chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 1:12 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 24.78.  Concomitant products were not provided. On 27-Apr-2021, Excursion time was 9 AM temperature was 35 total doses given for the day was 42, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 27-Apr-2021. 08 vials were sent to clinic. Vaccine BUD date was 19-May-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Ten minutes post vaccination patient reported bilateral localized itching on arms. Advised to take benedryl. Patient refused. Wanted to self medicate with Claritin. Patient observed for additional 15 minutes. Discharged at 1420. Patient advised to go to ER if any adverse effects continue.
flushing on the face; burning on the face and on the both arms; skin is burning; Nauseous; Appetite vacillates; Chills; Sore throat; Body ache; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was stated, "I can tell you side effect I am getting now, so you can't tell me if you ever heard the side effects or not, I am getting flushing on the face and I am getting burning on both arms, I am getting burning on the face and on the both arms, the other one would be normal one's except the extremely nauseous, my appetite vacillates, extremely nauseous this the 3rd day now after the shot and burning on both arms, of course chills you probably heard of chills, I also was getting sore throat and either the body ache you heard of but I think to press option 3 and call but I wanted to you know the burning in the arm and in the face, like skin is burning." The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Lengthened menstrual cycle by 5-7 days.  Immediately impacted the cycle after the shot and has yet to return to normal.
I really wanted to report that my symptoms were mild, but lasted for 3 weeks. My understanding was that I would possibly have side effects for 1-3 days. My muscle and joint pain started 24 hours after the first injection. Side effects of mild nausea began at midnight after my shot. The muscle pain was very sharp at times, and dull. It was constant. Everyday, 24 hours, for about 3 weeks. My shot was on the 7th. On the 15th I had the worst of the muscle pain. At times I felt that my arms and legs felt weak. Sometimes the pain would wake me. It wasn?t debilitating, but it was very uncomfortable.  I called my doctor and told them what was happening and they didn?t seem concerned. Just told me to keep taking ibuprofen.   I told him I was concerned that my symptoms haven?t improved after 3 weeks. I have a history of being very sensitive to meds. I did address this to my doctor. I have no issue with the vaccine, but am only concerned for myself. My body has a history of rejecting simple meds like antibiotics. I was apprehensive about taking this vaccine for myself.   By the 24th of January I finally started to feel better. The pains were not as frequent and I actually had good sleep. I was afraid to take the 2nd shot in fear that it would cause my pain to come back worse?. I just took my 2nd dose Tuesday the 1st. So far my symptoms seem normal according to CDC and I did have sharp muscle and joint pain 3 hours after 2nd dose but then it became mild.   Treatment was ibuprofen to control pain. Like I said. Maybe this isn?t life threatening but wanted to make sure to report it. 3 weeks is a long time to be in pain
Patient developed an induration that increased in size during the encounter with surrounding erythema and central hematoma, area was tender to touch.
loss of smell occurring 3-4 days after first vaccination. loss of smell lasting more than 5 days and fully recovered within one week
Patient was administered 1 dose of Afluria vaccine and experienced 2 episodes of syncope, though brief she did fall and hit her head on the floor. Blood pressure was 90/80.
shingles; Subsequent to the ZOSTAVAX inoculation, the pt was treated by a physician at a healthcare center for shingles.; This initial spontaneous report was received from a lawyer regarding a case in litigation involving a male patient (pt) of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2007, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) at a hospital as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and herpes Zoster related conditions. On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (herpes zoster). The pt was treated by a physician at a healthcare centerdue to herpes zoster (vaccination failure). It was reported that the pt would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the herpes zoster and vaccination failure was not reported.   The reporter considered the herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
About 30 minutes after leaving office, patient described pain and numbness of arms and legs, then chest pain and sudden onset of pounding headache.  Nausea and vomiting, loss of consciousness.  Transported to ER and treated with IV steroid and diphenhydramine; improved.
Bell's palsy staring 13 days (3/3/04) after immunization of 02/19/2004
Pt recvd 2nd dose of Hep B vax 7AUg92 & 8 hrs later devel rash, joint pain, throbbing welts, & swelling in hands, feet & face; ER or MD visit was required for tx;
PT RECEIVED 5 VACCINES ON 14MAR08; TYPHOID, TWINRX #1, MMR, DTaP, AND YELLOW FEVER. THERE WAS NO DOCUMENTION LOGGED AS TO WHICH ARM EACH SHOT WAS GIVEN IN. PT REPORTS TODAY COLD SX, FEVER, DIARRHEA, PRURITIC RASH, SORE, YELLOW SOFTBALL SIZED LUMP LOCATED LEFT TRICEP REGION. UNSURE WHICH VACCINE WAS GIVEN LEFT TRICEP, BUT MMR & YELLOW FEVER WERE GIVEN SUB-Q THAT DATE. OTHER THREE WERE GIVEN IM DELTIOD REGION, BOTH ARMS. PATIENT STATED REACTION ONSET BEGAN 3-4 DAYS AFTER VACCINATION
RUNNING EYES AND NOSE, ITCHING EYES, SWOLLEN CONJUCTIVA AFTER PLAYING OUTSIDE, REDUCED WHEN INDOORS AND ANTIHISTAMINES GIVEN. RESOLVED 3 WEEKS LATER. SEVRE HAY FEVER AFTER POLIO VACCINE.
Within 16 hours of receiving injection, patient developed erythema, swelling and pain in left arm, which progressed to erythematous rash on upper chest and back and extending to right shoulder. She was treated with prednisone 20mg bid for 5 days and antihistamines with improvement seen within 24 hours. She will be seen in f/u today 5 days after the event.
Initial misuse report received from a healthcare professional on 22 October 2013. The case was received on 21 March 2014 at GPV. The patient was administered only the ACTHIB component from PENTACEL. No adverse event was reported. List of documents held by sender: none. Addendum: 13 May 2014. Upon second medical examination of case at time of internal review the following has been modified in this case. The event as reported was taken as PENTACEL: States pt was administered only the ACTHIB component which was inadvertently reconstituted with sterile water, no adverse event. The event underdose was deleted from the case. It was reported that the patient was administered only the ACTHIB component which was inadvertently reconstituted with sterile water.
Patient is 12 year old pt who received Pediatric dose of Pfizer for ages 5-11.
Received all the required Pfizer vaccine (Pfizer COVID-19 Vaccine) and the required booster and I still got COVID; Received all the required Pfizer vaccine (Pfizer COVID-19 Vaccine) and the required booster and I still got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Lot number: GH9464), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: FN6205), in left arm, as dose 2, single (Lot number: ER8732), in left arm, as dose 3 (booster), single (Lot number: FE3592), in left arm and as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SIMVASTATIN; HYDROCHLOROTHIAZIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Received all the required Pfizer vaccine (Pfizer COVID-19 Vaccine) and the required booster and I still got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I have COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19 including Dexamethasone, 4 milligrams that she takes one twice a day and Azithromycin 250 Milligrams. Patient received all the required Pfizer vaccine (Pfizer COVID-19 Vaccine) and the required booster and still got COVID now. Luckily, patient did not have that bad. She just felt funny and went to the (withheld) because she thought she had strep throat she had very bad sore throat (Intent: COVID symptoms) and she caught COVID. She did not know how she got it. She had all the required vaccines and boosters and several months after she got the vaccine and booster. Just one Monday, she had the sore throat and she treated it and then she thought she had strep throat so she went to Medical Express facility and was confirmed with and was tested and the test result came out that patient have COVID. The gentlemen swab my nose and throat and the test result came back that she had COVID and stated she did not understand why.
My grandma got a PFIZER COVID VACCINE and has now experienced a blood clot that caused a stroke.; My grandma got a PFIZER COVID VACCINE and has now experienced a blood clot that caused a stroke.; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unspecified date  as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported.  The reporter stated that  "my grandma got a pfizer covid vaccine and has now experienced a blood clot that caused a stroke."  The patient experienced a cerebrovascular accident on an unspecified date with outcome of unknown and thrombosis  on an unspecified date with outcome of unknown. No further information was provided. Information on the Lot/Batch number has been requested.
itchiness at the area of the injection; swelling at the area of the injection; redness at the area of the injection; burning at the area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at the area of the injection), VACCINATION SITE SWELLING (swelling at the area of the injection), VACCINATION SITE ERYTHEMA (redness at the area of the injection) and VACCINATION SITE PAIN (burning at the area of the injection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at the area of the injection), VACCINATION SITE SWELLING (swelling at the area of the injection), VACCINATION SITE ERYTHEMA (redness at the area of the injection) and VACCINATION SITE PAIN (burning at the area of the injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Vaccination site swelling, Vaccination site erythema, Vaccination site pruritus and Vaccination site burning, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) for Vaccination site swelling, Vaccination site erythema, Vaccination site pruritus and Vaccination site burning, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PRURITUS (itchiness at the area of the injection), VACCINATION SITE SWELLING (swelling at the area of the injection) and VACCINATION SITE PAIN (burning at the area of the injection) outcome was unknown and VACCINATION SITE ERYTHEMA (redness at the area of the injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  The redness extended up to her shoulder and down to her elbow. The patient consulted her primary care physician who prescribed her with Benadryl Cream, Tylenol and advised her to apply cold compress on the area. The area of redness had decreased in size.
This spontaneous report was received from a physician refers to a unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (concentration, dose, dose number, route, anatomical place of vaccination and frequency were not provided) which had a lot # M027879 and an expiration date of 24-JAN-2018, for prophylaxis. Which were exposed to a temperature range between 32F and 36F for a time frame of 2 hours, without a temperature excursion. The report did not involve a data logger and no adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as the reporter did not provide consent for further contact.
1. My mind has been affected. I'd say 50% or more of my brain power is gone. There is damage to my brain. I know there is brain fog but mind is worse than just that.   2. Debilitating headaches every single day and all day.  Headache pressure all over my head in the front, side and back. It feels like my head is going to burst.    3. Stomach pain and constant belching throughout the day. Stomach feels and looks bloated and it's painful. There is roaring and rumbling in my stomach that is loud all day. I now have to take medication that doesn't help a lot.   4. Constant pain in my neck and it pops like it will break off. I can literally hear the bones popping.   5. Pain down the back of my neck and in the top portion of my upper back. It hurts so bad at times that a hot shower is excruciatingly painful.   6. Muscle aches and joint aches throughout the day.   7. Weakness and extreme fatigue. I have to sleep 10  -12 ours to function two hours per day. If I don't sleep well I can barely move some days and the pain is off the charts.    8.  I've been diagnosed with tachycardia and I take medication for it that causes more problems.   9.  My taste has been drastically reduced. I can only taste about 10-25% of the foodT I eat.   10. Vision is worse.   11. Hearing is more difficult b/c it's made the tinnitus worse and my head is popp9ing and crackling all the time. I had arthritis before and it's worsened it 10 times.   12. Communication is very hard for me. I rarely talk like I did before.   13. About 50% of my hair is gone.
Information has been received from a 61 year old male pharmacist with no known allergies, with a history of Atrial ablation, who on MAY-2008 was vaccinated SQ in the left  with a dose of ZOSTAVAX vaccine (Oka/Merck). Concomitant therapy included hydrochlorothiazide (manufacturer unknown), LISINOPRIL (manufacturer unknown), ATENOLOL and SIMVATATIN (manufacturer unknown). The pharmacist mentioned there are marks on both his legs that appear to be bug bites that are very itchy, red, raised and 1 cm round. The pharmacist was at a baseball game this past weekend on approximately 14-JUN-2008 and noticed these bug bites just after the game that evening. He believes these are just bug bites. At the time of the report the bug bites persisted. There was no product quality complaint. The patient did not seek medical attention. The patient's grandson also had an adverse experience after VARIVAX vaccine (Oka/Merck). (WAES0806USA07716) On23-JUN-2008 information was received from the pharmacist. He discussed his experience after vaccination with ZOSTAVAX vaccine (Oka/Merck) and he was quite sure he had bug bites on his legs. No rash was note on his trunk. No further information is available.
clerk overlooked pts age when checking patient in for the vaccine, then the pharmacist overlooked the pts age before administering the vaccine
Patient's mom called on Thursday (9/16/2021) to report that she had not slept the previous night because her arm was so sore.  She said that there was no rash, swelling, or heat on the arm.  The mother asked if the patient could take OTC Tylenol, etc. which I told her was fine.  I told her to call the doctor if event worsened.   The patient called back on September 18 to report that the previous day, a hive like rash developed.  The arm where shot was given down to the elbow has hives and throbbing.  She said that the arm felt like a hot iron was on the arm, and she had difficulty moving it.  She also said she has random spasms in the arm.  She also reported that she sweated profusely and that she has a genetic condition that causes her not to sweat.   The patient said she was nervous taking the shot because she is so sensitive to medication.  She will contact her primary care provider and let us know what the doctor says.
Developed an itchy rash in the right arm at the injection site of the Menactra vaccine. The rash became generalized, splotchy and slightly raised within approximately 1 hour. Was treated with oral Benedryl. No difficult breathing noted.Rash remained the same the next day with less itching. Continued Benedryl.
no adverse event; Expired vaccine that was administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients) and NO ADVERSE EVENT (no adverse event) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients).    Patient age was reported as 21 years and 1 months.   Concomitant medications were not reported.   Reportedly, the number of patients at facility that received this Moderna vaccine between 08Apr2022 and 15Dec2022.  Treatment medications were not reported.  ID number was reported as 80777027399.
TINGLING IN LEGS; WRONG DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned an 89 year old white female of unspecified ethnicity The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received 2 doses of non-company vaccines included: MRNA 1273 (Moderna) (form of admin, route of admin, and batch number were not reported),1 in total, dose was not reported (dose number in series was 1), administered on JAN-2021 and MAR-2021 for prophylactic vaccination and it was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 060H21A, and expiry: UNKNOWN), dose was not reported,1 total, (dose number in series was 2) administered on 09-DEC-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 09-DEC-2021, the patient requested a booster dose of the moderna vaccine but accidentally received booster dose of the Janssen Covid-19 vaccine (RRT: wrong dose of vaccine administered, LLT: Medication Error). On 09-DEC-2021, after 5 minutes of receiving the vaccine, patient had tingling in legs (dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tingling in legs and wrong dose of vaccine administered was not reported. This report was non-serious.
Post injection- severe headache, body aches, and fever.   2 days out from injection, partial loss of tase.  7 days out severe headache.  8 Days out eye irritation and development of Bells Palsy in left side of face which led to severe corneal abrasion..  Treatment with Prednisone and Valacyclovir, for eye... Erythromycin and Moxiflooxin  Bells Palsy is ongoing