chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nerve damage; Information has been received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. In or around June 2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered nerve damage. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the product, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The causality assessment was considered as related by the lawyer.  The event nerve damage was considered to be disabling by the lawyer.
headache; This is a spontaneous report from a contactable consumer. This female consumer reported in response to Non-HCP letter sent via telephonic follow up activity. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration as single dose on unspecified date for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
stiff neck in the back of her neck; discomfort there as well as in her upper back on the side but her arm seemed fine; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 51 years old female patient who experienced stiff neck in the back of her neck (musculoskeletal stiffness) and discomfort there as well as in her upper back on the side but her arm seemed fine (musculoskeletal discomfort), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ247AB (Expiry date 30-jun-2020) via unknown route in the left deltoid.  On 02-Oct-2019, the patient developed a non-serious stiff neck in the back of her neck (musculoskeletal stiffness) and discomfort there as well as in her upper back on the side but her arm seemed fine (musculoskeletal discomfort) 1 hour 30 min following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was stiff neck and Back discomfort.   It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for stiff neck and Back discomfort.  List of documents held by sender: none.
Small hematoma; Needle was only 1/4 in, instead of being all the way into the muscle as it should; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE HAEMATOMA (Small hematoma) and PRODUCT ADMINISTRATION ERROR (Needle was only 1/4 in, instead of being all the way into the muscle as it should) in a 20-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AR9237B) for COVID-19 vaccination.     Patient did not had any allergies. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 22-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2022, the patient experienced VACCINATION SITE HAEMATOMA (Small hematoma) and PRODUCT ADMINISTRATION ERROR (Needle was only 1/4 in, instead of being all the way into the muscle as it should). At the time of the report, VACCINATION SITE HAEMATOMA (Small hematoma) and PRODUCT ADMINISTRATION ERROR (Needle was only 1/4 in, instead of being all the way into the muscle as it should) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products were not reported. The patient put the thigh away while the vaccine was being administered and so the needle was only 1/4 in, instead of being all the way into the muscle as it should. Patient did not seek medical care for the adverse event.  Treatment medications were not reported.
Patient presented to the ED and was subsequently hospitalized for unstable angina within 6 weeks of receiving COVID vaccination.
Really bad and different type of headache.... affected my jaw, behind ears, forehead and back of neck, lasted 16 hours..  Chills and fever for 2 hours.
pt had fever/chills 3 days p/vax;pt devel severe h/a 5 days p/vax lasting about 48hr;pt seen by chiropractor x 2 w/resolution of h/a;
Chills, body ache/muscle pain, headache, tiredness, mild fever (100.5 F). Started about 12 hours after vaccination. Ended in about 24 hours after start.
body aches, chills, feverish Horrible vertigo with nausea and vomiting Vertigo lasted 3-4 days
Patient came in pharmacy 10/10/20 and asked to speak w/ rph about rash. Stated it appeared "right after" her flu shot and spread from shoulder to elbow, it was unclear whether or not it was seen in other places. Patient said she was in pain at first but no longer in pain at injection site. Patient said she went to MD (name unknown) and showed them the rash/explained situation. Patient said MD said t was likely related to the vaccine since it occurred right after and it was patient's first time receiving high dose flu vaccine. Patient states MD recommened warm compresses to treat. I inspected pts arm and there was a discolored area spreading from elbow to halfway up bicep, but not near when injection site would have been. All other details unknown.
Patient started to get fast hear rate, then throat got tough to swallow, "lump" feeling in throat, no breathing/inhaling issues. Then spread slightly up  throat, said felt little tough to swallow, minor anaphylaxis reaction.  Treatment administered benadryl oral solution first since patient tolerated swallowing and no true breathing or blockage issues, waited 10 minutes for improvement, administered second dose benadryl oral solution after patient claimed feeling slightly rose up throat with minor swelling.
headache since she got her second shot of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache since she got her second shot of the vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 036B21A;) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VENLAFAXINE, CHLORTHALIDONE, METOPROLOL, olmasartan, COLESTIPOL, CLOPIDOGREL BISULFATE (PLAVIX), PANTOPRAZOLE, ALUMINIUM HYDROXIDE, DICYCLOVERINE HYDROCHLORIDE, MAGNESIUM OXIDUM LEVE (DICYCLOMINE CO), praluent inj pen, CYCLOBENZAPRINE, CILOSTAZOL (PLETAL), ZOLPIDEM, HYDROCHLOROTHIAZIDE, mometasone cream, SALBUTAMOL (ALBUTEROL HFA), GUAIFENESIN (MUCINEX), METHYLCELLULOSE (CITRUCEL), cultural and VITAMIN B COMPLEX for an unknown indication, CURCUMA LONGA RHIZOME, PIPER NIGRUM FRUIT (TURMERIC +), VITAMIN D3 and LORATADINE.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 14-Apr-2021, the patient experienced HEADACHE (headache since she got her second shot of the vaccine). At the time of the report, HEADACHE (headache since she got her second shot of the vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment includes Extra strength Tylenol every 6 hours Cardiologist appointment 3May2021 Primary care doctor appointment 7May2021   This case was linked to US-MODERNATX, INC.-MOD-2021-106233 (E2B Linked Report). This case was linked to MOD-2021-106167 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106233:sister case
s/p 2 doses of Covid-19 vaccine.  Pt presented for weakness, SOB, fatigue progressive over the past month prior to admission.  Found to be pancytopenic with bone marrow biopsy consistent with MDS.  He was started on chemo but stay was complicated by neutropenic fevers, epistaxis, retinal hemorrhage, AKI, fluid overload, hypoxic respiratory failure, atrial fibrillation with RVR, and shock.  He ultimately had a heart attack while admitted and was transitioned to comfort care after medical interventions could not stabilize hemodynamics.
Three weeks to a month post second COVID-19 vaccine in May of 2021, I developed a high-pitch ringing (tinnitus) in both ears, some equilibrium issues when bending over, and hearing became muffled and difficult in some situations, especially watching TV. The ringing never stops and changes pitch and volume, sometimes closing my ear. I have difficulty understanding some conversation if not facing the person. Volume has to be increased on phones and TV.  After hearing tests and evaluation, I am now given the option of a hearing assistive device for sensorineural hearing loss (SNHL). I have discussed the possibility of the vaccine having this adverse effect and it is in my chart, however, the providers feel this is attributed to age-related SNHL and possible noise damage. My feeling is if that were the case, it would have showed up much earlier than coincidentally after the second vaccination, since the events of concerts and loud music were 30-40 years ago, and I've been riding a mower with intermittent hearing protection, for one to three hours weekly to biweekly at my home, over 20 years during the summer season of four to five months. This was reduced to one-hour weekly once a landscaper was hired to mow most of the property beginning with the 2020 season. I had no equilibrium issues, continuous tinnitus, or hearing loss until after the second vaccine was administered in May of 2021. At the same time, I had also developed a spontaneous onset of almost crippling fatigue that could only be treated by immediate closing of my eyes either in a chair or lying down for at least 15 minutes. Thankfully, this seems to be lessening as time goes on.
I had a headache and really tired. I tested positive for COVID-19 at the facility I work at. I called my doctor and he prescribed me an antiviral.
1st 2 days after shot, body sore, flu-like symptoms no fever, left arm/site sore with limited range of motion. 05/11/2021 started about 2 weeks of very easily fatigued with activity,  high resting heart rate, difficulty taking a deep breath,  left arm/left partial chest red/edema/extreme soreness/limited range of motion/heat intolerance/itchy/large raised area, nausea, muscle soreness/fatigue, migraine for 4 days and light sensitivity for 6 days. Symptoms had less duration/frequency and more tolerance over time. Not fully able to tolerate previous activity without above s/s for 4 weeks after shot.
Parent reported severe cramping, stabbing pain from shoulder to fingertips approximately 1 hour after receiving flu shot.
stroke in left arm, arm is weaker than the other, strength never came back; This is a spontaneous report from a contactable nurse. An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscular, administered in the left arm on an unspecified date (also reported as 12Feb2021 12:00; pending clarification) (batch/lot number: EM9810) as a single dose, and first dose intramuscular, administered in the left arm on 12Feb2021 12:00 (batch/lot number: EL3249) as a single dose for COVID-19 immunisation. Medical history included cancer, prostate to bone from an unknown date. The patient has no known drug allergies. The patient's concomitant medications were not reported. Facility type vaccine was public health clinic facility. No other vaccine in four weeks. No other medications in two weeks. No Covid prior to vaccination and no Covid tested post vaccination. On 12Mar2021 (as reported, however, also reported as 13Mar2021; pending clarification), the patient experienced stroke in left arm, arm was weaker than the other, strength never came back. The adverse event resulted in disability or permanent damage. No treatment was received for the event. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, it is unlikely that the reported event is related to suspect product. The reported event is related to this patients underlying morbidity of prostate cancer with metastases to the bone. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Breakthrough case admission after 3 vaccines  Moderna 3/14/21 lot# 044A21A;  Moderna 4/10/21 lot# 025B21A;  Pfizer 10/25/21 lot# FF2590;
Nausea, vomiting, chills, muscle pain, extreme fatigue, joint pain, fever, headache
Very ill; Sores all over his body / especially head; Extremely itchy sores; Scratching himself; Hard bumps filled with liquid; Hard bumps filled with liquid; Bumps; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced malaise, skin ulcer, pruritus, scratch, edema, crust and papular rash. The patient was treated with prednisone. On an unknown date, the outcome of the malaise was recovered/resolved and the outcome of the skin ulcer, pruritus, scratch, edema, crust and papular rash were not recovered/not resolved.   It was unknown if the reporter considered the malaise, skin ulcer, pruritus, scratch, edema, crust and papular rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix at the end of July. The reporter stated that, the patient should get the second shot by the end of January. After vaccination with dose of Shingrix, the patient had extremely itchy sores all over his body especially his head, they were hard bumps filled with liquid then they pop and crust over then the patient itching like crazy. The reporter stated that, it seems like chicken pox but the dermatologist said it was not chicken pox. The reporter adviced for follow up with doctor.
She received the vaccine 5/4/10 and developed pain, itching, and redness at the injection site 5/12/10. She came to the health center with these complaints on 5/14/10. She had slightly elevated patch of erythema 2.5cm x 3.5cm size left deltoid without swelling, warmth. She was advised to apply cool compresses and avoid neomycin and return prn.
SHINGRIX dose #2 administered by local Pharmacy not by reporting provider. Only partial product info available. Event: Patient seen in our clinic a few days after receiving his 2nd SHINGRIX vaccine. He was diagnosed with shingles rash to the right forehead. Symptoms onset the day after he received the vaccine (12/6/18), patient sent to Ophthalmology for urgent eval to rule out optic nerve involvement and was cleared for this. His primary provider would like this reported in case it is related to the vaccine in any way.
A couple weeks after the vaccine I had a right foot drop and having trouble walking. I kept going into the ER and finally a blood clot was discovered.
Approximately 4 weeks after the first MMR vaccination the employee reported redness/pink coloration and warmth to the injection site and the feeling of a hard lump. She went to Urgent Care on 3/17 and was diagnosed with an abscess and prescribed Keflex.
This literature marketed report as received from an other health professional refers to 2 patients of unknown age. On an unknown date the patients were vaccinated with human papillomavirus vaccine (manufacturer unknown) for prophylaxis. On an unknown date the patients experienced adverse event. The outcome of adverse event was unknown. The reporter considered adverse event to be related to human papillomavirus vaccine (manufacturer unknown). This is one of several reports derived from the same literature (MARRS # 1709USA000317, 1709USA000319, 1708USA012768). Sender's Comments: US-009507513-1709USA000317: US-009507513-1709USA000319: US-009507513-1708USA012768.
Severe Reaction; This case was reported by a pharmacist via call center representative and described the occurrence of nonspecific reaction in a 69-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced nonspecific reaction. On an unknown date, the outcome of the nonspecific reaction was unknown.   It was unknown if the reporter considered the nonspecific reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist on the line with the patient that had a history of a severe reaction to a flu shot and they think it was due to egg proteins. The reporter gave consent to follow up No other detailes were provided.
contracted covid; contracted covid; He still has the impaired sense of taste and smell unfortunately; He still has the impaired sense of taste and smell unfortunately; This is a spontaneous report from contactable consumer (patient) and from a Pfizer sponsored program. A 32-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date (at the age of 32-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient contracted COVID after the first dose of COVID-19 vaccine. He had been negative for a week now (at the time of report). He still had the impaired sense of taste and smell unfortunately. He has had that for 2 weeks. According to PCR test he was negative on an unspecified date. He had heard conflicting information about getting the second dose straight away or waiting 30 days. Outcome of the event impaired sense of taste and smell was not resolved and while contracted covid was resolved on an unknown date and drug ineffective was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Heart fluttering/pain, can feel it beating through my chest at times, rapid heart rate all beginnning a few days post shot and happening periodically at random times even while resting and currently waning down as time goes on and getting better without treatment or care.
2/1/21 noticed my heat rate was 140.   Went to the hospital and was treated for atrial fibrillation.  Went to ER 3 more times in February in atrial fibrillation with heart rate in 140s-150s.
After the vaccine I had systemic swelling that is unusual for me. I had constant associated palpitations X 3 days, SOB, generalized weakness and anxiety. I felt awful Saturday and went to the ER. At the ER, my vitals were as follows: Blood Pressure 172/107 Pulse 107 Oxygen Saturation 97% RR 22
Person developed severe itchy skin. No hives. Unable to sleep. Took BENADRYL and ZYRTEC. Itchiness is slowly resolving.
This spontaneous report as received from a physician via company representative refers to a 27 year old patient. On an unknown date the patient was vaccinated with the third dose of GARDASIL (lot#, dose and route unspecified). Patient was administered the third dose of GARDASIL at the age of 27 years. No adverse effects reported. Additional information is not expected.
101 degree fever, chills, headache, joint aching for a little over 24 hours. Fever broke around 24 hours.  Fatigued for 72 hours.  Treated with Tylenol.  Hemorrhaged a blood vessel in right eyeball, not yet resolved.  Seeking medical consultation today.
Headache, body aches, fever starting after about 14 hours after shot and lasting for about 36 hours. Swelling and redness at the injection site starting about 48 hours after the shot.  As of today swelling and redness is better but not completely resolved.
pt recvd vax 28OCT93 & 31OCT93 devel fever, diarrhea; seen by MD 5NOV93; poss viral illness; 6NOV93 devel rash over entire body which lasted 1 wk w/itching;
alopecia of left eyebrow. diffuse hair thinning. never had alopecia before vaccine. currently treating with minoxidil and latisse.
Presented w/ HTN, n/v, abdominal pain.Covid +. Tx w/ Vit C/D
Fever; Nausea; Extremely tired; This is a spontaneous report from a contactable consumer (patient's husband). An 85-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 17Feb2021 (lot number: EM9810; expiry date: unknown), at a single dose, for COVID -19 immunisation. The patient has no relevant medical history and was not taking concomitant medications. The patient previously received first dose of BNT162B2 for COVID-19 immunisation. Patient's husband reported that his wife had a reaction to second COVID shot. On 18Feb2021, the patient experienced fever, nausea and was extremely tired. The patient did not receive treatment for the events. Outcome of the events was not recovered.
Pain at injection site, fatigue, chills, fever, headache, nausea.  Symptoms started 6 - 12 hours after injection, and most resolved 36 hours after injection.  The pain at injection site lasted for 3 days..  Symptoms were treated with Ibuprofen, Acetaminophen, and rest at home.
Shingles (pain and burning started 24 hours after injection, rash appeared 5 days later, still currently experiencing symptoms)
Right after the vaccine, I had a horrible taste in my mouth. It got worse throughout the night, the burning on my tongue started around 6:00 in the evening. I also woke up in the middle of the night because my mouth was very dry, with a greenish color. After putting up with this for a week the color went yellow to white.  I also notice a film on my tongue as well . My lips also goes numb throughout the day. The burning has stop but I still somewhat have the taste in my mouth. I did receive the second vaccine on June 11, 2021. I did not experience anything with my tongue with the second vaccine just normal itching.