chrisvoncsefalvay/vaers-outcomes huggingface dataset:
113 Bivalent doses administered after the BUD to patients 12 and up.; 113 Bivalent doses administered after the BUD to patients 12 and up.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (113 Bivalent doses administered after the BUD to patients 12 and up.), EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (113 Bivalent doses administered after the BUD to patients 12 and up.), EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (113 Bivalent doses administered after the BUD to patients 12 and up.), EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (113 Bivalent doses administered after the BUD to patients 12 and up.) and EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    No relevant concomitant medications were reported. No treatment medication reported.    This case was linked (Patient Link).
Nausea, vomiting, headache, muscle pain, joint pain, feeling unwell, fast heartbeat,  weakness
Pt complained of headache, malaise, vomiting, local reaction of heat, swelling, pain. Facial rash of periorbital petechiae.
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     It was unknown if patient ever had tested or diagnosed positive for COVID. It was unknown if patient had Acute or Chronic/ long-standing illnesses at the time of vaccination or up to 1 month prior to vaccination. Information about other vaccines given within 1 month prior to Moderna COVID-19 vaccine was unknown.     On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 18-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age reported in the source document as 66 years 10 months. No concomitant medication information was provided. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process.  Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines. Vaccine NDC code- 80777-0273-99  No treatment medication was provided.
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 41 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Mar2021 as dose 1, single (Lot number: 044A21A), in left arm, on 15Apr2021 as dose 2, single (Lot number: 042B21A), in left arm and on 13Nov2021 as dose 3 (booster), single (Lot number: 066F21A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022, outcome "not recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Mar2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Mar2023) Positive; (27Mar2023) very faint line on a home test; (29Mar2023) test line was very dark again. Therapeutic measures were taken as a result of drug ineffective, COVID-19: the patient received treatment with Paxlovid from 29Mar2023 to 25Mar2023 (lot number 661321) for COVID-19 treatment. The patient tested positive on 20Mar2023 and began Paxlovid that night. By 27Mar2023, had no symptoms and a very faint line on a home test. On 29Mar2023, cold symptoms returned-headache, runny nose-and test line was very dark again. On 30Mar2023, symptoms remained.
Limited range of motion and severe pain. Pain and range of motion limitation started next day and lasted for 3 days. Then pain and range of motion issues persisted slightly and constantly for over 2 weeks. Ongoing.
2/12/18-Pt seen by a different provider for diaper rash but reported that some "new bite-like spots" had appeared that morning. Rx DIFLUCAN and LAMISIL and told to F/U in 1wk. 2/15/18-Pt seen by yet a different provider and DIFLUCAN refilled and Clotrimazole Rx. Told to F/U with PCP as Derm referral may be necessary. 2/21/18-PT saw PCP Dx w/reaction to vaccines. Rx Acyclovir and Cetirizine. Advised to stop fungal Tx and referred to Derm which is not yet scheduled per parent request.
flu-like symptoms; dizziness; heavy feet; This is a spontaneous report from a contactable pharmacist reporting for herself. A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek9231), via an unspecified route of administration on 07Jan2021 13:45 in left arm at single dose for COVID-19 immunization. Medical history included allergies to cherries and hazelnuts amd Hashimoto's thyroiditis from an unknown date and unknown if ongoing; h/o possible GBS (Guillain-Barre syndrome) from an unknown date and unknown if ongoing post influenza vaccine in 2016. Concomitant medication included fish oil, minerals nos, quercetin, thioctic acid, vitamins (EMERGEN-C) and multivitamins. On 08Jan2021, the patient experienced flu-like symptoms and bouts of dizziness, and a feeling of "heavy feet" 24 hours post administration of BNT162B2. No treatment was given to the patient for the events. The outcome of the events was unknown. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Pt had 1st flu shot 11/14/99, on 11/15/99, pt awoke with severe dizziness and nausea,  Pt unable to work.  Pt has never had dizziness with nausea in past.  Pt states has a sensative warm flush with infection.
slight redness (approx size of a quarter), slight swelling, and slight soreness to touch.
This spontaneous report as received from a Registered Nurse via a company representative refers to a 75 year old female patient.  The patient's medical history, concomitant medication use and concurrent conditions were not reported. The patient was vaccinated with pneumococcal conjugate vaccine (PCB 13) one year ago (2016, exact date not specified). On 15-MAR-2017 the patient was vaccinated with PNEUMOVAX23, 1 DF, (route not specified), (lot # N003997, expiration date 20-OCT-2018) for prophylaxis. On 16-MAR-2017 the patient called the physician within one day of receiving PNEUMOVAX23 and complained of "arms that are red, painful to touch and feverish."  The patient called the physician's office to seek treatment and received an unspecified treatment for these complaints.  The patient's condition at the time of this reported was reported to be recovered. Additional information has been requested.
Received shot on 5/4/23, painful at injection site but didn't spread out. Started not feeling late Tues/early Wed and got worse on Thur 5/11. 103 Fever and very Disoriented after mid day Nap Thursday. Was able to get fever down which kept maintaining high 101/102 until Sat. on 5/13 took to ER being we could not get down her 105 Fever causing excruciating pain in head and body. With each day that passed more symptoms followed. Started with just Fever, Eyes hurting and Headaches, which turned into a lasting high fever for 7 days straight. Developed a sore throat which went away for a day and then came back but with nasal congestion, upset tummy, couldn't eat, throwing up, body aches. Was tested for Covid, Strep and Flu - all Negative. Chest Ultrasound, blood test and urine test normal. They couldn't pin point it. Was given Antibiotic and Benedryl and sent home.
Information has been received from a Registered Nurse concerning her 18 year old daughter who on 31-JUL-2007 was vaccinated with the first dose of Gardasil.  Concomitant therapy included hormonal contraceptives (unspecified).  On 01-AUG-2007 the patient experienced headache, dizziness, tiredness, feeling hot and cold and a slight fever.  The patient treated herself with over the counter cold medicine.  As of 03-AUG-2007, the patient had not recovered.  Medical attention was sought.  No further information is available.
24 hours body aches, fever. In July2021, Diagnosed neuropathy in left and leg and left side of the face.
Immediate skin flushing: red, blotchy areas on upper chest, cheeks, arms, buttocks, ears.  Redness would come and go over 20 min. period. Vital signs WNL.  No resp. dizzness.  Referred to MD 20 min after vaccine given
No adverse effect reported; received improperly stored VARIVAX; This spontaneous report was received from an office manager, concerning a 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 05-AUG-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), lot # S008692 and expiration date on 21-MAR-2021, for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effect was reported. No product quality complalint was involved.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA002451:
Blurred vision and lost vision in right eye - went to ER r/t to stroke symptoms. ER DX with torn retina Ophthalmologist DX Stroke to right eye at follow up visit
Face got numb for about an hour (30 min after ) Severe arm pain Fever Chills Delirium, couldn?t think clearly Extreme fatigue Bad headache Whole body ached, especially back and neck Lasted about 48 hours
Nausea, local redness, edema and ecchymosis, dizziness that evening until 11/15/05.
Weakness; Aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) and PAIN (Aches) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ASTHENIA (Weakness) and PAIN (Aches). On 28-Jan-2021, ASTHENIA (Weakness) had resolved. On 28-Feb-2021, PAIN (Aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Concomitant medication was not provided.
This was much milder and easier to handle  than previous Pfizer vaccine 1&2. Mild dull headache within one hour of vaccine, mild nausea started 2 hours in manageable with ginger chews and ginger ale. Nausea increased and Intense nausea that night about 3-4 hours later crackers and ginger only helped for a few minutes then intense nausea wave back. Felt like I needed to vomit but never did.  I took 12.5 mg phenergan  about 5-6 hours in and then bed shortly after. Slept 12 hours, woke up, nausea was mild to moderate and still felt tired and slept another 4 hours. Up for about 2 hours, felt fatigued, body drained and sleepy, back to bed for 2 additional hours and would have probably kept sleeping but woken up by a phone call. Felt very fatigued and drained the rest of the day and the next day. Slept another 10hours that night, then mostly ok. Took a few days to shake off the fatigued drained feeling
1) MMR site pink, raised with several small vesicles about 2x2.5cm right arm. 2) DTaP site red and raised, warm to touch, about 2x2cm left arm. (Seen 07/31/04). Prescribed: Ice, Tylenol. Phone call: Mom 08/02/04 both sites and red and swelling.
This spontaneous report was received from a company representative who was informed by a physician regarding 12 unspecified patients. Concurrent conditions, medical history and concomitant medications were not provided. An unspecified neurologist informed the physician that 12 different unspecified patients developed Postural Orthostatic Tachycardia Syndrome or seizures within six months of receiving GARDASIL (dose, route, vaccination site, #lot unspecified). No further information was provided. Product quality complaint (PQC) was not reported. The outcome of the events and causality was not reported. Upon internal review, the event seizure was determined to be medically significant. Additional information has been requested.
Had Td 04/15/03. States always had a red, flat spot on arm. 2 days ago began itching and now has a red, raised bump-very small-3mm approximately and complained of itching.
Chest pain, tachycardia, brain fog, fatigue, depression, anxiety, insomnia
Extreme muscle spasms and contractions, leading to cervical spine damage and cervical spine impingement
After 20-25 mins, heart started racing, swelling started on lips, eyelids, neck , inside the mouth. Felt burning sensation in esophagus. Experience tiredness, chill and minor diziness as well. Took Benadryl  every 8 hrs and pepcid from over the counter. There is still minor swelling and continuing the benadryl after 24 hrs
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated 27 clients with expired vaccine), PRODUCT STORAGE ERROR  refrigeration date  on 27-Jul-2022 and vaccine was adminstered on 29-Jul-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial went to temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 017B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated 27 clients with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The (BUD) refrigeration date  on 27-Jul-2022 and vaccine was adminstered on 29-Jul-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial went to temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated 27 clients with expired vaccine), PRODUCT STORAGE ERROR (The (BUD) refrigeration date  on 27-Jul-2022 and vaccine was adminstered on 29-Jul-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial went to temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2022: Follow up received: Updated patient demographics and case narrative.
12/21/2001, Patient called and stated that she started having hives all over her body two day post vaccination. She has been taking Benadryl. Rash is better , but still on legs eleven days later. the patient never went to her PCP
patient received her first dose of the Moderna COVID-19 vaccine on 07 FEB 2021 , second dose on 24 MAR 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received her first dose of the Moderna COVID-19 vaccine on 07 FEB 2021 , second dose on 24 MAR 2021) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 041L20A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included ROSUVASTATIN and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received her first dose of the Moderna COVID-19 vaccine on 07 FEB 2021 , second dose on 24 MAR 2021). On 24-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received her first dose of the Moderna COVID-19 vaccine on 07 FEB 2021 , second dose on 24 MAR 2021) had resolved.            No treatment information was reported.   This case was linked to MOD-2021-378276 (Patient Link).
Described as "allergic reaction in my eyes." Watery & burning eyes. Developed morning after receiving vaccine. The patient hasn't tried anything to soothe the issue and wanted to report it as a vaccine adverse event. She said nothing else in her day or the past few days had changed, so a vaccine is the only thing she thinks it could be. She "doesn't have seasonal allergies."
Patient had a positive COVID test on 1/23/2022 and passed away on 2/18/2022.
Myalgia, Fever, NauseaVomiting, chills/hot flashes, malaise, pain in injection arm Narrative:
R arm at site of inject is red, swollen, and painful.  Pt advised to take ibuprofen and call back if no change or worsened. Did not call back.
Case number PHEH2015US024306 is an initial spontaneous report from a nurse received on 17 Nov 2015. This report refers to a 03-year-old female patient. The patient was inadvertently vaccinated with FLUVIRIN (batch number: 1511601) intramuscularly on 21 Oct 2015. No adverse event reported following this medication error (inappropriate age at vaccine administration).
One week after second vaccine fingers were tingly and it progressed to numbness, tingling, and pain. Went to pcp and they said they?ve had other recently vaccinated women  having same issue. Fingers and hand are numb and painful and it?s difficult to do normal activities because of this. Did not have other unusual symptoms except a little tired the day of both doses.
After vaccine 1: My period was about to end (brown, light flow), when a few hours after the vaccine, it started being bright red again.   After vaccine 2; My period started within 5 mins of getting the second vaccine. I got terrible back cramps almost immediately, which has lasted into a second day (unusual for me). They are so bad I can't stand up straight, or walk around.
The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 13-Apr-2022 post 30 days; The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 13-Apr-2022 post 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 13-Apr-2022 post 30 days) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 13-Apr-2022 post 30 days) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 014M20A, 038B21A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 13-Apr-2022 post 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 13-Apr-2022 post 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 13-Apr-2022 post 30 days) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 13-Apr-2022 post 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication was reported.  The patient was inadvertently administered an expired dose of the Moderna Covid-19. Post further investigation of the issue, pharmacist identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. Vaccine with lot number 084J21A was received and placed in the fridge initially on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA.  Patient has not reported adverse reaction to the health care professional's knowledge.  The vaccine in question did not experience any temperature excursions.  On 03-Nov-2021, patient received first booster dose. On 13-Apr-2022, patient received second booster dose.
Patient  did not have any reaction, however an expired vaccine was administered. Moderna Vial was punctured on 9/13/21 a little after 1:13 PM. Dose was given  a little after 4:15 PM on 9/14/21
red papular rash began under L axilla (vaccine given in L deltoid) 15 days after vaccine given and spread to R axilla, chest, abd, B inguinal areas, legs, feet, arms.  Still present today on 9/24/2021.  Not itchy or painful.  No other sx.  No other family members affected.  Pt has an allergy to bee stings.