chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Normal labor and delivery on date. Hospital admission was within 6 weeks of receiving the CVOID vaccine.
Information has been received from a medical assistant concerning multiple, unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (strength, frequency and route not reported, lot # was reported as L048466 with expiration date 02-DEC-2017). The vaccines were exposed to 2.4 degree Celsius for 20 hours. There was no previous temperature excursion. The temperature was back in range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Employee calling to report a reaction after receiving a COVID-19 vaccine.  Vaccine Name -  Pfizer Vaccine Date - ?  09/16/2021 Is this your first or second dose- 1st Date of symptom onset - ? 09/17/2021 Symptoms - ? Employee stated have a knot under skin at injection site, swelling, redness " a little bigger than a quarter", and the area is warm to the touch. Last day of work and shift - 09/17/2021 ?  Home remedies- Employee stated that she is taking Ibuprofen to help with the pain and swelling Any improvement- Employee stated it is helping the pain a little. Recommendation- Advised employee to continue taking Ibuprofen per package instructions as needed for pain and swelling, and to apply a cold compress for 20 minutes at a time every couple of hours. Also advised employee if symptoms persist or new symptoms develop to follow up with PCP. Employee voiced understanding. Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns ? No  Employee?s questions answered to employee?s satisfaction -Yes
My lips became swollen but that only lasted 2-3 days. Have papular rash through out my entire body. They are all different sizes and look resemble clusters of red fever blisters. As of today they have not subsided and I am still getting new ones throughout my body. Today, I finally took a Benadryl to see if it had any effect.
Left shoulder soreness - still present Chills - approximately 5 hours Severe body aches - approximately 12 hours
Shoulder pain limiting raising arm, that has not resolved since injection. Pain has made it difficult to dress and drive. Received shot high on arm near shoulder. The clinician was standing and I was sitting with a large table between us. During administration felt internal pressure feeling that my shoulder would burst.
Heart palpitation; pulse was over 100; blood pressure was high; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After first shot of Pfizer week ago and patient had a reaction after 4 hours with heart palpitation and his pulse was over 100 and blood pressure was very high. The patient underwent lab tests and procedures which included blood pressure measurement with result high and heart rate with result over 100 on an unspecified date. Patient wanted to know should receive a second shot. Patient was informed about Pfizer Medical Information Department. The outcome of the reported events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Seizure Activity: Nursing assessment: 1/28/2021 17:55  Staff asked writer to check on resident, stating that there was something wrong with him. Resident found sitting up in wheelchair. Resident noted to be nonverbal, making small jerking movements with upper extremities and head articulated to the left. As writer attempted to assess pupils, resident squeezed eyes shut and grimaced. Resident did squeeze with both hands, equal strength. VS: 94, 16, 138/86, 97% on RA. Resident put into bed with assist of two staff and hoyer lift.  MD notified: 1/28/2021 18:10  Return phone call received from Physician. Advised to continue to monitor and OK to send to ED if resident representative wants further evaluation done.  Nursing assessment: 1/28/2021 18:35  Resident found to be alert and smiling at this time. Resident speech is garbled per baseline. VS: 111, 20, 129/77, 100% on RA. Resident able to follow commands. ROM equal with strength at baseline. No incontinence noted. Resident noted to be fatigued. Start of episode of seizure-like activity not witnessed. The time between first found by staff to noted resolution was approximately 40 minutes.  No further  seizure  episodes noted.  No previous hx of seizure activity.
rash; This is a spontaneous report from a contactable physician (Pediatrics) via Pfizer sales representative.   A patient of unspecified age and gender received the 1st dose of meningococcal group b rlp2086 (TRUMENBA) via an unspecified route of administration at single dose on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced rash on an unspecified date with outcome of unknown.   The reporter queried If a patient developed a rash after a first meningococcal group b rlp2086 vaccination would it be considered ok to administer the 2nd shot six months later.  Information on the lot/batch number has been requested
There was temperature excursion from their freezer on 01Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer on 01Oct2021) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer on 01Oct2021). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer on 01Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications details were provided. No Treatment Medications details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Contact information updated.
out of commission; fever; pain; fatigue; headache; This case was reported by a consumer via call center representative and described the occurrence of impaired work ability in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (3 years ago). Previously administered products included Zostavax with an associated reaction of pain (received zostavax on an unknown date experienced pain and redness on site of injection).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced impaired work ability, fever, pain, fatigue and headache. On an unknown date, the outcome of the impaired work ability, fever, pain, fatigue and headache were recovered/resolved.   It was unknown if the reporter considered the impaired work ability, fever, pain, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experinced shingles 3 years ago. The patient first had Zostavax with very minor adverse reaction pain and redness on site of injection. The patient read that Zostavax loses efficacy after a coupe of years so the patient decided to take Shingrix. The first dose of Shingrix put the patient out of commission, fever, pain, fatigue, headaches for 2 days and felt better after 4 days. The patient recommended not to take Shingrix due to its side effects. The patient advised to get Zostavax shot every 2 years and side step these horrible side effect of Shingrix. This case has been linked to the US2019AMR124403, reported for the dose 2 of the same patient.
Sunday 3:00 pm- initial soreness right arm. Monday increased redness, swelling right arm. Tuesday- increased swelling, redness, tingling right arm. 5:00 pm- Weakness, dizzy, increased numbness. Stayed in bed due to pain. Wednesday- AM ER for treatment. Friday- Symptoms gone. Feeling much better.
SWOLLEN, CONSISTENTLY RED AREA ABOUT 4 INCHES BY 8 INCHES
Headache; Fatigue; This case was reported by a physician via sales rep and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and fatigue. On an unknown date, the outcome of the headache and fatigue were recovered/resolved.   It was unknown if the reporter considered the headache and fatigue to be related to Shingrix.  Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The reporter stated that the patient received first dose of Shingrix and experienced headache and fatigue.   The reporter denied to follow up from GlaxoSmithKline. For tolerance to the 2nd dose refer case US2022AMR094668.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094668:Same patient, different dose
Patient presents to the ED on 2/6/2023 with gradually worsening blurry and dark vision that started four days prior to admission.  He had received the Covid bivalent booster vaccine by Moderna on 1/10/2023.  He has been on vardenafil prn for 10+ years and had taken a vardenafil pill "around the time of the vision changes".  He was diagnosed with nonarteritic ischemic optic neuropathy, and treated with DAPT (ASA and Plavix).  Patient was discharged to home.  Following discharge, he was seen by his PCP and specialist from Clinic who both agreed with the diagnosis, and was instructed to continue with DAPT, stop vardenafil, and control diabetes and lipids.  Follow up phone call with nurse on 3/20/2023, documented that patient's vision is still compromised and he is unable to drive. He is now back at work, but requires a driver to help with transportation.
Diffuse Urticaria and L upper face angioedema starting about 2 days after vaccine
bp spike since Saturday, no fever  head ache and nausea , Shortness of breath and big discomfort in the chest and last 2 days whole hands swelled up during night and goes during the day time
Achy sore/heavy muscles (current to date) , fatigue that grew worse daily ( and current to date) , whole body chills that lasted 2-3 hours (until 1/25 and now on occasion) , night sweats ( 1/12-1/25) , diarrhea (1/23 - 1/25),  headache (1/25 to current date), dizziness (1/25).  On Jan. 25:  Went to bathroom around 3:15 p.m. with diarrhea and became woozy so decided to get off of the toilet and sit down on the floor.  Husband found me semi conscious on the floor with drool at about 4:10 p.m.  He tried to awaken me and found me not lucid, speech was garbled, fragmented responsiveness and could not keep upright position, could not give details to the situation.  Husband called 911.  Ambulance transported to hospital ER   during hospital exams and tests patient was not lucid and this continued for the next 32  hours.  EKG, EEG, CT scan, MRI, Blood/Lab work;  all tests were negative indicating no seizure , healthy heart, clear brain scan, no stroke, white blood count normal, dehydrated. All tests negative with all doctors unable to find a reason for this situation other than the Moderna vaccine considered highly for the situation.  Advised patient not to take the second dose of Moderna.
Pfizer vaccine was administered outside of the clinic - reported by patient   ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 8/6/2021 HEMIPLEGIA & HEMIPARESIS, RIGHT DOMINANT SIDE, LATE EFFECT OF STROKE
I started to experience chest pains, shortness of breath(Easily Exhausted with minimal effort), low heart rate(40's bpm), irregular heart beat(Fluttering) on or around April 2021. I was not aware of the possibility that the vaccine I was given could have caused these new symptoms I was experiencing until I seen something on TV that explained some potential side effects, that is when I sought medical attention. I have been prescribed an additional medication called Metoprolol Tartrate.
Headache,  fever, cramping,  nausea, joint pain,  injection site pain.
Pt had no issues after first vaccine. Pt waited 15 minutes before stating that her tongue was tingling but she wasn't having difficulty breathing. She reported that she has never had an anaphylactic reaction or needed an epi pen. Pt was given diphenhydramine and told to wait 15 more minutes. Pt stated she was feeling better before she left. I phoned the patient 2 hours after the shot and she said she felt normal and was not having any tongue issues anymore.
Janssen COVID-19 Vaccine EUA: patient hospitalized for cirrhosis. Underwent paracentesis, corrected electrolyte abnormalities, and discharged to home medically stable.
Moderna COVID-19 Vaccine EUA Tenderness and swelling of the lymph node in the same arm of the injection site
VACCINE PROVIDED MAJOR CHANGES IN BODY WHICH WERE POSITIVE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine provided major changes in body which were positive. The action taken with covid-19 vaccine was not applicable. The outcome of vaccine provided major changes in body which were positive was not reported. This report was non-serious.
Covid-19; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) and ARTHRALGIA (Joint pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In January 2022, the patient experienced COVID-19 (Covid-19) and ARTHRALGIA (Joint pain). At the time of the report, COVID-19 (Covid-19) and ARTHRALGIA (Joint pain) outcome was unknown.            No concomitant medication was reported. The patient had joint pain due to discontinuation of all medications. Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt called 8:15 AM to report arm painful at injection site and "down my arm". Injection site swelled, hot and arm swelled down to elbow. Advised ice packs to site and anti-inflammatory prn. Pt stated, "I have been up all night crying with pain."
This is problem I have had for a while. For several years I had a problem with my right heel. It is tender and swollen and burning, and after the vaccine it flared up. It has not cleared and its getting worse as more time goes on. It does not clear up as the hours go by in the day. Another problem I have is nodules in my thyroid, and I noticed that after the vaccine it is like they are more swollen. I have a harder time breathing and have to sleep in a position that allows me to remain breathing. Not sure if the vaccine is the fault for my pre existing conditions to be flared and worse, but do not know. Was not an issue before the 4th dose.
Throat and tongue started swelling administered epinephrine (EPIPEN) 0.3 mg and diphenhydramine 25 mg.
Tongue started to feel funny; Ears started to feel funny; Burning sensation in the ears; Arm was weak; Grip finger was weak; Felt a little dizzy; Rapid heart race; Warm sensation in the heart; Lips felt smuggling tingly; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOMFORT (Tongue started to feel funny), EAR DISCOMFORT (Ears started to feel funny), BURNING SENSATION (Burning sensation in the ears), MUSCULAR WEAKNESS (Arm was weak) and ASTHENIA (Grip finger was weak) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced TONGUE DISCOMFORT (Tongue started to feel funny), EAR DISCOMFORT (Ears started to feel funny), BURNING SENSATION (Burning sensation in the ears), MUSCULAR WEAKNESS (Arm was weak), ASTHENIA (Grip finger was weak), DIZZINESS (Felt a little dizzy), TACHYCARDIA (Rapid heart race), BURNING SENSATION (Warm sensation in the heart) and PARAESTHESIA ORAL (Lips felt smuggling tingly). On 24-Feb-2021, TONGUE DISCOMFORT (Tongue started to feel funny), EAR DISCOMFORT (Ears started to feel funny), BURNING SENSATION (Burning sensation in the ears), MUSCULAR WEAKNESS (Arm was weak), ASTHENIA (Grip finger was weak), DIZZINESS (Felt a little dizzy), TACHYCARDIA (Rapid heart race), BURNING SENSATION (Warm sensation in the heart) and PARAESTHESIA ORAL (Lips felt smuggling tingly) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Caller received the first dose of the Moderna vaccine 24Feb2021 on the right arm. Three minutes after receiving the vaccine, her tongue and ears started to feel funny and had a burning sensation in her ears. The arm of the injection started to feel weak and her grip finger was weak too. Caller felt a little dizzy, had a rapid heart race and had a warm feeling on her heart for two hours. Also, her lips felt smuggling tingly.
102 temperature for 36 hours, large swollen lymphnode under left arm. 1 week later, joint aches, body odor change to metallic sour smell, and excessive hair loss.
This spontaneous report was received from a registered pharmacist regarding a patient of unknown age and gender. On 07-NOV-2012, the patient was vaccinated subcutaneously with 0.5 ml VARIVAX (lot # not reported) instead of ZOSTAVAX. The pharmacist stated that this was related to a staff error and not product confusion. No concomitant mediations were reported. No adverse effect was reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
-Pt given Rotarix on 8/5/22 -Pt seen again on 8/8/22 for irritability, vomiting & diarrhea -Seen 8/16/22 for persisting symptoms
Client reports a "violent" reaction starting around 10:30 pm on day of vaccination. Shakes, sweats, headaches, sore arm lasting through the next day- 7/15/21. Client states he has never been that sick. Client called to report this on 7/16/21 at11:00am.  He states he has a residual headache but feels "ok". His concern is over the appearance of a small cluster of blister like papules over left eyebrow. 4-5  red papules are present, in an area of the size of a quarter. He was planning on going mountain climbing over the weekend and was concerned over the blisters that look like shingles. On 7/19, I called client who stated he felt fine and stated the blisters had scabbed over and were healing.
Post vax, the pt developed a local injection site reaction consisting of a red band-like induration on the arm where the injection was given. Within 72 hours, the induration resolved.
He had a huge Acute inflammatory response that required an ambulance transport due to his inability to walk. He needed fluids in the ED then dexamethasone which immediately changed his progress for the better. He then needed a blood transfusion due to low hemoglobin. He needed a platelet transfusion due to very low platelets. He had to stay for three and a half days.
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received in April 2018).  On 14th August 2018, the patient received the 2nd dose of SHINGRIX. On 14th August 2018, less than a day after receiving SHINGRIX, the patient experienced chills, nausea, pain, fever and viral infection. On an unknown date, the outcome of the chills, nausea, pain, fever and viral infection were not recovered/not resolved. It was unknown if the reporter considered the chills, nausea, pain, fever and viral infection to be related to SHINGRIX. Additional information was received as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The healthcare professional stated that all night the patient felt like she had a virus. The healthcare professional did not want to provide details about the patient (reporter's wife). This case is one of the four linked cases, reported by the same reporter.
On 7/13/00, the pt developed a fever of 104 degrees. Her mother treated her with acetaminophen and cool baths. She was seen in the physician's office on 7/14/00 where a diagnosis of acute otitis media was made. She was treated with Amoxicillin/clavulanate  and recovered.
Itching around the injection site; more like a rash but without swelling; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching around the injection site), VACCINATION SITE RASH (more like a rash but without swelling) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included Cardiac operation NOS (Patient had a heart operation about six year ago.). Concurrent medical conditions included Drug allergy (sulfa). Concomitant products included LISINOPRIL, PRAVASTATIN and CLOPIDOGREL for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching around the injection site), VACCINATION SITE RASH (more like a rash but without swelling) and VACCINATION SITE ERYTHEMA (Redness around the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching around the injection site), VACCINATION SITE RASH (more like a rash but without swelling) and VACCINATION SITE ERYTHEMA (Redness around the injection site) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.
Swelling warmth and redness at injection site - getting worse. Allergic vs infectious process. Rx - antibiotics antihistamines.