chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to) and NO ADVERSE EVENT (no adverse event) in a 50-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-May-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Total 26 doses from Lot 065K21A Monovalent doses were administered after the BUD to patients. Treatment medications were not reported.
weakness; nausea; vomiting; confusion; persistent muscle weakness; movement pain all over; pain all over including injection site; Muscle cramps; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Apr2021 at 19:45 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included post-traumatic stress disorder (Ptsd), depression, sleep apnea, asthma, migraine and carpal tunnel syndrome. The patient was allergic to wasps, yellow jackets and white-faced hornets. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other medications (unspecified) within two weeks prior to vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 20:45, the patient experienced weakness, nausea, vomiting, confusion, persistent muscle weakness, movement pain all over including injection site and muscle cramps. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. On an unknown date, the patient underwent nasal swab test and the result was negative. Since the vaccination, the patient had been tested for COVID-19.The clinical outcome for the events weakness, nausea, vomiting, confusion, muscle weakness, pain upon movement including injection site and muscle cramps were not recovered.   No follow-up attempts are needed; information about lot number cannot be obtained.
PT noticed increased redness, edema, pain and paresthesias. Tx with IV Nafeillin and steroids for possible perineural involvement. Symptoms improved in 72 hrs. Was discharged from hospital. Additional symptoms - nausea, low-grade fever.
After administering the vaccination into the deltoid the patient then started to bleed a little. Within a minute the patient had bled so much that the barrier bandage began to leak. The bandage was removed and there was an area about 2cm in diameter that was raised about 1cm.  A cotton ball was applied with pressure to decrease swelling. A traditional band-aid was placed and the arm was cleaned with an alcohol wipe was used to remove excess blood. The bump remained and bruising was beginning to appear about 3cm in diameter around the injection site when the patient left the room 3 minutes later.
large area of erythema, warmth and tender on arm where injections given/pruritic.
missed the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the second dose) 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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment history was not reported .   Reporter did not allow further contact
Pt recvd vax 31DEC90; 2-3 hrs following immun devel inc swelling & redness of the lt thigh & fever 102-103 range; Pt was hospitalized on 3JAN91 for tx of presumptive cellulitis; tx iv ATB;
Fever; Lethargic; Swollen lymph nodes under left arm, swelling in armpit was about the size of a baseball; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 22Mar2021 at 12:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 12:00, the patient experienced fever, lethargic and swollen lymph nodes under the left arm; the swelling in her armpit was about the size of a baseball. 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 events fever, lethargic and swollen lymph nodes under left arm about the size of a baseball were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pharmacist sterilized the vaccination area prior to starting immunization clinic. Patient received the vaccine on 10/08/2019. Patient states pharmacist swabbed her arm with alcohol and let it dry before administering the vaccine. The patient called on 10/10/19 stating she had a reaction to the vaccine and went to see Dr. Dr. then prescribed her doxycycline for what she thought looked like a cellulitis.
sneezing uncontrollably-wheezing, throat started closing-temp; rx w/ DPH took Chlortrimeton -trouble sleeping/breathing;
Patient was pale, blue lips and cold to the touch.  Decadron and benadryl were drawn up but not used.  Patient was lying down, given water as well as 2 reeses peanut butter cups to increase blood sugar.  She was feeling better after this, no hives or airway compromise.  Patient was observed for approximately 20minutes and was OK to go home with mom at this time.  Mom advised to go to ER should any difficulty breathing happen.
Headache, Myalgia & Fever  Narrative:  Per supervisor report: "received 2nd COVID  injection on 3/23/2021. C/O symptoms low grade fever, headache, body aches."
Patient is under 18 years of age and was given the 1st dose Moderna Vaccine.   Patient has no AE at this time.
Started experiencing hives on both arms just over 48 hours after receiving monkeypox vaccine. No issues breathing or other signs of serious reaction, just hives which appear to be getting better/going away just under 72 hours post- vaccine/just under 24 hours of noticing hives. Unsure if hives were caused by vaccine or unrelated factor but was advised to report.
Given 2 different COVID vaccines. Dose #1 Pfizer, Dose # 2 Moderna.  Patient was observed on site during both vaccinations, no reported adverse events.
Expired dose was given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMV8638A, expiry date 30th November 2022) for prophylaxis.   On 1st December 2022, the patient received Menveo. On 1st December 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 02-DEC-2022 Reporter's Comment: The reporter reported that the patient received a dose of Menveo and it was already expired.  The reporter consented to follow up by email. Additional Supportive Information: The use of Menveo dose, which was already expired on 30th November 2022, which led to expired vaccine used.
Nurse administered vaccine too high per patient. Says the moderna gave her a headache for a few hours within a few hours. However, within 2 hours from vaccination she had extreme pain, some bruising at injection site, difficult to lift arm up, was taking ibuprofen q 4 hours for pain. Wonders if nurse hit a nerve bundle. Is getting better now. Advised to be seen by a doctor.  Doesn't know if she will as it is getting better but her objective is education for this nurse on location of vaccine administration. She had received flu vaccine ~4 days prior.
PATIENT HAD THE FOLLOWING SYMTOMS AFTER RECEVING THE PFIZER COVID VACCINATION. MORNING OF MARCH 23RD HE WAS NOT WELL AND STATED HOME FROM WORK. SYMTOMS WERE AN UPSET STOMACH, UPPER BACK SORENESS, AND SORENESS OF ARM. DURING THE AFTERNOON HE TOLD HIS WIFE HE NEEDED TO LAY DOWN AND NEVER REGAINED CONCIOUSNESS BEFORE AND AFTER EMS WAS CALLED @7PM.  SPECIFIC DETAILS OF EMERGENCY MEDICAL CARE CAN BE GATHERED FROM THE HOSPITAL. UPON VISITING PATIENT AT POST MORTUM, STAFF NURSE INFORMED ME THEY WORKED ON HIM FOR OVER AN HOUR BUT THEY NEVER GOT A PULSE. FURTHER DETAILS SUCH AS LOCATATION OF VACCINE ADMINISTRATION MAY BE GATHERED BY THIS AGENCY FROM HIS WIDOW.
Extreme fatigue; Headache; Severe joint pain; severe nausea; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0187) via an unspecified route of administration in the right arm on 15Jun2021 at 18:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included Takayasu arteritis. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (MANUFACTURER UNKNOWN), calcium/ colecalciferol (CALCIUM D), multi-vitamins and vitamin d nos (MANUFACTURER UNKNOWN), all for unknown indication from an unknown date taken within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0176) via an unspecified route of administration in the right arm on 25May2021 at 18:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Jun2021 at 21:00 Within 3 hours of vaccination experienced severe nausea that needed medication. Approx. 24 hours post injection, on 16Jun2021 experienced extreme fatigue, headache, and severe joint pain that was so intense that she was unable to move without being in excoriating pain. Since the vaccination the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the reported events nausea, fatigue, headache and severe joint pain with zofran 8 mg and ibuprofen 500mg. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe nausea and headache was recovered on unknown date in Jun2021. The clinical outcome of the event extreme fatigue was recovered on 19Jun2021, 72 hours post onset. The clinical outcome of the event severe joint pain was recovered on 17Jun2021, 24 hours post onset.
I was test positive for COVID after receiving the first dose of the Pfizer COVID-19 vaccine; I was test positive for COVID after receiving the first dose of the Pfizer COVID-19 vaccine; fatigue; This is a spontaneous report from a contactable consumer. A 19-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number were not reported) as single dose for covid-19 immunization. The patients medical history and concomitant medications were not reported. It was reported I was test positive for COVID after receiving the first dose of the Pfizer COVID-19 vaccine. I have completed my 14 days of quarantine and still feel fatigue on an unspecified date. The outcome of the event was unknown for covid-19 and not recovered/not resolved for fatigue.   Information on the Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Slight swelling from injection site (RA) down to the elbow on back/side of arm, Warm to touch. Patient noticed the next morning and took Benadryl for the time until she came into pharmacy on 10/16/15 where she talked with me about interaction, I notified MD and told her to continue with Benadryl and to see doctor if anything gets worse or does not get better. MD suggested that the patient needed to come in only if the patient felt the need and did not require being seen.
Patient called pharmacy on 10/5/17 at 8:15pm. Stated she had extreme soreness/stiffness in arm as well as warm to touch and a rash. Told patient we would call physician. Educated patient to take diphenhydramine/available NSAID and ice area of injection. Educated patient to call physician as well in the AM. If symptoms continued to worsen, educated to seek medical attention. Will call patient back in AM on 10/6/17
Client arrived at clinic as walk in for influenza and 1st dose Pfizer monovalent. Through provider discussion, provider advised the client it is recommended and would benefit her health to complete Hep -A series. Client agreed. Provider administered the ped dose Hep A.  Client  left clinic after 15 minutes and before provider could notify her. Provider contacted client over phone to let her know she received the incorrect vaccine. Client agreed to receive the 1st adult dose when she returns for her second monovalent Pfizer dose on 4-28-23 @ 9AM. Client over phone reports no adverse events
Sterile abcess requiring incision and drainage at site of pneumococcal vaccination; patient had also received influenza vaccine in same arm; Influenza vaccine administered 10/24/05, 17:30; same arm used because patient being treated for cellulitis in other arm.
Fever and chills, myaglias that started about 12 hours after the vaccine, completely resolved by 24 hours after vaccine administration
PT PRESENTED AT PHARMACY 2 DAYS POST VACCINATION WITH REDNESS NOT AT INJECTION SITE. LATER PROGRESSED TO SWELLING ON THE INNER BEND OF THE ELBOW. HE REPORTS THAT HIS DOCTOR DIAGNOSED HIM WITH CELLULITIS AND PRESCRIBED DOCXYCYCLINE.
According to care giver patient had an allergic reaction with swellling, rash and pain in left  arm
Swelling, redness and pain began about 4 hours after administration. Fever, intense swelling, nausea, fatigue, weakness, persisted for about the next 36 hours. Saw my PCP about 24 hours later. Diagnosed as cellutius. Given Keflex and Prednisone. Symptoms began to subside about 36 hours after beginning prednisone and were mostly disapitated approximately 4 days later.
Patient received the vaccine on 7/2/19. Patient called 7/5/19 stating that she is in the hospital possibly due to adverse effect from the Pneumovax 23. She said her arm is extremely swollen and she had fevers.
pain in both rotator cuffs for about a month prior to the 2nd full dose due to rotator cuff tendonitis; experienced arm soreness and swelling in the injected arm after the 1st full dose; experienced arm soreness and swelling in the injected arm after the 1st full dose; This spontaneous case was reported by a patient and describes the occurrence of ROTATOR CUFF SYNDROME (pain in both rotator cuffs for about a month prior to the 2nd full dose due to rotator cuff tendonitis), VACCINATION SITE PAIN (experienced arm soreness and swelling in the injected arm after the 1st full dose) and VACCINATION SITE SWELLING (experienced arm soreness and swelling in the injected arm after the 1st full dose) in a 72-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ROTATOR CUFF SYNDROME (pain in both rotator cuffs for about a month prior to the 2nd full dose due to rotator cuff tendonitis), VACCINATION SITE PAIN (experienced arm soreness and swelling in the injected arm after the 1st full dose) and VACCINATION SITE SWELLING (experienced arm soreness and swelling in the injected arm after the 1st full dose). At the time of the report, ROTATOR CUFF SYNDROME (pain in both rotator cuffs for about a month prior to the 2nd full dose due to rotator cuff tendonitis) and VACCINATION SITE SWELLING (experienced arm soreness and swelling in the injected arm after the 1st full dose) outcome was unknown and VACCINATION SITE PAIN (experienced arm soreness and swelling in the injected arm after the 1st full dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Patient reported his experiences after receiving 2 primary doses (2nd dose lot # unknown).  Patient experienced arm soreness and swelling in the injected arm after the 1st full dose and patient wasn't sure if he experienced any injection arm soreness after the 2nd full dose because he had been experiencing pain in both rotator cuffs for about a month prior to the 2nd full dose due to rotator cuff tendonitis and thinks it may have masked any injection arm soreness they may have had. Patient has not experienced any injection arm soreness today and is now worried whether or not he received any vaccine.  No treatment details were reported.   This case was linked to MOD-2022-580217 (Patient Link).   Reporter did not allow further contact
This spontaneous report was received from a health care worker regarding a 3 month old male patient. On 25-FEB-2005, the patient was vaccinated with MMR II (therapy type HSA), subcutaneously when the patient was 11 months old. The patient also received first dose of VARIVAX at the age of 11 months. A second dose of MMR II was administered to the patient on 29-MAY-2009. The patient also received a dose of PROQUAD on 23-JUN-2004 due to the first dose of MMR II not being valid. No adverse effect was reported. Outcome of the medication errors was unknown. Additional information has been requested.
Anxiety. Increased migraines. Hypersensitivity to sunlight, noise. Swelling and pain at injection site.
The varicella vaccine was given on January 7th, 2019 in my son's left upper arm. On January 13th, a red spot appeared in the area where the vaccine was given. It was a red spot slightly bigger than the size of the quarter. The next day the spot became a lump and was hot to the touch. The spot has been like this for two days and I am still monitoring it at this time.
Initial and follow-up information has been received from a licensed practical nurse concerning a female patient who on an unspecified date was vaccinated with MUMPSVAX instead of with MMR II. There were no adverse effects reported. The nurse said the error was not due to product label confusion. It was reported that the first nurse pulled a vial from the MUMPSVAX box without verifying it. After dose administration, the nurse put the vial into the MMR II box. Subsequently, another nurse pulled the same MUMPSVAX and administered it. It was noted the neither nurse caught the error at the time of administration. The error was noticed at the end of the day. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. Additional information requested. This is one of several reports from the same source.
Developed acute appendicitis symptoms around 8:00am on 10/18/21. Taken into ER for testing by 12:30am on 10/19/21.  Bloating Cramps/tenderness in lower abdomen  Fever/chills Body aches Headache
No adverse event; HCP called in and reported that an expired dose of VARIVAX was administered on 10/31/2022. Caller did not report any temperature excursion. Caller reports the vaccines expired on 10/05/2022. No further information was provided to further clarify any; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported.  On an unspecified date, the first and second dosages of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, route of administration, indication, lot number and expired date were no reported). On 31-OCT-2022, the patient was vaccinated with an expired vaccine third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (oral liquid, third dose, Lot #1742084, expiration date: 05-OCT-2022 (strength, route of administration, and indication were not reported). It was specified that no mention of any temperature excursion was made, and no further information was provided to further clarify any. No adverse event was reported. At the time of reporting, the outcome of the event not reported.  The action taken with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) regarding the event was not reported  The causal relationship between the event and the suspect vaccine was not reported.; Sender's Comments:  US-009507513-2211USA000276
9 days after receiving the COVID 19 vaccine, the injection site became red, swollen, itchy, slight pain.   2 days later, still have the same symptoms. Cortizone cream and allergy medicine keep the itching at bay.
Patient was a 45 y/o,  G2P0, 39.3 weeks gestation, IVF pregnancy with Gestational Diabetes that was controlled with diet and gestational hypertension. Pt had history of 1 spontaneous abortion.  EDD 4/30/21. Pt received her second dose of Pfizer COVID 19 Vaccine on 4/23/21, on that same day she had an ultrasound to check on fetus and fetus received a Biophysical Profile Score of 8/8. On Monday, 4/26/21, pt went to hospital complaining of decreased fetal movement, ultrasound confirmed an intrauterine fetal demise.  Pt delivered via C-Section on 4/27/21, birth weight of baby was 8 pounds 12oz.