chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses administered after more than 1 temperature excursion during 33 weeks on 2021; doses administered after more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during 33 weeks on 2021) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:15 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 61.71.  No concomitant medications were reported.  Temperature excursion with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 35 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had history atopy: other (shell fish, latex, amoxicillin, ciprofloxacin and gentamycin). On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, in less than 30 minutes after vaccination, the patient experienced anaphylaxis. The symptoms included generalized pruritus, swelling (tongue), shortness of breath (SOB) and throat closure. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. She received treatment with epinephrine, parenteral antihistamine, IVT (intravenous transfusion) and bronchodilator (albuterol). The outcome was recovered. Reporter's comments: The attributed trigger was vaccine. ***Case correction (12-Jan-2016): Upgraded all events to serious.
Myalgia lasting for 6 days. Acetaminophen 500 mg prn.
A spontaneous report was received from a company representative who learned of this information from a physician regarding a male consumer who on 07MAY2013 reportedly suffered symptoms of TIC disorder after the administration of GARDASIL injection on 06MAY2013. Legal issue involved AE sent to legal. The patient's current status was reported as recovering. No further AE information was provided.
itchiness all over her body that comes and goes; hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and PRURITUS (itchiness all over her body that comes and goes) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced URTICARIA (hives). On 21-Mar-2021, the patient experienced PRURITUS (itchiness all over her body that comes and goes). On 13-Mar-2021, URTICARIA (hives) had resolved. On 21-Mar-2021, PRURITUS (itchiness all over her body that comes and goes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included cetirizine.
Symptoms: DIARRHEA, UNSPECIFIED, HEADACHE, DIZZINESS AND GIDDINESS, OTHER FATIGUE, PALPITATIONS, NAUSEA, CHEST PAIN, UNSPECIFIED.  This 39yo female advised receiving her first Pfizer covid vaccine on 12/30/2020. Within 15 minutes she had a metallic taste in her mouth, and felt nauseated. She had some diarrhea so she went home. (has hx of obesity and DM).  She reports 1-2 days later she felt light headed, and dizzy. Day 3 she has a headache, blurry vision with nausea and vomiting. Day 4 she had vertigo with heart racing (168bpm), chest tightness described as a pressure, with heavy legs "as if wearing ankle weights". She went to local ER (called 911 for transport). ER admitted even though had negative EKG, CE, PCR, for TTE. However when test done, it was halted immediately as her heart rate went over 182. She stated she was given a diagnosis by cardiology of POTS on discharge after further testing.  She was released with meclizine for vertigo prn, and propranolol for POTS which has helped improve s/s over past several months.  She uses her compression stocking and keeps herself hydrated.
Fever; Chills; Headache; Some muscle soreness; This is a spontaneous report received from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 3248) via unspecified route of administration in the left arm on 24Mar2021 at 11:30 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. The patients medical history included seasonal allergies, depression, anxiety and asthma. The patient past drug history included known allergy to antibiotic such as cefaclor (CECLOR). The concomitant medications included sertraline hydrochloride (ZOLOFT) at a dose of 200mg/day taken for unknown indication from an unspecified date and budesonide; formoterol fumarate (SYMBICORT) taken for asthma since an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 04:00, the patient experienced fever, chills, headache and some muscle soreness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the reported events. The clinical outcome of the events fever, chills, headache and muscle soreness was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a 75 year old female patient regarding herself. Patient's current conditions included high blood pressure and ceclor allergy. The patient had a history of kidney stones. On an unknown date in 2011, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported) in the left arm. No concomitant medications were reported. On an unknown date in April 2013, the patient experienced broke out in shingles. Patient sought medical attention. Patient was prescribed in antiviral for 7 days and some percocet things for a few days. Urine was processed about 2 weeks ago as follow up to the kidney stones (result not reported). She admits she sill has red bumps that have crusted over and some pain in her right breast area and other parts of her abdomen. The patient was recovering from shingles. Additional information has been requested.
The child received vax on 6/29/00. Dad brought the child in with a 3 cm red swollen area to the left thigh. No fever, no site tenderness. Advised to apply cold compress to area and symptoms should decrease in 24 to 48 hours.
pt took benadryl at 9:30 shot at 10:00, 10:13- felt hot.  B/p 129/76, p 79 100% 10:20 p 80 98% 129/84 1030: 122/78 P 74, 100%
Thought it was just an injection site reaction, red swelling about the size of a dime. A week later my arm swelled up with the size expanding to a little smaller than a clementine and a new dime size patch appeared. Had to visit urgent care twice where they advised me to ice, take benadryl, and prednisone. Consulted allergist who told me it looks like a delayed reaction
He got the immunizations at 10:00 AM. He seemed ok, just really tired. He took a nap until 12:00, then he woke up and nursed. He seemed fine (happy and playing). He laid down for his second nap at 1:30 PM. He woke up from his nap at 4:00 PM really fussy, crying, not nursing well, and with a fever of 101. So, I gave him Tylenol. I gave him Tylenol again at 9:00 pm. At 4:00 AM he woke up with a fever of 103. I gave him Tylenol. He got Tylenol again at 8:00 AM and 1:00 PM. Temperature is still 101 with the Tylenol. He nursing better, but still fussy. I called the doctors office to let them know about his fever.
This case was reported by a physician via call center representative and described the occurrence of fever in a 72-year-old male patient who received SHINGRIX. On 11th March 2018, the patient received the 2nd dose of SHINGRIX. In March 2018, several hours after receiving SHINGRIX, the patient experienced fever, pain, difficulty sleeping and muscle pain. On an unknown date, the outcome of the fever, pain, difficulty sleeping and muscle pain were unknown. The reporter considered the fever, pain, difficulty sleeping and muscle pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was reported by the physician who himself was the patient. The patient received SHINGRIX on the left arm. The patient experienced fever, aches, tough time sleeping, and muscular pain.
In error: Administered 0.1 ml Td ID instead of PPD. Left forearm 50mmx40mm erythema with 10mm area of induration. Mild itchy.
Inappropriate schedule of vaccine administered; Information as received from a lawyer and medical records and refers to a 63-year-old non-smoking female patient. Historical vaccinations inculded: tuberculine PPD, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (twice), influenza vaccine inact sag 3v(FLUVIRINE) and zoster vaccine live (ZOSTAVAX). On 06-OCT-2014, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot# and expiration were not reported) for prophylaxis. On 01-SEP-2016, the patient was vaccinated with a dose of pneumococcal vaccine conj 13v (crm197)(PREVNAR 13) 0.5 milligram, in left deltoid, lot # M5t193, expiration date 02-MAY-2017 for prophylaxis. On 06-SEP-2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot# and expiration were not reported) for prophylaxis. On 06-SEP-2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) in 0.5 milligram right deltoid, lot # N011491, expiration date 04-NOV-2018 for prophylaxis. Concomitant therapies included influenza vaccine inact sag 3v(FLUVIRINE).; Sender's Comments:  US-009507513-2101USA000011:
My healthy eighteen year old daughter received the GARDASIL vaccination in July, 2007. Immediately felt dizzy and had to lie down. The next week she mentioned that she had pain in her back and neck. Not knowing her symptoms were related to the GARDASIL vaccination, she had a second dosage in October, 2007. She went to the ER for a headache. She had numbness and tingling in her hands and arms, muscle weakness, and severe back pain. After many trips to the ER the neurology department - could not diagnose her. She had to use a wheelchair. A straight-A and once athletic student, she had to drop out of college due to her illness. Her EEGs were highly abnormal, including her evoked potential. We were sent to a clinic where they finally diagnosed her with fibromyalgia. The doctors didn't believe it was fibromyalgia and now her internal doctor feels it may have been due to the GARDASIL vaccine. Her doctor reported it to VAERS.
On 11/20/01, the pt exhibited brachial plexus palsy, 12 days after receiving the Flurvirin vaccine. The pt had received previous Influenza vaccinations but it is unknown if Fluvirin was administered. It is unknown if this developed on the same arm as the site of the Fluvirin injection. At the time of this report, the pt had not recovered. The reporter assessed the relationship of the study medication to the event as possible. Following internal medical review on 2/20/02, this case was upgraded to "Serious". OMIC
the patient had a syncope event after the shot. he was standing up waiting for his mom to get her shot
Menstruation has become more frequent, heavier and more painful. Following the second dose in June, predictable 28 day cycles have shortened to 23 days in August and 19 days in September. Normally very light periods lasting 3 days have become moderate to heavy lasting 5 days. Normally relatively painless periods are now marked by significant painful cramping, backaches, thigh pain, exhaustion.
Patient reported red area around injection site about the size of an avocado.  Reports redness, warm to the touch and sensitive to the touch.
Headache, Myalgia, Fever, fatigue, pain at injection site Narrative:
I gave the patient a TDAP (RD) and the Menveo (LD). I had patient laying down while I gave both shots. After the shots I had patient laying down with it tilted and had mom standing by his side. I asked the patient how he felt and he state he felt good. I was having them wait 15 minutes before leaving. About ten minutes later I hard mom yell help. By the time I got to the room he was slouched down on the bed. I had Dr come into the room and revalute the patient. The patient was clammy. We put and ice pack on his head, and checked his BP. We continued to have pt lay down. We checked his BP a few more times. Pt bp come up to normal and made sure he was able to stand and walk. PT state he felt fine, but the situation scared him. Once we knew he could walk/stand/and feel fine, we release his family. I gave mother the packed for vasovagal syncope packet, to go home with and to call for any other concers.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Mild, Additional Details: Patient passed out about 5 minutes after receiving immunization.  He came to fairly quickly but was confused, shaky and sweaty. After laying on the floor for a while he became nauseous but did not physically vomit while in my care. As the paramedics arrived the patient passed out a second time and was taken to the ER after evaluation.
I had a bad cold and was pretty tired but not like the first time. I completed an at home COVID-19 test which was positive. I was prescribed Paxlovid. My symptoms improved after 2 or 3 days to feel better but it took a full 2-3 weeks to feels.
2 weeks after I had a stroke, my right arm went completely dead and its coming back but it's not back to normal yet.
localized soreness in lt deltoid area occurred rt p/vax & has not resolved, seems to be worse when pt moves arm a certain way;seen by MD 15MAR97-no physical findings as of 20MAR97;same MD feels has devel a hematoma which is causing pain;
slight fever; headache; This is a spontaneous report received from a contactable consumer (patient) via Pfizer-sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection; Lot Number: Unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced slight fever and headache. Patient was scheduled for the second dose of the vaccine on 18Mar2021. Patient wanted to know if he can take Tylenol or Ibuprofen because he experienced slight fever and headache. At the time of this report, the outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Janssen COVID-19 Vaccine  During the injection I had extreme pain in my left arm at the injection site.  This lasted for about 1 hour and then calmed down to a dull ache.    About 7 pm Wednesday night (April 7) I started a low grade fever of 99.6 degrees.  Over the next three hours it increased to 102 degrees.  It stayed this high for about five hours.  (During this time I also experienced severe, almost uncontrollable shivering.)  Then it slowly dropped back down to 100 degrees by about 5 am.  It remained there for about 12 hours.  Then at about 5 pm it dropped to about 99.6 degrees where it stayed until I went to bed at 10 pm.  When I woke up at 2:30 am Friday morning I was covered in sweat and the fever was gone.    In addition to the fever, I had a moderate to severe headache, extreme body aches and Joint pain, as well as exhaustion.  As the fever diminished, these symptoms did as well.    By Friday afternoon all I had was some body aches and joint pain along with a minor headache.    By Saturday I was fully recovered other than some minor discomfort at the injection site.
MI-had catherization 4/3-transferred to hospital for possible CABG but had acute renal failureso deferred.  Underwent another cath 4/20 with stent placement
Rubella immunization 4/7/10. 8 days later -> onset of severe HA, L eye vision changes, then palate lesions that took 8 weeks to resolved. Then had severe joint pain and painful rash. Biopsy showed only inflammation in skin, an autoimmune or malignant origin. LE swelling & myalgia, & arthralgia - persist and are severe. Little response to medication.
Information has been received from a consumer concerning her 74 year old husband with type 2 diabetes mellitus and VALTREX allergy who on 04-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and Lot # not reported). Concomitant therapy included GLUCOPHAGE, TYLENOL, codeine and pain pills. The consumer stated her husband developed shingles after receiving the vaccine. He started with the pain on 06-APR-2011 and then on 08-APR-2011 he broke out with the rash. He had seen numerous doctors and was given VALTREX but it caused him nausea. The other doctors he saw provided him with pain killer and medication such asa TRAMADOLOR, codeine and TYLENOL to treat the nausea. There was no lab diagnostics studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
armpit was swollen; low grade fever; achy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 15Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced low grade fever and achy after vaccine on 15Mar2021. On 17Mar2021 (this morning), the patient woke up and armpit was swollen. All events were non-serious. Outcome of the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Rash appeared one week later below the site of injection. It got swollen the next day, was very warm and the swelling went down the day after, but the rash kept growing for the next 2 days until it was 3-4 inches in diameter. It has slowly been going away a week after the rash first started.
GARDASIL injection was given. Pt immediately had a sudden onset of headache & tonic-clonic shaking of head and arms lasting 3-5 seconds. Pt was assisted to exam table. Observed for 40 minutes, she was given juice, crackers 2 tabs ALEVE, TYLENOL 325 mg 2 tabs, she was discharged to home with a severe headache which lasted 2 days.
patient received covid booster instead of original series; she never had the vaccine before and was supposed to receive the original shot
Developed fever 101-103 off/on, rash on stomach/chest 5/29/06.
rash; injection site itching; A spontaneous report was received from a consumer concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site itching, rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the event(s) injection site itching. On an unknown date, the patient experienced the event(s) Rash.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), injection site itching, rash was unknown.
Lower lip swelling Presented to ED complaining of allergy to vaccine Treated with oral steroids and a dose of Benadryl and felt better so was discharged home
suspected vaccination failure; still got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's sister. The age at vaccination was not reported. The reporter stated that, his/her sister (patient) had the Shingle shot and still got the shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
Patient complaining of Altered Loc and Hypothermia.  Patient's been patient took a few days to improve.  This is now seems to be her baseline as she does have some vascular dementia.  Can continue home aspirin and atorvastatin. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Initial day of vaccine patient had headache, body aches, chills, flu like symptoms. On 1/20/2021 patient noticed left arm began to hurt and then a rash at vaccination site consisting of petechiae and erythematous macules
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. The Public Health District, per guidance from the Department of Health (ODH), Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the dose of vaccine that you received is valid.