chrisvoncsefalvay/vaers-outcomes huggingface dataset:
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    No concomitant medications were reported.  The case was reported for 27th out of 77 adult patients who had received the vaccine as reported by the reporter.  It was reported that the vaccine was administered approximately to 77 patients before it was known if the vaccine was ok to use after the excursion.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:case
Delayed localized cutaneous erythema with warmth occurring about 8 days following injection over left deltoid extending into upper anterior arm and clavicular region
This spontaneous report received from a registered nurse referred to a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-MAR-2017, the patient was vaccinated with VARIVAX (dose, frequency not reported, lot: M028546, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided. The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities and fever. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm, erythema of extremities and fever were recovered/resolved. The reporter considered the pain in arm, erythema of extremities and fever to be almost certainly related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient experienced extreme soreness immediately after receiving the vaccination on right deltoid. The patient took Ibuprofen 800 mg and the pain subsided in 2 to 3 days. When the patient discontinued taking Ibuprofen, she unmasked a fever. The pain lasted a total of 7 to 10 days. The patient stated that she called previously to report her experience regarding the 1st dose anonymously. For tolerance after 2nd dose refer case US2018GSK137621.
had no reaction except for a sore arm; I find that my arm is still hot, red and itchy; I find that my arm is still hot, red and itchy; I find that my arm is still hot, red and itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (had no reaction except for a sore arm), FEELING HOT (I find that my arm is still hot, red and itchy), INJECTION SITE JOINT ERYTHEMA (I find that my arm is still hot, red and itchy) and INJECTION SITE PRURITUS (I find that my arm is still hot, red and itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (had no reaction except for a sore arm), FEELING HOT (I find that my arm is still hot, red and itchy), INJECTION SITE JOINT ERYTHEMA (I find that my arm is still hot, red and itchy) and INJECTION SITE PRURITUS (I find that my arm is still hot, red and itchy).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant information  provided. No Treatment information  provided
8/24/21 had first Moderna vaccine injection with soreness of left upper arm. 9/03/21 developed dramatic erythema and induration of entire left upper arm extending from vaccine site all the way down to her left elbow. 9/06/21 swelling of vulva with redness and erythema. Saw PCP and had swab which was negative for yeast, HSV. 9/08/21 onset of maculopapular rash on neck and forearms which is pruritic.
Ectremely anxious; rubber band sensation extended to neck; rubber band sensation extended to throat.; exhausted; pain behind the eyes, like there were pins and needles; rubber bands tightly bound on her toes.rubber band sensation extended to her; pain in the throat, described as constricting and odd; 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 OROPHARYNGEAL PAIN (pain in the throat, described as constricting and odd), ANXIETY (Ectremely anxious), EYE PAIN (pain behind the eyes, like there were pins and needles), LIMB DISCOMFORT (rubber bands tightly bound on her toes.rubber band sensation extended to her) and MUSCULOSKELETAL DISCOMFORT (rubber band sensation extended to neck) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (pain in the throat, described as constricting and odd), EYE PAIN (pain behind the eyes, like there were pins and needles), LIMB DISCOMFORT (rubber bands tightly bound on her toes.rubber band sensation extended to her) and FATIGUE (exhausted). On 16-Nov-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (rubber band sensation extended to neck) and OROPHARYNGEAL DISCOMFORT (rubber band sensation extended to throat.). On an unknown date, the patient experienced ANXIETY (Ectremely anxious). On 13-Nov-2021, OROPHARYNGEAL PAIN (pain in the throat, described as constricting and odd) and EYE PAIN (pain behind the eyes, like there were pins and needles) had resolved. At the time of the report, ANXIETY (Ectremely anxious), LIMB DISCOMFORT (rubber bands tightly bound on her toes.rubber band sensation extended to her), MUSCULOSKELETAL DISCOMFORT (rubber band sensation extended to neck), OROPHARYNGEAL DISCOMFORT (rubber band sensation extended to throat.) and FATIGUE (exhausted) outcome was unknown.            No concomitant medication was provided by reporter. No treatment information was provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Non Significant Follow Up Appended; Reporters E-mail Address obtained.; Sender's Comments: The only reported events in this case are non-serious, hence no CC is required.
Severe chills with shivering Sweating Severe back and neck pain Headache Nausea
Developed injection site redness circular in shape approximately 3cm in diameter the following day after vaccine administered. Redness, itching and pain at site continued for 5 days. Then developed into a bruise, still have visible bruising at site. Used ice packs to area to alleviate itching.
A spontaneous report had been received from physician via medical representative concerning a 13 years, 13 weeks, 6 days old male patient, height 67.0 in; weight 110.00 lb. No information was provided regarding medical history and concomitant medications and concurrent disease of the patient. Patient received the Nasal FLUMIST (Intranasal) vaccine sometime in November or December of 2015.Patient went to the doctor on 10-Mar-2016 and was diagnosed with the B strain of the Flu. FLUMIST Quadrivalent was continued. The outcome of diagnosed with B strain of flu was unknown. The company physician assessed the diagnosed with the B strain of flu to be non-serious.
Beginning with nausea, followed soon after with all over body aches, low grade fever, chills, sweats, headache, for just over 2 days.  I accept this as price to pay for not getting or dying of Covid!
pt recv vax 22AUG96 & 1MAY97 pt devel a varicella-like rash consisting of approx 10 lesions on upper back;
Mother states pt. cried and was fussy for about two hours off and on, on 01/13/2016 and had a low grade fever. Mother states pt. is fine now and afebrile. Mother states, he seemed to possibly of had gas and he made a mess in his diaper yesterday.' Mother denies pt. having any symptoms currently.
On March 13, about 18 hours after my second shot, I arose to find myself with a fever of 100.5 degrees, headache, serious fatigue and severe body aches from my neck to my knees in every area in which I have had past surgeries and repairs (neck, back, wrists, hip and left breast [lymph nodes removed due to cancer]).  Most of that first full day I spent in bed sleeping, arising only around 6 p.m. for a bit of soup for dinner.  By 9 p.m., I was back in bed and slept through to 9 a.m. on March 14.  When I arose on March 14, the fever, headache and fatigue were gone, but the severe body aches remained in my hip and leg areas and became worse as the day went on.  I alternately tried ice and heat to relieve the pain, but nothing helped. I could not sleep either. Finally, at around midnight, I took to extra-strength Tylenol, which finally kicked in an hour later and I slept until 8 a.m. on Monday, March 15.  I had no symptoms when I awoke and continue with only a bit of fatigue.
Urticaria within 3 hours after vaccine administration right arm. Vaccine administered left deltoid IM.
For 1st injection, itching  on frontal edge of both armpits.   Noticed day after injection.  Still present as of 3-2-21.   Cortisone cream, Diphenhydramine Hydrochloride cream 2%;  after second injection Benadryl seemed to help.  For 2nd injection, itching all over body beginning day after injection, worse day later.  Benadryl for 3 days.  After that some tolerable itching for 3 days (didn't take Benadryl beyond this time because dried eyes.)
experienced joint pain in my pinky of my left hand that was diagnosed as trigger finger; experienced joint pain in my pinky of my left hand that was diagnosed as trigger finger; back spasm on my left side; This is a spontaneous report from a contactable other Health Professional (Patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 08Feb2021 16:30 (Lot Number: Unknown) and dose 1 via an unspecified route of administration on 11Jan2021 14:00 (Lot Number: Unknown), both as SINGLE DOSE (at the age of 43-years) in arm left for covid-19 immunization. Patient was not pregnant at the time of vaccination. Patient's medical history was not reported. Patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On an unspecified date, the patient experienced joint pain in her pinky of her left hand that was diagnosed as trigger finger. It happened very suddenly and had it before. She also experienced a back spasm on her left side. She went to urgent care and they told her that they are seeing many people with spasming. Patient received an unspecified anti-inflammatory injection, and muscle relaxer as treatment for the event. Since the vaccination, the patient was not tested for COVID-19. Outcome of the event back spasm on my left side was unknown and for all other events, it was recovered with sequel on an unknown date.
I felt tired maybe an hour after. About 9 pm i had body chills and aches. I checked my temp and had a fever of 101 and it started rising for about 3 days. I had joint pain and migraines.
became lethargic @ noc of vax;episode of staring, limp, out of it, then fussy x 3hr;high pitch cry, but consolable;lasted x 24hr;
No additional AEs,; via the intramuscular (IM) route instead of the subcutaneous (SQ) route; was administered VARIVAX and MMR II via the intramuscular (IM) route instead of the subcutaneous (SQ) route at another facility on 29-JUL-2021; This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.       On 29-JUL-2021 the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) reported as 1 time dose (dose, frequency, lot # and expiration date were not reported) via intramuscular (IM) route instead of subcutaneous (SQ) route.  No additional adverse event reported.
Patient was given a third dose of the vaccine.  Dates of vaccination (1/21/21, 2/19/21, 3/12/21)  She experienced injection site reaction on the third dose on 3/14/21 (Redness, mild swelling, hard to touch reported to Dr.  by e-mail).  Tylenol was given.
Pt became lethargic, slow to respond, speech muttered, shaking, drooping right eye, nauseous. BP 169/108, O2 sat=98%, pulse 100. Paramedics called and patient transferred to hospital.
Weakness in lower extremities, changes in concentration level, auditory hallucinations, admitted to the hospital and diagnosed with Guillan-Barre syndrome after lumbar puncture and clinical examination.
After her first COVID-19 Vaccine, she had a sore left arm; after her first COVID-19 Vaccine, she had a low level headache; This is a spontaneous report received from a contactable consumer or other non hcp (patient herself). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0176) via intramuscular route of administration, administered in left arm on 05May2021 as 1st dose, single for covid-19 immunization. The patient's medical history was reported as none and concomitant medications were not reported. On 05May2021 after her first covid-19 vaccine, she had a sore left arm that didn't hurt as much as other vaccines she had received, and a low level headache. The patient did not visited Emergency Room or Physician Office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient took Tylenol 500 mg tablet and was fine afterwards. The patient said she was very happy when she only had a sore arm after her first COVID-19 Vaccine because she always kind of got sick with vaccines .The outcome of the events was recovered on an unspecified date in May2021.
Patient diagnosed with hpv 6 and hpv11; This spontaneous report was received from a company representative refers to a female patient of unknown age. The patient's concurrent condition, medical history, drug reactions or allergies and concomitant therapies were reported as unknown. On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, anatomical location, lot # and expiration date unknown) intramuscularly for prevention of human papilloma virus. It was unknown if the patient received a two-dose series or three-dose series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On an unknown date in November 2019 (within the past month) the patient was diagnosed with Human Papilloma Virus 6 and 11 (papilloma viral infection). On an unknown date, the patient underwent Papanicolaou test (PAP smear test) (results were not provided). The patient had an unknown procedure to scrape her genital warts as a treatment for papilloma viral infection. The outcome of papilloma viral infection was reported as not recovered.   The causality assessment of the event with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Rt anterior lateral thigh 5cm x 5cm. erythema, warm to touch, cold compresses, TYLENOL 7/19. 7/20 warm compress. Return if no changes noted, to clinic.
Headache, Myalgia, Fever, Fever chills body ache fatigue and headache Narrative: Stayed home
covid 19; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) and DIARRHOEA (diarrhea) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.    Co-suspect product included mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (1st dose) in January 2021, Moderna COVID-19 Vaccine (2nd Dose, Lot#022M20A) on 25-Feb-2021, Moderna COVID-19 Vaccine (1st booster (Dose 3)Lot number- 939903 ) on 10-Nov-2021 and Moderna COVID-19 Vaccine (2nd booster dose(Dose 4) : 09Apr2022 004M21A) on 09-Apr-2022; for Product used for unknown indication: Flu Shot. Past adverse reactions to the above products included No adverse event with Flu Shot, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Lung cancer.   On 08-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2022, the patient experienced COVID-19 (covid 19) and DIARRHOEA (diarrhea). The patient was treated with TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid 19) and DIARRHOEA (diarrhea) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took  daily thyroid pills THYROID THERAPY as a concomitant drug. Patient had a feeling it was a mild reaction to the booster. Patient reported that they got a mild case of Covid back in March or April2022 and the warning sign was diarrhea.  Patient  took the Pfizer drug that took care of covid in 4 days.
The above patient received COVID-19 vaccine at 1400 on 03MAR21.  She came to the EH&S office at 1430 complaining of tingling lips and mild tongue swelling.  She was given Benadryl 25 mg po at 1437 by RN.  The patient emailed later that same day at 2139 and stated that she was completely fine.
Small hives that itch profusely appear if I am either hot or cold.  When cold the hive has a white circle around it, when warm it?s just red, no outer ring.  These appear in the ?soft skin? underarms, thighs, neck etc
Breakthrough case admission after 2 Janssen vaccines Jannsen 3/22/21 Lot# 1805020; Janssen 12/13/21 Lot# 1855191
Patient had a seizure 2 minutes after receiving the shot. He has never had a seizure before. He stared blankly and collapsed to the floor and started having jerking movements. This lasted about a minute total. As he was coming to, he yelled and then came out of it. He hit his head on the clinic floor when he fell.
Nausea began within 5 hours, vomiting and severe diarrhea becan within 7 hours
covered on arms, legs & face w/chickenpox like rash including inj LSQ site;start mild fever 27JAN98 100.00 & rash arrived 28JAN98 7AM approx 100+ lesions;
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 17-NOV-2014, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from her use of ZOSTAVAX : shingles. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Tdap and Menactra were given to patient on 4-3-06. They were overlooked and accidently given again on 7-20-07. patient had no reaction to injections.
Within 24 hours of injection had softball size swelling, redness, and heat at injection site.  L arm and L leg felt heavy and had difficulty walking.  Aching muscles and fatigue.  Temp 99-100. Also with headache, sore throat, and cough. Balance was off.  After 5 days, swelling remained the same but redness had improved.  Walking and balance improved but not back to normal.  L arm and L leg "continue to fee odd". Still with symptoms to date.
1) Ice cold toes & feet, sweat in toe area of socks 2) confusion, 3) chills
Index finger tips numb, chills, headache, body aches, diarrhea.
On 6/4/16 presented to ER with abdominal pain, fussiness. Xray and ultrasound done showing intussusception. Then transferred to another hospital for surgery and recovery.
Swelling on L upper arm. DTaP given 8/27/03 to LD. Mother called evening of 9/1/03 c/o child having swelling on L upper arm. Given quick appnt. for following am.  Seen by MD quickly, VAERS report sent. Family told to contact clinic if swelling did not go down.They did not call in the following days.