chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a register nurse concerning a patient of unknown age and gender who on 02-APR-2014 the patient was vaccinated with VARIVAX (Merck) instead of ZOSTAVAX. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Child developed diarrhea and arm became red and hot after vaccines were administered - dx with local reaction - prescribed Atarax and Elocon.
1)In the early evening I started to notice that I was feeling "movement" just below the skin in my arms and legs.  I was resting trying to let the vaccination work and it just kept happening.  It feels like it is in the nerve or muscles.  Today the sensation continues anytime that the muscles/body part are not actively in use.  2)I had a metal taste in my mouth minutes after the shot.  It went away after a couple hours.  3) My left arm was swollen and red for two days and now only hurts when pressure is applied and is now fine. 4)I did not have any fever, diahrea, vomiting,
This spontaneous report as received from a pharmacist refers to a 1 year old patient of unknown gender. On 23-SEP-2013, the patient was vaccinated with a dose of PROQUAD (Merck) (lot # J006869, expiration date reported as 14-DEC-2014, dose and indication not reported), subcutaneous, which was an order received into the pharmacy and placed into the refrigerator at normal refrigeration temperatures of 36-46 degrees Fahrenheit (F) on 16-SEP-2013. The patient received PROQUAD (Merck) along with VARIVAX (Merck) (lot #, expiration date, dose, route and indication not reported) in error. No known adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
20 minutes after injection metal taste in mouth. Metal taste as lasted 2 and half days. Seems to be lessening. Arm sore at injection site and to elbow. Gone after 2 and half days.
Woke up with left thigh red and swollen. Per MD had 3" x 4" skin reaction.
Patient experienced a mild reaction with first Covid vaccine and upon second vaccine administration, patient experienced numbness in ear and jaw, hives, nausea, dizziness, and tachycardic. Patient was seen in the emergency department given diphenhydramine 50 mg, famotidine 20 mg, ondansetron 4 mg, and 1L of sodium chloride. Patient was monitored, EKG normal, and then discharged.
FEELING LETHARGIC; HAVEN'T BEEN FEELING GOOD EVER SINCE; OCCASIONAL SHORT FEVER MILD; SEVERE NAUSEA; STOMACH UPSET EVERY TIME WHEN EATING AND FASTING; BRAIN FOG; BLOATING AFTER EATING; DISCOMFORT; This spontaneous report received from a patient concerned a 32 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced stomach upset every time when eating and fasting. On 11-APR-2021, the subject experienced brain fog. On 11-APR-2021, the subject experienced bloating after eating. On 11-APR-2021, the subject experienced severe nausea. On 11-APR-2021, the subject experienced discomfort. On 11-APR-2021, the subject experienced haven't been feeling good ever since. On 11-APR-2021, the subject experienced occasional short fever mild. On 12-APR-2021, the subject experienced feeling lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from occasional short fever mild, and had not recovered from stomach upset every time when eating and fasting, discomfort, severe nausea, brain fog, bloating after eating, feeling lethargic, and haven't been feeling good ever since. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.
A report was received from a health care professional on 01/03/03, concerning a pair of of twins between 1 and 1.5 years old of unknown sex who inadvertently received Fluvirin on an unspecified date. There was insufficient information to determine the reporter's causality assessment.
Pt recvd vax 12MAY92 & exp exacerbation of the dermatitis; seen by MD dx lichen planus;
Arm was swollen the size of a fist; Real hard; Real hot like you can light a cigarette off it; Fire engine red; Itch real bad; Light headedness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen the size of a fist), INDURATION (Real hard), FEELING HOT (Real hot like you can light a cigarette off it), ERYTHEMA (Fire engine red) and PRURITUS (Itch real bad) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen the size of a fist), INDURATION (Real hard), FEELING HOT (Real hot like you can light a cigarette off it), ERYTHEMA (Fire engine red), PRURITUS (Itch real bad), DIZZINESS (Light headedness) and CHILLS (Chills). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm was swollen the size of a fist), INDURATION (Real hard), FEELING HOT (Real hot like you can light a cigarette off it), ERYTHEMA (Fire engine red), PRURITUS (Itch real bad), DIZZINESS (Light headedness) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Tingling like sensation/left forearm/arm, headache. Evaluated by EMS-Cleared
pt recv vax; w/ in 3-4 hr p/ vax, felt hot and had chills, flu like sx and fever of 101; w/in 12 hr p// vax he was sweaty & fever of 103; tx apap, sx resolved;
Patient had Covid-19 after his first Moderna Covid-19 vaccination; Greater than 36 days between Moderna Covid-19 vaccinations/never received his second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient had Covid-19 after his first Moderna Covid-19 vaccination) and PRODUCT DOSE OMISSION ISSUE (Greater than 36 days between Moderna Covid-19 vaccinations/never received his second dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient had Covid-19 after his first Moderna Covid-19 vaccination) and PRODUCT DOSE OMISSION ISSUE (Greater than 36 days between Moderna Covid-19 vaccinations/never received his second dose). At the time of the report, COVID-19 (Patient had Covid-19 after his first Moderna Covid-19 vaccination) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Greater than 36 days between Moderna Covid-19 vaccinations/never received his second dose) had resolved.        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.   No Concomitant medications were reported. No Treatment medications were reported.; Sender's Comments: This spontaneous case concerns a 65-year-old male patient with  no relevant medical history who experienced non serious unexpected event of special interest COVID-19. The event occurred after the first dose of Spikevax however, the exact time to onset was not provided. Reportedly, the patient had only received the first dose of Spikevax and never received the second dose. Rechallenge was not applicable since no rechallenge was done and thus, recurrence is not applicable.  The benefit-risk relationship of drug is not affected by this report. Additional event of Product dose omission issue reported since the patient never received the second dose.
11 days after getting the Moderna vaccine I started getting  hives on my arms in the morning. Very itchy with small bumps. I have been taking Benadryl once a day when it occurs, and will try to see a dermatologist today.
Just below the injection site it was redness and slight swelling in the upper arm. The very next day the swelling went completely down her arm to elbow. It was itchy and red. The doctor said it was fluid, allergic reaction, and cellulitis of the left arm. It was an infection that was swollen and painful.  She was prescribed Bactrim to take one tablet twice daily for seven days. She started it on November 7th, 2021. Triamcinolone was prescribed to relieve the itching.  The was no reaction to the first two.
C/O stiff neck, blurred vision started about 3 days after. Vision cleared <24 hrs. Neck stiff about 48 hrs.
Myalgia, NauseaVomiting, Neck pain, Hot & Cold flashes, Injection site pain Narrative:
Per pt reported that she had intermittent "shocks in random parts of my body like my right hip my face and my breast." They lasted 1 week per pt then resolved.
Patient received a dose of Pfizer COVID-19 Vaccine (PEDS) pediatric formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9% NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL, 0.9% NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vial was initially stored in the refrigerator on 04 Nov 2021 and the vial did not undergo any temperature excursions. It was reported that, some patients took dose on 05 Nov 2021 and the other patients took dose on 12 Nov 2021.  The patient did not experience any events, because of this misadministration.  No treatment information was provided by the reporter.
No adverse event noted. Vaccine found to be given after 12hr of recommended stability at Room temp.
Patient reported that she had severe pain at the time of the injection on 9/11/12 but thought the pain would get better in a few days. She stated the pain did not get better and is very stiff and sore every morning. She went to a physician on 10/15/2012 and he referred her for a physical therapy evalation that is scheduled on 10/22/12. She states she was prescribed muscle relaxers and pain pills. This incident was reported to RN on 10/17/12.
Hot, red localized rash 9 x 13.5cm large ring. 75mm x 112mm darkie ring. Given Rabies, Typhoid, Meningococcal at same time. First noticed after approximately 24-36 hours slight redness. 48 hours had present reaction.
Pt given MMRV (Proquad) and Varicella (Varivax) in same visit. No reaction after 15 min observation. Advised to monitor for anaphylaxis symptoms or seizures and go to nearest emergency hospital and notify the health department after discharge.
I gave her combination vaccine DTaP + Hep B + IPV.  She didn't need Hep B + IPV.
Patient woke up the day after having her booster with a fever, chills, and body aches.
Within a minute of receiving the vaccine, while seated in the vaccination chair, RN noted the client's eyes were rolling backward and the client's body was sliding down in the chair after receiving the vaccine. RN assisted to hold the client's body in a safe position in the chair. RN responded and performed a sternal rub on the client. RN noted the client's legs kick a few times. The client was verbally responsive following the sternal rub. The client was alert and oriented to person, place, time, and situation. The client reported feeling cold, but denied any other signs or symptoms. RN responded. The client denied any current symptoms. The client denied any known allergies, chronic conditions, or current medications. The client last ate at 3:00PM but stated he was stressed prior to receiving the vaccine. When the client stated he felt safe to ambulate, he stood up unassisted, ambulated with a steady gait, and sat down in the anti-gravity chair in a high fowler's position. The client did not recall the period of time that he was not verbally responsive. The client stated, "I was dreaming." Vitals obtained at 5:18PM were as follows: BP 128/93, HR 72, and O2 96%. The client denied any symptoms. RN provided education regarding s/s of anaphylaxis and when to seek EMS. The client voiced understanding of this education. The client denied any history of syncope with receiving vaccines. The client previously received the 1st dose of COVID vaccine Jannsen (Lot# 1821286) on 06/17/21. At 5:25PM the client denied any symptoms. RN Portillo noted the client appeared calm and his body was relaxed. At 5:32PM the client verbalized he was "feeling good" and stated a friend was driving him.
approx 5-6PM started w/feeling sick to stomach, no fever then eeys swelled partially closed, face swelled;mom gaveDPH did not notify MD;mom noticed leg was not swollen, but had little bruise @ site
Chills, fever, fatigue, body aches. Started around midnight day of vaccine and continues 3 days later
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 07-JUN-2017, the patient was vaccinated with a dose of improperly stored ROTATEQ, orally, lot # M039061 with expiration date of 28-APR-2018 (dose was not reported). The vaccine experienced temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Digital data logger was involved in recording the excursion. No adverse effects were reported. Additional information has been requested.
Fainting synscope,  Extreme fatigue which continues to these day. Light-headedness, dizziness and new usage. Blood pooling in my feet.
Fever 102 F, chills, aches two nights, Tylenol as directed for three days.
Second day after shot I experienced fatigue, slight nausea for 24 hours.  Injection site was sore for approx. 3 days.    5 days after injection I woke up with hives on both legs.  7 on left leg and 4 on right leg.  They are not itchy.
numbness of left hand and fingers; Pain on forearm (Pressure feeling); Pain on forearm (Pressure feeling); This is a spontaneous report from a contactable pharmacist. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on 30Dec2020 at 12:30 on left arm at a single dose for COVID-19 immunisation. The patient has no medical history. The patient's concomitant medications were not reported. The patient started feeling numbness of left hand and fingers after 10 minutes (30Dec2020 at 12:40) and pain on forearm (pressure feeling) 30Dec2020 at 12:30. There was no treatment received for the events. The outcome of the events was recovered on an unspecified date.
Information has been received from a registered nurse practitioner concerning a 9 year old female with no medical history and no allergies who on 4/19/96 was vaccinated SC in the arm with a first dose of varicella virus vaccine live (lot # 616862/1504B). Concomitant vaccine therapy given SC in the arm included a first dose of MMR live (lot # 613405/1415B). There was no illness at the time of vaccination. On 5/29/04 the patient presented to the physician's office with about 500 plus lesions and a pruritic rash that spread to his back, arms, face, and legs. The patient was treated with diphenhydramine. No lab studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. No further information is expected.
Pt developed itching and induration (R) upper thigh and redness extending to ant abd. - by 2nd day seen urgent care given antibiotic - seen in office 3-4th day reaction persist only locally. Also lymphadenopathy (R) groin.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 1:33 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 1:33 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was unknown whether patient was ever diagnosed with COVID-19.  The information about allergies, acute illnesses, chronic or long standing health conditions, information about other medications (prescription, OTC, dietary supplements or herbal remedies) at the time of vaccination or at time of reporting were unknown.  The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial was initially stored in refrigerator on 03-Nov-2021 and moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions were reported.  No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
Body/joint aches, fatigue, headache, chills, labile blood sugar for 2 days. Pain to left arm for 1 week, limited ROM.  Lip ulcer (canker sore) 1 week after vaccination (last time I had one was in my 20's)
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions/allergies and medical history were not reported. On 06-JUL-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally, lot number was L037921 and expiration date of 31-MAY-2017(strength and dose were not reported). No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
severe headache, fatigue, dry mouth, generalized malaise began the evening of the administration. Teen took Tylenol and oral fluids. When mother called, she was advised to seek medical attention if symptoms persist.
Had the COVID during the trial; Had the COVID during the trial; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Had the COVID during the trial". Clinical courses is as follows: I had the COVID during the trial. we have already reported this information while we were a part of the COVID trials. Wife reports, My husband he needs the omicron/flu shot or he will die if he catches the flu.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
patient stated that a rash and itch appeared at injection site 7 days following the immunization. It got larger over a few days and patient took benadryl to help with the symptoms. She said she did reach out to her doctor at my suggestion but did not get any follow up form her doctors office.
Pt developed a 12 x 6 cm area of redness, swelling and warmth to touch on left arm.
Patient said the vaccination hurt when it was given. I told her that her arm may be sore for a couple of days.  On 10/9/14 the patient called and said that her arm was still sore and the soreness was moving up to her neck. The pharmacist that was talking to her told her to notify her doctor.
NARCOLEPSY, UNSPECIFIED 3/27/2022,  5/13/2022,  5/17/2022,  5/29/2022,  7/26/2022,  8/3/2022,  8/26/2022,  10/29/2022,   1/2/2023,  12/25/2022  -- RECURRENCE OF SAME SYMPTOMS
Bump and pain in left deltoid, still persistant, pain sometimes when moving along the arm. Patient using aleve for pain md suggested x-ray