chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt initially (3/11/21-3/19/21) had no reaction to left upper arm. On the 9th day following the injection (3/20/21) her arm began to hurt and swell at the injection site. She sought medical treatment on 3/25/21. She was diagnosed with cellulitis and began a prescription for Cephalexin 500mg TID X 7 days.
trouble talking; reaction to the fluzone high dose quadrivalent vaccine; started getting cold; shivering; shaking and trembling; was jerking; Initial information received on 06-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 73 years old female patient who was administered influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent] and experienced reaction to the fluzone high dose quadrivalent vaccine.  The patient's past medical history included Vaccination adverse reaction (Immunisation reaction), Feverish (Pyrexia), COVID-19, Cough, Fatigue and brain fog (Depressed level of consciousness). At the time of the event, the patient had ongoing Anxiety. The patient's past medical treatment included MUCINEX and the patient's past vaccination(s) included COVID-19 Vaccine. The patient's past family history was not provided.  Concomitant medications included clonazepam (klonopin) for Anxiety.  On 04-Oct-2022, the patient received 0.7 ml dose once of suspect influenza quadrival a-b high dose hv vaccine (strength; lot number; expiry date not reported) via intramuscular route in the left deltoid for prophylactic vaccination (immunization).  On 04-Oct-2022 the patient experienced reaction to the fluzone high dose quadrivalent vaccine (immunisation reaction), started getting cold (feeling cold), shivering (chills), shaking and trembling (tremor), was jerking (dyskinesia) and (speech disorder) (latency: same day) following the administration of influenza quadrival a-b high dose hv vaccine.  It was reported that the patient states that she was not having any itching or rash, any trouble breathing or swallowing, but her pharmacy stated that she should go to the ER.   Relevant laboratory test results included: Blood pressure measurement - On 04-Oct-2022: 175/115 UNK [blood pressure was 175/115 which is high for her] then 140/90 UNK [She states that the tremors stopped approximately 15 minutes later and her blood pressure was down to 140/90]  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for the event.
Information has been received from a physician and a certified medical assistant concerning a 14 year old female with no pertinent medical history who on 10-NOV-2006 was vaccinated IM with a first dose of Gardasil (lot #653937/0637F). There was no concomitant medication. On 12-NOV-2006 the patient developed "bad bruise". Unspecified medical attention was sought. On approximately 29-NOV-2006, the patient recovered. There were no laboratory or diagnostic tests performed. The physician reported that no further doses of Gardasil will be given until further information is received. Additional information has been requested. 5/14/10 Follow up: repored that medical attention was not sought. On approximately 29-NOV-2006, the patient recovered. There were no laboratory or diagnostic tests performed. The physician reported that no further doses of GARDASIL will be given until further information is received.
Fever, between 100 and 101 degrees approximately 12 hours after inoculation. Injection site soreness, muscle aches, fatigue, and a lip blister.
On the night after vaccine administration, patient woke up from sleep with pain near injection site. Pain radiated down L arm initially, but improved over time. Pain had not completely resolved ~1 month later and she sought medical attention on 5/25/23. During visit, she had a normal physical exam without impairment in strength or ROM. On 6/21/23 she sought care for acute on chronic low back pain and received a 5 day prednisone burst after which arm pain improved as well. She was again seen in urgent care on 7/31/23 and received referral to physical therapy for persistent arm pain. During visit on 8/16/23, had nearly constant pain described as a dull, aching sensation rated as 2-3/10. Pain aggravated by certain motions such as reaching across body or opening car door. No history of previous arm pain prior to third rabies vaccine. On physical exam, ttp in middle of L deltoid muscle belly, positive empty can test. No swelling, erythema, or virual abnormalities noted.
after my booster shot I experienced heartburn; GERD; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 02Feb2022 at 10:00 as dose 3 (booster), single (Lot number: FK9729) at the age of 66 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia", start date: 1991 (ongoing); "Chronic fatigue syndrome", start date: 1991 (ongoing); "Osteoporosis", start date: 2016 (ongoing); "IBS", start date: 2009 (ongoing); "Post-Concussion Syndrome", start date: 2020, stop date: 2021. Concomitant medication(s) included: AMITRIPTYLINE oral taken for fibromyalgia (ongoing); CLONAZEPAM oral taken for anxiety, sleep disorder (ongoing); METOPROLOL [METOPROLOL TARTRATE] oral taken for tachycardia (ongoing); NABUMETONE oral taken for fibromyalgia (ongoing). Vaccination history included: BNT162b2 (Dose 1, Batch number: FA6780, Anatomical Location: Left arm, Route of administration: Intramuscular, Vaccination time: 15:30), administration date: 10Aug2021, when the patient was 65-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Batch number: FC3182, Anatomical Location: Left arm, Route of administration: Intramuscular, Vaccination time: 11:00), administration date: 31Aug2021, when the patient was 65-year-old, for COVID-19 immunization. The following information was reported: GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 02Feb2022 at 10:20, outcome "not recovered", described as "GERD"; DYSPEPSIA (non-serious) with onset 02Feb2022 at 10:20, outcome "not recovered", described as "after my booster shot I experienced heartburn". The events "after my booster shot i experienced heartburn" and "gerd" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dyspepsia, gastrooesophageal reflux disease.  Additional information: After 1st and 2nd covid dose , experienced severe flare up of my fibromyalgia. Fatigue, muscle pain, burning nerve pain. Eventually recovered. After my booster shot patient experienced heart burn and GERD. It happened to minutes after booster shot. Patient never had those symptoms before. It is still an ongoing issue. Patient was currently on meds for this and will undergo an endoscopy in one week. The patient was on NSAIDS, so was at higher risk for upper digestive issue. Endoscopy was performed on 06Aug2022 for Gastritis. Fibro flare-up for 7 days with onset Date: 31Aug2021, 10Aug2021 (not serious).  AE Outcome: Recovered Specific relevant test for thromboembolic events with thrombocytopenia: None     No follow-up attempts are possible. No further information is expected.
I experienced the loss of a sense of taste and exhaustion one day after the shot and could not have the strength and attention pan to continue cooking. I have also been suffering from Lingering episodes of sudden physical faintness and mental stupor. This is most noticeable after engaging in my normal walks of one mile or less.
Pt recvd 1st dose of Hep B on 17DEC91 & 26DEC91 pt devel 5 to 6 small red papules on each arm; papules were pruritic & caused some excoriation from scratching;
Initial misuse report received from a healthcare professional on 18 March 2014. YF-VAX was inadvertently reconstituted with sterile water instead of the YF-Vax Diluent. It was a wrong solution used in drug reconstitution. No adverse event was reported. List of documents held by sender: None.
client given vax approx 1 1/2 mins p/vax; pt became rigid while sitting on chair, threw head back; had jerky of shoulders & eyes rolled up;  Pt was pale & BP 142/82;
Pfizer booster Over the course of 4 days, I experienced extreme pain in my right upper and lower jaw, then it was reduced to upper jaw, then reduced to one or two teeth.  By yesterday,  Tuesday September 20th, all pain had gone away.
Reports approx 5 hours after injection noted to have swelling, erythema and tenderness to left anterior arm distal to shoulder. Arm was tender to move and swollen. Took ibuprofen that first night. The next day it was improving. By 48 hours noted the redness had progressed to her lower arm. Denies any other rash, SOB, wheezing, fever or pain. No prior reaction to vaccines.
This is an unconfirmed spontaneous report from a lawyer referring to a 69 year old male who claims to have experienced ankle, knee and foot pain after the 1st and 2nd Lymerix vaccinations. The pt had no history of Lyme disease or arthritis. In July, 1999, the pt received his 1st dose of Lymerix and felt ankle, knee and foot pain (exact start date not provided). He reports that his physician "told him this would go away". A month later (August, 1999), he received the 2nd shot and his symptoms became dramatically worse. The most recent information received on 2/17/2000, reports the outcome of the events as unknown. Additional information has been requested.
got the first 2 J&J Jansen vaccines originally, then got the J&J Jansen booster; Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 74 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: j&j jansen vaccine (DOSE 1, SINGLE; Lot number: 1808982), administration date: 08Apr2021, when the patient was 73-year-old, for COVID-19 immunization; j&j jansen vaccine (DOSE 2, SINGLE; Lot number: 2, then either a 1 or L, then either a 1 or I, then D21A so either: 21LD21A, 211D21A, 2LLD21A, 2L1D21A or 2LID21A; this was from the CDC vaccine record card and was handwritten, hard to read.), administration date: 27Nov2021, when the patient was 74-year-old, for COVID-19 immunization; J&j jansen vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21May2022, outcome "recovered" (23May2022), described as "Sore arm"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 21May2022, outcome "unknown", described as "got the first 2 J&J Jansen vaccines originally, then got the J&J Jansen booster".  Additional information: For COVID she got the first 2 J&J Jansen vaccines originally. Then she got the J&J Jansen booster which was basically the same vaccine. Then she got the first Pfizer booster and had no bad effect from it at all. In fact she had less effects from the Pfizer booster than from the 2 J&J. With the Pfizer Booster it wasn't bad, but you could notice something, just a little bit of a sore arm; but she had no adverse effects or symptoms.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201325205 same patient, different product (dose number) and different event;
Patient receive meningococcal vaccine on 8/10/5. In late September or early October the patient developed weakness in the left hand and had trouble playing the clarinet and piano.  The patient was referred for physical therapy.  Symptoms resolved after approximately 30 days and physical therapy.
PNEUMOVAX23 Expired on 03-DEC-2021, was administered on 31-DEC-2021; This spontaneous report was received from a medical assistant regarding a 66-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.   On 31-DEC-2021, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml for prophylaxis, lot # T007790 with expiration date on 03-DEC-2021 (strength, dose number, anatomical location and route of administration were not reported). The dose was properly stored and temperature excursion did not ocurred.
Severe chills x 36 hours Muscle aches x 48 hours Headache x 36 hours Severe Exhaustion x 100+ hours
Shingles after receiving the second dose of Shingrix; Off label use; Inappropriate age at vaccine administration; Off label use; Inappropriate age at vaccine administration; This case was reported by a physician via call center representative and described the occurrence of shingles in a 46-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster otitis externa (experienced 6 times).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and 2 days after receiving Shingrix, the patient experienced shingles, off label use, inappropriate age at vaccine administration, off label use and inappropriate age at vaccine administration. On an unknown date, the outcome of the shingles, off label use, inappropriate age at vaccine administration, off label use and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's parent. The reporter stated that, 2 days after receiving shingrix vaccine,the patient had shingles. The patient experienced shingles 6 times till the time of reporting. The reporter stated that, the immunologist prescribed the vaccine despite the patient´s age, which led to inappropriate age at vaccine administration and off label use. The reporter consented to follow up.
The nurse is reporting that a patinet received improperly stored VARIVAX; No additional AE were reported; This spontaneous report was received from a Licensed Practical Nurse and refers to a 10-year-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On and unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (route of administration was not reported), lot #  U016065 and expiration date 20-MAY-2023 administered as prophylaxis.   The improperly stored dose of the suspect vaccine experienced a temperature excursion of 0.3 degree celsius (°C) for 2 hours and 34 minutes on an unknown date; no previous temperature excursions were reported.  No adverse symptoms were reported.  This is one of several reports received from the same reporter.  As of 29-OCT-2021, all telephone attempts trying to obtain additional information has been unsuccessful. No further information is available.; Sender's Comments:  US-009507513-2110CHN006820: US-009507513-2110USA006418: US-009507513-2110USA006855:
Red, swollen deltoid, from shoulder to elbow but decreased a lot in redness and size with Benadryl.
pt recvd vax; severe cramps in leg muscles in eve p/ doses;felt like could not move;next am,upon waking up,legs felt very sore;no oth sxs;healthy person;7dec93 f/u:completed series w/out further events;
Repeating nose bleedings - no medication was needed, stopped by itself  Slight pains in left-sided intercostal space (left side of the chest) - moderate pains, no treatment needed
This spontaneous report was received from an 86-year-old female patient who was reporting on herself. No information about the patient's medical history was reported. The patient's concurrent conditions included high blood pressure. On 14-DEC-2015, after physician's suggestion, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly (exact dose, lot # and expiry date were not specified). Concomitant therapies included "a lot of medication". On 16-DEC-2015, after receiving the PNEUMOVAX 23, the patient developed a head cold, the cold was treated with unspecified decongestant. The outcome of the event was reported as not recovered. The causality assessment was not provided. Additional information has been requested.
Information has been received from a mother concerning her 18 year old daughter who "sometime" in June 2007, was vaccinated with a first dose of GARDASIL vaccine (yeast). "Sometime" in July 2007 she was vaccinated with a second dose of GARDASIL vaccine (yeast). There was no concomitant medications. "Sometime" in October 2007 she was vaccinated with a third dose of GARDASIL vaccine (yeast). In the beginning of October 2007, the patient started to break out in rash on the front of her body and by the end of October she started to develop little bumps on her whole stomach. In December 2007 the bumps spread to her back from her chest down to her stomach. The bumps turned into open sores that were a little larger than a pencil tip but did get to the size of an eraser on a pencil. The sores healed and the patient "has brown spots on her body where the rash had been." The patient was seen and treated by a dermatologist. The patient had a biopsy (results not reported). The patient was treated with a cream (unspecified by reporter). The cream had faded the spots a "little bit" but the patient "still has the marks." At the time of the report the patient was recovering. Additional information has been requested.
ACUTE NON ST ELEVATION MI 12/1/2021 METABOLIC ENCEPHALOPATHY - 4/19/2022 ACUTE NON ST ELEVATION MI 12/1/2021 ACUTE NON ST ELEVATION MI - 12/1/2021 ACUTE NON ST ELEVATION MI 12/1/2021 ACUTE NON ST ELEVATION MI - 12/7/2021 ACUTE NON ST ELEVATION MI 12/1/2021 ACUTE NON ST ELEVATION MI - 12/7/2021
This spontaneous report was received from a physician refers to a patient of unknown age who approximately two months prior to the second dose (approximately on 15-OCT-2012) was vaccinated orally with the first dose in the series of ROTTEQ (Lot Number and dose not reported). No co-suspects were reported. No concomitant medications were reported. The physician noted that a patient was inadvertently administered an expired dose of ROTATEQ (Lot # 670011/1393AA, Exp date: 03-DEC-2012) (dose not reported) on 15-DEC-2012. This was the second dose  in the ROTATEQ vaccination series this patient has received. No adverse effect reported. Patient's outcome was unknown. Action taken not applicable. Additional information has been requested.
Rt thigh swollen, warm to touch & very red.  Pt crying and mom had not been able to calm him. Mom already gave Tylenol. Patient given 1cc  Benadryl per request of Dr. Mom instructed to give Tylenol q4h prn & Benadryl q6h prn.
He did not told me about any symptoms. He just died the next day of the vaccine. Still today doesn?t know why he died. He appeared to be in good health.
VACCINE ERROR:  FLUZONE HIGH DOSE ADMINISTERED ACCIDENTALLY WHEN PATIENT NOT ELIGIBLE BECAUSE OF HIS AGE.
One week after vaccination I noticed a brief loss of hearing in my left ear that lasted 1 minute. I also had mild body aches. The loss of hearing came back and I scheduled an appointment with the ENT doctor who did an exam and gave me prednisone 20mg 2 tabs daily x 5 days to help with inflammation and was told to follow back up with them if it did not help. I noticed on 5-8, everything seemed to have cleared up. I have fully recovered.
had a little rashes in her lower eye that going to her cheek; This is a spontaneous report from a contactable consumer (patient). This is a report received from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 18Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient informed that she was fine after the 1st dose of the vaccine last 18Feb2021 and was scheduled for the 2nd dose tomorrow 11Mar2021. On an unspecified date, the patient experienced had a little rashes in her lower eye that going to her cheek. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Redness, swelling, itching, diarrhea, chills, fever, headaches.
Body aches, very sore arm, feverish feeling, eye pain, mild headache, chills, restless legs, fatigue
2nd BI-VALENT BOOSTER GIVEN ON 12/16/22 1st GIVEN ON 10/27/2022 MODERNA LOT # 057F22A NO ADVERSE SYMPTOMS NOTED
Fever(highest 100.6), achyness, headache, and chills for three days. I had Covid in October, 2020, and the s/s then was not near as bad as I had with the vaccine!
broke his ankle; He had accident slipped on ice; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 28Jan2021 (at the age of 72-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Feb2021, the patient had accident slipped on ice and broke his ankle. He underwent a surgery. He was unable to get the 2nd dose scheduled for 18Feb2021 due to surgery. He asked if he can still get the 2nd dose of the vaccine and would like to know what were his options. The outcome of the events was unknown.  No follow-up attempts are possible. Information on Lot number cannot be obtained.
I was experiencing shortness of breath, I went for a medical test and I was told that I need to go to the emergency room. I was diagnosed with congestive heart failure.
Unknown reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Unknown reaction) in a 68-year-old female patient 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 an unknown date, the patient experienced VACCINATION COMPLICATION (Unknown reaction). At the time of the report, VACCINATION COMPLICATION (Unknown reaction) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-422870 (Patient Link).