chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received second COVID vaccine Moderna on Wednesday evening at 6pm.  Later that night, I was a little light-headed and achey, but went to bed. On thursday, my legs and arms were extremely achy. I took Tylenol and Motrin in the morning. It seemed to help some, but continued to feel very achy in my legs. I left work early (I am a pediatrician) on Thursday and went home and just sat and rested.  I felt terrible, but had talked to other colleagues who felt very bad that first day after the shot. Friday morning, I woke up still achy but feeling better overall. I took motrin and Tylenol again on Friday morning. I worked the whole day seeing patients. Was tired, but got thru the workday. At around 6pm, I noticed petechiae rash on my lower legs. The rash started spreading thru the night- up my legs and to my arms. I went to ER. They did order CBC, CMP. Platelets were undetectable- 1 platelet was seen under microscope. CMP was normal.  I was told to go to bigger hospital. I went, My platelets read as 4. I was admitted for two nights. Two doses of IVIG were given and I was put on Decadron 40mg PO daily for 4 days. I had tylenol, benadryl, zofran before the IVIG and after.  I will see Hematology next week for follow up. Platelets yesterday at discharge were 60.  Will be checked frequently for the next few months. ITP= diagnosis. COVID shot was trigger.
mucous membrane pemphigoid; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about medical history, concurrent condition and concomitant medication was not reported. In or around June 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered mucous membrane pemphigoid. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient 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 patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event mucous membrane pemphigoid was not recovered. The lawyer considered mucous membrane pemphigoid to be related to zoster vaccine live (ZOSTAVAX).   The event mucous membrane pemphigoid was considered by the lawyer as disability.  Upon internal review, the event mucous membrane pemphigoid was determined to be medically significant event.
Tip of right side of tongue no taste feeling of numbness; bottom lip right side and right side of chin also numb no feeling, right cheek ares numbness..(feels like a novacaine numbness); Tip of right side of tongue no taste feeling of numbness; Administration date: 28Apr2021,Dose Number : 01/ Other vaccine same date vaccine date: 28Apr2021, Dose Number: 02; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 (Lot number: EP7533) at the age of 51 years as dose 2, single and administered in arm left, administration date 28Apr2021 13:00 (Lot number: EW0172) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Vestibular Migraines" (unspecified if ongoing); "Allergies cats" (unspecified if ongoing); "Roaches" (unspecified if ongoing); "Pigweed" (unspecified if ongoing); "Ragweed" (unspecified if ongoing); "Mites" (unspecified if ongoing); "Back pain" (unspecified if ongoing); "carpal tunnel" (unspecified if ongoing). Concomitant medication(s) included: NORTRIPTYLINE; VENLAFAXINE; CETRIZINE; MECLIZINE [MECLOZINE]. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Apr2021, outcome "unknown", described as "Administration date: 28Apr2021,Dose Number : 01/ Other vaccine same date vaccine date: 28Apr2021, Dose Number: 02"; HYPOAESTHESIA ORAL (non-serious), TASTE DISORDER (non-serious) all with onset 30Apr2021 12:30, outcome "not recovered" and all described as "Tip of right side of tongue no taste feeling of numbness"; HYPOAESTHESIA (non-serious) with onset 30Apr2021 12:30, outcome "not recovered", described as "bottom lip right side and right side of chin also numb no feeling, right cheek ares numbness..(feels like a novacaine numbness)". Therapeutic measures were not taken as a result of hypoaesthesia oral, hypoaesthesia, taste disorder.  Additional Information: No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. No Known allergies.  Follow-up attempts are completed. No further information is expected.
Within 3-5 minutes after receiving the flu vac pt started swaying legs at arms back and fourth in a spastic movement - appeared to happen more with the right leg left arm. Pt was staring down an did not report to verbal question. No hx of seizures or hearing problems pt did not remember anything that occurred. Lasted about 10 seconds
Case number PHEH2013US021860 is an initial spontaneous report received from a nurse on 16 Oct 2013. This report refers to a 17-year-old female patient. Her medical history included SUDAFED allergy and concomitant medications were not reported. Her vaccination history included administration of MENVEO (batch number: not reported) in 04 Nov 2007 which was well tolerated. She was vaccinated with a dose of MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in the left deltoid on 31 May 2013. It was reported that the vaccine administered was compromised due to refrigeration error. No adverse event was reported following the medication error. The patient was notified to schedule for administration of re-vaccination. No further information was provided.
Significant pain in all joints and muscles that has increased since onset.  Leg cramps, muscle fatigue, and weakness. Has crawling sensation under skin all over body. Has a resting tremor that started after first covid vaccine on 9/15/21.
-3 hours after my first shot I felt very disoriented and nauseated. I immediately fainted and I lost consciousness for 5 minutes, while unconscious I also was incontinent and peed myself. When I came to, I was disoriented for about 2 minutes and very cold.  -For a week after I fainted I was very weak and couldn't stand up without feeling that I was going to faint.  -The second week after my shot I also felt pressure on my chest for 5 days that has since then gone away.  -Since I fainted 3 hours after my shot  I have experienced constant ringing in both ears that have not stopped for the past 30 days since I got the vaccine. I also experience blurry vision and vertigo that hasn't gone away.  -I have also developed headaches and recently I have an itchy rash on my neck.  -Since then it has been hard for me to focus and sometimes I feel like the world is in slow motion.
Patient was inadvertently given a 5-11 years formulation of Pfizer-BioNTech COVID-19 Vaccine for her 1st dose in her primary series. Patient and family was informed of administration error. Patient had no distress or adverse reaction to dose given.
This is a spontaneous report from a contactable consumer. A 69-year-old female patient received in DEC2014 first dose of PREVNAR13, via an unspecified route of administration in left arm, at single dose. The patient medical history and concomitant medications were not reported. The patient experienced rash all over the body, which started in DEC2014, within a few days of getting the shot. The rash was red, bumpy and itchy and it was worse at night. She went to the dermatologist who gave her a steroid cream that she has been using approximately 5 weeks. The rash was improving after 6 weeks and she needed to use less and less cream. Follow-up (13FEB2015): Follow-up attempts completed. No further information expected.
Pt recvd 3 booster doses of Engerix-B vax & was determined to be a non-responder; pt then recvd a 4thh dose;
This spontaneous report was received from a 66 year old male consumer reporting on himself with asthma and psoriasis and no drug reactions or allergies. On 11-APR-2013 the patient was vaccinated with PNEUMOVAX23 (lot # and expiration date unspecified) injection (dose, route and anatomical location unspecified). Concomitant medications were not reported. On 18-APR-2013, the patient reported that he had severe arthritis pain in his shoulders, neck, knees since he received the PNEUMOVAX23 shot. Patient sought medical attention by seeing physician and the treatment was prednisone 20 mg/once daily. Laboratory tests performed on unknown dates were: Chest x-ray (results unspecified), Computerised Tomography (CT Scan) (results unspecified), Positron Emission Tomography (PET Scan) (results unspecified). At the time of the report the outcome of severe arthritis pain in his shoulders, neck and knees was reported as not recovered/not resolved. Additional information has been requested,
A physician reported that a 6 month old female received her 1st dose of Prevnar, as well as, her 2nd doses of Acel-Imune, Hib-Titer and Engerix-B (SKB) on 8/14/00. The next day, she developed a mild truncal urticarial reaction and irritability. On 8/16/00, the pt was seen in the ER and was prescribed oral diphenhydramine. The pt has a medical history of diarrhea, 2 days prior to immunization. The reporter indicated that the pt had no further diarrhea. This is 1 of 2 pts from this facility who experienced an adverse event following receipt of Prevnar (lot 471203) and Acel-Imune (lot 472655).
At 12:20 patient began to feel dizzy and began closing her eyes. She stated that everything went black around that time. She was minimally following commands, but unable to do so reliably. She became diaphoretic and pale, and her pulse was thready and difficult to palpate. Her vitals were taken. Her heart rate was 35 and O2 saturation was 96% (both of these were taken by pulse ox). Her blood pressure was 110/86 taken manually.  For about 5 mins, she was having a very difficult time keeping her eyes open, and the EMS was called. After several more minutes, she began feeling much better, color increased, HR increased, and Level of consciousness increased as well. The paramedics evaluated her and suggested she be further evaluated at the hospital but the patient refused. The nursing staff and EMS agreed that it was most likely a vasovagal/syncopal event.
Immediately following treatment, I suffered severe intense arm pain which after 4 hours, my entire arm was stiff and a large egg sized know appeared.  On day six, the know turned red and became itchy with a rash.  The following day, the size of the rash is very large and has spread over night and the knot is still present.  For the first three days following the vaccine, I suffered severe exhaustion but other than these issues, no other side effects occurred.
Patient claimed she received the pneumovax vaccine at approx. 9 AM and an hour later she began to have swelling, erythema, and pain (9/10) in upper right arm where the vaccine was given.  Patient was treated with percocet (5/325 mg) for the pain until ultrasounds came back negative for cellulitis.  She was discharged home with instructions for using ice and elevation.
Initially given pfizer and requested second shot of moderna as patient is  in deployed setting and pfizer is not available
4 month old infant received 2nd immunization & became very irritable, fussy & refused to eat.  w/ 1st imminization, infant was fussy for about 3 days.
seizure activity had increased; seizure activity had increased; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; ofatumumab (KESIMPTA) (Batch/Lot number: unknown). Relevant medical history included: "Seizure disorder" (ongoing). The patient's concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), CONDITION AGGRAVATED (medically significant), outcome "unknown" and all described as "seizure activity had increased". The action taken for ofatumumab was unknown. The lot number for bnt162b2 was not provided and will be requested during follow up.
This case was reported by a consumer via call center representative and described the occurrence of adverse event in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient wanted to report side effects that she had after taking the SHINGRIX vaccine. The reporter consented to follow up.
Information has been received from a health professional concerning a female patient who was vaccinated with Varivax. The patient has recently, in approximately April 2006, been diagnosed with breakthrough chicken pox. It was reported that there was a swab of her lesions that diagnosed the chicken pox. The patient's brother (WAES 0605USA00024) was also diagnosed with chicken pox. Additional information has been requested.
Patient admitted to inpatient at Hospital on 4/1/2021 at 4:30 pm for new acute onset A.Fib with controlled ventricular response, acute on chronic combined diastolic and systolic CHF, and cardiomegaly. Anticoagulation started.  Patient was discharged on 4/3/2021. Of note-on 4/1/2021 (date of admission) patient tested positive for "asymptomatic COVID-19". Per physician discharge summary, "patient did not have active COVID by physical exam or history".  Also of note, patient was positive for COVID-19 on 8/29/2020, and was vaccinated with Pfizer COVID-19 vaccine on the following dates: 1/28/2021 (1st dose) and 2/18/2021 (2nd dose)
Received influenza vac 10/6/14 - 10/7/14 AM noticed redness at injection site - redness increased after that - 5x6 area redness upon presentation - no other symptoms - has been icing and taking ibuprofen - no unusual pain to arm (L).
Pt awakened from nap 2.5 hrs p/receiving immun very hot (didn't take temp), screaming uncontrollably, extreme pallor, lower eyelids swollen, screamed whenever touched until 10PM; exp vomiting p/feedings;
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case belonged to patient 109 of 190 patients described by the reporter.  It was unknown if the patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Right arm sore, red, hard to move, low grade fever, Benadryl, Then Claritin, Ibuprofen.
Eventually noticed that my sense of taste had become significantly duller, and sense of smell to a lesser degree.  It began to improve, but I have once again noticed a significant dulling of my sense of taste after the third vaccine.
Tiredness; Injection site pain; Injection site redness; Injection site swelling; Body ache; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  Concurrent medical conditions included asthma, hyperlipidemia, blood pressure high and sleep apnea. Concomitant products included fluticasone propionate + salmeterol xinafoate (Advair), salbutamol (Albuterol), rosuvastatin, carvedilol and furosemide.  On 28-MAR-2023, the patient received the 2nd dose of Shingrix. On 28-MAR-2023, less than a day after receiving Shingrix and an unknown time after starting Advair, Albuterol and furosemide, the patient experienced injection site pain (Verbatim: Injection site pain), injection site erythema (Verbatim: Injection site redness), injection site swelling (Verbatim: Injection site swelling) and general body pain (Verbatim: Body ache). On 29-MAR-2023, the patient experienced tiredness (Verbatim: Tiredness). The patient was treated with ibuprofen, paracetamol (Tylenol) and benadryl (nos) (Benadryl). The outcome of the injection site pain, injection site erythema, injection site swelling, general body pain and tiredness were not resolved.  It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, general body pain and tiredness to be related to Shingrix.  It was unknown if the company considered the injection site pain, injection site erythema, injection site swelling, general body pain and tiredness to be related to Shingrix.  Additional Information: GSK Receipt Date: 31-MAR-2023 The reporter was the patient himself. 1 day after receiving Shingrix the patient experienced tiredness. The patient had treated symptoms with Over the counter (OTC) product such as Tylenol, ibuprofen, and Benadryl. The symptoms were treated. The reporter had consented to follow-up.
Pt received Pneumovax 11-13-06; Next day noticed swelling to right deltoid and baseball round induration. Two days later noticed red streaks 3-5" long maybe 3/4" wide encircling upper armpit. Deltoid hot to touch and tender. Also red blotchy, red, raised rash to forearm/elbow. No itching.
It was reported, that a 14 year old female received a Fluzone SV '99-'00 vaccination on 10/20/99. That same day, the pt became red in the face, sweaty and experienced tightness, in her throat and wheezing. From additional information received on 11/5/99, it was reported that the pt "complained of chest pain with cough for 5 days". It was also reported that the pt recovered. Other additional information provided includes pt's information, past medical history and information regarding the responsible physician.
Rotavirus given 8/24/18. Patient experienced vomiting, diarrhea, dehydration arose on 9/8 and resulted in a 3 day hospital admission for IV fluids and evaluation by 9/12.
Swelling on the arm, pain all over the body, sleep all day, lots of beaches, chest pains
This is a spontaneous report from a contactable Pharmacist.  An 87-years-old female patient received PREVNAR 13 Histamine related reactions, intramuscular in  right deltoid on 09Nov2016 at 0.5 ml, single for immunisation , influenza vaccine (FLU SHOT) LOT #: A3AD2, Exp date: Sep2018, intramuscular in left arm on 09Nov2016  at 1 DF, single for an unspecified indication.  Medical history included hypoacusis (the patient was extremely hard of hearing) and breast cancer from an unknown date and unknown if ongoing. The patient had histamine related reactions for ZOSTAVAX and had allergy to certain things but not to any latex or egg or protein derivatives. The patient's concomitant medications were not reported.  The patient experienced histamine reaction/allergic reaction (drug hypersensitivity) (non-serious) on an unspecified date in Nov2016 with outcome of not recovered. The reaction came up be a day or few hour after the vaccinations, she did not know exactly. However the exact start date of reaction not known by pharmacist. The patient was advised to get some Cortisol cream or to do some ice pack. The event did not require an emergency room or doctor visit.
Patient started itching at site given, then itching all over, face turned red.  Heart rate increased had petit mal seizures.
The day after receiving his second COVID19 vaccine, he comes to our ER brought in by his neighbor.  Patient apparently was found down in the house.  He was covered in feces.  Patient is confused, and is not able to give a good history.  Apparently his daughter called and was not able to reach him.  She called his neighbor to check on him.  He does not have any complaints but he is confused.  He does have generalized weakness.  Tested for COVID19 on admission per policy and was incidentally found to be positive.  Patient was hydrated and became stronger and discharged.
Intense shoulder pain, weakness, limited mobility.  Went to physician, received Vicodin for pain and sling for arm referred to orthopaedic specialist. Diagnosed with tendonities and bursitis in right shoulder.
Injection site very hot and hard and tender. Chills and aches for a full day. Nodule in lymph area in neck.
first vax. started to hurt 2 weeks after.  site hurts, shoulder hurts. tylenol doesnt help.  had 2nd vax today on other arm.  three weeks today.  Right arm still hurts.  Doctor doesn't know why, or what to do.
6 month post 2nd vaccination with Pfizer vaccine, reoccurring left arm muscular and joint pain persists. This occurs upon and before waking and lasts several hours. Pain is restricted to shot site, but may radiate to left shoulder, elbow, and thumb.
A few palpitations after first shot. But that subsided. Quivers and tremors and pulsation through body began within last week of April/first week of May. Moves around body.  It seems to improve some, There?s slight trembling and vibration and light stinging feeling near eyes and in fingers.
I already have chronic urticaria but it is well-managed by taking Allegra, QD (OTC). I had to increase my dose of Allegra  to BID because the itching has intensified. I am getting an increased amount of random red/swollen itchy spots, mostly in my extremities.  Other adverse events present post dose include: nausea, fatigue, mild headache and mild dizziness.
frozen shoulder/extreme pain in shoulder lasting 3 days lingering stiffness and rash on chest and neck starting  March 14 2021 and remaining today March 18 2021. I'm not sure if it's related. I still have pain and stiffness raising my left arm .