chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered expired vaccine to patient after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patient after the manufacture date of expiration) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patient after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patient after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Expiration Date for the lot 048C21A was reported as 09-Nov-2021 with total of 168 doses.  The date in which the vial was initially stored in the refrigerator was unknown  The vial did not undergo any temperature excursions.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
swelling like a bump and pink around the injection site; swelling like a bump and pink around the injection site/swelling at the injection site; swelling like a bump and pink around the injection site; her arm was sore the first two days but then cleared up/ her injection site on her arm hurt; rash; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ED6203, Expiration date: unknown) via an unspecified route of administration at left arm (at the age of 64-years-old) on 09Mar2021 13:45 as single dose for covid-19 immunisation. Medical history included inflammatory eye problem and ileostomy (50 years). Concomitant medications were not reported. The patient had no history of all previous immunization with the Pfizer vaccine. The patient did not receive Prior Vaccinations (within 4 weeks). On 09Mar2021, her arm was sore the first two days but then cleared up. The patient wanted to know if there were any reports of this happening a week after the shot. During the night that day her injection site on her arm hurt for a couple of days and then that completely went away. Patient wanted to know if the symptoms would get worse and the patient also had arm hurt. The patient stated that a week after her first dose, she had swelling like a bump and pink around the injection site, swelling at the injection site on 17Mar2021. On an unspecified date in Mar2021, the patient had rash. She was planning to receive the second dose on 30Mar2021. Outcome for the events vaccination site pain, Vaccination site swelling, vaccination site erythema was recovering and for the event vaccination site mass and rash was unknown.  No follow-up attempts are possible. No further information is expected.
Hives on neck, chest, back, arms, abdomen with onset about 40 mins after receiving vaccine. Hives would subside after several hours and then continued to reappear until 4/13/2021. Rash on both arms also noticed near inner elbow, worse on left arm (injection arm). Hives and rashes continue to appear, but are getting less and less.
No additional AE; Medical assistant reporting VARIVAX was administered after expiration.; This spontaneous report was received from a Medical Assistant concerning to a patient of unspecified age and gender. The patient's medical history, drug reactions and allergies, concurrent conditions and concomitant therapies were not reported.  On 10-NOV-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #T037642, expiration date: 06-NOV-2022 (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (expired product administered).  No temperature excursion or additional adverse events were reported.
Pt developed a high fever over 102 degrees for 3 days after the injection. Pt was tested fro strep throat which came back negative.
She complained of headache, chills, nausea, vomiting,  and body aches the next morning after the vaccination. She took Tylenol and Ibuprofen for comfort.
Went to doctor on Nov 1 to get a pneumonia shot from her doctor and doctor saw that her arm was red running down to her elbow from the flu shot. Said she had a bacterial infection from the shot. Started on antibiotics.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 18-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 1188 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had a small stroke.  Thalamic Stoke. I believe this is a result of the Pfizer Booster I had Nov 30, 2022
shivering for hours; high temperature; dose number=3; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 58-years-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FF2587) via an unspecified route of administration, administered in Arm Left on 02Oct2021 at 14:00 (at the age of 58-years-old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included bipolar disorder (type I); obesity. Concomitant medications included influenza vaccine (FLU) taken for immunisation from 16Sep2021 to 16Sep2021; clonazepam; levothyroxine; lovastatin; oxcarbazepine all taken for unspecified indication start and stop date were not reported. The patient was not pregnant at the time of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in Arm Left on 09Mar2021 at 14:00 (at the age of 57-year-old) as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8727) via an unspecified route of administration, administered in Arm Left on 30Mar2021 at 18:00 (at the age of 57-year-old) as dose 2, single for COVID-19 immunisation and experienced put me out for the next day with all over body aches, muscle soreness, headache, fever after dose 2. The patient previously took Codeine and Ultracet and had allergies (known allergies: Codeine and Ultracet are meds that affect me badly). On 03Oct2021 at 02:00, 12 hrs after vaccination the patient experienced shivering for hours, high temperature. The patient underwent lab tests and procedures which included body temperature: high on 03Oct2021.Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. Patient received treatment for the events shivering for hours, high temperature with alka seltzer and ES Tylenol. Outcome of the events shivering for hours, high temperature was recovering.  Follow-up attempts are completed. No further information is expected.
fever of 100; 21Jan2021 6:00am woke up with bad body aches; This is a spontaneous report from a contactable Other HCP (patient). This 39-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number paa156051) intramuscularly on left arm on 20Jan2021 at 12:00 (at the age of 39 years) as single dose for COVID-19 immunisation. The patient had medical history asthma, depression, high cholesterol, tested positive for COVID-19 on 05Oct2020 and patient's known allergies included cephalexin, robaxin, naproxen, latex. The patient concomitant medications included cetirizine hydrochloride (ZYRTEC), venlafaxine hydrochloride (EFFEXOR), pravastatin, omeprazole taken 2 weeks prior of vaccination. Patient had no other vaccine prior to 4 weeks of vaccination. The patient had COVID prior to vaccination. On 21Jan2021 at 6:00, the patient woke up with bad body aches, which went away around 12:00. Then returned around 15:00 on/off for the day. On 22Jan2021, the patient woke up at 09:00 and felt good. At about 12:30 patient started having body aches and fever of 100, lasted all evening. Went to bed and woke up with no other symptoms on 23Jan2021. The patient received no treatment for events. The patient tested for COVID post vaccination. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
My arm started out sore with redness at the injection site, it decreased after a few days. Then the redness came back bigger in size than it was previously. My axilla started having pain, that pain is consistent and doesn?t subside with any intervention.  The pain seems to be increasing by the day. I have not sought evaluation on this, hoping it will go away soon.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # N005274, expiration date 03-APR-2018 . No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 0 to 1 degrees Celsius for 4 hours 54 minutes. Data logger was involved. There were no previous excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004569: US-009507513-1706USA004570:
cranky, t104.2 by 9PM excessive vomiting, gasping, glazed eyes;
Patient began to feel injection site pain 1 hour after shot was administer, which progressed to tingling in arm and hand of injection sight. This lasted for two days after which patient noted reduced range of motion in the affected arm and discovered injection sight was red and swollen.
Chills beginning 30 hours after vaccination and continuing for 3-4 hours.  Sore arm below injection site beginning shortly after injection and lasting for 3 days.
Patient developed hives on immz site 5 mins after immz were administered. 10 mins after immz hives spread to arms, chest and hack. Breathing normal. Pt was released 30  mins after hives no longer spreading.
Day 1-2:  Chills, lethargy, joint pain, intense headache, fever 101, Continued through the next day (30+ hours) Day 3 (today): Joint pain continues, headache faded a few hours after waking without medication.
No adverse event; It might be close to 10 weeks before they get their 2nd dose; It might be close to 10 weeks before they get their 2nd dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (It might be close to 10 weeks before they get their 2nd dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It might be close to 10 weeks before they get their 2nd dose) and NO ADVERSE EVENT (No adverse event) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (It might be close to 10 weeks before they get their 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It might be close to 10 weeks before they get their 2nd dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (It might be close to 10 weeks before they get their 2nd dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It might be close to 10 weeks before they get their 2nd dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown. No concomitant medications were reported. Four years old patient received their 1st dose of Moderna Covid-19 vaccine at the end of July 2022. It might be closed to 10 weeks before they get their 2nd dose. They can't get it sooner, because of their schedule.  No treatment medications were reported.   Reporter did not allow further contact
No additional AE reported; expired dose of PROQUAD was administered; This spontaneous report was received from a nurse and refers to a  twin patient of unknown age and gender. The patient's medical history and  concurrent conditions were not reported. Concomitant therapies were not reported.  On an 12-APR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliters (lot #T034825 with an expiration date on 11-APR-2022), administered for prophylaxis (strength, and route of administration were not provided).  No temperature excursion on the vaccine. No additional adverse events were reported.  This is one of two reports received from the same reporter.
anxiety; trouble breathing; weight loss; and the upper part of her body is really achy; its effecting my brain; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (anxiety), DYSPNOEA (trouble breathing), WEIGHT DECREASED (weight loss), MYALGIA (and the upper part of her body is really achy) and HEADACHE (its effecting my brain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (oesophageal) and Allergy multiple.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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, the patient experienced ANXIETY (anxiety), DYSPNOEA (trouble breathing), WEIGHT DECREASED (weight loss), MYALGIA (and the upper part of her body is really achy) and HEADACHE (its effecting my brain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ANXIETY (anxiety), DYSPNOEA (trouble breathing), WEIGHT DECREASED (weight loss), MYALGIA (and the upper part of her body is really achy) and HEADACHE (its effecting my brain) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant medication included four allergy medications, acid reflux medication and anxiety medications.
Information has been received from a physician assistant concerning a 13 month old female child who was vaccinated with VARIVAX (Merck). The child developed a rash after receiving VARIVAX (Merck). The specifics of the vaccination were not known as the physician assistant treated the mother of the child. As of 11-FEB-2009 the child was not recovered. The mother of the child with rash was pregnant and had not had varicella. The mother had no symptoms at the time of reporting. The mother had called office for medical attention. Additional information has been requested.
The following week exactly 7 days later, I broke out in full body hives. Blister looking bumps from my chest all the way down to my feet. I went to urgent care and told the provider I haven't made any new changes, I hadn't been anywhere new, ate anything new, used any new  soaps or fragrance or been around anyone who had. I have no documented allergies. I asked if it could be vaccine related and told him that I got my first dose less than 7 days ago, and he said he has seen " a lot" of cases of hives within 1 week of the 1st covid shot.
pt had 2 sz @ home onset 3AM 13JAN93; adm to hosp from ER; had 1 prolonged sz there-lasted approx 30-45 mins; pt was placed on Phenobarbitol; no problems since;
Severe intestinal issues for a full 2 months after 2nd dose of vaccine. Life altering, had trouble leaving house. Symptoms have improved and about 80% now
This spontaneous report as received from a nurse (who is also the patient's daughter) refers to a 74 year old female patient with no known allergies. The patient's concurrent conditions included diabetes and an unspecified cardiac disorder (reported as "cardiac patient"). The patient's medical history included pacemaker insertion. On 23-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX injection administered subcutaneously in the left arm (dose, lot# and expiry date unspecified). Concomitant therapies included glipizide, metformin, COUMADIN and potassium (unspecified). The nurse reported that, on 30-OCT-2014, the patient developed red, swollen left arm, the swelling went under the armpit and "looked like Popeye". On the same date, 30-OCT-2014, the patient sought medical attention, she went to the local urgent care center and was administered an injection of steroid in her buttocks. The nurse stated the steroid injection was repeated again, since the nurse told her mother "she had bony buttocks". Patient was not hospitalized. The treatment thereafter was an unspecified oral steroid medication. The nurse stated she thought the ZOSTAVAX was administered incorrectly, by subcutaneous injection. However, it was administered subcutaneously as per the prescribing information. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, the patient's events were considered to be medically significant. Additional information has been requested.
Started as fullness and heaviness in both ears occasionally during first two months after second shot. Since then, both ears have fullness and heaviness most of the time in varying durations, including ear popping and ear ringing. Both ears occasionally feel wet inside. Clear, water-like fluid occasionally comes out of both ears. Tested positive for COVID on Jan 2, 2023. Since then, have had EXTREME head pressure and increased ear fullness and heaviness.
Child vaccinated with HPV vaccine in office, no immediate adverse event, parent continues to deny adverse events.
got covid; got covid; This is a spontaneous report from a contactable consumer (patient's daughter). Same reporter reported similar events for two patients (father and Mother). This case is for her father. A 88-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient's daughter stated that her dad received the first dose of the vaccine on 05Mar2021. After the first dose he got covid on an unknown date in Mar2021. The patient's daughter wanted to know when they can get the second dose. The outcome of the events was unknown.  Information related lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021345764 same drug/event, different patients
he's cold; he is running a fever; he is tired , he's sleeping; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (he's cold), PYREXIA (he is running a fever), FATIGUE (he is tired , he's sleeping) and CHILLS (chills) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A2A) 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) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced FEELING COLD (he's cold), PYREXIA (he is running a fever), FATIGUE (he is tired , he's sleeping) and CHILLS (chills). At the time of the report, FEELING COLD (he's cold), PYREXIA (he is running a fever), FATIGUE (he is tired , he's sleeping) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No concomitant product was reported.
Raised skin reaction and itching. Some heaviness in the arm down to the hand. Was seen 2 days later at a clinic but only recommended to keep track of the reaction and if worsens to return.
injection site hotness; injection site swelling; injection site tenderness; injection site red circle; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (injection site hotness), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE PAIN (injection site tenderness) and INJECTION SITE ERYTHEMA (injection site red circle) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced INJECTION SITE WARMTH (injection site hotness), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE PAIN (injection site tenderness) and INJECTION SITE ERYTHEMA (injection site red circle). On 04-Apr-2021, INJECTION SITE SWELLING (injection site swelling) and INJECTION SITE PAIN (injection site tenderness) had resolved. At the time of the report, INJECTION SITE WARMTH (injection site hotness) and INJECTION SITE ERYTHEMA (injection site red circle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medications were reported.
Pt has history of seizures but had not had one in 4 years (controlled by medication). Pt had received flu vaccine several times in the past with no adverse reaction. 10 minutes after administration, pt had seizure and fell to the floor convulsing. She required consciousness within a minute but was very drowsy with flickering eyes for the next 10-15 minutes. Monitored then sent to PCP.