash on face/torso. BENADRYL 12.5mg/5ml - 2.5 ml given PO.
Swelling of lips and face; and rawness inside of mouth after approximately 3 days. lasted approx 3 days with swelling gone completely after 7 days.  Rawness and blisters in mouth are still active.
Soreness at injection site, minor headache and body aches for first 24 hours. Starting approx. 24 hours after injection, started showing Influenza A symptoms including fever (101-103 degrees Fahrenheit), headache, body aches, and disorientation.
Patient was supposed to get FLUZONE-QUAD but was given FLUZONE-HD, he is not of indicated age to receive the HD. Patient said he reported no adverse effects and felt fine. Counseled him that increased risk of injection site reaction, low grade fever, or malaise were the most common things he would have been at risk for.
Red rash, raised above skin over the abdomen and upper and lower extremities which has caused itching. Dx urticaria
Itching skin, chest tightness, 0 SOB, 0 dizziness, 0 nausea, IM Benadryl (25 mg) given, symptoms - pt felt better. BP was 110/62. 73 HR. Pt felt better - husband will drive home.
Upon receiving the vaccination roughly 15 min post administration I experienced slight tingling to mouth and lips. The symptoms continues through bilateral upper extremities and lower. I was offered water and was told to sit for a few more minutes to see if the symptoms subsided.  Slightly after 2pm the nurse took my vital signs and I was tachycardic in the 130?s and my blood pressure was 157/97. I was asked to go continue to sit and ?wait it out? maybe it was anxiety. Approximately 30 minutes had passed and vitals were taken again..SBP 140?s but heart rate dropped to 120?s. My director advised me to get evaluated in the ER. I was discharged and told to follow up with my PCP but if symptoms got worse to got to the ED. 10pm at night although the ?pins and needles? remain in my mouth and lips..they have  slightly subsiding throughout my upper and lower extremities but transitioned to a ?hot/burning sensation? and I still remain tachycardic.
vaccine administered after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered after the expiration date) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered after the expiration date). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered after the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications  were reported. No treatment information was provided Reporter stated that none of the patients experienced any reported symptoms and no treatments or additional doses have been provided.   This case was linked to MOD-2021-413535, MOD-2021-413554, MOD-2021-413434, MOD-2021-413560, MOD-2021-413600, MOD-2021-413598, MOD-2021-413599, MOD-2021-413597, MOD-2021-413594, MOD-2021-413593, MOD-2021-413591, MOD-2021-413590, MOD-2021-413587, MOD-2021-413581, MOD-2021-413568, MOD-2021-413560 (Patient Link).
46 year old patient with no history of heart disease or prior A-fib. Came to ER on Nov 18 with paroxysmal atrial fibrillation with rapid ventricular response lasting approximately 8 hours on EKG 12 Lead, with heart rate exceeding 170 at times. Converted pharmacologically with diltiazem. Discharged and prescribed diltiazem, apixaban, and flecainide to reduce re-occurence and reduce stroke risk.