chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Vaccine administered past the 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered past the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered past the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered past the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered past the 30 day beyond use date).    No concomitant medication was reported.   It was reported that Vaccine administered past the 30 day beyond use date and conduct a lot assessment for the following Lots with Dates moved to refrigeration: Moderna, 014B22A, 13-JUN-2022 Moderna, 011B22A, 21-JUL-2022 Moderna, 063B22A, 12-SEP-2022 Moderna, 074B22A, 04-NOV-2022 Moderna, 015B22A, 04-DEC-2022 Moderna, 020H22A, 07-NOV-2022 Moderna, 011H22A, 04-DEC-2022 Moderna, AS1414B, 21-JUN-2022 Moderna, AR9236B, 28-AUG-2022 Moderna, AR4504B, 18-JUL-2022 Moderna, AR5186C, 09-SEP-2022  Source email was from MI-00010791.  It was reported that the office was aware of 3 patients that had received mention vaccine vials.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-705204, US-MODERNATX, INC.-MOD-2023-706506 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2023: Significant follow-up appended _Dosage information updated. On 31-Jan-2023: Significant Live follow up appended : Dosage information updated On 31-Jan-2023: Significant live FU received: Narrative updated. On 01-Feb-2023: Non Significant follow up appended; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705204:Master case (Patient 1 of 3) US-MODERNATX, INC.-MOD-2023-706506:Patient 3 of 3
Shingles rash onhis left waist; Rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient after vaccination broke out with singles. The patient stated that probably was coming down with them. The patient asked whether to get quadravalent flue shot and 2nd dose of Shingrix. The patient really do not like adverse reactions. The patient consented to follow up.   Follow up information was received from the pharmacist on 14th November 2019: The reporter followed up with Medical Information on 14thNovember 2019 and stated the shingles rash was located on his left waist and his physician prescribed Valcyclovir and a Medrol dose pack, which he has completed. In September 2019, 3 days after receiving Shingrix, the patient experienced rash.  On an unknown date, the outcome of the rash were unknown.  It was unknown if the reporter considered the rash to be related to Shingrix. No further details provided at the time of reporting.
After receiving her vaccine for the flu, patient watched her father receive his flu vaccine, and as her mother was about to receive her vaccine she started to not feel well and fainted in her chair and urinated. I used an Ammonia inhalant and she was alert within 30 seconds. She was monitored over the next  20 to 30 minutes and felt better before leaving with her parents.
ProQuad given SubQ to L leg. Swollen, hard at injection site. Seen in office 2 days after shot administered because of parental concern. Also-site was itchy.
He states he had the first Pfizer COVID-19 vaccine in the series on 4/13/2021.  He states that two days later on 4/15/2021 he felt like his feet were heavy.  He continues to experience that sensation in his feet, and even feeling like his feet are asleep at nighttime and when he first gets up in the morning.  The asleep feeling in the feet gets better when he gets up and moves around but the heavy sensation in the legs does not get better.  He states that his mobility is affected though that his legs feel heavy and he is not as easily mobile as he used to be. He feels his balance is off. Patient later reported that he did have and episode of syncope about 5 minutes after he got the vaccine but otherwise was doing okay until 4/15/2021.  He presented to the ED with these symptoms on 5/3/2021 at approximately 7:14pm and was admitted to the hospital for evaluation.  Patient states that he normally exercises regularly and has been having a great deal of difficulty especially with squatting and now has difficulty walking up stairs, feels very weak and his legs feel heavy.   He reports that the numbness and tingling sensation of his feet when sleeping is new and he has never had it in the past.  Symptoms get worse with exertion and prolonged activity.  Neurologist was consulted and several tests were ordered.  Neurology consult noted that patient had a prior COVID 19 infection in November 2020.  Per neurologist notes: His symptoms first started about two days after he received Pfizer COVID vaccine on April 13, 2021.  He recalled feeling his feet heaviness and it was hard to pick them up.  He also had some calf pain.  He also had difficulty with doing his stretches and yoga positioning.  A week ago, he began to have difficulty with picking up a ball or anything from the ground.  He also developed pins and needles at the fingertips at the same time he developed tingling sensation of his feet.  He also has lower back pain.  He tested positive for SARS-COV-2 antigen on November 12, 2020.  He recalled having symptoms lasting for a few days consisting of diaphoresis, cough, and flu-like symptoms.  Per neurologist, symptoms seem to resemble acute inflammatory demyelinating polyneuropathy (AIDP).  Patient was treated with IVIG for 5 days.
Patient was given Moderna Bivalent vaccine but only received one dose of Moderna Monovalent vaccine. Patient should have been offered and given dose two of Moderna not Bivalent booster.
patient had patch of hives on thigh; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; trade name reported as "Comirnaty"), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunization. Medical history included allergic reactions (has had allergic reactions before). The patient's concomitant medications were not reported. On an unspecified date, post first Pfizer vaccine for COVID, the patient had patch of hives on thigh with outcome of unknown.   Information on the batch/lot number has been requested.
gen hives & facial swelling approx 30min p/vax;most notable urticaria around DTP inj site;
On 11/21/20222 I had headache, scratchy throat. I tested positive on 11/22/2022 using a home COVID-19 test.  After testing positive  I had more symptoms such as  a fever, cough, body aches and head cold. I did a telehealth on the same day with  my doctor who then  prescribed me with Paxlovid for 5 days. I did a home test 11/30/2022 which was negative. After 5 days on 12/04/2022 I tested positive again. I had a rebound case of COVID-19. I woke up with a scratchy throat in the morning. I was light headed for 1 week. This time I didn't take any medication I got better in a week.
22 week old infant presented to clinic with mother on 1/21/22. Mother requested that child receive only Rotavirus vaccine at this visit. Mother presented vaccine record from child's pediatrician office. Child had been vaccinated for all other age appropriate routine vaccines at pediatrician's office on 1/11/22. Mother reported that pediatrician referred her for Rotavirus vaccine because they did not have it in stock. I administered one dose of Rotateq orally during clinic visit on 1/24/22. Two hours later, I realized that the dose was given in error, due to the child's age of 22 weeks. First dose of Rotateq should not be given if child is older that 15 weeks.   I contacted  the child's mother by phone at 4:50pm on 1/21/22. I explained the error, and risk of intussusception. I provided education on warning signs of intussusception- increased fussiness, signs of abdominal pain like drawing up knees, straining, inconsolability, vomiting & changes in stool (blood or mucus in stool). Mother agreed to watch for signs and to contact pediatrician right away if she sees any in the next 7-10 days, or go to ER.  I also discussed the recommendation to complete the Rotateq series now that it has been initiated, and she agreed to return to the clinic in 4 weeks so that child can receive 2nd dose.
Redness and swelling noted at injection site, RD extending to elbow. C/O H/A and nausea advised to take BENADRYL, TYLENOL, ADVIL as directed and if no allergies as needed and to follow-up with MD.
Hives all over body for two weeks. Treatment: still treating with benadryl, patient will see doctor soon.
Case number PHEH2014US022570, is an initial spontaneous report received from a nurse on 10 Nov 2014, with a follow up report received from the nurse on 15 Dec 2014. This report refers to an 11 year old female patient. Her medical history and concomitant medication were not reported. Her vaccination history include administration of HVP4 (human papilloma vaccine), FLUMIST and TDAP vaccines in the past. On 24 Oct 2014, she was given the initial application of MENVEO (batch number: M14023) intramuscularly at a dose of 0.5 ml. It was reported that before administration the MENVEO had a temperature excursion of 1.4 degree C for 12 minutes (not frozen). No adverse event was reported following this administration error (incorrect storage of drug). Follow up report received from the nurse on 15 Dec 2014: Updated patient demographics (initials and age), vaccination history and suspect vaccination details (initial application, at 0.5 ml).
Moderna COVID-19 Vaccine EUA injection site developed a rash and blister on day 2. Left injected arm itched from day 1-7.
Possible shingles outbreak left thorax /back radiating to lower left breast. Burning, painful rash with cluster of papules. Began 10/27/21. Associated with fatigue, headache, diarrhea, body pains, chills.  Also noted swollen glands on right side of neck. This was in setting of frequent skin eruptions to bug bites during the summer of 2021. Received booster  covid vaccine 9/20/21. Patient started valtrex on 10/27/21 1000 mg TID for 7 days and complete treatment along with topical hydrocortisone.  The rash resolved within a few days of treatment but has residual burning sensation at that site.
not feeling well; sinus issues; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting) from a Pfizer sponsored program Support. A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number and expiration date was not reported), via an unspecified route of administration on 20Feb2021 at a 1st dose, single for COVID-19 immunization. Medical history included COVID-19 from 18Jan2021 (the caller stated she tested positive for COVID on the 18Jan2021 or 19Jan2021). The patient's concomitant medications were not reported. On 20Feb2021 the patient experienced the reporter stated she tested positive for COVID on the 18Jan2021 or 19Jan2021. Her husband scheduled her to get the vaccine and when patient got there, they said she should wait 90 days to get the vaccine but since patient was there they said she could go ahead and get it. Patient received this dose, the first dose, on 20Feb2021. She was not feeling well then when she got the vaccine and then she had a little downturn after the vaccine and was not sure if it was from the vaccine or from getting over COVID . She did not have a fever, just some sinus issues. Patient called to ask, if you had COVID and get the first dose and the second dose necessary. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
This spontaneous report as received from a physician refers to an 13 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 05-JUL-2017, the patient was vaccinated with an improperly stored GARDASIL 9 lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766.
Pt vaccinated with DTP on of two children who had a "severe" crying spell within 3 hrs of immunization.
Body ache; soreness at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache) and VACCINATION SITE PAIN (soreness at site of injection) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced MYALGIA (Body ache) and VACCINATION SITE PAIN (soreness at site of injection). At the time of the report, MYALGIA (Body ache) and VACCINATION SITE PAIN (soreness at site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Anaphylaxis - Benadryl, Epinephrine, Prednisone
Information has been received from a registered nurse RN concerning a 4 year old male who on 12FEB2003 was vaccinated with a dose of varicella virus vaccine live (lot 643593/0868M). The RN reported that on 15FEB2003, the patient developed several vesicular lesions at the injection site. Unspecified medical attention was sought. At the time of this report, the outcome was unknown.  The RN also reported that the patient's 7 month old sibling also developed vesicular lesions after being exposed to the brother's vesicular lesions (WAES0303ISA002901). Additional information has been requested.
Itchy, chest pain immediately after injection, SOB increase HR. EMT providers on site, EKG, vitals. No medications administered.
Day 1.  Pain and soreness , red at injection sight, upper left arm,and a few hours later, pain in both sides of neck, subsided after a few minutes. Day 2. Pain and soreness red, at injection sight Day 3. Pain and soreness , red at injection sight, and experienced small muscle spasm from right corner of nose to right side of mouth, lasted only a few minutes, had never experienced anything similar in the past. Day 4-8 Slight soreness at injection sight Day 9. Injection area became itchy, as I scratched I noticed my arm felt warm and thicker than other arm.  Almost dome shaped and the size of my  hand as I touched it.  Skin felt leathery somehow,  and appeared red in a circular shape around injection site. Day 10 (today) Less sore but still slightly tougher feeling, leathery, slightly pink in the area of injection, dome shape seems to have lessened.
Pt received her second dose of Moderna COVID-19 on 3/29/21. Lot number is not specified in medical record. Pt was admitted to reporting hospital on 8/23/21 with an admitting diagnosis of weakness and diarrhea. Pt was reported in the ER to have diarrhea, generalized body aches, headaches, cough and weakness. Admission test for COVID was positive per PCR NP swab on 8/23/21. Pt is currently still admitted.
Chills started last night , progressed to more chills , body ache , fatigue fever of 100.5  still going on at this time , 4pm March 7th 2021
This spontaneous report as received from a licensed vocational nurse and registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of PNEUMOVAX23 (lot # K006681 with expiration date 21-OCT-2015; dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Arm and face tingling. After we got home from appointment. I went to take a 30 min nap and my arm tingled in the upper half near the injection site (in the same way it would feel waking up from being asleep).  Around 6:15pm that evening, I was taking a walk and my face began to tingle in the same way (though the "pins" felt smaller then on my arm. Tingling was all around mouth, up into sinus areas on my face. This concerned me and lasted until around 10pm that night. Arm was very sore for 4-5 days.
Fever 102.5 axillary the evening after immunizations administered. Advised to give Tylenol.
Received dose from vial punctured for more than 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured for more than 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured for more than 12 hours). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured for more than 12 hours) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F)24 hours. It was at room temperature since the moment it was punctured and the vaccine was administered 24 hours after that.  Concomitant medications was not provided by the reporter. Treatment information was not provided.
vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 26Jul2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 26Jul2022) and NO ADVERSE EVENT (No adverse event) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 26Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 26Jul2022).    No concomitant product use was reported.  Reportedly, Patient received half dose. Vial did not undergo any temperature excursions.  No treatment information was provided.
I felt completely normal after getting the vaccine. Then at 8 pm (5 hours after getting it) I felt heat rushing to my head and face. I became very weak in my legs and I had to lay down. I took ibuprofen at 9 pm because my body aching was very intense. I woke up at 11:30 pm with such terrible body aches I could not sleep and I was crying from the pain. I had freezing chills and a throbbing headache. When I tried to stand up, I almost fell over because I felt so light-headed. I thought I was going to faint. I was so concerned about the amount of pain I was in that I called my doctor and public safety came and checked on me. I couldn't get out of bed for 3 hours. I drank Gatorade and took more ibuprofen. I was able to check my temperature. I had a 101-103 degree fever.  The entire next day (Tuesday) I took ibuprofen every six hours. My body was still very weak and aching everywhere as well as a headache. I stayed in bed the entire day. Today (Wednesday) I feel much better??both of my arms still ache a lot and my body feels exhausted.
Pentacel was given to a patient who is 5 years and 10 months old; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 5 years 10 months old patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (formulation: unknown, lot number, expiry date, route and site of administration were not reported), on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error inappropriate age at vaccine administration.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of document held by sender: none.