chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients were given shots during excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients were given shots during excursions) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 16-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients were given shots during excursions). On 16-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (patients were given shots during excursions) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
Arms and legs severely numb and tingling to point of being asleep even with movement. Could not walk well at 3:30am beginning 3:30am 10/07/21. Left out fingers and toes completely numb. Symptoms waning but still tingling as of 10/19/21. Severe and persistent headache 10/07-10/19/21 (today.) Dizziness even when not moving 10/07-10/19/21 (today.) Chills and cold sweats with no fever at onset-now waning but present. Swollen tongue and eyes as well as lymph nodes under left arm, neck, and groin. Rash on face, head and hands. Racing heart which could be felt in the headache. Not able to communicate properly, scattered thought and unable to find my words the last 13 day and nights. Light sensitivity last 13 days but now waning. Lower back pain. Easily bruised legs. Extreme fatigue and weakness the last 13 days. Have had to take many sick days off work due to these horrible side effects.
1st night:  arm pain peaked in the middle of the night, but better by morning 3 days after injection:  had pain in left shoulder blade and about 5-6" radius of very tender scalp that hurt to barely touch 4 days:  left shoulder blade pain better....tender scalp remains 5 days:  pain has moved up toward shoulder..lesser pain on scalp     6 days:  left shoulder pain gone, but now have arthritis type pain in left shoulder and back area and neck area...still some scalp pain 7 days:  continued arthritis type pain in left shoulder and back area and neck area...still some scalp pain 8 days:  still a little arthritis pain in left shoulder and back area and still a little scalp pain  for the shoulder blade, shoulder, back and neck pain, I used ice
Pt developed worsening muscle pain at the site of injection over the past several weeks. This has required referral to Orthopedist.
After my first shot on 12/23/2020, I felt nauseous and had a headache. I came home and took a nap. Three days later, I began to have migraines. They would last hours to more than a day. I would go to bed with a migraine and wake up with the same migraine. I would wake up in the middle of the night with a migraine out of nowhere. They would come on with no warning and I wouldn't be able to drive, do the dishes, be able to think, listen to any kind of noise, or look at light.  By the time I received my second shot on 1/11/2021, I started having bilateral wrist pain on the top. I could not push myself off the bed, open my car door, or do a push-up. I sent a message to my doctor on Feb. 18th after the pain had been going on for more than a month.  By April 11th, I emailed my neurologist for numbness and tingling in my hands and feet. By June, I became so weak, I couldn't lift anything, hold a glass of water, or open a jar. I became so fatigued, I would come home from an 8 hour shift at the hospital and take a 3 hour nap. My brain became so foggy.  Since then, I have seen numerous doctors. I take Gabapentin and Cymbalta to keep my pain under control. I have increased my Topamax for my migraines and take Maxalt as a secondary if needed. I have now tried botox from the Stanford neuro clinic to help with the migraines. Some days are better than others. I am tired all the time.
Information has been received from a medical assistant (M.A.) referring to a 64 year old patient of unknown gender. No relevant medical history or concurrent conditions were reported. On 02-JUN-2015 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J012660, expiration date 10-JAN-2015; dose and route not reported). No adverse effects had been observed or reported. Additional information has been requested.
Other patients had side effects after Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Other patients had side effects after Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Other patients had side effects after Moderna vaccine). At the time of the report, ADVERSE DRUG REACTION (Other patients had side effects after Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-089398 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089398:
Red, itchy and many congregated blisters at the injection site. Oozing fluid at injection site.
Patient developed a fever and was listless beginning that evening. Overnight, he developed higher fever and had three seizures. He stopped eating formula and breastmilk, and began vomiting within 24 hours. He eventually became dehydrated and was admitted to the hospital.
Mental confusion, itchy nose, pain in the bones behind the back when getting up, pain in the knees, itchy arm 2 days, pain in the arm, runny nose, pain in evacuation, one night with persistent cough, allergy follows.
30 MINS POST VACCINE, PATIENT COMPLAINS OF MILD GENERAL ITCHING. BROUGHT TO OBS VIA WC. NO VISIBLE RASH NOTED. ADMITS TO SOME ANXIETY REEGARDING DEVELOPING A REACTION. BP ELEVATED BUT VSS BEFORE PATIENT DEPARTURE. PATIENT DENIES ANY CHANGES OR WORSENING OF S/S AND ESCORTED TO EXIT WITH NO ISSUES AT 1120. INSTRUCTED ON USE OF BENADRYL FOR S/S THAT WORSEN/BECOME INTOLERANT, AND SEEK FURTHER EVAL/TREATMENT IF NEEDED.  1105 INITIAL BP 176/93 HR 70 RR 18 SATS 100% RA 1110 BP 160/90 HR 99 RR 20 SATS 99% RA 1115 BP 158/89 HR 88 RR 18 SATS 99% RA
administration of flublok to patients younger than intended/ patient age is 11 months and indication given as 18 years plus with no reported adverse event; flublok inadvertently ordered, staff administered to six patients. should have been fluzone with no reported adverse event; Initial information was received on 09-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 11 months female patient administration of flublok to patients younger than intended/ patient age is 11 months and indication given as 18 years plus with no reported adverse event and flublok inadvertently ordered, staff administered to six patients. should have been fluzone with no reported adverse event    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Jan-2023,  Influenza quadrivalent recombinant vaccine dose of 0.5 ml (unknown formulation, expiry date, strength, frequency) via intramuscular route in unknown administration to be used for Immunisation with batch number 4J93AA where administration of flublok to patients younger than intended/ patient age is 11 months and indication given as 18 years plus with no reported adverse event (Product administered to patient of inappropriate age) and flublok inadvertently ordered, staff administered to six patients. should have been fluzone with no reported adverse event (Wrong product administered ).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Additional information received on 17-Jan-2023: the case upgraded from non-valid to valid, event of wrong vaccine administered was added, suspect date of administration, route, dose and batch number was reported and narrative was amended accordingly.
A nurse reported that a female received an injection of Flu Shield '00-'01 and within 24 hour, she developed mastitis in her right breast. She was treated with antibiotics. She recovered. No further information was available at the date of this report.
Came close to passing out within seconds of vaccine administration  Low blood pressure when returning home 90/52  has continued to drop periodically  No appetite
white patches on her skin on sides, folds of legs and near anus; vitiligo; This is a spontaneous report received from contactable reporter(s) from medical information team.  A 5-year-old female patient received BNT162b2 (BNT162B2), on 27May2022 as dose 1, single (Batch/Lot number: unknown) at the age of 5 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 10Jun2022, outcome "not recovered", described as "white patches on her skin on sides, folds of legs and near anus"; VITILIGO (non-serious) with onset 2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated her daughter was giving her granddaughter a bath noticed large white patches on the patient's sides, around folds of her leg and near her anus, states they are extremely pronounced white patches. Reporter stated her granddaughters has naturally dark skin. The preliminary diagnosis from the pediatrician is vitiligo. Reporter states they have been doing research and have come across two hits that showed cases of hyperpigmentation problems after the vaccines, so she sent the doctor those articles. The patient had blood work drawn and they were waiting on the results of these. Reporter stated her daughter would have more information as she was patient's mother and able to get a hold of her at any time. It was unknown where the patient got the vaccine, probably at her pediatrician's office but she is unsure. Reporter read that there is an ultraviolet light therapy that if caught soon can really help with treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mouth has about 6 ulcers in it; immune reaction; lymph node about the side of a baseball under her left arm; chills; aches/pain; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH ULCERATION (mouth has about 6 ulcers in it), IMMUNISATION REACTION (immune reaction), PAIN (aches/pain), LYMPHADENOPATHY (lymph node about the side of a baseball under her left arm) and CHILLS (chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 039D21A, 030M20A and 012L20A) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL HYDROCHLORIDE (INDERAL), SERTRALINE HYDROCHLORIDE (ZOLOFT), MELATONIN and TRAZODONE for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced PAIN (aches/pain) and CHILLS (chills). On 16-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MOUTH ULCERATION (mouth has about 6 ulcers in it), IMMUNISATION REACTION (immune reaction) and LYMPHADENOPATHY (lymph node about the side of a baseball under her left arm). At the time of the report, MOUTH ULCERATION (mouth has about 6 ulcers in it), IMMUNISATION REACTION (immune reaction), PAIN (aches/pain), LYMPHADENOPATHY (lymph node about the side of a baseball under her left arm) and CHILLS (chills) outcome was unknown.            No Medical History information was reported. Patient reported not tested positive for COVID-19 at any point. The lymph node under her left arm  looked like someone took a red magic marker and drew a sun on her arm. Treatment included heating pad under the arm and patient had not taken anything so far, the patient reported that she might take Tylenol.
Patient came in for a moderna bivalent for the age of 7years old.  The staff administered a moderna bivalent for 6months to 5 years.  The patient has received 2 previous doses of pfizer at the age of 5 years old.
ON FEBRUARY 19,2021, PATIENT HAD A GRAND MAL SEIZURE IN THE EVENING. SHE REPORTED TO THE EMERGENCY DEPARTMENT AND THE CASE WAS DISMISSED AND SHE WAS SENT HOME. ON FEBRUARY 21, 2021, PATIENT HAD ANOTHER GRAND MAL SEIZURE AND WAS HOSPITALIZED. SHE WAS DISCHARGED ON KEPPRA 1000 MG TWICE DAILY. SHE REPORTS SHE HAS SWELLING ON THE LEFT SIDE OF HER BRAIN AND CONTINUES TO HAVE SMALLER SEIZURES  WHERE SHE IS AWAKE BUT NOT RESPONSIVE.
Today during our morning vaccine clinic, we had seven patients here for their  second Covid- 19 Moderna vaccine. After the morning was over, I went to  account for the vaccine left over. I then realized my count was off and the  only reason for that would be I gave one of the Moderna patients a Covid-19 Pfizer vaccine mistakenly. There is not a way for me to know which one it is,  so I have listed all seven of them on the next page. I have been able to  contact three of them but not the four. I will send a letter to them.   The adverse event is just that. No reaction. One patient given the wrong brand of COVID vaccine.  I will continue to try and contact patients I have not been able to.
feeling a little nauseous; dizzy; This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2020, the patient received the 2nd dose of Shingrix. On 18th January 2020, 1 days after receiving Shingrix, the patient experienced nausea and dizziness. On an unknown date, the outcome of the nausea and dizziness were unknown.   It was unknown if the reporter considered the nausea and dizziness to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. After vaccination, the patient felt a little nauseous and dizzy. The patient asked whether the event occurred are from vaccine. This case has been linked to US2020AMR011237 and US2020AMR011215, reported by the same reporter.
This spontaneous report as received from a physician assistant, refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiration date not reported) (dose, not reported, intramuscular route). No other co suspect or concomitant medications were reported. The reporter stated that "within 3 days" after administering ZOSTAVAX on an unspecified date, the patient began to experience "marked redness and swelling" around the injection site. Also it was reported that ZOSTAVAX injection "may have been administered intramuscularly". The patient sought medical attention by visiting to physician assistant's office. At the time of the report the patient's outcome was recovering for the marked redness and swelling" around the injection site. Additional information is not expected.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 22-APR-2014 the patient was vaccinated with GARDASIL dose 1, intramuscular. On an unknown date the patient missed her second dose of GARDASIL due to a product quality issue. No adverse experience was reported. The patient planned to receive the second dose of GARDASIL as soon as possible. Therapy with GARDASIL was not discontinued. A product quality complaint has been filed. Additional information has been requested. This case is linked to 1411USA002040 (same reporter link).
Patient scheduled an appointment with her PCP, on 3/17/21. She presented with 2.5 weeks of flushing, sweats, and intermittent pruritic hives since receiving her first COVID-19 vaccine on 2/27/21. She reports that the pruritis and flushing is worse with exercise. For one week, she has had a pink ovoid lesion 2-3 cm in length on right chin and left neck that are now scabbed without drainage. Neck and chin lesions treated with bactroban, patient is already on antihistamines, and instructed her to follow up if worse.
shingles; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The age group was not reported but was captured as adult as per vaccine indication.  Patient reported that after receiving 1st dose of Shingrix in september 2020, patient experienced shingles. Patient wanted to know when 2nd dose could safely get.
Swelling of tongue; Taste metallic; Allergy to vaccine; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swelling of tongue), DYSGEUSIA (Taste metallic), ALLERGY TO VACCINE (Allergy to vaccine) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (Swelling of tongue), DYSGEUSIA (Taste metallic), ALLERGY TO VACCINE (Allergy to vaccine) and HEADACHE (Headache). At the time of the report, SWOLLEN TONGUE (Swelling of tongue) had not resolved, DYSGEUSIA (Taste metallic) outcome was unknown and ALLERGY TO VACCINE (Allergy to vaccine) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.  The patient had a really bad headache after injection.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of ALLERGIC REACTION TO MODERNA VACCINE, TONGUE SWELLING, METAL TASTE IN MOUTH AFTER BEING INJECTED and BAD HEADACHE was not provided.  No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
ONE HOUR AFTER RECEIVING VACCINE PATIENT REPORTED A RASH ON LEFT ARM AND ITCHY SCALP
At injection site has "grape sized" mildly itchy swelling. Not painful. Right thigh.
pt recvd vax;subsequently rubella titer was neg; retest neg;f/u blood testing showed no detectable antibodies;
pt recv vax 30NOV04 & 40 mins p/vax pt exp generalized rash w/o pruritis; f/u info indicated pt devel erythematous maculopapular rash on upper chest & neck 4 hr p/vax;
Patient stated that she had vomiting 7 times the day of vaccination along with aches in joints at knees, elbows, dizziness, and chills. She stated that all symptoms resolved by the next day, but the next day she felt weak.
Shingles vaccination Zostevax received Fri, 11AM, 8/7/09.  Evening of injection, slight fever, muscle ache down arm to hand and up neck behind ear and across, injection site very tender to touch and very hot. 8/8 rash all around injection site and very hot to the touch.  Achy full length of arm, slight fever. 8/9 Diarreah, rash has spread wider and down upper arm half way down the back of arm and is very hot. Fever is gone. 8/10 Three "pox" like blisters in rash area - itches like mad and is still very hot, occassional achy in back of arm. Reaction is not over yet but wanted to let dr. and CDC know about it.
Constant ringing in my ears; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 07Apr2021 13:30 at the age of 48 years old (Lot Number: ER8733) as DOSE 1, SINGLE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included achalasia from an unknown date. There were no concomitant medications. The patient stated, "constant ringing in my ears" on 07Apr2021 22:00. The patient has been COVID-9 tested since the vaccination, COVID-19 rapid nasal swab test: unknown on 13Sep2021. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage.  The outcome of the event was not recovered. Treatment oral appliance received for the event.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a pharmacist refers to a patient of unknown age. On an unknown date(reported as a long time ago), the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date, the patient experienced rash. The outcome of rash was reported as recovered. Additional information is not expected.
This spontaneous report as received from a pharmacist (a physician reported to the pharmacist) refers to a 64 year old female patient. Medical history was not reported. No known allergies (NKA). On 31-MAR-2014, the patient was vaccinated with ZOSTAVAX lot # J002240 expiry date 21-MAY-2014 (dose and route not reported) for vaccination. Concomitant therapies included ciprofloxacin (manufacturer unknown). In April 2014 (reported as few days after vaccination), the patient developed shingles. The patient sought for medical attention (contacted physician and pharmacist). The patient received treatment with an unspecified steroid and acyclovir (manufacturer unknown). At the time of the report, action taken regarding therapy with ZOSTAVAX was not reported. The outcome of shingles was reported as not recovered. Additional information has been requested.
pt recv vax; devel swelling around inject site; also c/o achy flu like sx;