chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rhabdomyolysis; bilateral arm weakness; This is a literature report.  A 12-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: RHABDOMYOLYSIS (medically significant, life threatening), outcome "unknown"; MUSCULAR WEAKNESS (medically significant), outcome "unknown", described as "bilateral arm weakness". The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase: 7000 IU/l.; Sender's Comments: As there is limited information in the case provided, the causal association between the event RHABDOMYOLYSIS , MUSCULAR WEAKNESS and the suspect vaccine Comirnaty cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product 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.,Linked Report(s) : US-PFIZER INC-PV202200056097 Same article/drug/event and different patient.;
shingles; Other zozter -related conditions; death/wrongful death; This initial spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions, or allergies were not reported. On 22-NOV-2012, the pt was vaccinated with the first dose of zoster vaccine live (ZOSTAVAX) subcutaneous injection (dose, strength, vaccination scheme, route of administration, anatomical location lot number and expiration date were not provided) administered for long-term prevention of shingles and zoster-related conditions. In addition, on unknown date, resulting from pt's zoster vaccine live (ZOSTAVAX) use including shingles (herpes zoster) and other zoster related conditions (ill-defined disorder), resulting in injuries to the person represented and survivorship action. In addition, it was reported that on 19-NOV-2020, the patient passed away (death). The cause of death was not reported and it was unknown if an autopsy was performed. The outcome of the events of herpes zoster and ill-defined disorder was unknown. The reporter considered all the aforementioned events to be related to zoster vaccine live (ZOSTAVAX).  The patient's death was determined to be a medically significant event.
Fever of greater than 100.2 F starting 24 hours after vaccination. Resolved 2 hours after taking 800 mg ibuprofen. Muscle pain - generalized. Starting 11 hours after vaccination. Resolved 36 hours after vaccination. Muscle weakness - generalized. Starting 11 hours after vaccination. Still unresolved.
Red face/neck, hives and itching to body, starting att approx 3:40 then throat felt raw and Benadryl 50mg was administered IM.
Vaccine given on 10/4/11 in (R) arm. On 10/6/11 noted blisters. Area painful starting night of 10-5-11. On 10.7.11 reddened area 7" wide and 3 3/4" long.
pt recv vax;back pain;27jun95 weakness in legs;30jun95 progressive weakness;24jul95 to hosp;dx GBS; tx w/ plasmaphoresis
A report has been received from a Health Professional concerning a patient of unknown gender. No medical history provided. The patient had been receiving FLUMIST QUADRIVALENT (intranasal) started on an unknown date. Nurse practitioner wanted to know if a child had the entire dose of FLUMIST given in one nostril, should the dose be repeated. No symptoms to report. The patient had entire dose of FLUMIST given in one nostril. The outcome of the event of entire dose of FLUMIST given in one nostril was unknown. The reporter considered event of entire dose of FLUMIST given in one nostril to be non-serious.
Fever up to 102 onset 24 hours after vaccine, continued currently now approaching 48h since vaccine.  Treated with acetaminophen and ibuprofen with relief, but still remain febrile.
4/24/02 Mom came into clinic to get above name his 4-6 year immunizations. Mom stated that in 1997, when child received immunization in clinic, about 2-3 hours later, he developed a very high temp of 106 and a rash on body. States child was taken to ER and was given Benadryl and medication to lower temp. Was red; probably had reaction to one of the shots. Mom stated she took child to clinic on 10/16/97 the day after and was told that child had reaction to Hepatitis B shot.
Sever Sciatia Pain in left hip ,pelvic, and left leg,  Pain was so bad I was unable to sleep,  went to Er Saturday morning around 3 am,  received steroid shot, toradol shot,  script for steroid pack,  Meloxicam 7.5 .  also Tramadol 50 mg (which I can not and have not taken the Tramadol)   Followed up with my GP,  prescribed more Meloxicam.  wait to see if it doesnt get better.  finished steriod pack ,   Leg and hip continued in pain , not as bad as day I went to er,   Pain started to get worse again 8/29/2021.  again could not sleep
1. Constant Headache 2. Very Lathergic + disoriented 3. Couldn't sleep 4. Cold spells 5. Sweating spells - 10 min.  6. No apatite 7. Some nausia.  Lasted about 10 days I recieved Minosine (chemotherapy infusion) on the same day).
Room was spinning; Dizzy; Nausea; This is a spontaneous report from a contactable consumer (patient).  This 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 26Jan2021 (at 12:00) at a single dose on the left arm for COVID-19 immunisation. Relevant medical history included arthritis, blood pressure and allergies. Relevant concomitant medications included atorvastatin, furosemide and metoprolol. On 27Jan2021, the patient woke up in the morning the room was spinning and she was so dizzy she couldn't even get up. She remained dizzy for quite a while - she was not sure if she should receive the next dose. She also had nausea. The patient was not treated for the events. Pre and post vaccination COVID tests were not performed. The patient had recovered from the events on unknown date in 2021.  Information about Lot/Batch number has been requested.
Acute onset severe upper abdominal pain necessitating hospital admission, multiple a mission and serial doses of IV narcotic analgesia and anti- inflammatory drugs,  bowel rest and IV fluids.
Severe Nausea, jaw pain,  neek pain, a headache. muscle pain, fever, fatigue
This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 16Feb2021 at 17:15 (lot number and expiration date were not reported), as second dose, single for COVID-19 immunisation. Medical history included asthma, osteoarthritis (OA), rhuematoid factor positive, coagulation problem, high cholesterol, COVID prior vaccination and had known allergies: latex, peaches, and nuts. Concomitant medications included sertraline hydrochloride (ZOLOFT); omeprazole (PRILOSEC [OMEPRAZOLE]); montelukast; beclometasone dipropionate (QVAR); and diclofenac. The patient previously took morphine sulfate and experienced allergy and BNT162B2 dose 1 administered in left arm on 25Jan2021 for COVID-19 immunisation (vaccine in four weeks). On 18Feb2021, 35 hours after injection, at 4.15 AM, the patient had itching, burning, and redness at site, that woke her from sleep. By 17:40 the itching returned, more redness, ruby colour, more swelling with a lump beneath blue area given, and warm. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. The patient was not COVID tested post vaccination. The outcome of all the events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
It started with chills and aches then the next day my arm was red and a little swollen. I felt like I had a fever but my temp actually went down to 96. I was very tired and achey the whole next day.
no appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01, Unknown manufacturer.), for Covid-19 Immunization. The following information was reported: DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite".  Additional Information: Forwarded as an Adverse Event by the team on 09May2022 Reporter provided verification of contact address on 06May2022. Customer Verbatim: I received two initial and then the booster. I have been left with a metallic salty taste in my mouth. I have no appetite since the second one. Is there anything I can do  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache; Rash - Near Injection Site; Redness - Near Injection Site; Swelling (hardness) - Near Injection Site; Hot to Touch Sensation - Near Injection Site; Joint pain; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), ARTHRALGIA (Joint pain), HEADACHE (Headache) and VACCINATION SITE RASH (Rash - Near Injection Site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Respiratory disorder.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and ARTHRALGIA (Joint pain). On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), HEADACHE (Headache), VACCINATION SITE RASH (Rash - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling (hardness) - Near Injection Site). The patient was treated with ACETAMINOPHEN for Pain, at an unspecified dose and frequency. On 30-Jan-2021, PAIN IN EXTREMITY (Arm pain) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), HEADACHE (Headache), VACCINATION SITE RASH (Rash - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling (hardness) - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
On 10/4/05 L upper arm toward back with redness and swelling approx 1" in diameter. Experienced pain along the whole arm.
Sudden fatigue; feverish, insomnia x 3 days, all symptoms resolved.
Within one day, hospitalized with high fever, swollen face (her right side) with oozing sore, dehydration (all for four days). Non-reactive to antibiotics. Then diarrhea, colitis, rashes, yeast infections, unable to eat. Suffers recurrent staph-like infections that require pain meds, and sometimes antibiotics.  Nurse follow up on 07/28/04 states: "facial cellulitis; MRSA."  Nurse follow up on 08/05/04 states: "no new information."
Extreme swelling of lymph node in arm of injection site. Armpit lymph node is approximately the size of two marbles
Initial unsolicited report received from a healthcare professional on 29 October 2014. A 63-year-old female patient had received first dose of ADACEL, (batch number U4655AA, expiry date 13 December 2015, route of administration not reported) in left deltoid on 29 October 2014. The patient had received a dose of HEPATITIS B VACCINE (Manufacturer Merck, batch number, dose in series, route and site of vaccination not reported) on 08 September 2014. The patient had no illness at the time of vaccination and had history of allergy to codeine and hypertension. On 29 October 2014, 12 to 24 hours after receiving the vaccine, the patient developed left leg swelling and pain. The patient was sent to emergency room and evaluated by physician. An ultrasound was performed which was negative. The patient received some treatment (unspecified). At the time of this report, the patient had not recovered. Documents held by sender: none. Follow-up information received form a physician on 22 May 2015. It was reported that physician has no additional information to provide. List of documents held by Sender: None.
No swelling or heat. Sore arm since the vaccination and APAP does not help. Pain seems to be progressing down arm. Recommended MD visit/consult with cardiac MD to see if pt can use Ibu and rule out other illness.
uncomfortable; This case was reported by a consumer via (GSK Chatbot) interactive digital media and described the occurrence of discomfort in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On 28th September 2021, the patient received Shingrix. In September 2021, less than a day after receiving Shingrix, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was unknown.   It was unknown if the reporter considered the discomfort to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter said they just had the vaccine yesterday from the day of reporting and they felt uncomfortable all day and night. The follow-up would not possible as no contact details were available. The case had been linked with US2021AMR205344 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205344:same reporter
hematochezia the day after given the vaccine. It was streaks of blood in the stool x 2
Rash, swelling, tenderness from knee to toes on both legs. Rash was red & splotchy.
Administered dose labeled on the vial of 0.5ml. This was a booster vaccine which should have been 0.25ml. No adverse reaction or treatment required.
received an expired vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old patient who received HBV (Engerix B pediatric) (batch number 53YL7, expiry date 22nd December 2022) for prophylaxis.   On 22nd February 2023, the patient received the 3rd dose of Engerix B pediatric. On 22nd February 2023, unknown after receiving Engerix B pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-FEB-2023 Reporter's Comments: The medical assistant had twins (male and female) who one of them probably received an expired Engerix-B vaccine. The reporter consented to follow up. Additional Supportive Information: The patient received an expired Engerix-B, which led to expired vaccine used. This case was found as duplicate of case US2023029942. All the information from the case US2023029942 was merged into this case. The case US2023029942 was deleted and this case stand as case of record for this patient
I am nine days out from getting the vaccine and I still have a half dollar size red itchy patch on my injection site.
Fever at 17:00 of 100.6.  Seizure lasting up to 5 minutes at 17:30.  Generalized tonic-clonic seizure.
Severe back spasms; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and MUSCLE SPASMS (Severe back spasms) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). On 21-Jun-2021, the patient experienced MUSCLE SPASMS (Severe back spasms). The patient was treated with DIAZEPAM (VALIUM) for Spasms, at a dose of 1 dosage form and FENTANYL for Spasms, at a dose of 1 dosage form. At the time of the report, HERPES ZOSTER (Shingles) and MUSCLE SPASMS (Severe back spasms) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Itching in face and neck began around 4pm, itching and hives on back and torso began around 5pm, Benadryl po taken to relieve symptoms
Customer stated - had 1/2 inch raised area behind arm with 4 inch in diameter rash with blisters and severe pain.
Information has been received from a respiratory therapist and medical records concerning a 30 year old female with asthma, sinusitis, multiple environmental allergies, diabetes, thyroid goiter, obesity, restless less syndrome, and a history of partial thyroidectomy and cesarean section x2 with treatment of pre-eclampsia who on 06-AUG-2007 was vaccinated in the right deltoid with a first dose of PNEUMOVAX 23 (lot 655152/0889F). Concomitant therapy included ADVAIR, montelukast sodium, ZYRTEC, PRILOSEC, phentermine, WELLBUTRIN XL, MIRAPEX, and PROVENTIL. On approximately 08-AUG-2007, 2 to 3 days post vaccination (previously reported as 06-AUG-2007), the patient developed increased pain at the site of vaccination accompanied by erythema, swelling, increased tenderness. On 09-AUG-2007, the patient's right arm was swollen, red, and very warm to touch from shoulder to wrist. The patient was unable to bend the elbow secondary to edematous of length of arm. On 09-AUG-2007, the patient was hospitalized for further evaluation. Admission and discharge diagnosis was cellulitis. The patient was empirically started on therapy with vancomycin and ZOSYN. On 10-AUG-2007, x-ray of the right arm showed soft tissue swelling of the right humerus, but no fracture or osteomyelitis. CT of the arm showed increased density suggesting fluid or edema in the region of subcutaneous fat, posterior elbow. MRI of the humerus showed no localized fluid collections. There was subcutaneous edema of the right upper extremity, greatest in posterior elbow region, consistent with either cellulitis versus reaction to PNEUMOVAX 23. Infectious disease consultation thought it was likely right upper arm cellulitis associated with instrumentation from IM injection, less likely an allergic reaction since no pruritis or exacerbation of asthma. The patient had localized confluent erythema and warmth and tenderness also along the cellulitis infection. CPK was normal. Clindamycin was added to the patient's regimen. She continued to do well. She defervesced. Cultures were negative. She was transitioned to an oral regimen with continued improvement of her cellulitis and deemed stable for discharge home. On 12-AUG-2007, the patient was discharged to home on therapy with AUGMENTIN 875mg twice daily for 10 days and BACTRIM DS 1 tablet twice daily for 10 days. The patient was instructed to follow-up with primary care physician the following week. The respiratory therapist considered the patient's cellulitis to be disabling and an other important medical event. This is one of two reports from the same source. No additional information is expected.
27AUG93 brought to ER following generalized sz; mom describe a rhythmic movements over the infants body & hiccups; also described 30-40 second postictal apneic period where circumoral cyanosis was noted; afebrile upon ER admit-t98.2, HR164
Patient received her 2nd dose of Pfizer on Monday, 8/30/21 and said she started feeling some tightness in her chest the following day (8/31/21) but was monitoring this. On the third day (9/1/21) patient notified me about her concerns for what she was experiencing. She said her "lungs hurt", rating her pain a 2/10 pain scale. She said her lungs also "burned a little" and she can't seem to take in a full deep breath without pain. She stated she also had a severe headache which wasn't abnormal for her and that she knew headaches were also a side effect of the COVID-19 vaccine. She did not have heart palpitations at this time. Her health history was positive for sports-induced asthma, but the patient stated she had not participated in any activities to induce her asthma nor had she taken any medication related to that diagnosis within the last 3 days. The patient does not have a primary care physician so I advised her to reach out to the local urgent care and see if she could be seen to rule out any significant health changes. She acknowledged she would. As of submission, I do not know if the patient has done that yet or not, or the outcome.
Systemic: Fainting / Unresponsive-Mild, Additional Details: pt briefly lost consciousness... no injury..did not fall...came to quickly\r\nshe was nervous and had not eaten breakfast
This spontaneous report as received from a physician refers to a male patient of unknown age. The patient was allergic to sulfur and had no pertinent medical history reported. In the past, the patient was vaccinated with 3 doses of VARIVAX (Merck) injection (dates, strength, frequency, dose, route and lot # not reported). Concomitant therapies included lisinopril (manufacturer unknown). On an unknown date, it was determined that the patient was a "non-responder". No Lab Diagnostics Studies were performed. Causality between VARIVAX (Merck) and non-responder was unknown. The outcome of the "non-responder" was reported as not recovered/not resolved. Additional information has been requested.
Patient was given vaccination and almost immediately had redness + itching at the injection site. She put ice on it and was given 25mg IM diphenhydramine 45 min later she developed an itchy/burning throat, shortness of breath and nausea. She was given another 25mg IM diphenhydramine but did not improve so she was sent to the emergency room with an epi pen just in case
3 minute episode of staring and twitching/twirling of right hand - mom caught the last minute of it on video.  Wasn't responding to mom's voice.  Has since been treated as seizure activity by neurologist with oxcarbazepine.
No adverse effect, reporting patient was 16 at time of Moderna vaccine administration vaccine was give off-label
This spontaneous report as received from a pharmacist refers to a 26 year old female patient. On 08-AUG-2013 the patient was vaccinated with the second dose of 0.5 ml VARIVAX (Merck) (lot # 669680/0669AA, expiration 05-MAY-2013), subcutaneously, and it was an expired dose. No adverse effects reported. Additional information has been requested.
AT APPROXIMATELY 8 AM , I BEGAN A "SNEEZING FIT" OF 12 OR SO CONSECUTIVE FORCEFUL SNEEZES.  IT CONTINUED FOR SEVERAL MINUTES.  I HAVE  NASAL CONGESTION SINCE 8 AM (IT IS NOW 11:15 AM), SNEEZING, AND I AM CONSTANTLY BLOWING MY NOSE. I AM EXPERIENCING SEVERE COLD SYMPTOMS. I HAVE  SORENESS IN THE ARM THE VACCINE WAS GIVEN. OTHERWISE I AM FEELING FINE.
Cellulitis - 6 x 7cm area, red x 11 days - No treatment.
Vax "did not convert" following a series /w Engerix B dosing schedule 0,1,6