chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient received expired Bivalent Booster >12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Booster >12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2022 at 8:57 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Nov-2022 at 8:57 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Booster >12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Booster >12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Booster >12 hours post puncture).    No concomitant medication was reported.   Patient received first Primary monovalent dose on unknown date,2nd Primary monovalent dose on unknown date, First Monovalent Booster dose on unknown date and unknown Lot number and expiry date.  vial size was 2.5ml Date the vial was initially stored in the refrigerator was 05OCT2022. Date and time vial was first punctured on 02-NOV-2022  at 4:58 PM. The vial did not undergo any temperature excursions. the vial was stored at room temperature in an amber pill vial after post puncture. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was reported 15 hours. No treatment information was reported.   This case was linked to MODERNATX, INC.-MOD-2022-668752 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2022-668752: Patient 1
Symptoms: Fever, Severe Headache, Nausea, Chills, Redness, and Swelling at injection site, and Pain at injection site.
Pt recvd Engerix-B vax in late NOV & exp antigenemia;
Itching; Scaliness of the skin, Similar to eczema; Scaliness of the skin, Similar to eczema; swelling of the right leg, Now also swelling in left leg.; dryness of skin; chills; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route, administered in Left Arm on 04Mar2021 at 13:30 (76-year-old at time of vaccination) as a Dose 1, single for Covid-19 immunization. The patient's medical history included diabetes mellitus, blood pressure. The patient received diabetic medication and blood pressure medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 infection. On an unknown date in 2021, the patient had experienced itching, scaliness of the skin, similar to eczema, swelling of the right leg, dryness of skin, chills. Now also swelling in left leg. The adverse event resulted the patient to visit Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19 infection. The patient received antibiotics, benadryl, lotion for skin as treatment medications for the resulted events. The outcome of the events was not recovered.  Information on the batch/lot number has been requested.
brain fog; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (brain fog) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (brain fog). At the time of the report, FEELING ABNORMAL (brain fog) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.
Information has been received from a registered nurse concerning an adult patient who on approximately 18-OCT-2010 ("this week") was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665925/0932Z). On approximately 18-OCT-2010 the patient developed adverse reactions. Injection site reactions included swelling, erythema, and pain. The nurse requested a lot check. At the time of the report the outcome of the patient was unknown. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Bright pink hives roughly the size of quarters appeared after about five minutes. Both thighs were pink, somewhat swollen, and warm to the touch in roughly five inch circles around the injection sites. The baby was crying uncontrollably for roughly an hour following the vaccinations. Later that night, the baby cried/screamed for several hours and was inconsolable. The baby received Tylenol during this time but it did not appear to help. The following evening, the baby had a temperature of 102.5 after not having any Tylenol for roughly 5 hours. After receiving more Tylenol, the temperature dropped to about 100. The baby had a fever for roughly three days following the vaccinations and was treated with Tylenol to prevent it rising. The baby acted generally sick and sleepy during this time.
9/27 at 9:45am received DTaP, IPV vaccines, small amount redness immediately , fussiness, and decreased appetite all day. 9/28: woke with redness , warmth, swelling around injection site. Continued fussiness and decreased appetite. 9/29: increasing local reaction. 8cm in diameter. Started oral antihistamine q 6-8 hours.
About a month after receiving the J&J vaccine, I noticed a bump in the top of my left calf, which caused some discomfort and also noticed slight numbness in left foot / toes.  Primary, Dr., sent me for ultrasound, which showed I had several blood clots in my leg.  I have never had any blood clots before.  Dr.  referred me to Hematologist, Dr.  She ran extensive blood tests and found no genetic predisposition for clots.  She stated it was likely the vaccine that caused me to develop blood clots.  I am now on blood thinners to try to dissolve them and may have to take them for life if the clots don't go away in the new few months.  Follow up ultrasound scheduled 9/7/21.
Information has been received from a 36 year old female consumer with no known drug allergies who at the end of 2000 was vaccinated with the two dose series of varicella vaccine. There was no concomitant medication. Subsequently, the pt had a recent titer done and it did not show that she seroconverted. No other symptoms were reported. Unspecified medical attention was sought. Additional info has been requested.
p/vax pt exp 4 sz;pt has a hx of childhood sz & has been sz-free for 10 to 15 years;
Patient received a pediatric vaccine that had the wrong expiration date  on the label but the actual expiration was 09/30/2022. They received the vaccine  on  10/02/2022. I have not heard any complaint from the parent
event: severe chest pain / pressure on right side  that woke me up from sleep.  (Thursday, 19).  some radial extension to right arm for only a short period treatment: 19th - OTC advil;
Sore arm at location of injection with large read patch around injection site Headache - 6/23 Chills - 6/23 General aches and pains - 6/23 Joint Pain - 6/23 Fatigue - 6/23 Itchy - 6/24 to present Blotchy patches - 6/24 to present
One week after receiving the Pfizer vaccine I developed severe tinnitus while laying in bed. No previous exposure to loud sounds preceded this, I was working from home at the time and was not going out at all.  I am now on short term disability because my job was very difficult in nature and I couldn?t concentrate. I have a psychiatrist which I now see every week to help deal with the absolute agony that is severe tinnitus.
I received a Zoster vaccine on October 7, 2009. As may happen, my upper arm became very swollen, red and rashy all the way around. This lasted about five days. More trouble was the series of clear blisters that appeared on my abdomen that itched like mad and did not go away for a week. I also now have two areas on my upper back that have been burning, and very sensitive to the touch of even the softest fabric. There does not appear to be anything visible in these areas, but the pain is very real and not subsiding. I am very healthy and have never had any reaction to any other vaccine such as the seasonal flu shot I get each year. I have no conditions that would compromise my immune system and did not have any colds or allergies at the time of my shot. I feel as if the Zoster vaccine has given me shingles instead of protecting me against them. Based on my experience, I would not have gotten the shot if I had known and I do not believe that it should be recommended for most people.
part that is kind of like welted up; is hot to the touch; redness at the site; looks like swelling; it's tender; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (part that is kind of like welted up), INJECTION SITE WARMTH (is hot to the touch), INJECTION SITE ERYTHEMA (redness at the site), INJECTION SITE SWELLING (looks like swelling) and VACCINATION SITE PAIN (it's tender) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced URTICARIA (part that is kind of like welted up), INJECTION SITE WARMTH (is hot to the touch), INJECTION SITE ERYTHEMA (redness at the site), INJECTION SITE SWELLING (looks like swelling) and VACCINATION SITE PAIN (it's tender). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (part that is kind of like welted up), INJECTION SITE WARMTH (is hot to the touch), INJECTION SITE ERYTHEMA (redness at the site), INJECTION SITE SWELLING (looks like swelling) and VACCINATION SITE PAIN (it's tender) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Tingly face with some puffiness; Tingly face with some puffiness; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the arm right on 09Apr2021 at 10:45(at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included high BP, high cholesterol and hypothyroidism. Concomitant medications included olmesartan medoxomil (BENICAR), levothyroxine sodium (SYNTHYROID) and rosuvastatin calcium (CRESTOR) for unknown indication and from an unknown date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 11:00, the patient experienced tingly face with some puffiness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event tingly face with some puffiness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
This is a spontaneous case, initially received from other health professional (nurse) on 20-Dec-2017, concerning a 48-year-old, adult, male patient. The patient's concomitant medication included: Diltiazem. On 13-Dec-2017, the patient was inadvertently administered with FLUCELVAX QIV (dose: 0.1 ml, route of administration: intradermal, batch no: 195125, expiry date: 30-Apr-2018 and anatomical location: left forearm). It was reported that, the nurse meant to administer PPD (purified protein derivative) instead of FLUCELVAX (explicitly coded as wrong vaccine administered, inappropriate route of vaccination and incomplete dose administered). On an unspecified date, after vaccination, the patient developed a large (25 mm) induration. The patient did not receive any treatment medication. At the time of this report, the patient was still recovering from the event injection site induration. The reporter assessed this case as non-serious.
Pt. states that after receiving the 3rd dose of Phizer 12/28/2021, started to experience symptoms 01/02/2022 of hairloss 01/12/2021 Hair Dresser visit with noticing patches. No Primary visit/communications.
Within 3 days of first and second shots, patient developed punctuate papules, primarily on forearms and sparsely on chest and legs.
102 Fever, Headache, body ache, swollen left arm at injection site, extreme fatigue
a man came to the pharmacy this morning stating his wife has been experiencing a tingly arm and puffy face after receiving the Moderna covid vaccination.  He said she had taken benadryl with no resolution of side effects.  It was recommended that she contact her Doctor and to go to be seen.
Approximately 39 hours after immunization  I woke with abdominal cramping. Upon standing I became light- headed and fell. My legs and arms  turned red and warm and started itching. Itching subsided  in an  hour but redness remained for several hours. After itching stopped chills started and lasted several hours . By 7am symptoms were gone except for redness.
Initial unsolicited misuse report received from a consumer (patient herself) on 01 December 2016. This case involves a 35-year-old female patient who was vaccinated with a dose of Fluzone NP (Batch number: UI629AA, expiry date: 30 June 2017, dose and dose in series were not reported and route of administration was reported as subcutaneous or intramuscular) in the left deltoid on 12 October 2016. Patient's medical history as Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not reported. Illness at the time of vaccination was also not reported. The patient stated she experienced low grade fever of 99 degree Fahrenheit and general body aches every year after she had received a flu shot. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 15 October 2016, three days following the vaccination, the patient had developed low grade fever of 99 degree Fahrenheit and general body aches. Patient stated that she did not need to be seen by her physician. It was reported that dose of Fluzone NP might have been administered more subcutaneous than intramuscular. It was a case of inappropriate route of vaccination. Laboratory investigations were not reported. Corrective treatment was not reported. It was reported that she did not need to self-treat her symptoms. The patient was recovered from events on an unknown date. List of the documents held by sender: none
sensorineural hearing loss left ear; This literature-study case was reported in a literature article and describes the occurrence of DEAFNESS NEUROSENSORY (sensorineural hearing loss left ear) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Inner ear disorder (Prior oto history was stable).    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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DEAFNESS NEUROSENSORY (sensorineural hearing loss left ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS NEUROSENSORY (sensorineural hearing loss left ear) outcome was unknown. Possible      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DEAFNESS NEUROSENSORY (sensorineural hearing loss left ear) to be possibly related.    No concomitant medication was reported. Treatment information was not reported.  This study includes 18 patients with post-vaccination otologic symptoms.  Most of our patients are still undergoing treatment, which may include oral, IT steroids, and/or antivirals. In all cases magnetic resonance imaging of the internal auditory canals was also ordered. Our pre-treatment audiograms, with the PTA and WRS recorded, have given us a good baseline with which to document any treatment effect, as well as review outcome versus specific treatment given, to be reported in the future. The extent of hearing recovery and/or symptom resolution was currently unknown.  Company Comment: A 77-year-old female, with concurrent inner ear disorder, presented with a serious unexpected event of sensorineural hearing loss. Event latency 30 days after second dose. Event outcome not reported. Rechallenge not applicable. Reporter causality assessed as possibly related. Causality possible from temporal association. Event consistent with current knowledge of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-337903, MOD-2021-337994, MOD-2021-337995, MOD-2021-337997, MOD-2021-337998, MOD-2021-337999, MOD-2021-338000, MOD-2021-338001, MOD-2021-338002, MOD-2021-338003, MOD-2021-338004, MOD-2021-338005, MOD-2021-338006, MOD-2021-338007, MOD-2021-338008, MOD-2021-338009, MOD-2021-338010 (Patient Link).; Sender's Comments: A 77-year-old female, with concurrent inner ear disorder, presented with a serious unexpected event of sensorineural hearing loss. Event latency 30 days after second dose. Event outcome not reported. Rechallenge not applicable. Reporter causality assessed as possibly related. Causality possible from temporal association. Event consistent with current knowledge of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
A few minutes after I received the shot I experienced an extreme intense feeling of warmth rush through my body.   My heart rate increased,  I had a sudden headache towards the back of my head and I became lightheaded.   The pharmacist gave me water and within 3-5 minutes, the reaction subsided and I felt better.  I felt fine the rest of the day after this brief reaction.
8:00pm - left arm soreness 2:00am - chills, difficulty sleeping 9:00am - tiredness, body aches, fever 12:00pm - felt mentally out of it 11:00pm - throat soreness
pt recvd vax & fainted; pt regained consciousness 10 seconds p/fainting; pt was oreinted to time, place, & person;
Patient received vaccine that was stored in freezer for 19 days before being moved to refrigerator.
Flare of arthritis all over body, particularly feet, ankles, and knees. Trouble walking due to the pain. Headache that started the day after the vaccine, and is still current. Chest tightness and pain, elevated heart enzymes, inflammation surrounding the heart.
mild headache; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In May 2020, unknown after receiving Shingrix, the patient experienced headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The patient age group was not reported, however captured as adult as per vaccine indication. The age at vaccination was not reported. The patient received 1st booster dose of Shingrix. After receiving Shingrix, the patient experienced mild headache. The patient received 2nd dose on 17th May 2020 and experienced severe chills, headache and muscle ache and felt crappy for tolerance see case US2020AMR088575. The patient was hoping to get a Covid-19 test early next week, as the patient was not sure why he/she felt this way, Shingrix or Covid .
21 y/o M, Airman calls Call Center with onset of skin rash some 3 weeks after receipt of SPV, AVA, and Typhoid vaccines. Rash diffuse on hands and groin areas. The rash is pruritic. Some of the lesions are painful.
Information has been received from a physician concerning a 21 year old female with acne who on 23-MAY-2008 was vaccinated IM with a first 0.5 ml dose of GARDASIL (lot # 659437/1266U).  Concomitant therapy included BENZACLIN.  On 23-MAY-2008, immediately after vaccination, the patient seizure, fainted and lost consciousness while in the physician's office.  The patient sought medical attention in the physician's office.  There were no laboratory or diagnostic tests performed.  At the time of the report, the patient was recovering.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested.
10/18/13 I received a shingles vaccine in upper left arm. Next day my arm was tingly, then by Sunday (10/20) it had a red rash (10"x3"). I took LYSINE and the itching and tingling subsided but rash has not completely gone away. Arm continues to ache.
I got a hive on my left hand, which was the same side that I got the shot on. It went away in about 3 hours and no other side affects after. I did receive my 2nd dose and I had no reactions.
urticaria of face, neck, extremities 4hr p/vax;localized wheal @ typhoid inj site;