chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left hand got very swollen; Left wrist got very swollen; Could barely move his fingers without any pain; She give her husband an Aleve to ease some of the pain; This is a spontaneous report from a contactable consumer (Patients Wife). A 75-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0181 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 20Jun2021 at 10:30 (Age at vaccination was 75 years) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included atorvastatin taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took flu vaccine vii, shingrix, pneumococcal vaccines. On 22Jun2021 about two days after receiving the first covid vaccine patients wife stated that her husband had his first vaccine this past Sunday and yesterday (22Jun2021) he noticed in the same arm he received the vaccine, his left hand and left wrist very swollen and he could barely move fingers without any pain. She wrapped it in a ace bandage and she don't know if that's ok or not. She also give her husband an Aleve to ease some of the pain but had heard that it might not be ok to give with the Covid 19 vaccine. She wasn't sure what the time parameters were before she could give him some Aleve or if she could give him some Tylenol. Patients injection site did not bother him at all. She isn't sure if this was from the Covid 19 vaccine but her husband doesn't remember doing anything to make his hand and wrist swell. She reports her husband gets his flu vaccine every year and has never had a reaction. He was had the pneumonia and the shingles vaccines and did not have reactions to either of those. She have appointments in Jul2021 with their new primary healthcare provider. Vaccination facility type was drug store. The patient did not perform any relevant test. Therapeutic measures were taken as a result of pain. The outcome of the events was not recovered.  Follow up attempts are needed; Additional information has been requested.
Was getting my period on a regular basis- it was about to start the day of first Pfizer Covid vaccine- it literally stopped in it's tracks- It may be coinicidence because of my age- however my mom started menopause at 58 and I had no symptoms or indication that menopause was starting- my period just straight up stopped and has not returned
redness in arm; soreness in arm; swelling in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), PERIPHERAL SWELLING (swelling in arm) and ERYTHEMA (redness in arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #003621A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm) and PERIPHERAL SWELLING (swelling in arm). On 11-May-2021, the patient experienced ERYTHEMA (redness in arm). At the time of the report, PAIN IN EXTREMITY (soreness in arm), PERIPHERAL SWELLING (swelling in arm) and ERYTHEMA (redness in arm) outcome was unknown.            No concomitant medication and treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Developed multiple cherry angiomas scattered across torso and face - blanching micro red papules.
On the evening she received her second dose of Shingrix, the patient experienced chills, a low grade fever, elevated heart rate (153 bpm), elevated blood pressure, and increased urination.  She went to the hospital and was managed with Benadryl and discharged home.  After 4 days at home, her symptoms returned (elevated blood pressure 180/93 mm Hg, chills) and she went back to the hospital.  3 hours after being discharged from the hospital that time, she again had her symptoms return prompting another ER visit.  She underwent cardiac testing to rule out other causes.  Her problems lasted for 1 week from the time of her vaccination and she has been fine since then.
Three hours after vaccine (vaccine at 11 am)  headache started, around 5pm body ache started with fever of 100.5; this continued all night. Sunday still had fever and body pain with headache. Monday same symptoms and exhausted. Tuesday still have headache, fever diminished but very tired.
4/1/2009 MOTHER PRESENTED TO HEALTH DEPARTMENT FOR CHILD'S VACCINES.  MOTHER REPORTED THAT CHILD HAD SWOLLEN RED THROAT AND DIFFICULTY SWALLOWING FOR 5 HOURS AFTER RECEIVING VACCINES ON 7/17/2008.  NO KNOWN TREATMENT AFTER.
Aching  Fever low grade Chills Muscle pain Headache Insomnia
This spontaneous report as received from a nurse who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ) lot # M046000, expiry date 27-JUN-2018 and lot # M041768, expiry date 25-JUN-2018, orally (dose was not reported) for prophylaxis. The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77F for 3 hours and 38 minutes and from 47F to 77F for 3 hours and 14 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA009203: US-009507513-1709USA010539: US-009507513-1709USA010540.
approx 3mos p/vax pt lab rpt eval revealed neg varicella titers.
Information has been received from a pharmacist referring to a 62 year old male patient. The patient had no drug allergies/reactions. On 23-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose not reported) subcutaneously. Concomitant therapy included cholesterol and blood pressure medications. The pharmacist reported that "within three months" of the administration of ZOSTAVAX (on an unspecified date in 2015) the patient developed what was diagnosed by an unspecified physician as a "psoriasis-like rash". The patient was currently being treated with an unspecified "topical steroid" (manufacturer unspecified). At time of this reporting, the patient had not recovered. The causality was not provided. Additional information has been requested.
Patient stated she was feeling tired and felt like her heart was racing. She was instructed to sit down as a precaution to passing out. She stated she had a breakfast biscuit and half a cup of coffee for breakfast. She was given crackers and water as a precaution. Pt waited a total of 50 mins and drank all the water and did not eat the crackers. She also stated that she had only had 5 hrs of sleep, which may have been a contributing factor. She also had stated that when she received an epidural she had started feeling the same way and they had to give her epinephrine due to a very low blood pressure. Her blood pressure was taken and was 133/88 HR 85. She continued to wait and stated she had been feeling better. She was instructed to wait another 15 mins to see if her symptoms continued to improved, which they did, and patient said she felt fine to go home. She was instructed that if she started to feel worse, had trouble breathing or swelling to see immediate medical attention as allergic reactions can occur up to 4 hours after vaccination.
1)Experienced sporadic pulling/tugging pain in left breast. 2) Menstrual cycle was late by 16 days and is usually extremely regular.
Patient is a 69-year-old female with past medical history of diabetes, anxiety, asthma who presents with possible allergic reaction.  She had her second Covid vaccine this afternoon and within 5 minutes felt throat tightening and hoarseness.  She self administered 50 mg of Benadryl p.o.  EMS was called and she was given 50 mg Benadryl IV and an albuterol treatment.  She had a similar reaction after her first Covid vaccine and was treated in this ED and given IM epinephrine which resolves her symptoms.  She states she had many anaphylactic reactions to various allergens including vaccines.  She states this feels like how her anaphylactic reactions began.  She also notes some GI discomfort.  She denies shortness of breath, chest pain, nausea, vomiting, diarrhea, or skin rash. Patient was provided epinephrine in the ED and within a few minutes noted that her symptoms were resolved. She was monitored for 4 hours in the ED with no recurrent symptoms. Patient was discharged home, will follow up with PCP and does have an EpiPen at home. Patient was feeling back to her baseline at discharge.
Information has been received from a physician concerning a female who was vaccinated with Gardasil.  Subsequently the patient experienced syncope.  Unspecified medical attention was sought.  At the time of the report the patient recovered.  Additional information has been requested.
8hrs after injection onset of fatigue, Fever with chills, body aches, major lower back aching, nausea, dizziness  restlessness. Lasted for 24 hrs. Majority of symptoms have subsided. Random lightheaded and dizzy spells have continued multiple times daily,  with  occasional nausea.
Menveo administered without reconstitution; Menveo administered without reconstitution; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA724Z, expiry date 30th September 2023) for prophylaxis.   On 14th September 2022, the patient received Menveo. On 14th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The nurse reported that a new staff member administered a dose of Menveo to the patient without reconstituting with the powder portion. Therefore, the patient only received the liquid CYW component of the vaccine. At the time of reporting, the dose has not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. This case is for 2 of 2 linked patients, reported by same reporter. Additional supportive information: The patient received only liquid CYW component of Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022135067:Same reporter
Pt stated that injection was given into the muscle and she developed a large welt on her skin.  The injection site was hot and she had a fever for several days.
Tachycardia, chest tightness, headache starting approximately 10 days after vaccination. Started on 24 hour holter monitor x14 days. Saw Cardiology had an ECHO and started on metoprolol
Rash started 4/6/15-spread all over 4/7/15.
pt tolerated vaccine well. Mild discomfort locally  at site of injection on 8/14/20 at night. woke up on 8/15/20 much better. Developed prickly sensation on skin above umbilicus and across mid back on  8/18/20 lasting 3d. Rash developed 8/21/20
recvd MMR & Td w/o incidence; had grand mal seizure in back seat of car;
I believe that the vaccination heightened my MS. It was a level that I never experienced before. My spouse had to help me stand & I was unable to walk. I had a fever. My symptoms subsided by mid-day the next afternoon.
This spontaneous report was received from an unknown reporter regarding an unspecified number of children of unknown age and gender. On an unknown date, the patient was vaccinated with GARDASIL (strength, dose, frequency and lot number not specified). No co-suspect medications or concomitant medications were reported. On an unknown date the children developed POTS (Postural orthostatic tachycardia syndrome) while on GARDASIL. No laboratory diagnostic studies were reported. At the time of reporting the outcome of the event was unknown. There was no Product quality complaint. The relatedness of the event to the suspect product GARDASIL was unknown. Additional information is not expected as no contact details were provided.
COVID-19 recurrent; drug ineffective; Maternal exposure during pregnancy; Vaccination site pain; Headache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not aplicable). The reporter is the patient. Other Case identifier(s): 22K-163-4292780-00.  A 35 year-old female patient (pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date Sep2021 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single, intramuscular, administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease, psoriasis. The patient was 10 weeks pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant), outcome "recovered", described as "COVID-19 recurrent"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "drug ineffective"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Maternal exposure during pregnancy"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Vaccination site pain"; HEADACHE (non-serious), outcome "unknown", described as "Headache". The action taken for adalimumab was unknown.  The reporter considered "vaccination site pain" and "headache" not related to bnt162b2.  Additional information: On unknown dates, the patient experienced maternal exposure during pregnancy, Covid three times, headaches after vaccine and sore arm after vaccines. On an unknown date, Covid three times resolved. The fetus was exposed to maternal use of Humira in utero. She was ten weeks pregnant. It was unknown if patient was enrolled in a covid-19 vaccine trial.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of maternal exposure during pregnancy and Covid three times with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of headaches after vaccine and sore arm after vaccines was not provided.  Causality for Humira (Solution for injection in pre-filled pen) (Adalimumab) for the events Maternal exposure during pregnancy, Covid-19 recurrent was No Reasonable possibility and for the events Headache and Vaccination site pain was Not reported.  Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran) for the events Maternal exposure during pregnancy and Covid-19 recurrent was not reported and for the events headache and vaccination site pain was not related.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
Patient received her third Gardasil vaccine 2 months too soon. She has had frequent breakouts of a hive type rash, which required three hospitalizations resulting in IV medication. She was prescribed cortisone and Benadryl. I recently found out the vaccine contains a sulfur ingredient, which my daughter is allergic and which she stated upon doctor visit when history was obtained. Patient still experiences breakouts as recently as two weeks ago. Follow-up Information 04-Sep-2008: I am writing to update my daughter's symptoms. She has continuous hive/type rash breakouts on her face and left arm. Her face will be red and swollen and her lips get puffy. In January 2008, she went to the emergency room and, as several times before, she was given IV medication and Benadryl. In July 2008, she was at the emergency room twice in three days became of insect bites that were swollen and red and also spread to the size of a small plate on her leg. The doctor and a couple of his colleagues had never seen anything like it. He outlined the bite to make sure it didn't spread. Each time, my daughter had been outside no longer than ten minutes and was the only one to have such a reaction. In August 2008, she returned to the emergency room with swollen, red palms of her hands and soles of her feet, which were very painful with a burning sensation. Seven doctors examined my daughter and were baffled. They decided to test her for everything possible. The test results were negative and the symptoms lasted for three to four days. Also, my daughter was given antibiotics to treat the insect bites and the hands/feet episode. I am very concerned that the Gardasil vaccine may have changed my daughter's metabolism especially since she is allergic to sulfur drugs, and the vaccine has a sulfur ingredient, and the vaccine was improperly administered by being given to my daughter two months too soon (the third injection). Please feel free to contact me at any time. I appreciate your attention to this matter.
12/29 approximately 5 hours post injection severe pain down entire left arm where  vaccine was given.  trouble lifting small object such as gallon of milk.  Also developed Metallic taste in mouth approximately 2 hours post injection.  Both have improved some over the last 2 days. 12/31 Today developed right jaw pain and numbness in right lower lip.
Approximately 7 days after vaccination, patient experienced a rash and swelling on right leg. He was seen by his physician,  and MD recommended Benadryl to help relieve symptoms which resolved after an additional 7 days.
She was walking out of clinic. Felt faint.  Got dizzy, eyes rolled, & started shaking.  Sat down.  Started to feel better.
Breakthrough case admission after 3 vaccines Pfizer 2/24/21 Lot# EN6200;  Pfizer 3/17/21 Lot# ER2613;  Pfizer 10/26/21 Lot# NOT LISTED
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater then 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was stored at room temperature post puncture/vial exposed to room temperature for about 24 hours) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Pfizer booster) on 06-Nov-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2022 at 9:30 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2022 at 9:30 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater then 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored at room temperature post puncture/vial exposed to room temperature for about 24 hours) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered greater then 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was stored at room temperature post puncture/vial exposed to room temperature for about 24 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered greater then 12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was stored at room temperature post puncture/vial exposed to room temperature for about 24 hours). No relevant concomitant medications were reported. Date the vial was initially stored in the refrigerator was 04-Aug-2022. Date and time vial was first punctured was 10-Aug-2022 at 9:06 AM. The vial was stored at room temperature post puncture. The vial did not undergo any temperature excursions. The vial was exposed to room temperature range (8° to 25°C equals to 46° to 77°F) for about 24 hours. No treatment information was provided.
Patient developed a red rapidly spreading rash at the injection site ((L) arm), and c/o shortness of breath and "never felt this way before". Patient was pale and clammy.
At 10 am, felt slightly chilled, achy muscles, low grade headache.  An hour later chills and aches increased and had brain fog. temp at 11 am was 98 with Tylenol.  Around noon, chills, aches, headaches increased.  By 6 pm symptons increased to extremely painful headache, chills, aches, tired. Around 7 pm shooting abodiminal pain for 5 hours. At 9 am my temp 99.3, then took Tylenol.  By next morning symptoms subsided.
pt recv vax 21DEC96 12:00; the evening of vax pt exp fever & itchy rash on back, neck & inj arm;tx was given;sx resolved w/in 24hr;
2nd dose 1 week later after 1st; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number B4722, expiry date 17-FEB-2024) for prophylaxis.   Concomitant products included PEDIARIX.   On 01-NOV-2022, the patient received the 2nd dose of Pediarix. On 01-NOV-2022, an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose 1 week later after 1st). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date:22-Mar-2023. Pharmacist reported that a 6 month old male patient received the 1st dose of Pediarix at his 2 month old visit on 26th Oct 2022 and accidentally got another dose 1 week later. No symptoms was reported. The reporter consented to follow up. Patient received 2nd dose of Pediarix earlier at 9 weeks than the recommended schedule, which led to  drug dose administration interval too short.