chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccine on 10-Nov-2021/Vaccine expired on 09-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 10-Nov-2021/Vaccine expired on 09-Nov-2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 10-Nov-2021/Vaccine expired on 09-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 10-Nov-2021/Vaccine expired on 09-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. Vaccine manufacture date of expiry reported was 09-Nov-2021.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains no new information.
Headache, body ache, slight fever, cough, sinus congestion for about 5 days. Symptoms weren't as bad as when I had the flu.   I've had 3-4 months of sinus infections that I couldn't get rid off and more frequent headaches. i took 2 different rounds of antibotics but didn't clear up the sinus infection. And I've been more tired though my asthma hasn't been affected.
This case was reported by a nurse via call center representative and described the occurrence of pain localized in a 69-year-old female patient who received HAVRIX 1440 adult (batch number TB995, expiry date 25th October 2020). On 3rd May 2018, the patient received the 1st dose of HAVRIX 1440 adult (intramuscular) 1 ml. On 7th May 2018, 4 days after receiving HAVRIX 1440 adult, the patient experienced pain localized. In May 2018, less than a week after vaccination, the patient experienced fatigue and fever. On 7th May 2018, the outcome of the fatigue and fever were recovered/resolved. On an unknown date, the outcome of the pain localized was not recovered/not resolved. The reporter considered the pain localized, fatigue and fever to be probably related to HAVRIX 1440 adult. Additional details were provided as follows: The patient reported to the licensed practical nurse (LPN) that she had a stabbing pain 2 inches below the injection site (local pain). The pain was on and off. The patient also reported feeling fatigued and believed she might have had a fever (possible fever), but did not get confirmation.
Following second dose of Shingrix, developed rash on my back that has lasted for 7 days thus far
No adverse event; received the wrong booster/received booster from incorrect vial; got the pediatric 6 to 11 year old formulation; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (received the wrong booster/received booster from incorrect vial), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (got the pediatric 6 to 11 year old formulation) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 06-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (received the wrong booster/received booster from incorrect vial) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (got the pediatric 6 to 11 year old formulation). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (received the wrong booster/received booster from incorrect vial), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (got the pediatric 6 to 11 year old formulation) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT (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 assessments were provided for INCORRECT DOSE ADMINISTERED (received the wrong booster/received booster from incorrect vial) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (got the pediatric 6 to 11 year old formulation).    No concomitant medication were provided.  It was reported that the patient was were supposed to get a booster, but they got the pediatric 6 to 11 year old formulation. The box showed booster doses on the outside. The pharmacist reported that an HCP grabbed a vial of the vaccine for 6-11 year old and administered on 06-Sep-2022 to patient who was going for booster shot. The pharmacist reported that it was confusing because the vial states Moderna COVID-19 Vaccine for booster doses only. There was a purple border on the carton, but not on the vial. It did not mention an age group on the carton at all.  No treatment details were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-642008 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-642008:(same reporter)
18 year old female / was given the adult dose (20mcg) instead of the pediatric dose (10mcg) by accident; 18 year old female / was given the adult dose (20mcg); This case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 18-year-old female patient who received HBV (Engerix B adult) (batch number P4DJ5, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th March 2021, the patient received the 1st dose of Engerix B adult 20 mcg/mg and Engerix B Pre-Filled Syringe Device. On 8th March 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The pharmacist reported via online chat. The pharmacist reported that the patient (18 year old) received the 1st dose of the Energix-B vaccine and was given the adult dose (20 mcg) instead of the paediatric dose (10 mcg) by accident, which led to accidental overdose and adult product administered to child. The pharmacist wanted to know if we all had any more information regarding how they should go about dosing the subsequent vaccinations with the patient. The patient did not have any adverse effects since. The reporter did not consent to follow up. No other information was reported
arm soreness, thirsty,  at 5pm.  pain in shoulders, elbows, hips, back overnight and in am following.  chills, shaky.  headache nausea late afternoon over 24 hrs after injection.  arm soreness three days. other effects 24 hrs.
Hands were numb, legs were numb down to the feet; he couldn't walk or stand; Fever; couldn't walk or stand; he had no balance; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, Lot number: ER8731) via unknown route of administration on 20Apr2021 11:30 (age at vaccination 63-year-old) as dose 2 single in left arm for COVID-19 immunization. Medical history included ongoing chronic kidney failure (states at least 8 years ago. patient reported 5 stages of kidney failure, with the most severe stage as 5, and he reports he is in Stage 4), Covid in Dec2020 (patient states he had some type of infusion, clarified as a monoclonal infusion, while he had Covid, because if not, he would not have had a good outcome). No Prior Vaccinations (within 4 weeks). Family history reported as his mother who was 86 years old, had both Pfizer vaccines with no reactions. Concomitant medications reported that he was on 9 medications that he has taken for 30 years. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE) on 23Mar2021 10:30 AM for COVID-19 immunization and also took Flu vaccine with which his stomach felt nauseated, also he did not feel great. It was reported that immediately after the vaccine he reported his hands were numb, his legs were numb from he knees down, his feet were numb and he had no balance, couldn't stand without support and he felt like his feet were not underneath him. patient stated he went to the emergency room again, after the second vaccine, and he couldn't walk and he was put in a wheelchair on 20Apr2021 12:00. Reclarified, he had an MRI of the brain, blood tests and because of his balance issues and difficulty standing, they wanted to rule out a stroke. patient stated he did have an MRI of the brain and the results were normal. patient stated he had trouble for the rest of the day walking and had to hang onto walls to go upstairs or move around. patient reported that he had a fever of around 100 degrees on 20Apr2021 12:00. patient stated he was able to eat and drink and was not dehydrated. patient reported that he was on 9 medications that he has taken for 30 years, and he does not think they are relevant to the report. patient was assured that any symptoms or side effects were normal with the covid vaccine. patient was told he may be experiencing more side effects because of his, history of kidney failure. Patient visited Emergency Room for adverse events. The outcome of events was unknown.  No follow-up attempts are needed; No further information is expected.
Reported large red area, hot to touch 4"x3" in size, with pain, but able to move.
Itching experienced at the site of the injection one week  after the injection on Jan. 30, 2020.  The next morning (Feb. 6,2021) an oval, red rash developed around the injection site approximately 5cm x 10cm.  The rash is still somewhat present at this filing on Feb. 10.
Really really dizzy; Weakness; Blurry eyes; Severe headache; Fever; Muscle pain; Bad nausea; not able to work; A spontaneous report , was received from a consumer (patient), concerning a 42 year old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe headache (headache), fever (pyrexia), dizziness (dizziness), weakness (asthenia), blurry eyes (vision blurred), muscle pain (myalgia), inability to work, and bad nausea (nausea).  The patient's medical history was not provided. No concomitant medications were reported for the patient.  On 5 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 030A21A), intramuscularly for prophylaxis of COVID-19 infection.  On 05 Mar 2021, two hours after the vaccination, the patient experienced severe headache, fever, dizziness, weakness, blurry eyes, muscle pain, inability to work, and bad nausea. On an unspecified date, headache and fever went away. The events muscle pain, dizzy, eyes blurry, and little weak were not recovered/not resolved/ongoing. The patient was not able to work, got dizzy when she tried to get on the computer. Treatment details included taking aspirin for headache.  Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of events, severe headache and fever was considered recovered. Dizziness, weakness, blurry eyes, and muscle pain were considered not recovered.  The event of nausea was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Minor back pain began on the 21st. Significant discomfort and limitation of mobility by evening of the 22nd. Increasing discomfort throughout the 23rd, such that I could not twist my torso or reach across my body without acute pain. Currently, severe cramping/spasms of muscle groups left of the spine even without attempted motion. It feels as if someone is punching my left lung from the back. There is, however, no numbness or weakness anywhere, no radiating pain, no lung problems or any other issue. Just constant muscle cramps/spasms. May end up visiting a hospital.
Approximately 12 hours after receiving the vaccine, I had hot flashes, joint pain, severe arm pain in the arm that received the injection and a mild headache. I could not move my left arm at all without extreme pain, and I could not move my fingers without pain. This lasted about 24 hours.
Extensive inflammation of right thigh 24 hrs after immunization (19cm x 14cm).
I rec the senior high dose flu shot. Around the evening time I started feeling weak and my arm was sore  so I went to sleep. Woke up at 2 am and heart was pounding and I was feeling very fatigued also feeling like I could not get out of bed and so I sat on the floor. I did the not have the strength to get up so I woke my husband up at 6am and we went to the ER. ER stated I had high blood pressure and labs came back clear.
While driving home from the vaccine chest felt weird.  Got home told my mom, went upstairs and felt bad discomfort on my upper left-side and middle of chest.  Sharp pain kind of on the left-side of rib cage below arm pit.  Took a several  days for it to go away.
Treated for pneumonia shortly after vaccine. Constant pain in shoulder chest infections continualy severe intestional problems. Trouble breathing, shortness of breath over 7 mth period.
2021/01/16 10:00 AM - Numbness in face (lips, jaw, gums) similar to the feeling from localized anesthesia. Also numbness and tingling in left hand. Vision is blurred and spotted vision loss.  2021/01/16 10:45 AM - Numbness in face and hands diminishing. Head ache on right temple. Vision issues persist.  2021/01/16 11:15 - Muscle pain on right abdomen and numbness beginning in feet. Vision issues cease. Headache persists.  2021/01/16 2:15 - All symptoms cease
Information has been received from a registered nurse concerning a 28 year old female employee with a serum varicella virus antibody < than 10 on 05/30/1995 who was vaccinated SC in the right arm with a first and second dose of varicella vaccine on 06/05/1995 and 07/17/1995 respectively. On 09/21/1995, lab evaluation revealed varicella zoster virus antibody of 10. On 01/11/2001, lab evaluation revealed varicella zoster virus antibody <than 10. No adverse experiences were noted. Medical attention was sought. Additional info has been requested.
Tics (eyes, nose, head and neck) and twitches (shoulder, arm, leg, body all on right side only) began occurring during times of rest daily. 2 months later, during an hour of rest, the tics and twitches would occur the entire hour with maybe a minute of rest the entire hour. They have become non stop.
pt recvd vax & 10 days later was evaluated by MD for sxs of Hodgkin's disease; pt has not recovered;pt cont to receive dose intensive chemotherapy;MD uncertain as to whether there is a relationship between flu vax & hodgkins disease
shingles; Eyes swells a lot; headache; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concurrent medical conditions included Drug allergy. Concomitant products included HYDRALAZINE, LOSARTAN, ATENOLOL, AMLODIPINE, OXYCODONE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) and Ibuprofen for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced HEADACHE (headache). On 05-Apr-2021, the patient experienced HERPES ZOSTER (shingles) (seriousness criterion medically significant) and EYE SWELLING (Eyes swells a lot). At the time of the report, HERPES ZOSTER (shingles) had not resolved and EYE SWELLING (Eyes swells a lot) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient could not see good due to swelling of eyes. Her face was itching, had rash and bumps on her face due to shingles.  Treatment details include acyclovir tablet 800mg 5 times a day, acyclovir ointment.  Company Comment:Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded. Some vaccines have been known to exacerbate latent herpes zoster. Patient has a history of shingles/.  Headache is consistent with the product known safety profile.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.
feels like she is going to die today; sore; red; warm to the touch; swelling in her shoulder and clavicle on the same side of the vaccination; pain in arm; a red circle at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), INJECTION SITE ERYTHEMA (a red circle at the injection site), INJECTION SITE PAIN (sore), INJECTION SITE ERYTHEMA (red) and INJECTION SITE WARMTH (warm to the touch) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025520A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and ZINC for an unknown indication.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in arm) and INJECTION SITE ERYTHEMA (a red circle at the injection site). On 18-Jan-2021, the patient experienced INJECTION SITE PAIN (sore), INJECTION SITE ERYTHEMA (red), INJECTION SITE WARMTH (warm to the touch) and INJECTION SITE SWELLING (swelling in her shoulder and clavicle on the same side of the vaccination). On 19-Jan-2021, the patient experienced FEELING ABNORMAL (feels like she is going to die today). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency. On 14-Jan-2021, PAIN IN EXTREMITY (pain in arm) and INJECTION SITE ERYTHEMA (a red circle at the injection site) had resolved. At the time of the report, INJECTION SITE PAIN (sore), INJECTION SITE ERYTHEMA (red), INJECTION SITE WARMTH (warm to the touch), INJECTION SITE SWELLING (swelling in her shoulder and clavicle on the same side of the vaccination) and FEELING ABNORMAL (feels like she is going to die today) outcome was unknown. Not Provided   It was reported that patient took zyrtec but doesn't know if it worked or not.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Developed shingles beginning 12 days after second dose of Pfizer vaccine.  Condition was diagnosed by a doctor on the 15th day after the vaccine.
Fatigue, Weakness, Fever, swollen lymph nodes (swollen in neck), Nausea, Body Aches, Chills, Sweating, body always felt hot and over heated , headache Used Motrin and Tylenol to help the symptoms
Sore arm, fever onset at 12pm, chills, body aches, joint pain, vomiting and nausea, headaches, profuse sweating
soreness in his right arm injection site; tired/may have felt tired because he was very busy at the time.; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (soreness in his right arm injection site) and FATIGUE (tired/may have felt tired because he was very busy at the time.) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness in his right arm injection site) and FATIGUE (tired/may have felt tired because he was very busy at the time.). At the time of the report, VACCINATION SITE PAIN (soreness in his right arm injection site) and FATIGUE (tired/may have felt tired because he was very busy at the time.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medication were provided.   This case was linked to MOD-2022-568134 (Patient Link).
Sedation, Angioedema, UrticariaPruritus, urticaria right forearm and neck, angioedema of face and neck
Patient was seated in the counseling room after getting the shot and lost consciousness for about 15-20 seconds and came back to consciousness quickly. She was sweating profusely and dehydrated. EMS was called and took further assessments.
Numbness in arm tingling extremities are blue and purple muscle spasms head jerks.
So far four people who were vaccinated in Jan and has already COVID; So far four people who were vaccinated in Jan and has already COVID; This is a spontaneous report from a non-contactable other healthcare professional. This other healthcare professional reported similar events for four patients. This is the first of four reports. An elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 (Lot number and expiration date was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that the patient was vaccinated in Jan2021 and already had COVID. The reporter stated that they don't think they have, they are associating to it at the hospital, but patient was symptomatic. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202101392304 different patient, same event and dose;US-PFIZER INC-202101392306 different patient, same event and dose;US-PFIZER INC-202101392305 different patient, same event and dose
SHARP PAIN AND PRESSURE IN HEAD WHEN BEND OVER; PERSISTENT NAUSEA; NOSE BLEEDS; VERTIGO, SENSITIVITY TO LIGHT; FOGGY BRAIN/DAZED; EXTREME FATIGUE
Increased T ( T not taken /felt hot) Rash beginning on arms->face->chest->back.  Red/blister (similar to chicken pox rash) stomache ache & headache
sore throat, t102, chills, vomited x 4, pain around naval;