chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a pain in the right arm like someone was punching me in my arm constantly. Between 3:00 and 4:00 PM was when it started hurting really really bad. I went to ER. They did vital signs but no other testing. They told me it was normal symptoms and to go home. They sent me home from ER. Like someone was giving me a dead arm from 3:00 PM until when I passed out that night. I got chills too, and I think it was shaking from how bad my body hurt. My boyfriend rubbed my back until I passed out from the pain. I stayed home from work the next day the arm was better but it still hurt. I didn't feel totally back to my normal self until Monday.
Fever, nausea, severe myalgia in body areas other than the vaccination site (e.g. upper back, neck)
Patient presented back to the pharmacy after waiting 30 minutes for observation and leaving the store. She stated that she was experiencing tingling in her left arm, felt like she was having trouble swallowing, and that her tongue was swelling. She was given some water and a benadryl 12.5mg tablet and EMS was called. Paramedics arrived on scene and she walked out to the ambulance for further evaluation. At that point we did not have further contact with the patient.
Pt was brought to EMT area by EMT staff. Pt was lethargic, not answering question, sweaty, pallor, hard to arouse, slumped over.  Vital signed were taken and staff attended to pt to keep patient alert. pt slowly started to become more responsive after snacks and juice was given. he sat down 30minutes and become more alert and oriented. pt was arranging for someone to pick him up and dint want to leave car.  he stated that someone was going to pick him and left after he was feeling better.
Lump on the palm of her right hand; Tingling; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Lump on the palm of her right hand) and PARAESTHESIA (Tingling) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 NODULE (Lump on the palm of her right hand) and PARAESTHESIA (Tingling). At the time of the report, NODULE (Lump on the palm of her right hand) and PARAESTHESIA (Tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter. Treatment of events was not reported.
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  It was reported that the vial did not undergo any temperature excursions and the vials were received at the HCP office on 20-Aug-2021 and were stored in refrigerator till dates administered as indicated on the list 10 vials were used.  The patient received the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Dosage number for the suspect drug was updated.
Shingles over her left eye; This case was reported by a other health professional via call center representative and described the occurrence of ophthalmic herpes zoster in a 89-year-old female patient who received Herpes zoster (Shingrix) (batch number AL34K, expiry date 11th February 2022) for prophylaxis.   On 6th August 2020, the patient received the 1st dose of Shingrix. On 8th August 2020, 2 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster was recovering/resolving.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. After receiving 1st dose of Shingrix, the patient started to had shingles over her left eye. At the time of reporting, the patient was doing good.
Unanticipated pain at the time of the injection followed by significant pain in the shoulder, tricep, bicep, and elbow x 3 weeks.
The patient started off with tingling in the left hand which spread to muscle spasm and twitching. PharmD administered 25mg benadryl, the tingling continued to spread to the right side as well, patient was moved to the floor, involuntary movement  of the legs started. 911 was called.  Weakness in right and left hands, chatter in face but patient stated she was hot and sweating.  Heart was not racing. Left hand weakness did show some improvement, then jaw clenching was starting. Neck and face redness. Ambulance arrived to take her and husband was notified.
Had a seizure while watching TV with my family.  I was setting in a chair, not stressed.  Family called 911 and ambulance came to take me to office
Lower back pain 2 days after first dose 3/27, Shingles 2 days after second vaccine on 4/21 Facial filler edema on 6/5/21 received 2 months prior to first vaccine
Patient reports she received Pneumovax on 4/7/08 and approx. 6 hours later she developed temperature of 103.9 by 1.  She was covered in hives, throat was swollen - completely covered in rash.  Took Tylenol temp decreased to 102 the next day and on Saturday temperature was 104 and on Sunday April 13 no further fever.
A few minutes after receiving his first moderna vaccine patient experienced chills, dizziness, paleness, and sweats. We had the patient lay down on the floor until he was ready to sit up again. (about 5 minutes). After laying down we had the patient sit and wait in the pharmacy wait for another 10-15 minutes. In total patient was here for about half an hour
Left arm achy, tender to the touch, Quarter sized red area at injection site, warm to the touch
Site of varicella injection has slight swelling and redness, 9/7/06 arm burns swelling and redness size of quarter, able to stay in school, 9/8/6 11:30am school calls mother. Large 5" area of redness, tenderness on right side of neck.
At midnight, developed full body tremors and chills. This progressed to body aches involving bones and muscles. Later stomach and chest pain developed. All symptoms gradually improved until about 5 am at which time the patent felt recovered. At this time no lasting issues.
About 48 hours after my second Moderna vaccine, I started getting jaw pain and back pain. The jaw pain seems to center around the joint on the right side of my jaw and affects the nerves, radiating into my lower teeth on that side. I have been medicating with two to three 200 mg. Advil tablets around the clock (and sometimes three 200mg advils & one extra strength tylenol). I went to the dentist on Friday for an x-ray of my teeth, to make sure it wasn't something in need of remediation. The x-ray showed no damage to the teeth. I still have the jaw pain this morning (Sunday), although I think it is a little less severe than yesterday. I also have a bad headache today but am holding off taking pain reliever, to better judge the full effect.  My back started hurting as well on Wednesday and proceeded to worsen until it was difficult to function on Friday. I wore my back brace Thursday through Saturday, as well as taking a muscle relaxer in addition to the advil. It feels a bit better today.
atrial fibrillation; giant cell arteritis/fatigue, weight loss; nerve pain; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On or about 06-JAN-2014,  the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered from nerve pain, fatigue, weight loss, atrial fibrillation and was diagnosed with giant cell arteritis. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitation not present prior to using the Company's product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, 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 the Company's conduct, the patient has suffered and incurred damages, including medical expanses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality was related.  The events of atrial fibrillation, nerve pain and giant cell arteritis were considered to be disabling.  Upon internal review, the event of atrial fibrillation was considered to be medically significant.
This spontaneous report was received from a medical assistant referring to a patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 12-OCT-2017, the patient was vaccinated with PEDVAXHIB lot # M025194 (anatomical route was not reported) for prophylaxis. On an unknown date, the medical assistant reported, the patient received a dose of improperly stored vaccine, no adverse effects reported. Temperature time frame 28 Fahrenheit for 48 hours, no previous temperature excursion, the call was due to a data logger.
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: pt recieved vaccine on 6/27 and documenting daily the spread of rash which now has been spread below injection site with burning and possible form of cellulitis
The patient received a second dose of VAQTA earlier than recommended; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 15-JUL-2021, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (strength, lot #, expiration date, route of administration, anatomical location not provided); and on 17-DEC-2021, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 mL, lot # T035721, expiration date: 15-APR-2022 (route of administration, anatomical location not provided), earlier than recommended, as prophylaxis (inappropriate schedule of product administration).
Covid test date: 25Dec2021, Covid test result: Positive; Covid test date: 25Dec2021, Covid test result: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 (Lot number: FC3184) at the age of 66 years as dose 3 (booster), single, administration date 10Mar2021 (Lot number: EL9269) as dose 2, single and administration date 17Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The vaccine was administered in Pharmacy or Drug Store. Relevant medical history included: "known allergy: environmental" (unspecified if ongoing); "known allergy: pet danger" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "coccydynia" (unspecified if ongoing). The patient took concomitant medications in two weeks. It was unknown if other vaccine was received in four weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Dec2021, outcome "not recovered" and all described as "Covid test date: 25Dec2021, Covid test result: Positive". The event "covid test date: 25dec2021, covid test result: positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Dec2021) positive, notes: Nasal swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Patient noted 20-30 flat, non-raised, red blotches on his chest, back, and legs approximately 24 hours after receiving vaccine. The spots were about 1/2 the size of a dime. Patient also reported periods of slight lightheadedness.
Second dose (February 21) and booster (December 21) both caused flare ups of my ulcerative colitis that had been in remission for about six years. Ended up having to be admitted to the hospital to manage the flare up.
Case number PHEH2015US017653, is an initial spontaneous report from a nurse received on 09 Sep 2015. This report refers to a 57-year-old male patient. Medical history was not reported. Vaccination history included administration of FLUVIRIN, (batch number: not reported) two times and the patient tolerated the vaccinations. Concomitant medication was not reported. The patient was vaccinated with 0.5 ml of FLUVIRIN, (batch number: 157103) intramuscularly at left deltoid on 08 Sep 2015 (at 12:45). It was reported that patient received an out of temperature range FLUVIRIN pre filled syringe which was stored at a temperature range of 33.2F. The case was reported as non-serious. No adverse reaction was experienced by the patient following this medication error (incorrect storage of drug). Follow up report from the nurse received on 27 Oct 2015. Updated patient demographics, vaccination history, vaccination time, vaccination site and other clinically relevant information in the narrative.
Severe headache, photophobia, tingling in feet reaching above knee, tingling in right fingers 11/9/09 Medical records received for dates 10/27/09 to 11/2/09. DX: Rt. lower hand/finger tingling. Assessment: WNL, tingling rt. hand/fingers. Pt. c/o receiving H1N1 vax on 10/26 now with c/o HA, rt. lower hand/finger tingling. As of 11/2/09 sx. resolved.
pt's mother states patient was instantly sleepy, waited 30 minutes inside tented waiting area, walked to car and became difficult to arouse/respond.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Nov2021 as dose 3 (booster), single (Lot number: Ew0196) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cyclic vomiting syndrome" (unspecified if ongoing); "migraine" (unspecified if ongoing); "known allergies: Chocolate" (unspecified if ongoing), notes: known allergies: Chocolate. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Positive, notes: Return of positive antigen test after testing negative; (May2022) Negative, notes: Return of positive antigen test after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient got Paxlovid treatment from 03May2022 to 07May2022. Metallic taste Return of fever, fatigue, cough, and muscle aches after symptoms had resolved with treatment Return of positive antigen test after testing negative.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Swollen injection site - knot  Swollen lymph node above collar bone  Mouth ulcers on the top of roof and left cheek
The patient received a Fluad vaccination on 11/13/23, and it was discovered that she also received a Fluad vaccination on 9/27/23.  The state reporting integration system was down on that day, so the Fluad from 9/27 was never reported.
1. 24hrs post vaccine - itchy rash, welts lower legs, top feet. 2. Unable to sleep- took BENADRYL - no response. 3. Cleansed area (Neutrogena) - no response. 4. 11/11/09 - Dr visit (private) - hydrocortisone cream/ BENADRYL ointment - little response. More than one week - welts/itching  encircled body, chest, back, neck 2nd visit 11/19 PERIACTIN and prednisone shot.
pt recv vax; exp swelling & erythema at inject site;also exp n,v & fever of 101;seen by MD;
Throughout the day my mouth was very dry, no matter how much water I drank. Other than that my first major symptom was mucsle aches and body soreness which started about eight hours after the shot. A couple of hours later I started having chills which felt like I might have a fever, but thermometer said my temperature was normal. The muscle soreness remained moderate throughout the night. About 3am I took my temperature again and found that I had a fever of 99.6. The next morning the fever, aches, headache, and chills remained. The aches continued but lessened in severety by 04/03/2021 later afternoon and the fever had disappeared. Arm of the injection sight remained sore the entire time.
No Adverse event; received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) 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 ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose).    No concomitant medications were reported. Reporter saw that the dosage was changed to 0.5 ml. For the past month, reporter had been giving 0.25 ml. 19 patients received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022 and 06-Oct-2022. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662961, US-MODERNATX, INC.-MOD-2022-662973 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662973:Same reporter US-MODERNATX, INC.-MOD-2022-662961:Same reporter
This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 72 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 09Nov2021 13:42 (Lot number: FA6780, Expiration Date: Dec2021) at the age of 72 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1, Time: 1342, Route of administration: Intramuscular), administration date: 05Mar2021, when the patient was 72 years old, for COVID-19 immunization; Bnt162b2 (DOSE: 2, Route of administration: Intramuscular), administration date: 22Mar2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Nov2021 13:42, described as "Dose: 3rd"; OVERDOSE (non-serious) with onset 09Nov2021 13:42, described as "inadvertent vaccination with a higher dose of the Pfizer Covid vaccine"; PRODUCT PREPARATION ISSUE (non-serious) with onset 09Nov2021 13:42, described as "higher concentration than recommended"; HEADACHE (non-serious) with onset 10Nov2021, described as "Headache". Therapeutic measures were not taken as a result of headache.  Additional info: The caller is calling to report a patient who was vaccinated with the Pfizer covid vaccine using two different vials, so it was a higher than authorized dose. Caller states the patient was given 0.1 ml from an undiluted vial and 0.2ml from a diluted vial equaling the right volume but a higher concentration than recommended. Volunteer stated that she was trained more than 6months ago and did not remember that she was not supposed to mix vials, and she was not familiar with diluting vaccines (all other clinics, vaccine was pre-drawn). Drug result: Unrelated.   No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning her 25 year old daughter who in September 2006, was vaccinated with her first dose of Gardasil, intramuscular injection in "gluteal region". There was no concomitant medication. In November 2006, the patient received her second dose of Gardasil, intramuscular injection in deltoid. On 08-MAR-2007, the patient received her third dose of Gardasil, intramuscular injection in deltoid. On 09-MAR-2007, the patient experienced tenderness at injection site, erythema at injection site, a raised lump size of quarter at injection site and scar at injection site which was described as the skin being discolored and having a different texture with underlying hardness. As of 02-APR-2007, the patient had not recovered. The product quality complaint unit was not involved. Additional information has been requested.