chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The night after getting the vaccination I had extreme pain in the joints and muscles as well as headache and fatigue. The pain kept me from sleeping, and woke me up at night for several nights in a row. The joint pain didn?t completely subside for over two weeks.  I was also very fatigued, sleeping 10 to 12 hours a night for two weeks. I normally sleep 7 to 8 hours a night.  My muscles also felt weak and sore for over a week.  Shot one messed me up bad.  The first night I also had clammy feeling skin and a slight feverish feeling, although I didn?t take my temperature.
Booster dose of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 06-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Dizziness, felt faint, blacked out momentarily. Every time I stood up, felt like I was going to pass out. Could not ambulate properly without feeling lightheaded.
Information has been received from a consumer concerning his approximately 4 year old female daughter who on 28-MAR-1994 was vaccinated with her first dose of MMR II (Lot number 618168/0885D). On 21-Jul-1997, the patient was vaccinated in her right arm with her second dose of MMR II (Lot number 618168/0885D). It was reported that following the second dose the patient nearly died and experienced several adverse effects. In 1997, the patient developed mood, memory, and intellectual changes. She exhibited autistic symptoms and became "zombie-like." She experienced dehydration, would stop eating and sleeping, and had fecal impaction on different occasions over the last few years. In 1998, the patient nearly died because she was extremely dehydrated with acidosis. She has been treated with mental health medications but her symptoms worsened and therefore her medications were discontinued. The reporter stated he has sought medical attention for his daughter and that she had been in the hospital on four separate occasions for a total of three months in the past few years and had six emergency room visits. The consumer reported his daughter's symptoms have worsened during puberty. She currently had cerebral edema. The consumer believed many of his daughter's symptoms were caused by a reaction to sorbitol. The consumer reported that on 23-OCT-1993, his daughter was also vaccinated with DTAP and this vaccine may have contributed to her symptoms. The patient's outcome has not recovered. Upon internal review, autistic symptoms was determined to be an other important medical event. Additional information has been requested.
3-6 days after receiving the vaccine I began having a rapid heartbeat and a hard time breathing at night time. This only happened for one night, i have a fitness watch that can monitor my heart rate and my heart rate is usually in the 70s while laying in bed and sleeping. I was trying to fall asleep when my heart started to flutter and have an irregular beat then it started pounding at an alarming rate and when I checked my HR it was 166 at its highest, this happened to me at least 4 different times throughout that night along with shortness of breath, I was on the edge of going to the hospital but the only thing that kept me from going was that I was not having 'chest pains' & I also did not want a hospital bill. So I made it through an incredibly stressful and sleepless night of tossing turning and focusing on breathing. The ONLY variable I can come to the conclusion is taking the vaccine, nothing else changed in my daily life and I do not smoke or drink.
DIARRHEA; STOMACH CRAMPS/SEVER STOMACH PROBLEM; GAS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine(suspension for injection, route of admin not reported, batch number: Unk) 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 2021, the subject experienced diarrhea. On 2021, the subject experienced stomach cramps/sever stomach problem. On 2021, the subject experienced gas. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from diarrhea, stomach cramps/sever stomach problem, and gas. This report was non-serious. This case, from the same reporter is linked to 20210516975.
I had the first shot of the Shingles vaccine June 14 and I have to say it packs a wallop-literally. Besides being the most painful injection I ever had-and I could not lift my arm afterwards, I became somewhat sick within a few hours. Tired and achy and I had a hard time sleeping that night. Saturday morning I had diarrhea, fatigue and anxiety. I did begin to feel better during the day but feel asleep on the couch Saturday afternoon not to awaken for almost 14 hours. I am feeling better but was wondering if this is unusual as I still have shot #2 to get.
Shingrix GSK Y77XY left arm IM on 8/10/23 tdap 8/15/2023 GSK M4E4A  left arm IM rash bilateral antecubital fossa starting 8/19/23, progressed to entire back with diarrhea and headache. "blistered" per patient. went to UC, was given prendisone, hydroxyzine and famotidine however patient only took famotidine which did help a bit. Evaluated in my office 9/1/23, advised to add zyrtec and famotidine. Prednisone again given if not significantly improved. no wheezing or difficulty swallowing.
Periorbital edema and ecchymosis- patient woke up the day after the vaccine with this. Presented to office 2 days after the vaccine. treatment- cool compresses, antihistamine.
shortness of breath, rapid heartbeat, barely able to move arm at all, dizziness, could barely walk at all, constantly shaking, hard to swallow
Pt. became faint, B/P dropped to 80/32, O2 sats 68, pulse 37. Client was to receive 5 injections. He was very nervous. Talked with client and provided instruction. Three shots were administered into his left arm and two shots in the right arm. Client proceeded to act faint and the nurses attempted to arouse the client. The client did open his eyes and a cool pack was placed behind the client's neck and a glass of water was given to the client. He drank the water and then gave us the cup. His head went back and his eyes were closed. Continued to try to talk with client and he was not responding. Asked his mother if he had ever done this before and she replied with a yes. The questions on the questionnaire that was reviewed by the nurse state no previous reactions to vaccines and no allergies. An interpreter was called on the mother's phone and the nurse talked with the interpreter. The client is extremely scared of needles and blood. The last time it took 40 minutes for the client to come around. Again, attempts were made to arouse the client. An oximeter was applied to his finger. O2 sats were in the 90's on room air. Pulse was in the 60's. B/P was taken at 80/32. O2 sat continued to drop into the 80's and then the 70's. One nurse continued to try to arouse the client while the other nurse administered 0.5cc of epinephrine IM. Ambulance and Medical Director was called. O2 sats did come up into the low 90's. The client was placed safely onto the floor. O2 sats continued to run in the low 90's. The ambulance crew arrived and the client was transported to the hospital.
Narrative: 01/14, Pfizer, dose #1 02/04, Pfizer, dose #2 11/10, Pfizer, dose #3 09/10 COVID swab, result: not detected 10/12 pt cc: exposure: unknow 10/12 COVID swab, result: detected 10/12 SARS-COV-2 Variant Sequencing result: pending 10/26 COVID swab, result: not detected.
choking and was not feeling well generally. She went to the ER and received epinephrine. she was being monitored till 6:30 pm.
pt recv vax 22FEB99 & typical varicella lesions noted on exam by clinician 18MAR99 (1st appeared by hx 15MAR99);
This spontaneous report as received from a pharmacist refers to a 45 year old female patient. Patient's pertinent medical history included rheumatoid arthritis. Other relevant medical history was not reported. On 11-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (lot number: K009809 with expiry date of 16-MAY-2015)(dose, frequency and route unspecified). Concomitant medications were not reported. The pharmacist reported that the patient experienced soreness at the injection site and at the shoulder after receiving PNEUMOVAX 23 on 1-SEP-2014. The pharmacist reported that the patient experienced the soreness for over 4 weeks and described that the pain was very bad and the patient felt like she broke her arm or shoulder. No treatment was given for the events. The patient did not sought medical attention. The pharmacist stated he would stop giving PNEUMOVAX 23 to his patients until further notice. The outcome of the events was reported as recovering/resolving. The causality of the events with PNEUMOVAX 23 was not reported. Additional information has been requested.
chronic pain at the injection site/ I have pain after 3 months; had a football shaped red welped area on my arm and the spot where it was injected; damaged nerve; inflammation; feel this pain in the deltoid muscle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jun2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE PAIN (non-serious) with onset Jun2022, outcome "not recovered", described as "chronic pain at the injection site/ I have pain after 3 months"; NERVE INJURY (non-serious) with onset 2022, outcome "unknown", described as "damaged nerve"; MYALGIA (non-serious) with onset 2022, outcome "unknown", described as "feel this pain in the deltoid muscle"; INJECTION SITE ERYTHEMA (non-serious) with onset 2022, outcome "unknown", described as "had a football shaped red welped area on my arm and the spot where it was injected"; INFLAMMATION (non-serious) with onset 2022, outcome "unknown".  Additional information: Caller reports that 3 months ago he received the prevnar 20 vaccine, still having chronic pain at the injection site. He has seen his PCP and arm specialist they don't have any solution or know how to deal with this, seeking information if Pfizer has recommendations on what to do? Caller states one week after injection he had a football shaped red welped area on my arm and the spot where it was injected if I squeezed deltoid muscle blood would still come out. Caller also states that if he took a hot shower the blood in that football shaped area would travel to elbow to above my shoulder. Caller states he has remaining lingering pain but the physical stuff that you can see is gone. almost like a damaged nerve, inflammation, something affecting the nerve that comes and goes. Reports that at nighttime if its cold, if I move my arm outward lift it up feel this pain in the deltoid muscle. Caller states he is on day 90 of pain at the injection site. He is 61 years old with no previous history of pneumococcal vaccine. Caller asked how long people experienced injection site pain in the clinical trial? I have pain after 3 months. I would like to know what can I do for this cause I have gone to the doctor and nobody seems to know."So I am just trying to find out something that remedy the situation here. I am sure I am not the only one with this problem."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a healthcare professional (also the subject's mother) and described the occurrence of joint effusion in a 18-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 25 August 2003 the subject received 1st dose of ENGERIX B (unknown route, unknown arm). The subject did not receive the 2nd dose of ENGERIX B because he had a cold at the time it was due. The healthcare professional did not consider the cold related to vaccination with ENGERIX B. On an unspecified date in November 2003, approximately 3 months after vaccination with ENGERIX B, the subject experienced joint effusion of his knees, hands and elbows. He also experienced difficulty walking and hand tremor due to the joint effusion. Relevant test results included "slight blood work abnormalities, but nothing they were concerned about". The subject was treated with prednisone and evaluated by his physician. At the time of reporting the events were resolved. The vaccination course with ENGERIX B was discontinued.
Patient states 6days after injection patient had very painful back pain when breathing in. Patient also states chills and fever of 102.0.
70 doses of Pfizer Covid Vaccine for pediatric patients (orange cap) Lot FK5618 were delivered assigned a beyond use date (BUD, do not use after date) by the manufacturer due to previous storage and handling issues at another facility.  The doses were mistakenly administered to 70 patients on 11/26/21
Patient had large skin/soft tissue reaction. Area was 8.2 cm x 7.6 cm with a central darker red, tender hot area of 4.0 cm x 3.5 cm caused her to limp. No fever.
Information has been received from a registered nurse concerning a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions and allergies were not provided. The nurse reported that the patient was administered a dose of MERUVAX (dose, route, lot# and expiration date were unknown) on 21-FEB-2007 and a dose of VARIVAX (dose, lot# and expiration date unknown, subcutaneously) on 12-MAR-2007 (Drug use for unapproved schedule). The outcome of drug use for unapproved schedule was unknown. No adverse effects reported. Additional information is not expected because there was no consent to contact the reporter.
Client phoned health dept on 4/12/21 stating she had developed shingles and needed to re-schedule her 2nd dose moderna vaccine scheduled for 4/15/21.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Terrible reaction to first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced VACCINATION COMPLICATION (Terrible reaction to first shot). At the time of the report, VACCINATION COMPLICATION (Terrible reaction to first shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product use was reported. No treatment information was provided. Reporter did not allow further contact.
irritable, crying hard for 1/2 hr, then became very listless & just laid there t101.6; taken to ER:
delayed injection site reaction, 2 days after administration. large 6 in diameter red rash at injection site. Painful to the touch with swelling and tissue firmness.  reaction began to reduce at 4 days and continues to resolve. Appears to be "covid arm".
night of 4-7-2021 102 degrees F fever, chills, extreme shaking  4-8-2021 - 4-9-2021 102-103 F fever, body ache/pain, muscles and bones, especially hips, upper legs, lower back 4-10-2021 afternoon,  extreme nausea, took prescription suppository, Promethazine 25 mg sup,, seemed better on 4-11-2021, 4-11-2021 and 4-12-2021 improved, but had bloating and some stomach pain, was on a light diet 4-13-2021 abdominal bloating during the day, then had diarrhea in the evening,  then, 4-14-2021 had extreme watery diarrhea, stayed on liquid and then light diet, fatigue for a couple of days,  then improved
pulmonary embolism diagnosed on 23Sep2021; Patient diagnosed with DVT left leg on 21Sep2021 (left peroneal and left popliteal)/She then had a new DVT diagnosis right leg (right popliteal ) on 03Oct2021; This is a spontaneous report from a contactable physician. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 10Jul2021 (Batch/Lot Number: EW0180) (at the age of 50-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient had no covid prior to vaccination and was not covid tested post vaccination. Medical history included obesity, fibroids, hypertension (HTN), asthma, type 2 diabetes mellitus (DM), gastritis, sleep apnea; and known allergies to seafood, dust mites, cats, dogs, rabbits, birds, mold, and grass. The patient's concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 19Jun2021 (Batch/Lot Number: EX0198) (at the age of 50-year-old) for covid-19 immunization. Patient diagnosed with deep vein thrombosis (DVT) left leg on 21Sep2021 (left peroneal and left popliteal) and started Eliquis, then pulmonary embolism diagnosed on 23Sep2021 and switched to Warfarin. She then had a new DVT diagnosis right leg (right popliteal) on 03Oct2021 while on warfarin which was therapeutic international normalised ratio (INR) 3.2. Prior to COVID vaccination she never had a DVT or PE. She has a risk factor for DVT which was obesity. The events resulted to doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The events were life-threatening and caused hospitalization for 3 days. The events were treated with anticoagulation. On unspecified date, the patient recovered from the events.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of  deep vein thrombosis, pulmonary embolism . 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
Itch a little bit; Rash of 8 inches in left arm toward  elbow; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number HE4P7, expiry date 25th January 2024) for prophylaxis.   On 4th November 2022, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pruritus and rash. On an unknown date, the outcome of the pruritus and rash were recovered/resolved.   It was unknown if the reporter considered the pruritus and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-JAN-2023 Reporter's comments: The Healthcare Professional (HCP) had called up to report that a patient received the 1st dose of Shingrix vaccine in her left arm, and got a rash that was about 8 inches long that went down her arm toward her elbow, and itched a little bit. The rash went away a week later. The reporter did not consent to follow-up.
Product: COVID 19 Treatment; Product: COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; manufacturer unknown), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Product: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Apr2022) Positive; (19Apr2022) Negative. Therapeutic measures were taken as a result of covid-19. Tested negative three days after paxlovid regimen and then tested positive again. Patient had other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Feeling so faint, I could not stand up without falling about 10 hours.  Fever for a couple of hours
Patient presents to the ED  with body aches, headache, cough, fever, and sore throat.  Patient is admitted with Covid and treated with remdesivir.
Two vaccine not a problem at all they are extremely painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles with an associated reaction of pain (received 1st dose, two years ago of reporting date, for tolerance refer case US2021AMR130051).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient himself or herself. The age at vaccination was not reported. The patient stated that the he/she received vaccine over 2 years ago, there was not a problem at all but was extremely painful.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR130051:Same reporter.
PFIZER COVID VACCINE #3 GIVEN 9/9/21, LOT # FC3184; pt had a positive COVID test at Medical Center; per death certificate, pt passed away at home with cause of death being COVID 19; no other records.
Patient complained of sore/scratchy throat, harder to breath especially when seated, & numbness in hands & feet. He said it started & progressed after his vaccine.  He called approximately 1 hour later & I advised him to go to urgent care.  He said it resolved by the time he got there, but was seen anyway & cleared.