chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines were stored after beyond use date and expiry date; vaccines were administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines were administered past the expiration date) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and expiry date) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines were administered past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines were administered past the expiration date) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was reported that the on 31-Mar-2021, vaccines were stored in a standard freezer maintained at 2 degrees Fahrenheit high to minus 1 degrees Fahrenheit low. The date and expiry date was reported as 22-Sep-2021. No treatment drug was reported. This case contains information for the 27th of 45 adult patients described by the reporter.
Nausea; Vomiting; Lymph node pain and swelling; Back pain; Felt pretty sick; Felt terrible; Rash in her face that started in the upper lip; Fever; Shivering; Crumping behind the neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE SPASMS (Crumping behind the neck), BACK PAIN (Back pain), MALAISE (Felt pretty sick), FEELING ABNORMAL (Felt terrible) and RASH (Rash in her face that started in the upper lip) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Controlled), High cholesterol (Controlled), Breast cancer, Penicillin allergy, Drug allergy (Nucynta, Keflex, Cipro, Morphine, Citroen, Cephalexin, Sulfametho.) and Sulfonamide allergy. Concomitant products included TRANEXAMIC ACID (NEXIM) for Acid reflux (oesophageal), HYDROCHLOROTHIAZIDE and CARVEDILOL for Blood pressure management, ROSUVASTATIN CALCIUM (CRESTOR) and EZETIMIBE (ZETIA) for Cholesterol, SIMVASTATIN for High cholesterol.   On 28-Jan-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021 at 11:37 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced MUSCLE SPASMS (Crumping behind the neck). On 25-Feb-2021, the patient experienced BACK PAIN (Back pain), MALAISE (Felt pretty sick), FEELING ABNORMAL (Felt terrible), RASH (Rash in her face that started in the upper lip), PYREXIA (Fever) and CHILLS (Shivering). On 26-Feb-2021, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting) and LYMPHADENOPATHY (Lymph node pain and swelling). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at a dose of UNK dosage form and ALPRAZOLAM (XANAX) for Adverse event, at a dose of UNK dosage form. On 26-Feb-2021, MUSCLE SPASMS (Crumping behind the neck), BACK PAIN (Back pain), MALAISE (Felt pretty sick), FEELING ABNORMAL (Felt terrible), PYREXIA (Fever) and CHILLS (Shivering) had resolved. On 03-Mar-2021, RASH (Rash in her face that started in the upper lip) had resolved. On 12-Mar-2021, LYMPHADENOPATHY (Lymph node pain and swelling) had resolved. At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Patient confirmed that she was not pregnant. On 09-May-2021: Medically confirm changed, Allergies, Concomitant medication and patient race added, Change in outcome of events.
Feeling weak; Body ache; When walking feeling a litle light headed; Really tired; Left arm got sore; Left arm swelling; Chills; Muscle ache; A spontaneous report was received from a healthcare professional concerning a 42-year old, female patient who received Moderna's COVID-19 vaccine and experienced a sore arm, swelling, lightheadedness, chills, muscle ache, feeling tired, feeling weak, and body ache.     The patient's medical history included Covid-19 in December 2020. No relevant concomitant medications were reported.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient's left arm became sore and swollen. That night, she started to feel lightheaded, chills, and muscle ache. At the time of report, the patient reported feeling tired, feeling weak, chills, body aches and lightheadedness.  Treatment for the event included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The events of feeling really tired, feeling weak, chills, body ache, and when walking feeling a little light- headed were ongoing at the time of this report. The outcome of the remaining events 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 event, a causal relationship cannot be excluded.
1/2 hr p/vax, pt exp temporomandibular joint pain, inject site pain & overall weakness; BP 104/60, pulse 68, temp 97.8; sx lasted 3 hrs then abated; no inject site findings; nl PE;
Patient taken to EMS room and laid down. Patient stated she passed out when getting vaccinated but is feeling alright. Patient states she has a metallic taste in mouth; lightheaded. Patient laid down for 28 minutes; sat on side of cot for 2 minutes; then stood up slowly; walked around for a couple of minutes. Stated she feels alright.
I have a relative who ended up in rehab who I am responsible for. We were visiting the rehab for a meeting to prepare for his discharge. My relative did not look well, but had not been tested for Covid due to the fact that he did not have a fever and had a negative chest x-ray. At that point I double masked because I found it hard to believe that he did not have Covid. Two days later, my husband and I both had symptoms. By Tuesday 6/21, they tested my relative for Covid. He and four other patients on his floor tested positive for Covid. My symptoms began with mild headache and sore throat. I tested Wednesday and Thursday, with at home test and it was negative. By Friday, my symptoms had progressed so I went for a PCR test and received positive results the next day. I've had headache, postnasal drip which is causing a bit of nausea, and sore throat. I have been trying to reach my doctor this morning but have not gotten through so I plan to call later today. My husband and I were both prescribed Paxlovid on Friday. I began taking it on Saturday 06/25.
Initial date when the vaccine was stored in the refrigerator: 02Dec2022; No adverse event; accidentally administered a dose of the Moderna Covid-19 vaccine which was beyond the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (accidentally administered a dose of the Moderna Covid-19 vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (Initial date when the vaccine was stored in the refrigerator: 02Dec2022) and NO ADVERSE EVENT (No adverse event) in a 33-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 015B22A and 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Jan-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (accidentally administered a dose of the Moderna Covid-19 vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initial date when the vaccine was stored in the refrigerator: 02Dec2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (accidentally administered a dose of the Moderna Covid-19 vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (Initial date when the vaccine was stored in the refrigerator: 02Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (accidentally administered a dose of the Moderna Covid-19 vaccine which was beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Initial date when the vaccine was stored in the refrigerator: 02Dec2022).    No concomitant or treatment medications were provided. Initial date when the vaccine was stored in the refrigerator was 02-Dec-2022. The patient was being monitored at the facility at the time of the call and no adverse events have been reported so far.
Pentacel was administered to a patient on 07-Oct-2020 without the powder being mixed in with the solution/no AE; Initial information received on 07-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional.  This case involved an unknown age female patient who received a 0.5 ml once dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiry date not reported) via intramuscular route in left lateralis for prophylactic vaccination on 07-oct-2020 without the powder being mixed in with the solution (Product preparation issue).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to Inappropriate reconstitution technique (latency same day).   At the time of reporting, no adverse event was reported.  A clinic reporting on behalf of a patient having a medication with Pentacel described as only the liquid portion of the DTap-IPV was given and not receiving the ActHib powder portion. The caller reported that information is unknown to the reporter due to the reporter was not in the office and did not access at the time to the information. The caller was instructed on the site. At this time, the caller would like to know if the patient must be revaccinated.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Pt received second dose of Pfizer (lot #FH8028) at 1651. While pt was waiting in observation area family member called RN over to inform that pt was experiencing "itching in her arms". Pt denies trouble breathing, shortness of breath, trouble swallowing or dizziness. Pt denies any other symptoms besides "itching". Pt was transferred to tent and vitals were taken. Family member states that this itching occurred with the first dose of Pfizer and she was "given benadryl" in the tent.    1700  BP 122/63 O2 98 HR 83 Temp. 98.9 RR 16  On call ED doc, Dr. was contacted. Vital signs above were reported. Dr. ordered 25 mg diphenhydramine orally via phone. Pt states that the itching is felt "all over" but itching is not getting worse. Family member states that she was given "10 ml of benadryl was given at 1500". Dr. was notified and states that it is still okay to administer the additional 25 mg of diphenhydramine orally".   1710 BP 111/65 O2 98 HR 84 RR 16  Pt given diphenhydramine 25 mg orally with water. No problems swallowing.   1720 BP 115/66 O2 96 HR 74 RR 16  Pt states she is feeling relief from medication and is no longer "itchy".  Pt and family member were told that if symptoms return they should seek medical care at ED/urgent care.
Raised red rash just below injection site  Metallic taste in mouth Slight nausea  All started about a week after injection
I had sudden onset of pain in my 2nd toe, followed by numbness, stiffness, and toe turned blue.
Information regarding Flumist nasal solution was received from a consumer regarding a 10 year old male patient who experienced headache, runny nose, fever and sore throat. At 10 years of age, the patient received a dose on 12/10/2003. Relevant medical history was not reported. Indication for Flumist was immunization. Product was administered on 12/10/03. Dose regimen was 1 dose 1 time per day (IN). Concomitant medications were not reported. On 12/13/03, the patient experienced headache, runny nose, and fever which ranged to 102 degrees F axillary. A sore throat developed on 12/15/03. He was treated with unspecified over the counter medications. No additional information was available at the time of this report.
chills; face, neck and head are itchy; red rash on back head and face; Bad arm pain to touch; cold; minor arm redness/swelling at shot site; minor arm redness/swelling at shot site; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 06Apr2021 at 12:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, blood pressure high and overweight. The patient was allergic to pets, latex, alcohol, skin products and seasonal allergy. The patient previously received sulfadiazine (SULFA) on an unspecified date for an unspecified indication and experienced drug allergy. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) 7.5 mg. Prior to the vaccination, the patient was diagnosed with COVID-19 was unknown. 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.  On 06Apr2021 at 18:30, the patient experienced chills, face, neck and head are itchy, red rash on back head and face, bad arm pain to touch, vaccination site erythema, vaccination site swelling and cold.  The patient reported in order of occurrence, chills, face and neck hot and itchy, red rash on face, back itchy, red rash across back, head itchy. The patient could not tell if it was rash. She experienced bad arm pain to touch, not usual shot arm pain, the patient could not lay on left side to sleep. She felt cold all night, used 2 blankets instead of usual 1; fitful sleep. As of this writing: arm pain was better but minor arm redness/swelling at shot site; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday; felt cold. No therapeutic measures were taken as a result of the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the events chills, itchy, red rash, pain in arm, vaccination site erythema, vaccination site swelling and cold were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Systemic: Fainting-Medium, Systemic: Other- Pt felt sob and went to go get help, he fainted a while after. When EMS arrived he was feeling better, and was left at the facillity. Pt awaiting pacemaker, may have underlying condition.  Symptoms lasted 1 day
A patient received an Adacel which had been frozen and thawed which was dropped to 1.4 C and 1.5 C and same vaccines have gotten down to -4 C a month before this current excursion occurred /No AE; Based on information received on 07-Aug-2019, the report previously considered as non-valid became valid: [patient received the vaccine identified].  Initial information received on 17-Jul-2019 regarding an unsolicited non-valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA224076, 2019SA224136, 2019SA224137, 2019SA224138, 2019SA224139, 2019SA224140, 2019SA224141, 2019SA224142, 2019SA224144, 2019SA224145 and 2019SA224143 same reporter.  This case involves patient of an unknown demographics who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Lot- C55608AA, expiry date-25-01-21; Lot- C5585AA, expiry date-10-03-21) via intramuscular route in unknown administration site (received between the date 26-Mar-2019 - 24-Jun-2019) which had been frozen and thawed.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to incorrect product storage.  There were no side effects.  Caller stares that her facility was using the Adacel vaccine and she was going through the fridge log and realized that she was not being informed when the vaccines were out of the 2 to 8 C range. Caller states that there are 2 situations. Caller states that she looked at July and the vaccines dropped to 1.4 C and 1.5 C.Caller states she consulted with a scientist and was told that their thermometer was not the appropriate one for the vaccines and that it was only monitoring the air temperature and not the vaccines. Caller states that the same vaccines have gotten down to -4 C a month before this current excursion occurred. Caller states that a new thermometer with fluid was ordered so that the readings can be more accurate now. Caller would like to know what are the next steps that she needs to take in ensuring that her patients are properly vaccinated  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.  Documents held by sender: none.  Follow up information received on 18-Jul-2019 regarding an unsolicited non-valid non-serious case received from a consumer (Office Staff).  No new information updated.  Documents held by sender: none.  Follow up information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from non health care professional (office staff).  Validity of case was updated, vaccine route, batch number and expiry date was updated.  Documents held by sender: none.
Cough; Cough and phlegm; Congestion; Sore throat (similar to Laryngitis); Pain on the right underarm/axillary; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the right arm on 07Sep2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 08Sep2021, the patient experienced cough and phlegm, congestion, sore throat (similar to laryngitis) and pain on the right underarm/axillary. The patient took multiple COVID tests and all came out negative. The events resulted in a visit to the doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment prescribed by the doctor with an unspecified inhaler (MANUFACTURER UNKNOWN), guaifenesin (MUCINEX) and an unspecified nasal spray (MANUFACTURER UNKNOWN). Since the vaccination, the patient had been tested for COVID-19. On 10Sep2021, the patient underwent Nucleic Acid Amplification Test (NAATS) via nasal swab and the result was negative. On 10Sep2021, the patient underwent 3 Antigen Tests via nasal swab and the result was negative. On 11Sep2021, the patient underwent Polymerase Chain Reaction (PCR) test via nasal swab and the result was negative. The clinical outcome of the events cough and phlegm, congestion, sore throat (similar to laryngitis) and pain on the right underarm/axillary was resolving at the time of the report.
On 6/16/21 patient received her first shot of Moderna  RX  7800192  that as administered my Registered Pharmacy Technician.  At 5:58 pm she received the immunization.  Within about 2 minutes her boyfriend, alerted us that patient was not feeling well.  It was then that I, went to the patient to see how she was doing.  At this time patient was very week, she said she felt hot, tied, felt nausea. I then had pharmacy technician to assist me  (with note taking)with the patient .  Brought out our immunization cart to assist with the needs of the patient.   At this moment we called a Code White for store management to call for an ambulance, notified our market manager.  I applied a cold compress on patient's back and a wet compress for her forehead to help with the flushing she was experiencing.  She was responsive but very weak.  She was so week that she was not able to move at the time, so she remained in a chair and laid her head down.  As she was doing this I continued with the cold compress (back and head) and asked if her breathing was ok.  She continued to say yes. No Epi-Pen was needed at this time.   Blood Pressure at 6:05 was 116/88  HR 65.  Blood pressure was taken again about 5 minutes later 121/71  HR  66.    Her boyfriend who was with her provided us with a history and said in the past she has been dizzy from shots before.  But it has not been this bad.    I continued to stay with the patient and asked about her breathing of which she said she was ok.  She continued to say she just felt very weak.  I continued with the cold compress (head and back) to help with temperature of which she said was helpful.  I continued to console patient to let her know that she was ok.     I asked her if she was breathing ok or had any tightness in her chest.  She responded that her breathing was ok.  I told her I was going to continue to ask her as we were waiting for the ambulance to arrive.    An ambulance arrived at 6:17pm and assess the patient.  Pharmacy technician provided the paramedics with the shot and Lot number:  Moderna and lot number provided.   Paramedics convinced patient to go to the ER with them.  I told her it was just precautionary to make sure she would be ok.  Patient agreed.    I then proceed to get a phone number from boyfriend and told him we would like to call in a day or 2 to make sure she is ok.  He said thank you.  We will follow up with boyfriend to check on patient in a few days.