chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Registered Nurse and refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The reporter stated that doses of RECOMBIVAX HB (lot # M046373, expiry date: 04-NOV-2018) were improperly stored at temperature 47 Fahrenheit degrees to 77 F degrees, for 46 hours. The digital data logger was involved. This improperly stored RECOMBIVAX HB were administered to unspecified number of patients: one dose on 08-MAY-2017, and another dose on 10-MAY-2017. No adverse effects were reported. Product quality complained was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA014879:
I received the flu vaccine on the morning of October 13th 2017 and the round 10 - 11 PM that night the vision in my left eye started to become blurry I thought maybe I was tired because I was working two jobs at the time so I just brushed it off as being tired over the course of the next two to three days the vision and my left eye continue to deteriorate I called my manager at the time and told her what was happening and she instructed me to contact the company's employee health which I did and they sent me to urgent care but they could not help me so they sent me to an eye doctor Who inspected my eye in depth and could not find anything wrong with it he told me that if it did not get better within a week that he would send me for an MRI wow about 2 days later after that appointment the vision had gotten so bad I could not see at all out of my left eye so on Friday October 20th at about 11:30 PM I decided to go to the emergency room where they did two separate MRIs one with contrast and one without contrast and it came back that I was diagnosed with multiple sclerosis and I was then admitted into the hospital for the next three days.
This spontaneous report as received from a Medical Assistant referring to an unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with RECOMBIVAX HB Lot # N002913 with an expiration date on 23-FEB-2019 for prophylaxis, that had been improperly stored. No adverse effects were reported. The vaccines were stored at 48°F during 2 hours and 58 minutes and no previous temperature excursions were reported. The call was because of a data logger. This is one of two cases received from the same reporter.; Sender's Comments: US-009507513- 1708USA004151:
This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with the first and the second dose of M-M-R II (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. On an unknown date, patients have received the third dose of M-M-R II (dose, route of administration, lot number and expiration date were not reported) due to have negative titers (date not reported). The outcome of the event was not reported. The relatedness between the event and M-M-R II was not reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Information has been received from a healthcare professional concerning a 44 month old female who was vaccinated with a first and second dose of hepatitis B virus vaccine. On 20-OCT-1993 the patient was vaccinated with a third intramuscular dose of Recombivax. Three days later, on 23-OCT-1993, the patient started to lose her hair. It was reported that a follow up consult with a dermatologist diagnosed it as an adverse reaction to Recombivax HB. It was noted that the patient was now 16 years old and has her hair. The patient was reported as recovered. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from a registered nurse indicated that there was no other information to report. Additional information is not expected.
I was given the first shot of Moderna. That night (03/18/2021) I start having chills very bad> My entire body would shake. I also start having pains in my neck, head  and shoulders. I?m also very weak>
Syncope within 3-5 minutes of giving the  vaccines; slumped from the exam table to chair, briefly unaware what had happened. No difficulty breathing, no swelling of face; had normal BP, pulse and respiratory rates. No headaches, no dizziness and no seizure activity. After a brief interval of being unaware of what had happened, responded to name, asking what had happened. He complained of abdominal pain that felt like a knot. He had no nausea, vomiting, headaches or dizziness. Discharged home with Mom after 1 hr of observation.
Next day (Friday) Very sore arm at injections site, body aches, muscle aches, join ache, temperature 100.5 day after. Felt like I got hit by a bus. Better on Saturday
possible infection; doctor says should receive a 3rd Shingrix dose; This case was reported by a consumer via interactive digital media and described the occurrence of infection in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix and Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced infection and intercepted drug prescribing error. On an unknown date, the outcome of the infection and intercepted drug prescribing error were unknown.   It was unknown if the reporter considered the infection to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comments: The case was reported by patient via interactive digital media. The patient reported that his/her doctor said he/she should receive a 3rd Shingrix dose because of signs of a possible infection. Additional Supportive Information: The doctor said the patient should receive a 3rd Shingrix dose, which led to intercepted drug prescribing error. Follow up would not possible as no contact details were available.
No additional AE reported; ROTATEQ was inadvertently administered on 13APR2021 after a temperature excursion ocurred; This spontaneous report was received from a physician concerning a patient of unknown age and gender. Information regarding the patient's current concomitant therapies, conditions, medical history and historical drug was not provided.  On 13-APR-2021, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral (dosage regimen was not reported), lot # T039454 and expiration date 14-DEC-2021 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -9 degree celsius (°C) for timeframe of 10 hours and 56 minutes on an unknown date; no previous temperature excursions were reported.  The call was made due to a digital data logger. No adverse symptoms were reported.; Sender's Comments:  US-009507513-2104USA003768:
Urine bleeding at the day of injection.  Heavier period, nose bleeding, and fatigue
Complained of "hard lump" to right arm - creatinine treated 8 cm with some redness tenderness and slight bruising. Child able to move right arm/fingers. Grandma states right arm looks worse today than yesterday. Referral to clinic. Diagnosed cellulitis right arm. Rocephin 75 mg intramuscularly given; discontinue with Keflex 250 7/4 four times a day; warm compress three times daily; Advil a teaspoon every 6 hours as needed; RTC for 1 day.
Administered at 12/31/02. Patient developed right upper lung lobe pneumonia with sinus tachycardia and right upper extremity tremors. Patient hospitalized. The discharge summary states hyperkalemia and elevated platelets.
Left arm, at injection site.... big red circle around injection site (4.5inches) Red area is very hard and itchy Tender to touch
Woke up around midnight with fever of 102.8 and chills.  My normal temp is 97.4.  Felt slightly dizzy when standing up.  Took Tylenol and started feeling better after about 2-1/2 hours.  The next morning, the 25th, felt like I had a mild case of the flu but, again, Tylenol seemed to help.  No soreness in arm or other symptoms.
This spontaneous report as received from a 63 years old male patient with allergies refers to herself. The patient did not have any drug reactions/allergies. The patient was vaccinated with PNEUMOVAX 23 (route, dose and lot # were unknown) on 10-JAN-2013. No other co-suspects were reported. Concomitant medications included ASTELIN, SINGULAIR, QVAR and fluticasone. On 10-JAN-2013 the patient was found to have a tooth infection. The patient had sought medical attention via seeing his dentist, X-ray of tooth performed and put on AMOXICILLIN (manufacturer unspecified) for treatment. The outcome of event was reported as not recovered/not resolved. The relatedness for event is unknown for PNEUMOVAX 23. Additional information has been requested.
woke up to severe chills and body aches, headache and extreme pain at both injection sites. fatigue.
Immediate pain in arm at tiem of injection Pain went into neck and felt nauseated. Pain from shoulder to elbow X 2wks. Had difficulty straightening arm.
Injection given 1/10/05 - swelling and redness about 2.5 inches on 1/11/05 - additional swelling, redness and warmth to touch late 1/12/05 and 1/13/05 to double in size. On 1/13/05 patient was sent to be seen in the ER for tmt of symptoms
I didn't get sick or tired, only sweating. Today I went to the bathroom and have a rash on my hip, its hard like with a bunch of spots on it and it hurts to touch. It feels like I got a shot in my hip and it's about the size of a 50cent piece and my leg feels a little bit numb under the skin. Its weird and hard to explain.
Uveitis since September of 2022. Treated with injections, drops and Rx. Inflammation  and swollen back of eye.
Pt. received DTaP, MMR, IPV. Now parents states rash on the MMR injection site, face and body. Increased fever at night after shots exam by MD.  12/28/01. Reveled cellulitis right proximal thigh and resolved fever today (tactile yesterday) and erythmatous rash both thighs and cheeks likely secondary to MMR
Bleeding gums; This is a spontaneous report from a non-contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. On 30Apr2021, the patient had bleeding gums. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event bleeding gums was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv vax 20JUN95 & 28APR97 pt devel a varicella type rash w/more than 100 lesions;@ time of report MD had not yet seen the pt;
09/27/15 developed first pain then numbness in bilateral thighs followed by weakness, urinary incontinence and retention. Febrile w/strength 1/5 in bilat quads 0/5 in bilat low extremities. Reflexes 0/5 in achilles/patella. Hosp course: infectious workup was neg MRI showed T2 abnorm at T7, 8 T 11-12 consistent w/transverse myelitis or MS. Received IVIG, steroids; Pt. improving. Still in hosp.
Pt was at the pharmacy to receive third dose Moderna for immunocompromised. She was inadvertantly given Pfizer.
achy all over; swollen arm with hot spot; severe headache; red rash all over the injection site; Fever 100.1F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy all over), PERIPHERAL SWELLING (swollen arm with hot spot), PYREXIA (Fever 100.1F), HEADACHE (severe headache) and VACCINATION SITE RASH (red rash all over the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, METOPROLOL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and RIVAROXABAN (XARELTO) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (achy all over), PERIPHERAL SWELLING (swollen arm with hot spot), PYREXIA (Fever 100.1F), HEADACHE (severe headache) and VACCINATION SITE RASH (red rash all over the injection site). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PAIN (achy all over), PERIPHERAL SWELLING (swollen arm with hot spot), HEADACHE (severe headache) and VACCINATION SITE RASH (red rash all over the injection site) outcome was unknown and PYREXIA (Fever 100.1F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 100.1 f (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Email was updated
24 hours after injection - low blood pressure (90 over 68) rapid heart rate - 110 to 115 for approximately 4-5 hours
pt recvd vax & c/o urticaria, pruritus & tingling sensation in lt arm w/in +- 10 mins p/vax; ice pack & sx dec @ 11AM;
PATIENT COMPLAINED OF A SORE ARM AND THEN SAID HE COULD NOT FEEL IT BUT WAS FEELING LIKE A SHOCK ACROSS HIS BODY. WE CALLED THE PARAMEDICS AND ASSESSED HIM. WE DID NOT GIVE HIM ANY MEDICATION TO TREAT THE EVENT. PARAMEDICS ARRIVED AND SAID HE WAS FINE. THE PATIENT REFUSED TO GO WITH THE PARAMEDICS. HE LEFT SHORTLY AFTER.
right foot is dragging; muscle spasms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (right foot is dragging) and MUSCLE SPASMS (muscle spasms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (right foot is dragging) and MUSCLE SPASMS (muscle spasms). At the time of the report, LIMB DISCOMFORT (right foot is dragging) and MUSCLE SPASMS (muscle spasms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient developed R-brachial DVT and L-cephalic DVT during hospitalization roughly one month after vaccination despite DVT prophylaxis with enoxaparin 40 mg daily. Patient was admitted for EtOH withdrawal and new onset seizure activity. Per nursing patient did not have IV access in either of these sites. R-side IVs were only in the hand and L-side IVs were in the AC
red circular rash. warm to the touch, irritated, and "hard as a rock". sore arm for multiple days, rash traveled from injection site down a few inches, decreasing in size.
Case fully vaccinated with Pfizer. Last dose on 2/24/2021. Tested positive for COVID 19 on 08/31/2021. Admitted to  Hospital on 8/31/2021. Expired on 9/7/2021 while still hospitalized.
ITCHING AT THE INJECTION SITE; BURNING AT THE INJECTION SITE; SWELLING AT THE INJECTION SITE; PAIN AT THE INJECTION SITE; BODY ACHE; DIZZY; NUMBNESS IN MOUTH AND FACE; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and seasonal allergy. The patient experienced drug allergy when treated with cefuroxime axetil, and erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced dizzy. On 19-MAR-2021, the subject experienced numbness in mouth and face. On 19-MAR-2021, the subject experienced fatigue. On 20-MAR-2021, the subject experienced body ache. Treatment medications included: paracetamol. On 22-MAR-2021, the subject experienced itching at the injection site. On 22-MAR-2021, the subject experienced burning at the injection site. On 22-MAR-2021, the subject experienced swelling at the injection site. On 22-MAR-2021, the subject experienced pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body ache, and the outcome of dizzy, fatigue, numbness in mouth and face, pain at the injection site, itching at the injection site, burning at the injection site and swelling at the injection site was not reported. This report was non-serious.
Headache, Myalgia, Diarrhea, CHILLS AND REDNESS /WARMTH/PAIN AT SITE OF SHOT,FATIGUE Narrative:  Stated she took OTC tylenol with some relief in symptoms
Friday 9/7/12 pt noted increase in pain & swelling to (L) deltoid. Called hotline Saturday but no answer. Feels swollen under arm & at site warm to touch. Referred to clinic for tx. Pt would like to delay tx. 1 more day. Taking ADVIL & ice pack. 9/11/12 Left msg for f/u. 9/12/12 Left msg for f/u. 9/16/12 Patient had no treatment & symptoms resolved.
Increased pain and stiffness of cervical spine about 1 week following 2nd vaccine.  Progressed to muscle spasms and/or contacted muscles, up back of neck, into back of head, causing headaches up the back of head.  Tinnitus set in around April 7th, and continues.  Nausea started on 4/12/21, and continues
Presented with recurrent pericarditis 1-2 weeks after first Moderna dose, treated with NSAIDs and colchicine.  NSAID dose tapered with clinical improvement. Got second dose of Moderna and pericarditis symptoms re-worsened, necessitating increasing dose of NSAIDs. TTE showed suggestions of constrictive pericarditis (new at least since acute pericarditis episode in 2019)
Pt recvd vax & beginning 830PM that day exp arm ache & laryngitis which lasted until 14JAN93;
12:00pm- severe headache on R side, took Tylenol 1800- Felt fatigue 1900- Body Aches 2100- Temp 100.1, arm pain in L deltoid "I cannot stand even the sheets touch it."
Rash/edema @ injection site followed by generalized rash & severe itching. Claritan 10 mg po stat, Hydrocortisone ungt applied & ice applied to injection site.
Patient complained of soreness at injection site about 7 hours after shot.  Injection site was slightly red and warm to touch.  By evening patient would not move her right leg and dragged it was she walked because of extreme pain when bending leg. Slight fever of 100 or so the day after shot.  Limping continued for 3 days (Friday - Sunday).
Twelve days post vax the pt developed a varicella rash, fever of 103F and rhinorrhea. Her symptoms were classified by physician as a moderate case of chickenpox. Follow up information from a physician indicated on 03/15/2000, the patient develeloped myalgias, fatigue, cough, headache, and nausea. The rash was described as pruritis. Additional information has been requested.
BOOSTRIX given on 8/20/12. Pt referred to pharmacy on 8/23/12 reporting itching & rashes on both arms, left chin & neck. Pt given Diphenhydramine 25 mg - 2 stat, 1-2 q 4-6 h prn.
Vaccine Dose #1  Swelling on bottom of both feet near toes.  Painful when walking.  Lasted 2 days   Vaccine Dose #2  Nausea, Violent and frequent vomiting, chills, sweating, headache, dizziness  left side chest pain, with body and joint pain. Cannot retain liquids. Unable to sleep. All symptoms lasted for about 24 hours.  During adverse event: High blood pressure  180/100 due to stress and pain.( Normal Blood Pressure is 110/60. )  Pulse rate = 74-80 bpm, blood oxygen saturation = 96%, and oral temperature = 98.1 F  event.  95% Recovered from symptoms 36 hours after start.
Day after vaccination mild fever and chills and fatigue  4 days after vaccine with fever of 104 and extreme headache blurry vision and dizzy. Went to primary care doctor and thought could be secondary infection, was treated with antibiotics and sent for blood work and chest X-ray. X-ray was good but blood work showed elevated inflammation levels was prescribed prednisone. I?m 3 weeks post vaccine and I?m still having migraines and blurry vision and dizzy and having elevated heart rate that all came on suddenly post vaccination. I never had headaches before and my vision was perfect. Still in process of a diagnosis.
I received the first Moderna injection on Feb. 4 and the second on March 10 both in 2021.  My side effects from both injections were identical.  Left arm (site of both injections) was minorly sore.  Headache, body ache and feverish sensation were severe and comparable to having Type A influenza and seemed to last around 35 hours.  I had to resort to taking the maximum dosage of Tylenol to somewhat suppress the side effects.  I am feeling slightly better from yesterday's injection and expect to be back to normal tomorrow.
My left arm was very sore after the first dose and although my armpit area did not swell, it became painful and did subside after a few days, but the pain has never fully gone away and becomes worse intermittently and for seemingly no reason. My purse strap sometimes makes it feel worse or when my boobs swell during my cycle.
Had last shot on April 1st, and ended up with Chills and Headache for two days.   On May 27, started with severe leg cramps, neck pain, and shooting pain running down both arms, and legs, with lower back pain along with numbness in hands/fingers/ and feet and toes.
incorrect product storage; This spontaneous report was received from a medical assistant referring to a 12 months old female patient (also reported as 14 months old). No information on patients' pertinent medical history, concomitant medications, drug reaction or allergies was provided.  On 20-JAN-2023, the patient received improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # W006412, expiration date: 23-FEB-2024, strength, dose and route were unknown) for prophylaxis. The vaccine underwent a temperature excursion (product storage error). Temperature excursion occurred as result of reading from digital data logger.
Information has been received from a registered nurse concerning 2 females who were vaccinated with Gardasil and fainted about 5-10 minutes after being vaccinated while the physician was out of the room.  No further information was provided.  No lot numbers were provided for either patient.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.
Arthritic condition in my right hand. My ring finger curled up and would not extend, If forced, it was exceedingly painful.   Sometimes the condition was worse than others. Sometimes it would uncurl, but not all way. Sometimes it remained curled up all the way and would not extend at all.