chrisvoncsefalvay/vaers-outcomes huggingface dataset:
liver lesions; This spontaneous case was reported by a physician and describes the occurrence of HEPATIC LESION (liver lesions) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEPATIC LESION (liver lesions). At the time of the report, HEPATIC LESION (liver lesions) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test increased: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.
Allergic reaction; Migraine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6207; Expiration Date: Jul2021), via an unspecified route of administration on 11Mar2021 as dose 1, single for COVID-19 immunization. Medical history included mild case of covid infection (prior to first shot) and did not develop any antibodies as per a PCR test done 2 and 3 weeks after infection. The patient stated that she was at high risk for covid infections. Concomitant medications were not reported. On an unspecified date in 2021, the patient experienced allergic reaction, migraine for 14 days. On an unspecified date, the patient underwent lab tests and procedures which included polymerase chain reaction: did not develop any antibodies. The outcome of events unknown.  No follow-up attempts are needed. No further information is expected.
Chills; Soreness in arm; Aches; Nausea; Headache; Lethargy; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in her left arm on 26Mar2021 at 10:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. No medical history and concomitant medications were reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in her right arm on 05Mar2021 at 12:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 01:00, the patient experienced chills, soreness in arm, aches, nausea, headache and lethargy. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events chills, soreness in arm, aches, nausea, headache and lethargy was recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
No Adverse reaction as of yet. - Dilution was supposed to be 1.8ml instead it was 1.4ml. Patient was called by provider to watch for any side effects.
Pfizer vaccine was ordered for patients first dose. Moderna booster dose documented.  Unsure if actually received Moderna Booster dose or if this is a documentation error.  Person who administered is no longer with our agency.  Subsequent dose was Pfizer Orange Cap
3 hours after receiving second shot I started to shake uncontrollably in my right arm and right hand.  1 hour later I lost speech formation and started to stutter.
small amount of tireness at 2nd day.  Tiredness increassing and then decreasing on 3rd day.Itching and swelling on 3rd day. Redness at site and beyond, gradually migrating down upper arm. Still migrating downward but not outward on 7th day.  Treated with benydryl, tylenol,  added antibiotic 2x day on 7th day.
I had flu like symptoms; ache; ran a low grade temperature a 100; had sores in my mouth and broke out around my mouth, fever blisters around my mouth/fever blisters around my mouth/I had 3 fever blisters on the lower lip; Diarrhea; the glands in my neck was sore; I didn't really feel well; This is a spontaneous report from a contactable other hcp (Patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: EN5318), via an unspecified route of administration (Age at the time of vaccination 77 years) on 09Feb2021 as dose 2, single for COVID-19 immunization. Medical history included thyroid disorder and osteoporosis from an unknown date and unknown if ongoing. Concomitant medications included denosumab (PROLIA) taken for osteoporosis, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot Number: not reported), via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunization. In Feb2021 after the second vaccine the patient experienced flu like symptoms, ache, ran a low-grade temperature a 100, had sores in her mouth and broke out around her mouth, fever blisters around her mouth/fever blisters around her mouth/she had 3 fever blisters on the lower lip, diarrhea, the glands in her neck was sore, She didn't really feel well. The patient underwent lab tests and procedures which included body temperature was ran a low-grade temperature a 100 on unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
pt fainted shortly after the vaccine was given, we tapped her shoulder and called her name and she came to and she was given water.. called 911 she denied going to the hospital...her friend drove her home after 30 minutes.
I woke up nauseated and dizzy in the middle of the night. At 5 AM when I tried to get up for work, I couldn?t walk due to the dizziness and headache. I attempted to shower, but was so dizzy I had to go back to bed. I felt terrible all day - nausea, headache, dizziness, muscle aches, pain at the injection site, and severe fatigue.
3 patients were given doses that expired on Saturday; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients were given doses that expired on Saturday) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients were given doses that expired on Saturday). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (3 patients were given doses that expired on Saturday) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was provided.  No Treatment medication was provided.
Narrative: COVID infection after completion of COVID vaccine series: 03/19/2021 COVID vaccine dose#1 04/09/2021 COVID vaccine dose #2 06/18/2021 COVID negative per facility nasopharyngeal swab after exposure to COVID positive contact 07/11/2021 Pt reported onset of sore throat 07/13/2021 Pt presented to facility ED c/o flu-like symptoms including low-grade fever, chills, nasal congestion, non-productive cough, myalgia. Pt also reported mild HA, but denied sinus pain and loss of sense of smell/taste. 07/13/2021 COVID positive per facility nasopharyngeal swab 07/14/2021 Pt reported continuation of symptoms 07/15/2021 Pt reported onset of loss of taste/smell but partial improvement of cough and fever 07/16/2021 Pt reported biggest complaint is sinus congestion. Wanted to self-treat with Sudafed, but PCP denied based on PMH of HTN. Advised to use ipratropium nasal spray. 07/17/2021 Pt reported improvement in most symptoms except for congestion. Requested to be dc'd from daily phone contact.
Spontaneous report received on 26OCT2015 and 28OCT2015 from a consumer. The consumer reported that he had received BioThrax (Lot FAV390) intramuscularly in the left arm on 05MAY2015. Five days later, on 10MAY2015 he experienced a large painful lump under his left arm and left pectoral muscle. He reported that he was being seen by a physician who was trying to determine if he was allergic to "some chemical in the anthrax shot". The consumer reported that he had an unspecified blood test (result unknown). No treatments were reported. At the time of report he had not recovered. Concurrent medications and medical history were not reported.
15-20 minutes after administration, pt's left thigh was red and hot to touch. The doctor ordered childs Motrin and gave mom the name and dose amt for her to give the pt some Benadryl.
After receiving the first vaccine, started experiencing a little neck pain and swelling on and off for 2 month since first vaccination on December 30th. After second dose of Pfizer, the swelling and pain in the neck escallated and three nodules were discovered in my neck at ER visit due to pain from neck and radiating in ears and head. Extremely fatigued and headache was unbearable. ER MD discovered nodules, high white blood count, etc. Sent to follow up with Endo. Endo could not explain. Thyroid labs are all normal but the symptoms and nodules makes this suspicious. ANother ER visit with 3 days hospitalization due to pain and now elevated pulse (even while sitting in ER bed at 135-140 pulse). Low grade fever, nausea, vomiting, lethargic, elevated labs, etc.  Now on propranolol for heart regulation and prednisone to monitor. Multiple CT scans and Ultrasound confirmed the nodules.
Received a 0.25ml dose of the Moderna Covid-19 Vaccine instead of a 0.5ml dose as their 3rd dose today; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received a 0.25ml dose of the Moderna Covid-19 Vaccine instead of a 0.5ml dose as their 3rd dose today) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received a 0.25ml dose of the Moderna Covid-19 Vaccine instead of a 0.5ml dose as their 3rd dose today). On 05-Jan-2022, ACCIDENTAL UNDERDOSE (Received a 0.25ml dose of the Moderna Covid-19 Vaccine instead of a 0.5ml dose as their 3rd dose today) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.     No treatment medications were reported.    The patient did receive Moderna as 1st two doses as well.
Shingles; This initial spontaneous report was received from a lawyer and a patient of unknown age and gender, regarding a case in litigation on 06-JUL-2020. The patient's concurrent conditions, concomitant medications, medical history, drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered an outbreak of shingles. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX); patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. The patient also sustained severe, permanent and incurable personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate results of zoster vaccine live (ZOSTAVAX), patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of shingles was considered as not recovered. The reporters considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).     The reporters considered shingles to be a disabling event.
p/vax pt got hives all over was lethargic;taken to ER;throat was swelling;dx rxn from shot;throat was swelling;mom states rxn was PCn shot;
When I went I asked if they could do the injection in my arm because I have Muscular Dystrophy and it's the first time I've remembered to ask since a nurse suggested I don't get it in my arm and I get up my butt off and that year which is about five years ago I had no problems. Pharmacy said they couldn't do it in any area other than my arm and everything went fine until a few days later and then the pain started up again and it hasn't stopped. There's a pain in my arm that leads into my shoulder and it's where the injection site was it's very uncomfortable and it's nonstop. I'm pretty sure I see injection site when I got home because I didn't want to she will the bump but the bump happens for me and wasn't anything abnormal at the same thing that happens every year I get the injection and then it gets a bump it's red it's hot it's sore for a couple days and it goes away this time it came back and it hasn't gone away.
Approximately 24 hours after the vaccine my resting heart rate was over 140 and my blood pressure was also very high.  I went to urgent care when they did a ECG and chest X-ray which appeared normal, I was told to follow up with my primary care doctor and to monitor for worsening symptoms.  My blood pressure and heart rate did not return to normal until approximately 72 hours after the shot.  I had to leave work early the day after my shot and was unable to go to work 2 days after my shot.  I was also extremely fatigued for approximately 4 days.
The patient developed diarrhea (10 watery stools per day, 2 days after to Rotavirus vaccine.  He also developed diarrhea after the rotavirus vaccine given at 4 months of age.  The diarrhea at that time had blood in it.  A stool culture and rotavirus test were negative.
One week after the MMR injection the pt developed localized warm, red, tender, edematious reaction.
Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Mar2021 (Lot number: EM9810) as dose 1, single and administered in arm left, administration date 18Apr2021 (Lot number: EW0169) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional information- It was reported that patient administered drug at pharmacy store . Patient administered flu shot the week before in her Right Arm prior to the vaccination.  No follow-up attempts are possible. No further information is expected.
Patient had anthrax vac on 9Feb08 and had adverse reaction on or about 11-12Feb08.  Member did seek medical care.
C/O hives 3 days after takeing 1st shot of Moderna,pt continues to    break with hives all over her body.
pt recvd vax; exp a fever of 103, conjunctivitis, and rash, for one 1wk to ten days; was dx w/ outbreak of the measles; adm to hosp;
After about 12 hours of second vaccination, began to feel achy and soreness at the Injection site. About 24 hours after second vaccination, noticed a rash on the inside of both arms. Took Benedryl, rash on arms wasn?t as noticeable. Around 18 hours after second vaccination, noticed rash on both ankles and feet.
COVID ARM? Itchy, red rash near injection site several days after injection. Within a couple of days of that, started noticing itchy/painful rash forming and getting worse on index fingers and thumbs on both hands. Diagnosed as erythema multiforme.
Patient is a 4 year old male who presents with: Immunization - pt had a reaction to the vaccines given in his L leg. He was given Dtap and IPV in left leg 2/10/2014. The reaction is near the Dtap site. Skin: brisk capillary refill, good skin turgor and 10 cm x 8 cm area of erythema, warmth and mild induration at left upper anterior leg, no fluctuance or punctum.
Induration of shot site extending diameter of 5cm developing withing 24 hours of administration. Left arm.
Arm became so sore, could not lift above my head - fever from night of shot, thru all next day, and night highest 99.8, - arm also large red place, big as my hand, stayed sore for five days (felt horrible).
Flublok given to child under 18.  Notified parent who reported no adverse affects.  They will monitor.
Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), on 19Jul2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (First Booster dose, unknown manufacturer), for covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 19Jul2022, outcome "unknown". Additional information: The reporter's wife got the second booster today (19Jul2022) and she is experiencing chills.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diarrhea starting 8/15/14 lasting 4 weeks, contact dr. said possible side effect. At 5 weeks massive hive break out 3 trips to ER. 3 trips to allergist, felt internal hive break out from stress on her body. No one thinks its related to shot, but we do.
This case was reported by a pharmacist (also the subject) and described the occurrence of arm rash in a female subject of unspecified age who was vaccinated with FLUARIX, GlaxoSmithKline.  There were no concurrent medications.  On 27 October 2008 at 11:00 the subject received a dose of FLUARIX in the right arm.  On 29 October 2008, 2 days after vaccination with FLUARIX, the subject experienced a rash on her arms and legs.  The rash has resulted in scarring in the rash areas since the rash has not resolved.  The subject was evaluated three times at an urgent care office.  The pharmacist considered the events were clinically significant (or requiring intervention).  She was first treated with three doses of Depo medrol at 80 mg (this was thought to be the dose).  Then one week later, the subject was prescribed a 6-day prednisone taper for the continuing rash.  The taper started at 50 mg and she was instructed to decrease the dose by 5 mg every 2 days.  At the time of reporting, the subject was at 35 mg and the rash was not improving, but was getting worse.  The subject also tried treatment with Atarax and Zyrtec which did not resolve the rash.  The subject developed bronchitis some time after receiving FLUARIX for which she was prescribed Amoxil.  The subject did not relate the FLUARIX to the development of bronchitis.  The subject initially thought that the Amoxil she was taking for bronchitis was improving the rash, but then the rash worsened again.  The subject has not been evaluated by a dermatologist, nor had a skin biopsy.  Blood work performed was normal.  At the time of reporting the rash was unresolved and worsening at times, scarring was unresolved and the outcome of bronchitis was not specifically mentioned.  The rash was considered possibly related to treatment with FLUARIX.  The pharmacist mentioned that she was not certain of the brand of flu vaccine that she received, but she knew it was a GlaxoSmithKline product and that it was in a single dose syringe (FLUARIX) versus a multidose vial (FLULAVAL).
REDNESS, SWELLING WITH SWELLING OF 10 CENTIMETERS BY 5.5 CENTIMETERS AT INJECTION SITE. WAS TREATED AT CLINIC WITH A SHOT OF BENADRYL AND TOPICAL HYDROCORTISONE CREAM. AT THIS TIME REACTION IS IN PROCESS OF RESOLVING. LINE WAS DRAWN AROUND AREA TO OBSERVE SIZE.
Whole deltoid area/shoulder was swollen for 1 day, 1 day following the injection on left side.
Large (size of child?s entire thigh) redness and bruising at injection site and the redness is burning to the touch. Appeared about 30 hours after vaccine.
Arm started with redness, heat and itching. Progressed to puss-filled blistering of right arm.
pt recvd vax 530PM, lt immun room & fainted in hallway, invol voiding, eyes rolled back, felt weak BP 100/52, P84 strong, no resp distress, flushed; improved w/in 5-10 mins; color nl drank soda, ate chips, talking;
Employee states she "felt hot", never did take temperature, felt dizzy, was nauseous but never did have emesis, got a headache-migraine like. Symptoms started a few hours after she received vaccine and continued through the next day. States she felt this way last year too after receiving vaccine at her previous employer.
Patient had high-pitched, inconsolable screaming that lasted about 5 hours.  Also had low-grade fever of about 101 degrees