chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients).    Case contains the information regarding patient 10 of 100 reported.  Concomitant products were not reported.  Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, lot numbers unknown to the HCP.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:
3OCT91 3 to 4 hrs p/DTP/OPV/HIB mom stated that pt was pale & limp lasted less than 5 sec; ER temp 101;
I had balance problems for the first time ever in between the first & second shots. After the second vaccine, I developed Peripheral Neuropathy with muscle wasting & muscle weakness. I can't stand up easily, I can't drive, & I can't walk more than a few steps. Going up stairs leaves me winded. I was totally healthy & functional prior to vaccination, although about 20 years ago I had a flu vaccine & my arm was paralyzed the next day. Then I developed an autoimmune disease which has since gone into remission.
A report has been received from a Health Professional concerning a female subject, who had been receiving Nasal FLUMIST (intranasal) for INFLUENZA. FLUMIST (intranasal) started on an unknown date for INFLUENZA. The patient experienced RUNNY NOSE, SLIGHT HEADACHE and CONGESTION IN CHEST. The patient recovered from the event of RUNNY NOSE, SLIGHT HEADACHE and CONGESTION IN CHEST on an unspecified date. The report was considered to be non-serious by the company physician.
Initially presented with a headache 3 days past vaccine, presented to hospital now found to have dural venous sinus thrombosis. Currently stable on anticoagulation drip.
Initial report received on 11 January 2011 from the Investigator participating in the above-mentioned post-marketing observational surveillance study under the reference number M5A16. This is one case in a series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 3-year-old, female subject (initials not collected) was identified by the investigator based on review of data. The subject's vaccine history included 4 doses of TRIPEDIA: lot number U1751BA received on 20 April 2007, lot number U1751BA received on 20 June 2007, lot number U2290BA received on 21 August 2007, and lot number U2470BA received on 10 March 2009 (route and site of administration not reported). Approximately 21 months after the last dose, the subject developed a paroxysmal cough on 25 November 2010. The subject also developed symptoms of cold-like illness, posttussive vomiting, apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 07 December 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 14 December 2010. The subject was not hospitalized. At the time of final contact on 20 December 2010, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
On 4:29 AM Monday morning September 6th I woke up with a severe tension headache in my temples behind my eyes and also realized I couldn't smell anything or taste anything. The headache lasted for over 48 hours. My body was also extremely weak and it is also numb in a way to where I can feel things to a point but it's like the sensitivity is mostly gone as well.
01/18/2006 Moderate Other Had 100-101 fever, reported that arm felt sore and had a lump on her lymph gland. Went to her (lymph node swelling was the size of baseball size.
complained of a left sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 immunization; Bnt162b2 (Dose:2), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "complained of a left sore arm".  Additional Information: Reported stated that she wanted to report that after the Covid booster (third shot) that her husband complained of a left sore arm. Reporter seriousness for complained of a left sore arm was unspecified.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported a localized reaction at injection site which included redness and swelling and pain. They reported pain going down arm as well. Patient called the day after to report these symptoms. Patient was advised by pharmacist to use ice pack, benadryl, hydrocortisone cream to help with reaction. PCP was contacted and made aware of reaction and agreed with recommendation. Patient called back the next day report symptoms were resolving. Pharmacist recommended seeing doctor or urgent care if symptoms worsened.
A large lesion - erythematous, with very large bullae; Feels more painful now than when it contained fluid; It's more like a burn; Felt very tired; Stressed; Cutaneous hypersensitivity; A large lesion - erythematous, with very large bullae; The vaccine went SC or ID instead of IM; A spontaneous report (United States) was received from a  concerning female patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  and experienced  cutaneous hypersensitivity, large lesion - erythematous, with very large bullae, tiredness, stress, burning sensation, pain, blisters.  The patient's medical history was not provided. Concomitant medications were not reported.   On 13-Feb-2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  12 hours post vaccination patient experienced cutaneous hypersensitivity. and large lesion-erythematous, with very large bullae. On 18-Feb-2021, patient experienced  burning sensation, pain, blisters, tiredness, stress.  No treatment was given.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events were unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced serious unexpected event of Dermatitis allergic along with NS unexpected events of Incorrect route of product administration, skin lesion, blister, pain, skin burning sensation, fatigue and stress.  The events occurred the same day as the first dose of mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information regarding the patient's past medical history, concurrent conditions, or concomitant medication was provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 05-NOV-2013 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 04-JUN-2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, also known as shingles. The patient was prescribed valacyclovir hydrochloride (VALTREX) for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
INJECTION SITE SORENESS; This spontaneous report received from a patient concerned an 81 year old male. The patient's height, and weight were not reported. The patient's past medical history included injured trapezius.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, 1 total administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for drug used for unknown indication, and clopidogrel bisulfate for drug used for unknown indication. On 12-MAR-2021, the subject experienced injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site soreness was not reported. This report was non-serious.
Received vaccine at Noon 10/21/08.  Within 2 hours, I was coughing, wheezing, short of breath, fatigued.  Severe headache and back ache set in.  At 6:30 pm, temperature was 99.6.  One Advil was taken.  At 7:30 pm, temp was 101.  At 8:00 pm, temp was 102.6 and I was getting dizzy.  I drove to local ER.  Pulse ox was low, pulse and BP high.  Full bloodwork was taken, urine, nebulizer for wheezing.  Discharged 3 hours later with diagnosis of severe reaction to flu vaccine.  Today, I still have low temp, malaise, myalgia, clammy.
Patient vaccinated x2 (Janssen: 4/3/21,12/6/21) Patient admitted to Hospital and later tested positive during admission on 6/30/22
on multiple unspecified dates, multiple unspecified patients may have been administered improperly stored GARDASIL 9; No adverse effects reported; This spontaneous report was received from a pharmacy technician referring multiple unspecified patients of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On multiple unspecified dates, multiple unspecified patients may have been administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis (product storage error). No adverse effects were reported. The vaccine underwent temperature 50 Fahrenheit, highest temperature above 47 degrees Fahrenheit/9 degrees Celsius for a duration of 21 days. There was no previous temperature excursion and data logger.   This is a non-valid case due to lack of patient identifier.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis.  On 2nd October 2018, the patient received the 1st dose of SHINGRIX. On 3rd October 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On 5th October 2018, the patient experienced generalized aching, chills, headache and nausea. On 6th October 2018, the patient experienced tiredness. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain, generalized aching, chills, injection site erythema, headache, nausea and tiredness were unknown. It was unknown if the reporter considered the injection site pain, generalized aching, chills, injection site erythema, headache, nausea and tiredness to be related to SHINGRIX. Additional details were reported as follows: This case was reported via online chat. The batch number and expiry date were not reported. One day after receiving vaccination, the patient experienced some soreness and redness around the injection site. The patient thought, she was good but not. On 5th October 2018, the patient also experienced severe headache, severe chills and aching all over. The patient felt nauseous and went to bed after taken the ibuprofen. On 6th October 2018, the patient felt very achy and tired. On 7th October 2018, the patient had intermittent episodes of chills.  On 8th October 2018, in the evening the patient had again another episode of chills. The patient was concerned about that, whether she should receive a 2nd dose in next 2 to 6 months. The patient not looking forward to a repeat of this for next dose.
Two occurrences of phlebitis in small vessels of index finger of left hand and posterior aspect of right wrist; headache of 3-4 hrs; soreness/warmth at injection site x4 days.; soreness/warmth at injection site x4 days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date May2021 (Batch/Lot number: unknown) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Stage IV uterine cancer" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "recurrent migraine" (unspecified if ongoing); "recurrent major depressive disorder" (unspecified if ongoing); "essential HTN" (unspecified if ongoing); "chronic severe widespread MSK pain" (unspecified if ongoing); "Phlebitis" (unspecified if ongoing). Concomitant medication(s) included: MEGESTROL; FLUOXETINE; ASA; PROPRANOLOL; LOSARTAN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. can't read handwriting on card, Location of injection: Arm Right), administration date: Apr2021, for COVID-19 immunization. The following information was reported: PHLEBITIS (non-serious) with onset Sep2021, outcome "recovered with sequelae", described as "Two occurrences of phlebitis in small vessels of index finger of left hand and posterior aspect of right wrist"; HEADACHE (non-serious) with onset Sep2021, outcome "recovered with sequelae", described as "headache of 3-4 hrs"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset Sep2021, outcome "recovered with sequelae" and all described as "soreness/warmth at injection site x4 days.". Therapeutic measures were taken as a result of headache, vaccination site pain, vaccination site warmth.  Additional information: Patient received second dose at 11:30. It was reported as not a serious, seriousness criteria-results in death, seriousness criteria-life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-disabling/incapacitating, seriousness criteria-congenital anomaly/birth defect. Reason why batch/lot is Unknown was reported as can't read handwriting on card. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since vaccination. No known allergies. Two occurrences of phlebitis in small vessels of index finger of left hand and posterior aspect of right wrist with no known cause. Only other cases of phlebitis in patient history were after insertion of peripheral IVs, which patient have not had since February 2020 and were not inserted in the vessels in question. Side effects in the days following each vaccination included headache of 3-4 hrs and soreness/warmth at injection site x4 days. Treatment reported as warm compresses, ASA for 3 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
got shot in march, since then sick with pain; got shot in march, since then sick with pain; romatoligust doctor and he said I have polymyalgia; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got shot in march, since then sick with pain), PAIN (got shot in march, since then sick with pain) and MYALGIA (romatoligust doctor and he said I have polymyalgia) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got shot in march, since then sick with pain), PAIN (got shot in march, since then sick with pain) and MYALGIA (romatoligust doctor and he said I have polymyalgia). At the time of the report, ILLNESS (got shot in march, since then sick with pain), PAIN (got shot in march, since then sick with pain) and MYALGIA (romatoligust doctor and he said I have polymyalgia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment information included steroids.   Reporter did not allow further contact
I21.4 ACUTE NON ST ELEVATION MI 11/14/2022 ACUTE NON ST ELEVATION MI I95.9 HYPOTENSION 2/8/2023 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 11/14/2022 ANEMIA I95.9 HYPOTENSION 2/8/2023 ANEMIA I21.4 ACUTE NON ST ELEVATION MI 11/14/2022 ACUTE NON ST ELEVATION MI I95.9 HYPOTENSION 2/8/2023 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 11/14/2022 ACUTE NON ST ELEVATION MI I95.9 HYPOTENSION 2/8/2023 ACUTE NON ST ELEVATION MI
Noticed morning after, that range of motion had been affected.  Patient could lift arm up in front of body, but at side, impossible unless helped with other arm. By next day, effect was better, by Monday almost normal.  This was more than soreness;  actually affected range of motion.  Appeared muscular.  Muscle weakness.
Received shot on 9/9/10. Had tender muscle soreness around 6pm that nite. Next day could not lift arm from body. No swelling or redness at site. Pain I went to doctor about a week 1/2 after. Seems to be getting better but has spasms at nite. Still has a crackling or popping in upper arm. Doctor said shot may have been a bit higher the shoulder.
pt recv vax; had a local skin rxn of approx 3" in diam; redness noted;
As i had my booster shot OI also got my shingles vaccine too. I have got rash on inside of my left leg and right leg. I have also got a blister yesterday inside my left leg. I also got the rash from my second dose,  but only on my left leg.
3 days post-injection patient experienced rash/redness/soreness at injection site. Over next couple days rash spread over entire body. Treated herself with BENADRYL and Cortisone cream. Getting better but still itchy. No current PCP so recommended Urgent Care if not better or doesn't clear. Rash getting better.
pt recv vax w/no complaints; pt got off parent lap & walked around room; went to door back to mom & fell to door hitting head w/door knob slide to rt behind door to wall; pt very rigid & pupils dilated sz, grunting; DPH given; BP 120/60;
I  awoke at 6 am with an extremely painful  headache in my left temple on Monday, April 12, subsequently diagnosed by  my GP,, Dr. , as shingles, It affects the whole left side of my face, including my eye.  An article in the NY Post  on Tuesday, April 20  lists shingles as  a possible side effect of the Pfizer vaccine, with about 6 recent  cases in the NY area.  I am reporting with the hope that more information will be published  about this so that anyone experiencing this will see their doctor immediately when antiviral medication is more effective.  I will notify Dr. that I have reported to you.
Patient called on 11/8/18 and reported smaller than pea sized blisters on side of neck and all over arm that was vaccinated. Later in the day RPh called to check back in with her. She didn't report any other signs or symptoms. Advised pt. to use BENADRYL, hydrocortisone, calamine lotion and to call her PCP. Also, reporting nausea.
About a month after receiving my Moderna Covid booster (12/22) I started experiencing an overall itching (burning, tingling) sensation over different parts of my body. Initially feeling this was seasonal and/or a skin reaction due to dry weather and overuse of the heating system, I tried using different lotions and tub soaks to relieve the itchiness. However, the reaction I was having was not area specific as you would see with a skin reaction or even an allergic reaction. Sometimes my ears or bottom of my feet would itch, though it still seemed skin related since I have had itchy skin before. This was different from the beginning. After several weeks, I visited a dermatologist in February who gave me steroid cream and advice on some over the counter antihistamines. Zrytex and Allegra have helped, but make me feel terrible. Both are non-drowsy per se, but my system reacted with nausea, brain fog. With Allegra I feel less so. I have never had any allergies before, not to medicine nor to food or environmental causes. I had to ultimately deduce that based on the timing and what I've heard about others reactions, this is related to the Covid vaccine. I was all for taking the vaccine, but now have second thoughts about the long term result.
Initial report received from the pt on 12Oct05. A 51 yr old female pt had received an injection of Fluzone, no preservative 2005-2006, lot number U1752LA, route/site not reported on 29Sep05. On the day of vaccination, the pt experienced shortness of breath, weakness and numbness in her head. Per the reporter, it won't go away. The pt denied illness at the time of vaccination. She would not reveal information regarding pre-existing medical conditions or use of other medications at the time the time of vaccination. At the time of this report, the pt had not recovered from these events and is being evaluated by her own physician next week.
My tongue swelled up and I had to go to the ER and was treated with an EPI shot, intravenous prednisone along with two other types of  histamines. Upon release I had to take prednisone pills for 4 days. And now I have to carry an EPI pen with me at all times.  I have never had my tongue swell before.