chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received a Menactra vaccine on 07-JUN-2019 and also received a second vaccine of Menactra, today, 08-AUG-2019 in error; Initial information received on 08-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 18 years old male patient who received first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] on 07-Jun-2019 and 0.5 ml second dose of the same vaccine (with lot: U6455CA, expiry date: 15-Nov-2020, via intramuscular route in the left deltoid) on 08-Aug-2019 in error.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given that time.   It was an actual medication error due to the extra dose administered.  It was unknown whether the patient had any adverse 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 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.  List of documents held by sender: none.
4/8/21- unable to walk with normal stride 4/9/21 severe pain in right hip making it difficult to walk or go up stairs 4/10/21 morning - unable to walk at all. Called my doctor, who after discussion, prescribed 5 days of prednisone for severe inflammatory response 4/11/21 able to walk again and complete course of steroid.   4/16/21 some inflammation in joints and hip persists.
36 hours later - Shake, fever, chills, achy, fatigue, cough, sore throat, headache. Tylenol and sleep. Still with symptoms.
4/10/2021 experienced some right side facial paralysis upon waking.  Called urgent care who directed me to go to a hospital as soon as possible and asked about all events leading up to this, noting that the vaccine may potentially have this side effect, as written in the medical journal.  Went to the ER, they put me in stroke protocol, did CAT scan, negative results, blood tests (including for Lyme), MRI to look for tumors after the CAT scan was negative, and an echocardiogram as they detected a new heart murmur never present before. MRI showed Bell's palsey in one facial nerve, all other tests are negative, including for Lyme's disease, a common cause.  I am still experiencing it, and am on Valtrex (anti viral) and Prednisone, but the symptoms still exist. There is no other change in my life or health, the only thing I've done differently is have the vaccine (for which we are grateful).
This spontaneous report as reported from a nurse practitioner refers to 18 patient who might have been vaccinated with doses of GARDASIL (Lot # H020910, expiration date 10-JUN-2015) that were exposed to 31F for accumulative of 1 hour and 30 minutes between 04-OCT-2013 and 06-OCT-2013. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Tingling in arm, slight hypertension.  EMS called and evaluated patient.  Pt. refused transport, sx resolved
This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD (Merck) (administration route, lot number and expiration date were not provided) that was exposed to a temperature outside of the recommended. No concomitant therapies were reported, neither was any adverse event. Additional information has been requested.
Presented with syncope and fall; no other symptoms; +Covid in ED- had + covid test 1 week prior as well; admit with Covid PNA; treated with Vit B12, levaquin, Zinc, Vit D; no O2 needed
Some fever; Headache; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th November 2021, the patient received Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were unknown.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had some fever and a headache after taking the Shingrix shot.  The patient asked if he/she could take Tylenol.
As of 10-1-10 still have very bad cough. 9-17-10 felt like I was getting a cold, sore throat 9-20-10 went to Dr got shot and cough medicine. Got worse 9-24 went back to Dr got chest x-ray LEVAQUIN antibiotic, very tired, earache developed. Went to Dr 10-2-10 and on 10-5-10.
Information has been received from a nurse concerning unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the unspecified patients received doses of improperly stored ZOSTAVAX (lot # L046899, expiration 23-FEB-2017, dose and route were not reported) for prophylaxis. The vaccines were stored at 60 F for 11 hours in refrigerator and at 30.9F for 11 hours in freezer. Previous temperature excursion information was at 48F for 24 hours, 56F for 6 hours in refrigerator and 25F for 6 hours in freezer. Data logger was not involved in the case. No adverse effects reported.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA014500: US-009507513-1612USA014504: US-009507513-1612USA014502: US-009507513-1612USA014503: US-009507513-1612USA014499: US-009507513-1610USA013229:
second dose of vaccine missed; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose of vaccine missed) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-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 PRODUCT DOSE OMISSION ISSUE (second dose of vaccine missed). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second dose of vaccine missed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
CIDP (CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY); GUILLAIN-BARRE; SUSPECTED COVID-19 INFECTION; NAUSEA; VOMITING; This spontaneous report received from a consumer concerned a 51 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 09-MAR-2021 to left deltoid for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 51 years old. No concomitant medications were reported.  On an unspecified date in 2021 after the injection, the patient experienced nausea and vomiting. On an unspecified date in 2021, shortly after receiving vaccine, the patient caught COVID (suspected covid-19 infection). On 14-APR-2023, patient saw neurologist who said that the COVID vaccine might had triggered patient's onset of CIDP (Chronic inflammatory demyelinating polyradiculoneuropathy). On an unspecified date, the patient had Guillain-Barre. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, vomiting, suspected covid-19 infection, CIDP (Chronic inflammatory demyelinating polyradiculoneuropathy) and Guillain-Barre was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20230569029- Guillain-Barre. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration. 20230569029-CIDP (Chronic inflammatory demyelinating polyradiculoneuropathy). The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
RASHES ON FACE, ARMS, LEGS, SCALP & SCALP HAS LARGE SPOTS WHERE THERE IS NO PIGMENT. THE DR. HAS PRESCRIBED TOPICAL MEDICATION WHICH IS HELPING
flue like for about two days; feet are having extreme cold flashes left one; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flue like for about two days) and FEELING COLD (feet are having extreme cold flashes left one) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flue like for about two days) and FEELING COLD (feet are having extreme cold flashes left one). At the time of the report, INFLUENZA LIKE ILLNESS (flue like for about two days) and FEELING COLD (feet are having extreme cold flashes left one) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant product use was not provided by the reporter.   Reporter did not allow further contact
Eye strain, possibly conjunctivitis. Some very slight flu like symptoms (sneezing, congestion)
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 12-JAN-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K006682 with expiration date of 17-DEC-2015; dosage and route unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
My knees started bothering me, they weren't sore but uncomfortable. The best way to describe it is when I am asleep when I went to straighten my leg fully there would be a shooting pain from my knee cap. I would have to rub my knee to get rid of the pain. It only lasted a few seconds. Sometimes I would wake up with soreness but not every time. It wasn't every night, it was random. My knees would be stiff after being bent for too long. My primary care doctor told me to see a orthopedic doctor. He also did a blood test to rule out auto immune disease, they all came back normal. I went to see the orthopedist and the x-ray showed that my knee looked normal. I was told that I would need to do quad exercises because the cartilage in my knee was inflamed. I started to do that and I haven't had the shooting pain but I have had some soreness. I also experienced some shoulder pain around this time as well.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 10-AUG-2015, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # K015464; expiration date 09-SEP-2017) dose and route of administration were not reported. Concomitant therapy was not reported. No adverse events have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
On 12/31/20 at 2:00pm I developed a HA, with chills, & body aches.   My right arm started to swell,  redness  from injection site approx. 6 inches very  painful   On Jan 1st temp 100.9  HA body aches and slept all day in bed.  The redness in my arm finally went away on 1/7/2021
The next day, she work up with  very bad headache, hot flashes, GI upset, body aches. low grade fever 100.3.  Symptom are continuing. very bad headache, hot flashes and body aches now 5 days out.
10/16/16 approximately 900-930 AM onset of numbness both legs and feet with pins and needles. Back pain. Hip pain. Moderate swelling in feet. No discoloration. 10/17/16 ER at 900 AM d.t. severe pain. They questioned Guillain-Barre Syndrome. A spinal tap was going to be performed; however, her symptoms improved and it was not done. They gave her pain Rx x 2 days. 10/20/16 doctor visit with Dr (primary provider). He drew blood which was within normal limits. He also questioned GBS. Over the next 1 1/2 weeks the symptoms gradually resolved. She is reported to be back to normal by her mother which provided this summary of events.
17:00 given shots 5-10 mins after shots started with itching. 17:15 given 1.5 tsp BENADRYL & 1/2 tsp 15 min later. Felt like throat closing. Hives appeared. No wheezing, mild edema of lips, some hyperventilation. 17:45 given 60 mg of SOLUTAB PRELONE & 15 ml MAALOX. 18:00 calmer breathing, hives resolving less itching.
an expired dose of MENACTRA was inadvertently administered to a patient with no reported adverse event; Initial information received on 27-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old male patient who received an expired dose of meningococcal a-c-y-w135 (d conj) vaccine [Menactra] with no reported adverse event.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Meningococcal Vaccine B and HPV Vaccine for Immunisation.  On 20-Jun-2022, the patient received a Dose:2 of suspect meningococcal a-c-y-w135 (d conj) vaccine (dose: 0.5 ml total, frequency: once, Strength: standard, lot U6951AB, expiry date: 06-Jun-2022, Solution for injection) via intramuscular route in the left deltoid for Immunisation.   On 20-Jun-2022 the patient developed a non-serious event as an expired dose of menactra was inadvertently administered with no reported adverse event (expired product administered) (Latency: same day). The caller wanted to know if the dose was valid and/or whether it should be repeated.   Action taken was not applicable.  Outcome: unknown   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.
Rash in my chest, under my breast and some in the side. Experience some tingling, itching in my legs.
1st dose/arm pain for 3-4 weeks at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 15:30 (Lot number: EN6204) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LYSINE; FISH OIL; SAW PALMETTO [SERENOA REPENS]. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Mar2021, outcome "not recovered", described as "1st dose/arm pain for 3-4 weeks at injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient was not pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. The patient received other medications within 2 weeks of vaccination which included multi-vitamin. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The 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. Since the vaccination, the patient had not been tested for COVID-19. The patient received second dose of vaccine on 06Apr2021 at 15:15 pm. The case was assessed as non-serious.  No follow-up attempts are possible. No further information is expected.
after administering vaccine to right arm the patient fainted, when the patient came to both her and her husband said it was a usual occurance and that she has been prohibitted to give blood beacause her fainting happened too regularly. patient was siiting in a chair while giving the vaccine so there was no other harm/injury from the fainting episode. we gave a glass of water as well because she said she was dehydrated.
I received the vaccination at 9pm on August 6th. On August 9th  at 5:30 am noticed swelling, pain, aching, soreness, itching, and stiffness from the deltoid to below the elbow. A reddened,  swollen, warm, and sore area several inches lower and right of injection site. I took ibuprofen, lortadine, and benadryl. Injection site sore the night of vaccination, next day tiny pink area around the site and soreness. Yesterday morning the same. Then around 11am achy and fatigue. Subsided later in the day.
A non-serious spontaneous report of inadvertently administered FLUMIST to a pregnant woman was received from a registered nurse concerning an adult female. Medical history and concomitant medications were not reported. The patient's obstetrical history included one full-term delivery. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experienced any adverse events during the pregnancy. Additional information was received on 05-Nov-2009 and incorporated into the narrative: included number of full-term deliveries.
Sweating; Chills; Muscle aches; Diarrhea; Fever; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Sep2021 11:00 (Lot number: 30135BA) at the age of 57 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Pseudobulbar affect (PBA)" (unspecified if ongoing). Concomitant medication(s) included: NUEDEXTA [DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE;QUINIDINE SULFATE DIHYDRATE]; SYNTHROID. The following information was reported: HYPERHIDROSIS (non-serious) with onset 25Sep2021 15:00, outcome "recovering", described as "Sweating"; CHILLS (non-serious) with onset 25Sep2021 15:00, outcome "recovering", described as "Chills"; MYALGIA (non-serious) with onset 25Sep2021 15:00, outcome "recovering", described as "Muscle aches"; DIARRHOEA (non-serious) with onset 25Sep2021 15:00, outcome "recovering", described as "Diarrhea"; PYREXIA (non-serious) with onset 25Sep2021 15:00, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 25Sep2021 15:00, outcome "recovering", described as "Headache". Therapeutic measures were not taken as a result of hyperhidrosis, chills, myalgia, diarrhoea, pyrexia, headache.  Additional information: The 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. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
I was very tired.  I wake up the next day with vision impaired.  I have wiggly lines in my vision when I look at something.
vertigo started 10PM day of shot & cont from Friday Pm to Sunday Pm sick for over a week w/flu sx;might have been exposed to flu;
Initial not concerning:  Bad headache the next morning which passed by the end on the day. Injection site swelling and discomfort for a few days.   The reason I am submitting this form is fatigue, mild diarrhea, moderate nausea, and vomiting starting 8 days after the vaccine. So far it's nothing serious. I haven't been out to catch anything so it seems related. I thought you may want the data because of the strang delay in gastrointestinal symptoms.
Upper left arm pain when lifting arm or turning into certain positions. Pain between range of motion of 30-60 degrees active and passive. Duration 3 1/2 weeks. Heat application, exercises, Metrol Dos Pak currently.
She got her vaccine, it was in a church and she got home and she was fine, everything went back to normal.  Did her normal activities.  She went to bed at her usual time, and when she moved her arm at 1:00 she woke up and when she tried to move her feet they were both numb.  They were like they were asleep and she got scared and called her son.  He came to her room and told him that she could not move her legs and he helped her to get up and got her a cane.  She didn't know what to do and was waiting for the numbness to go away and it did not.  The next day or so her niece brought her a wheelchair as she could not use a cane, and her son took her to the UC and they did an X-ray.  They did not see anything and told her to go home and take Tylenol.  This did not help and the next day she called her PCP at that time and she was not able to see her due to the pandemic and she sent her to get an MRI, which took 2 months to get.  She waited for that and then she went and had a CT scan as the MRI did not show anything.  She had a CT Scan which made her break out in a rash, and was given pills to take which did not help.  She was given a pill at night to go to sleep which did not help either.  She still had the rash and they kept checking her for COVID.  All this time she was trying to get a hold of somebody to report it and she had asked her doctor and she did not want anything to do with it, and would not report it.  She was sent to a neurologist who did not find anything wrong either.  She went to a foot doctor and gave her a cortisone shot and she asked if it was going to help her, which he told her that it should.  It helped her for about an hour, but after that she was back to where she was, not able to walk up the stairs to get to her house.  Dr. did surgery on her toes as they were crooked.  Her right leg stayed numb all this time and is still numb, and her toes are also numb, and she cannot step down to walk due to this.    She is able to use a walker and she is able to get to the bathroom and has to sit down again as she gets very tired and exhausted.  Her children have bought her machines and drinks that they have seen that helps on TV, but nothing seems to work.  She is crying and she cannot do anything and the county said she did not qualify for somebody to clean her house and she cannot afford to pay somebody.   Her PCP told her not to get the other vaccines, to wait so that it didn't make things worse.  She was watching her grand-children and now is not able to as she cannot walk in order to take care of them.   She is just miserable and has been that way for about 2 years, and she does not know what to do.    She does get a flu shot every year, and has not had any problems with them.