chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Jynneos and the punctured vial was left at room temperature; Case reference number US-BN-2022-002002 is a spontaneous case report initially received on 22-Aug-2022 from other health care professional from via agency (reference number: USBAV22-1114) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown), at an unknown dose or route of administration, for unknown indication.   It was reported that the punctured vial was left for two hours at room temperature and that only one patient received a dose before excursion (explicitly coded as 'underdose').  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received on 22-Aug-2022 from Bavarian Nordic included local BN case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with the first dose of Jynneos vaccine, at an unknown dose or route of administration, for unknown indication however it was reported that the punctured vial was left for two hours at room temperature and that only one patient received a dose before excursion which is considered as underdose. Underodose is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the first dose of Jynneos vaccine, at an unknown dose or route of administration, for unknown indication however it was reported that the punctured vial was left for two hours at room temperature and that only one patient received a dose before excursion which is considered as underdose. Underodose is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
After flu vac, walked and got into my to car. Suddenly breathing felt tight,face flushed and then SEVERE low back spasm. Unable to move for 5 minutes, then opened windows for air and to call for help. After another 5 min, back pain subsided enough to drive  and completely subsided after 15min.
Mother reports fever began 2 days after receiving vaccines temp reported to be 100 -101. Associated with headache. No other symptoms. Took ADVIL 400mg, po.
I?ve been breaking out in hives every 2-3 days. The original rash is still here a month later but now it?s gray.
This spontaneous report as received from a other health professional refers to a 24 year old patient.    On an unknown date the patient was vaccinated with GARDASIL 9 dose 3, 1 DF for prophylaxis. On an unknown date the patient experienced inappropriate schedule of drug administration and no adverse event. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to GARDASIL 9.
This spontaneous report as received from a pharmacy student refers to a 77 year old male patient. The patient's pertinent medical history, drug reactions and allergies were not reported. On 24-NOV-2015, the patient was vaccinated with 0.5 ml dose of (Oka/Merck) VARIVAX injection, lot # K003411, expiry date 06-MAR-2016, subcutaneously instead of ZOSTAVAX. No concomitant therapies were reported. No adverse effects were reported. Additional information is not expected as the reporter did not wish to be contacted.
Vaccinated on 10/22/10 4:30pm, on 10/27/10 patient returned. Displayed quarter size yellowish bruise on R shoulder with 18 pin sized scabs running linearly thru bruised area in a vertical line. Patient had no apparent redness or swelling at site. Patient states area is tender. Has felt lethargic for several days.
9-10 hours after injection became feverish, chills, migraine headache, muscle aches, dizzy.  Swollen and painful at injection site on arm.   Over next 36 hours fever was between 100-102. Nausea began 48 hours after injection.  It is now Tuesday, almost 4 days since injection and am still dizzy and weak.  Fever stopped yesterday and only light headache today.   My husband also had all my symptoms except a much lower fever.  We are wondering if we could have got a bad batch???  They said to expect 1-2 days of mild discomfort.  This was like the worst flu I've ever had.
Redness & hives-like swelling at and around injection site (L) deltoid developed within 10 min. of receiving injection. Dr. was notified and examined child. Ordered BENADRYL 2 tsp. Parent instructed to apply ice and repeat BENADRYL in am if swelling present. Father called 1-4-11 -> reaction resolved; no further problems.
Itching, burning, pimple like rash on right side of face. Continued to spread along with pain, tingling and some numbness. Headache and some nausea. Ear pain.
began screaming in high-pitch manner 1/2 hrs p/shot was administered; pt ran a high temp & screamed all noc was stiff w/pain; leg was huge & hot @ site; hasn't been right since; chemical imbalances; OCD, TS poss sensory integration prob
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date the patient was intramuscularly vaccinated with PNEUMOVAX 23 (dosage schedule was not reported) which had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included keratosis. On 9th May 2018, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced injection site pain, general body pain, injection site erythema and rash. On an unknown date, the outcome of the injection site pain, general body pain, injection site erythema and rash were recovered/resolved. It was unknown if the reporter considered the injection site pain, general body pain, injection site erythema and rash to be related to Shingles vaccine. Additional details were provided as follows: The patient received 1st dose of Shingles vaccine in left arm. The patient had redness, soreness at the injection, general aches, rash. She also had a prior condition of benign keratosis with spots all over her body. For tolerance after 2nd dose, refer case US2018GSK149529.
A spontaneous report has been received from Medical Rep concerning 14 year old, female subject. Patient relevant history, concurrent diseased and concomitant drugs were not provided. Patient has been receiving nasal FLUMIST Quadrivalent started on an unknown date. The reporter stated that the patient experienced got the flu which started on 13-DEC-2014. The outcome of the event of got the flu was unknown. The reporter assessed the event of got the flu to be non serious.
Body aches, headache, fever of 100.5, soreness in entire upper arm (of arm injected).
At 12 noon Dizzy, drowsiness, nauseous, all left side lymph nodes became swollen, sore throat, Lasted for several weeks.
Pt's arm was red and swollen from Deltoid down to elbow. Pt used Cortizone Cream which she stated helped.
Patient began with watering eyes and faint rash 12:20. After 5 min rash was more intense, raised with warmth to touch (T=97.5 AX) more rash, vomiting and wheezing (Epinephrine, Benadryl)
This spontaneous report was received from a Registered Nurse and refers to a female nurse of unknown age. The patient's medical history, concurrent conditions or drug reactions were not reported. It was reported that the nurse, attempted to withdraw a PNEUMOVAX 23 vial into a syringe. Due to vacuum pressure, the liquid "squirted" out where the needle was inserted. The liquid did get on the patient's hands, however she was wearing gloves at the time of the event. No adverse events were reported. Product quality complaint was filed. Additional information has been requested.
This case was considered medically important (OMIC). Information regarding Hib-Titer vaccine was received from a consumer regarding a 3 year old male patient who received a dose on 7/10/00 and 9/15/00. The child also received a dose of Acel-Imune on 6/23/00 and 8/26/00 and other concomitant vaccines on 4/19/00, 5/8/00, and 7/17/00, and experienced mood swings, temper tantrums, irritability, extreme tiredness and heavy metal toxicity. Relevant medical history was not provided. Indication for Hib-Titer vaccine was immunization. Product was administered on 7/10/00 and 9/15/00. Dose regimen was one dose (IM). Additional suspect vaccines included Acel-Imune vaccine administered on 8/26/00 and 6/23/00, Act-HIB administered on 5/8/00, Infanrix administered on 8/19/00 and Poliomyelitis vaccine inactivated administered on 5/8/00 and 7/17/00. Concomitant medications were not reported. A consumer, the mother of a 3 year old male patient, reported that her son received a dose of Hib-Titer on 7/10/00 and 9/15/00. The child also received a dose of Acel-Imune on 6/23/00 and 8/26/00 and other concomitant vaccines on 4/19/00, 5/8/00, and 7/17/00. The reporter stated, her son was diagnosed with heavy metal toxicity in 2003. She also stated, that when her son was around 12 months old, he began having mood swings, temper tantrums, irritability, and was always extremely tired. She stopped vaccinating her child at 10 months. The reporter indicated that her child has not recovered and declined to grant permission for follow up investigation with her pediatrician. No additional information was available at the time of this report.
Pt came in for the pfizer covid bivalent booster and the pfizer covid monovalent vaccine was administered inadvertently.
48 hours after first dose I started with swollen sore, glands followed by a week of cold sores and blisters in my mouth. I also had swollen, painful, bleeding gums.; 48 hours after first dose I started with swollen sore, glands followed by a week of cold sores and blisters in my mouth. I also had swollen, painful, bleeding gums.; 48 hours after first dose I started with swollen sore, glands followed by a week of cold sores and blisters in my mouth. I also had swollen, painful, bleeding gums.; 48 hours after first dose I started with swollen sore, glands followed by a week of cold sores and blisters in my mouth. I also had swollen, painful, bleeding gums.; 48 hours after first dose I started with swollen sore, glands followed by a week of cold sores and blisters in my mouth. I also had swollen, painful, bleeding gums.; 48 hours after first dose I started with swollen sore, glands followed by a week of cold sores and blisters in my mouth. I also had swollen, painful, bleeding gums.; 48 hours after first dose I started with swollen sore, glands followed by a week of cold sores and blisters in my mouth. I also had swollen, painful, bleeding gums.; 48 hours after first dose I started with swollen sore, glands followed by a week of cold sores and blisters in my mouth. I also had swollen, painful, bleeding gums.; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for self that the 54-year-old patient of unknown gender received first dose of bnt162b2 (BNT162B2), via Intramuscular on 22Dec2020 05:00 PM on Left arm at a single dose for covid-19 immunisation. Medical history included Known allergies: Zithromax. No other vaccine in four weeks. Concomitant medication included in two weeks sertraline hydrochloride (ZOLOFT). The patient reported "48 hours after first dose I started with swollen sore, glands followed by a week of cold sores and blisters in my mouth. I also had swollen, painful, bleeding gums. I have never had any of these symptoms at any other time in my life". The events started from 24Dec2020 07:00 PM. The outcome of the events was recovered. No treatment was received. No COVID prior vaccination.  COVID tested post vaccination: covid test type post vaccination was Nasal Swab on 09Jan2021 with covid test result of Negative.  Information on the Lot/Batch Number has been requested.
Approximatley five hours after injection eyes became very red and swollen. The developed facial swelling. Symptoms subsided with Benadryl and Patanol drops
Have shingles, I got the shingles vx/ Suspected vaccination failure; Think I have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of (suspected) vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had shingles but got the Shingles vaccine at least 4 years ago of reporting. The patient asked could he/she still get shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Pt with abd pain and bloody diarrhea after imm and admitted to hosp with above as well as vomiting.
Sweating; Very sore arm; Nausea; Constant headache; Freezing with chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Very sore arm), NAUSEA (Nausea), HEADACHE (Constant headache) and CHILLS (Freezing with chills) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 040B71A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Very sore arm), NAUSEA (Nausea), HEADACHE (Constant headache) and CHILLS (Freezing with chills). The patient was treated with MEFENAMIC ACID (ADVIL [MEFENAMIC ACID]) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Very sore arm), NAUSEA (Nausea), HEADACHE (Constant headache) and CHILLS (Freezing with chills) outcome was unknown.            The concomitant medications were not provided.   The action taken with mRNA 1273 with the events was considered as not applicable.
Felt dizzy 10-15 minutes right after the shot, but managed to drive home. High fever at night with chills, body ache, headache, abdominal pain, ear pain, arm pain, burning eyes and hot flash. Fever didn't go away unitl 7/12 evening, chills were gone but all other symptoms stay. Since 7/8, also developed painful sore throat and canker sore on tongue. Dizziness is constant since day (7/7). On 7/14, had sudden increased dizziness, scalp twitching/headche, ring in left ear and sharp ear pain from right ear, right face hot to touch, almost fainted. Saw Internal doctor on 7/15, was diagnosed as Vestibular Neuronitis. Til today, I have constant dizziness, headache with scalp twitching, ear pain and right face hot to touch.
Woke up on the morning of 4/18/21  with difficulty taking a deep breathe withourt experiencing pain in my lower right back.  All day I rested and increased my water intake. Applied a heating pad to reduce the pain.  No relief the next day, so after work I went into the urgent care clinic to see what the problem was.
Headache on only the left side of the head - treated with Advil 200 mg 4X daily.  Lasted 11 days and was worse late in the day.   Fatigue and weakness for 48 hours.
3 minutes after admini, patient exhibited redness and warmth at face, arms, chest. Blood pressure measured at 1:45pm was 145/69 pulse 82. Patient reports having normal/low usual BP.  1:49pm BP 123/62 pulse 68. 1:54pm BP 123/68 pulse 67. Paramedics came to assess patient at 1:56pm.  Paramedics cleared and released patient at 2:05pm.
08/04/2017 Extreme fatigue, severe headache, moments of blurry vision, ocular photosensitivity, sore throat and right inner ear pain, red spot on roof of mouth. Too painful to walk barefoot and awake to swollen finger joint pain, no energy at all. 08/11/2017 behind ear pain and neck pain, pink skin turned into papular rash on right side of neck below right ear, chills, rash was painful rather with moments of itchiness, continued to spread even with benedryl - treated as possible eczema but no history of eczema. Fatigue, headaches and joint pain continuing, maybe a virus? or a flu? 08/20/2017 rash turned vesicular and continued to spread on neck and behind ear, spot on mouth turning white. 08/23/2017 rash spread so far up under jaw and up into scalp behind right ear went to clinic, diagnosed with shingles and started Valtrex 08/27/2017 vesicular rash dried up and almost gone, severe neck and chest pain at night. 08/28/2017 woke up to weeping sore on neck and new red spots on right ear and down by collar bone and chest; went to PCP who cultured fluid and treated as a dermatitis. Rx doxycylcine and steroid cream and off work until 08/31/2017. 08/31/2017 neck rash cleared up but new red spots on chest are growing. Saw different MD in PCP practice - who believed vesicular rash is reaction to MMR, possible allergic reaction or mild form of measles. cultured rash for measles but not very much fluid 09/01/2017 Rash continuing to spread across center of chest between breasts, more fluid in vesicles 09/02/2017 Vesicles scabbing over, redder skin.
Post vax, pt experienced fatigue, collapse, and could not walk. Dx with acute arthritis. Rushed by ambulance to hospital. She still has acute pain in her joints. 60 day follow-up states the pt has an autoimmune Lyme arthritis. Cannot work, has severe joint and muscle pain, severe fatigue and arthritis throughout body, joint swelling and stiffness. The pt also has concentration difficulties. The annual follow-up states joint pain (disabling); muscle pain; joint swelling.  Follow up on 02/07/2003: "The most recent information, received on 01/23/2003, did not provide the outcomes of the reported events.  Information received on 11/01/2002 indicated that, as of 09/30/2002, the autoimmune arthropathy persisted and the most recent urinary tract infection was resolving.  The outcomes of the other reported events were not provided.  Information received on 11/21/2001 indicated that the subject was unable to work due to "Vaccine induced autoimmune Lyme arthritis".  Therefore, this event was considered disabling, and this report was reclassified as serious, unexpected."
Chills, muscle aches and pain, headache, stomach cramps/upset stomach . Went away with Tylenol.  Lasted about 12 hours
Narrative: 39 yo male patient on ponatinib x ~ 1 yr for chronic lymphoid leukemia, reports that 48 hrs after his COVID # 3 shot (8Sep2021), that he had SEVERE b/l intermittent muscle aches lasting a few  seconds then resolving spontaneously, that sometimes were so bad that they interfered w/ his ability to sleep. The myopathies are still present 3 months after COVID #3 shot, but improving somewhat.
Headache, Myalgia, Arthralgia, Rash, chills. Onset 6 hours post-vaccination, persisted for several days, slowly improving. Narrative:  Other Relevant History:
racing heartbeat; This is a spontaneous report from a contactable consumer via Medical information team. A female patient of an unspecified age (reported as age: 55, unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient died a few days later after getting vaccinated from a racing heartbeat. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information about batch/lot number has been requested.; Reported Cause(s) of Death: racing heartbeat
Patient was crying hard, then seemed to hold her breath, mom sat her up, her face was blue and she was floppy; she was quickly stimulated and 'came to' within 1-2 seconds.  She seemed to have a vasovagal response to holding her breath.
Was supposed to received a 3rd full dose but received only half dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Was supposed to received a 3rd full dose but received only half dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CERTOLIZUMAB PEGOL (CIMZIA) for an unknown indication.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced ACCIDENTAL UNDERDOSE (Was supposed to received a 3rd full dose but received only half dose). In November 2021, ACCIDENTAL UNDERDOSE (Was supposed to received a 3rd full dose but received only half dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was provided by the reporter. No treatment drugs were reported. Pharmacist stated there were no adverse event to report.
Received the vaccine on December 29, 2020.  On Saturday, January, 2, 2021, the patient started itching in her bilateral breast area.  Did not look to see if there was a rash at that time.  On Tuesday, January 5, 2021, the patient was getting ready for work in the morning and her bilateral breasts started itching again.  She looked down and noticed that she had a long red rash across her medial breasts.  She applied a topical cream to the affected area and she states that the itching has improved.
Extreme joint pain lasting 4 days, fatigue and arm pain with painful lump for 6 days
Developed shingles in the distribution of nerve root that encompassed the injection site within 1 mo of ZOSTAVAX admin..
Pt got shot ADACEL on 9/6/12. She comes back today 9/8/16 with redness swollen arm 4x4 inches size of reaction. Pt is looking for advice. I advice her to go urgent care.