chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from two pharmacists via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 09-MAY-2018, the patient was vaccinated with an expired dose of VAQTA (strength and dose were not reported) with lot # N005605 and expiration date of 08-APR-2018, intramuscularly for prophylaxis. No adverse effects were reported. This is one of two reports received  from  the same reporter.; Sender's Comments: US-009507513-1805USA006121:
Upper left arm retained fluid, was red in appearance and warm to touch. This occurred on inside of upper arm, not where the shot itself was given. Patient declined to seek treatment, said she could tell it was slowly improving when she notified pharmacy 2 days after vaccine was given.
10/18/07 and 12/30/07 RE: 10/18/07 pt-Had 2nd Gardasil vaccine & Flu shot at about 5:15 PM. When I called to schedule her 2nd Gardasil shot, I asked if she could also receive her Flu shot at the same time. I was told "sure, no problem". On 10/18-when they were getting things ready-they mentioned that when pt returns for her 3rd Gardasil vaccine, she should also received her 2nd chicken pox vaccine. When the nurse took the vaccine out of the refridgerator, she dropped it. She then said "Oh, that's not good". I don't know which of the two vaccine she dropped. My daughter was sitting in the chair, she received one shot in each arm. (I don't recall which one first, or which one in which arm). She remained seated for a minute or two, then she got up & I sat down to get my flu shot. Just as my shot was complete, I was putting my shirt sleeve back in order, I heard a bang. It was daughter-she had fallen back, hit the wall, and had gone down to the floor. Her eyes were rolling back & she went out. The nurses & I got her flat & then raised her feet up onto a chair. She was out for a short time...when she "came to" we removed her jacket. Her head, neck, and back hurt. They called for a Dr. to come check her out. They looked into her ears, and eyes. They told me to keep an eye on her, and that she maybe sore from hitting the wall & going down. She had never had anything like this happen to her before, so she was quite shaken up. Then on Sunday 12/30/07-she had been snowmobiling with her Dad through out the day, up at his cabin (which is three hours away from home). They had slept in, went out for breakfast. Rode during the day, and had stopped for pizza around 5 PM. The pizza was just about to come out of the oven, and while she was standing up, she suddenly told her dad that she felt dizzy. As quick as he stood up, she had gone down (Again). They got her up & put her in a chair...they got her some water to drink. There happened to be a nurse there, and she said no, give her Orange Juice, that'd be better. The nurse suggested that she go to the ER. So, they borrowed someone's car and went to Hospital ER. They drew blood tested urine and checked her out. They could not find any apparent reason for the fainting. I did request and receive the records from them.
MISSED THIRD DOSE; This spontaneous case (PVX2019-1347) report was received from a caregiver on 27-May-2019. It describes a male consumer who "missed third dose", while being on Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on Wednesday and the second dose on Friday, but he forgot to take the third dose which was due on Sunday.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed third dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed third dose" was considered as not applicable.
pt was given 0.2ml of the Pfizer adult covid 19 vaccine  dose rather than the pediatric  vaccine.  pt reported a sore arm
Irregular heart beat, significant increase in blood pressure. Treatment-now taking Amlodpine Besylate 2.5 mg/day for the high blood pressure. Monitoring and reporting blood pressure at least twice daily to cardiologist.
Vaccines were given at 10:30 AM. Pt woke up from her nap at 2:30 crying. She cried for 2 hours. Rt leg at injection site inflamed. No fever. Tylenol was given. Pt slept for 1/2 hour and was then herself again.  Mom continued Tylenol every 4 hours overnight.
suspected vaccination faliure; Shingles; Pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (ZOSTAVAX) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and ZOSTAVAX. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination faliure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were resolved (duration 3 months).   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-JUL-2023 This case was reported by a patient's wife via interactive digital media. The patient had a shingles vaccine, Zostavax, was not told you could still get shingles might be a mild case. The patient got shingles with a vengeance, they were so bad and they lasted 3 months with much pain. The reporter stated that did not get the shingles vaccine. It was unknown if the reporter considered the shingles and pain to be related to Zostavax. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Pt did not respond p/recvd Engerix-B; no other info is available @ this time;
Moderna covid-19 vaccine EUA. Fatigue, headache, muscle pain, chills,  nausea,  fever,  and dizziness.
neck, back & shoulder pain; neck, back & shoulder pain; neck, back & shoulder pain; headache; exhaustion; This is a spontaneous report from a contactable consumer. A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3247, expiry date not reported), via an unspecified route of administration on 20Jan2021 14:30 at a single dose in the left arm for covid-19 immunization. Medical history included arthritis, high cholesterol, high blood pressure, allergies to food (oats, corn, chocolate), and thyroid (thyroid disorder). The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included meloxicam (MOBIC), and other medications the patient received within 2 weeks of vaccination for blood pressure, thyroid, and cholesterol. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Jan2021 15:00, patient experienced neck, back and shoulder pain, headache, exhaustion, started 24 hr (hour) after vaccine and resolved in 12 hr (hour). The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). No treatments received in response to the events reported. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events neck, back and shoulder pain, headache, and exhaustion was recovered on 22Jan2021 02:00; reported as resolved in 12 hr.
3 cm diam. lump, redness at Dtap site R thigh 1 hr 20 min after injection, pt had itching at waist band vs wnl. SP02 98% room air. No fever. Benadryl 1 1/2 tsp given based on wt of 44 lbs at 4:10PM. Mom to rpt dose at 10PM.
9 days p/vax pt devel new fever;w/in 4 hrs of fever onset exp 1min tonic clonic sz w/postictal period;fever 102 w/sz, 104 soon after
Six months after receiving the second dose of Pfizer Covid vaccine, she contracted the flu. We had her tested and she tested positive for Influenza A. It really knocked her down and it took her a while to get over it. After she felt better, she was thirsty all the time. She was drinking a lot. We tested her blood sugar at home and the meters kept reading high. We took her to the emergency room and they tested her blood sugar there. Her blood sugar came back at 680. She was admitted that night and had to stay for 2-3 days. While there they stabilized her blood sugar and taught us how to manage her blood sugar and new diagnosis of Type 1 Diabetes and Hashimoto's disease. She was on a glucose monitor and now she has a pump. Overall, she is doing well adjusting to her new diagnosis.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Tachycardia-Severe, Additional Details: patient went to hospital after vaccine with racing heart, difficulty breathing, was told in ambulance that se has poor vital signs. on 09/16/2022 was complaining of still having continued shortness of breath and using albuterol inhaler. tried to reach on 09/17 to get an update, not able to reach patient.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration 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)) (batch no. 023C22A) 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 (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration 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 (20 Patients received Spikevax past the 30 day expiration date).    No concomitant medications were reported. No treatment information was provided. The case contains information of 11th patient out of 20 patients.
Raised red itchy rash that started on ankle then developed on back then developed all over body. Started  late September. Went to urgent care in October 2021 then went to a Dermatologist in Dec 2021. Had 2 biopsy to confirm eczema. No relief with prescribed creams. Then started injections of methotrexate in Feb and after 3rd dose started feeling better but rash is still apparent. Still following up with Dermatologist.
On 7/9/2021, the patient received her dose of Janssen COVID-19 vaccine a little after 0900AM. A couple of minutes after receiving the shot, the patient began to complain about dizziness. The patient was given some water which alleviate some of her symptoms  but she remained dizzy. Then the patient was given a lollipop after she stated she had not eaten breakfast and did not have any food allergies. Meanwhile, her vitals were taken: Blood pressure 143/90, respiratory rate 16 breaths/min, heart rate 68, and oxygen saturation 100% on room air. The site lead contacted emergency medical services - her symptoms progressively worsened - she was experiencing worse dizziness, chills, palpitations, and she felt tired. A second set of vitals were taken and her heart rate was 76 and oxygen saturation 100%. The emergency medical services arrived at the site and the patient was taken to the hospital.
Patient states that she noted soreness at the injection site and the underside of her arm immediately following the injection administration and continuing but improving through present. Patient also noted redness below the injection site and the underside of her arm in the am of 11/12/14.
Post vaccine, patient began having issues with nausea and itching & rash on stomach. Managed with medications.
Received phone call from client. She stated 'Flu like symptoms with temp 100.3 and vaginal bleeding." Client stated there was no way the bleeding was normal, was not due for menses, but was heavier than menses. This began on 8/25/21. Client did see her physician on 8/26/21 who told her bleeding was from the vaccine.  Stated bleeding has slowed some. Flu symptoms had resolved. Client has long term MS and takes ocrelizumab. Client will contact physician if bleeding continues, gets worse, or has other unusual symptoms. She wanted a VAERS submitted. She was told she could also submit a VAERS herself. She was enrolled in program for COVID-19 vaccination 1 & 2
Developed blister at or near injection site, blister burst, advised otc antibiotic ointment and contact primary care doctor
pt recvd vax; pt devel flu-like symptoms & a hypersensitivity reaction including arthritis, arthralgia, a fever, fatigue, abdominal cramping & nausea; pt devel also diarrhea & anorexia & exp'd persistent fatigue;
Dizziness.  Didn't seek medical treatment, but did take Meclizine at the beginning to help the dizziness.   Dizziness started on April 14th in the evening and was present on April 15th.  Again on April 16th in the evening and throughout the day on April 17th. Happened again on April 22nd and 23rd.  On the days the dizziness wasn't bad, I still felt that things were a little off in my system. I'm finally starting to feel normal again on April 25th. Hopefully the dizziness doesn't return.
1 of 4 children immunized w/DTAP over the last 2 wks (11JUL-22JUL) who exp a rash around inj site (raised/swollen: approx 1.5" diameter) Non of the children reported itching, fever or other systemic rxns; Rashes resolved w/in a few days
Gross hematuria 13 days after 2nd vaccine dose. . Dark blood in urine for 6 hours.   GP ran blood tests and CT scan with normal results. Referred to urologist. Urologist performed CT scan and cystoscopy with normal results.
Fatigue, headache, itchiness at injection sites start 20min after both shots. Three days post booster and flu injections, symptoms of severe vomiting, nausea, aches, chills, dizziness, low-grade fever, confusion. Six days post injections, fatigue, and dizziness persist with lack of appetite.
Itching, raised and warm whelts, started on injection arm and chest 6 hours after vaccine, 24 hours after whelts on stomach, back, shoulders, neck. Felt "fluish", feverish, sore throat, headache, achey, tired, little nauseous. Had Benadryl 25mg, 2 Tylenol x-strength in ER at 10:30 AM, then 50 mg Benadryl every 4-6 hours till next AM. Oct 9: felt better, little tired, went to work. 10/10/03: still having occasional hives popping up randomly in different areas.
24 hrs p/vax; pt became lethargic & affected arms was red to the elbow & hot to touch w/tenderness, nausea; facial puffiness-resolved w/no treatment;
Fingers felt stiff; Burning at injection site; Injection site red; Injection site itching; Lump in her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump in her arm), MUSCULOSKELETAL STIFFNESS (Fingers felt stiff), VACCINATION SITE PAIN (Burning at injection site), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PRURITUS (Injection site itching) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Thyroid disorder. Concurrent medical conditions included Allergy to antibiotic (Amoxicillin) and Sulfonamide allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), AMLODIPINE, METOPROLOL, ATORVASTATIN and ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE MASS (Lump in her arm). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Fingers felt stiff), VACCINATION SITE PAIN (Burning at injection site), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PRURITUS (Injection site itching). At the time of the report, VACCINATION SITE MASS (Lump in her arm) had resolved and MUSCULOSKELETAL STIFFNESS (Fingers felt stiff), VACCINATION SITE PAIN (Burning at injection site), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PRURITUS (Injection site itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants- Refresh for eyes No treatment was provided.   This case was linked to MOD-2021-281501 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Significant Follow-Up received on 10-AUG-2021. : Reporter contact information, patient demographics, historical condition, concomitant medicines, events reported and out come of the event lump in arm updated as recovered after 3 weeks.
redness / arm was bright red; light skinned; arm was bright red and bumpy like pustules all around; coughing; stuffy nose; sore throat; like breathing through a screen and feeing could not breathe deeper but was able but the message to her brain was she cannot breathe deep; Blood absorption was at 95% and now 98%; going to have a permanent scar where the injection was made/it is red, it is raised and it is bumpy; tightness in my chest; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2) formulation solution for injection, dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration at arm on 27Feb2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, she received the first dose of Covid vaccine on February 27 (not clarified) which was now eleven days ago, and it looks like she going to have a permanent scar where the injection was made and is that a known side effect?. Consumer asked received Pfizer 1st dose on 27FEB. Was light skinned and her arm was bright red and bumpy like pustules all around. Now little less red but very noticeable. Worried on getting the 2nd. Has also coughing which never had that before? Her Dr. Died a week before the vaccine so could not get his advice. Also developed stuffy nose, sore throat and like breathing through a screen and feeing could not breathe deeper but was able but the message to her brain was she cannot breathe deep. Her body temperature is well. Blood absorption was at 95% and now 98%. Can the Vaccine leave a permanent scar for light skinned people at the injection site?. When paraphrased the concern, consumer stated, she also had other problems. she feels like tightness in her chest, and she feel like she wants to cough, and these things did not exist before. Frequently asked questions do not do anything, she went to the website, and it was ridiculous, you can barely see what you are asking, and she finished the captcha like three, four or five times and it keep saying verification was expired even though it was the next second after getting the verification, so it was useless. She very upset because she asked in advance, would this cause a scar and it was red, it was raised, and it was bumpy and in addition to the tightness in the chest and feeling like coughing. Consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department limited information was available over the call as consumer hung up abruptly. Hence, product details (LOT#, expiration date, NDC#, and UPC #), purchase details and other details were unknown. Outcome of the events was unknown.    No follow-up attempts are possible. Information on lot/batch number cannot be obtained.
She did get covid vaccine 2-3 days ago and was having intermittent dizzy spells; This is a spontaneous report received from contactable reporter(s) other HCP and a contactable female consumer (patient).  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing). Concomitant medication(s) included: LETROZOLE; IBRANCE taken for breast cancer female, start date: 05Apr2021. The following information was reported: DIZZINESS (non-serious) with onset Apr2021, outcome "unknown", described as "She did get covid vaccine 2-3 days ago and was having intermittent dizzy spells".  Additional information: The dosage of drug Ibrance was decreased to current dosing from previous dose:125 mg 1 tablet daily 21 days, 7 days off. The patient reports her ibrance was lowered to 100 mg dose per md it is time to decrease. She did get covid vaccine 2-3 days ago and was having intermittent dizzy spells, md not aware.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe pain and swelling in the lymph nodes of the left armpit. Swelling in the area of the vaccine. The pain started on Friday night and today Monday continues. It has decreased in intensity but I am also having discomfort in the lymph nodes of the right arm and some discomfort in the breasts.
Generalized pustular rash on back/neck/arms and trunk.  Consistent with Erythema Multiforme
Started with a stiff neck turning to the right, then two days later woke up with a feeling of concussion syndrome, vertigo, head nausea, brain fog and then buzzing in both ears, this has been on going since the first vaccine, it got worse after the second vaccine on February 21st . I have had a brain MRI, and Neck MRI both appear normal, I have been checked by ENT for ear issues none noted, being treated by neurologist now for all the head symptoms
Patient was seen as new obstetrical patient on 9/13/07 USN done 9/7/07 intrauterine preg at 19 + 4 weeks gestation. Patient received vaccines on August 10, 2007 at 15 + 4 week gestation. Patient currently under 0B care with doctor. Follow-up Information 14-Sep-2007: Pt pregnant, unknown risk to unborn fetus.
Starting 7/10/17 after receiving shot patient reported swelling in the arm and pain in the arm, arm pit and down into breast. The injection site was red and hot to the touch. The patient had chills and thinks she probably had a fever. By the morning of 7/11/17 these symptoms started improving. As of 7/12/17 she still has some pain and redness in the arm but is feeling much better.
none covid 19 vaccine expired 11/22/2022 given 11/29/2022
Patient noticed swelling in left arm, from joint of shoulder extending to halfway down to elbow. First noticed symptoms in the middle of the night. It wasn't until she woke up in the morning that she realized it was swollen. She said initially there was warmth & itching but that had resolved by the time she called me late morning. She did not feel reaction was severe or required medical attention. I recommended diphenhydramine, ibuprofen and/or ice compress. She said she may apply ice but no medications.