chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 12 hours following administration pt noted fever- (not eval. by thermometer), and tenderness to site. Self-medicated with TYLENOL- 1/2tab. Awoke 4:30 am with fever "broken", sweaty. Noted redness to injection site of 3"x2". 3:00p - No further fever, or lethargy, redness remains but is resolving.
Syncopy, vasovagal reaction, laid patient down with feet raised and head down, took BP, cold compress to back of neck, offered water or juice and snack, waited for his BP to resume normal and HR normal.
On 2/28/00, the pt experienced irritability. On 2/29/00, the pt experienced chicken pox. Follow up data states the patients temperature was 99.3 degrees F. The patient recovered on 03/04/2000. No further information is available.
This spontaneous report was received from the registered medical office manager referring to an unknown number of patients of unknown age and gender. The patients medical histories and concurrent conditions were not reported. On unspecified dates in 2015, reported "since 24-JUN-2015", the patients were vaccinated with improperly stored doses of VAQTA (Lot# L001849, expiration date: 02-FEB-2017; L008665, expiration date: 10-FEB-2017) (dose and route of administration were not reported). Concomitant medications were not reported. No adverse effects reported. There was not a product quality involved. This is one of the several reports from the same source. Additional information has been requested.
Painful R arm; Back disorder; Nerve Pain; Arthritic Pains; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Painful R arm), BACK DISORDER (Back disorder), NEURALGIA (Nerve Pain) and ARTHRALGIA (Arthritic Pains) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    The patient's past medical history included Back disorder, Arthritic pains and Nerve pain.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Painful R arm), BACK DISORDER (Back disorder), NEURALGIA (Nerve Pain) and ARTHRALGIA (Arthritic Pains). The patient was treated with Physical therapy for Pain in extremity; Physical therapy for Back disorder; Physical therapy for Neuralgia and Physical therapy for Arthralgia. At the time of the report, PAIN IN EXTREMITY (Painful R arm), BACK DISORDER (Back disorder), NEURALGIA (Nerve Pain) and ARTHRALGIA (Arthritic Pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product reported.  Treatment includes Physical therapy on 15-apr-2021.
Pt w/hx of allergy to penicillin,trimethoprim-sulfamethoxazole (Bactrim),& nitrofurantoin-macrocrystals (Macrodantin) was vaccinated w/ HeptavaxB in 1986. Within 12 hrs of vaccination, the pt experienced rt arm  facial numbness, SEE WORM.
Fever of 102, muscle aches, severe headache, nausea, vomiting, severe fatigue starting 2 hours post injection and lasting 30 hours. Low grade fever, nausea, moderate headache, fatigue continued another 12 hours. Treated with Tylenol.
Sudden sharp pain deep within the right shoulder when moving it and shoulder weakness on day 1 post-vaccination. Saw a doctor two days after and they said the pain should go away. Saw another doctor over a month later and still had the deep sharp pain with certain movements and shoulder weakness.  Asked for a referral to a sports specialist. Was able to get in a month later and was diagnosed with rotator cuff injury from vaccine. Was given a cortisone shot and referred to physical therapy. Working on improving shoulder weakness at physical therapy currently.
This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th February 2019, less than a day after receiving SHINGRIX, the patient experienced injected limb mobility decreased. On 14th February 2019, the patient experienced muscle pain. In February 2019, the patient experienced itchy rash. On an unknown date, the patient experienced blotchy rash. The patient was treated with medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the injected limb mobility decreased and muscle pain were recovered/resolved and the outcome of the itchy rash was recovering/resolving and the outcome of the blotchy rash was unknown. It was unknown if the reporter considered the injected limb mobility decreased, muscle pain, itchy rash and blotchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient received her dose of SHINGRIX on an unknown arm and that evening her arm felt stiff at the injection site. The next day all her muscles were achy and that lasted a week. The second week after the injection, the patient developed a rash in a band around her arm that was very itching. The rash was improving, and was at the time of reporting a blotch instead of a band, but it was still very itchy. The patient saw her doctor and was advised to ice the rash. Emergency room visit required. The patient consented to follow up.
Skin itches mildly, repeatedly. Shoulders arms breasts back abdomen hurt.  Ibuprophen  is not helping enough.  Now, 34 hours after shot, I feel the worst so far. Headache., joints hurt, abdomen hurts, shoulders hurt, knee ache, back is  sore,  unable to sleep  due to  aches.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date during 2012, the patient was inoculated at a pharmacy with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 18-SEP-2014, the patient was treated for a blistering vesicular outbreak on her eyelids, which was diagnosed as herpes zoster dermatitis of the eyelid. On or about 17-OCT-2014, the patient sought subsequent treatment for a persistent ocular rash, which was diagnosed as anterior uveitis with elevated IOP (intraocular pressure) OS (left eye). On or about 18-NOV-2016, the patient sought further treatment at an eye center for worsening eye symptoms, which were diagnosed as zoster iridocyclitis OS, which affected the central opacity of the left eye which is secondary to herpes zoster. On or about the dates of 27-JAN-2017 and 17-FEB-2017, the patient received additional treatment at the eye center for ongoing zoster iridocyclitis secondary to zoster which had resulted in scar tissue that inhibited her vision. The patient was prescribed a year regimen of topical steroids to help heal her inflammation and irritation of her eyelid for the diagnosis of zoster iridocyclitis. The outcome of the herpes zoster dermatitis of the eyelid (shingles of the eyelid) and anterior uveitis/zoster iridocyclitis left eye was not recovered. The outcome of the other events is unknown. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Upon internal review, herpes zoster dermatitis of the eyelid and anterior uveitis/zoster iridocyclitis left eye were determined to be medically significant. Additional information has been requested.
Pt received Janssen COVID-19 vaccine, pt is 15yrs at the time of vaccination. No immediate adverse reaction noted, pt was monitored. Provided pt's mother copy of vax record for Janssen COVID-19 vaccine. Discussed with pt's mother the event including signs and symptoms to observe and instructed to contact primary provider and call 911 for severe reactions post-vaccination. Addressed pt and pt's mother's questions, both verbalized understanding.
This male subject was enrolled in the study 110870 (MenACWY-TT-057). On 27 August 2008, 22 October 2008 and 23 December 2008, he received the 1st, 2nd and 3rd dose of combined (Hib-MenCY-TT, IM L thigh) and (PEDIARIX, IM right thigh). On 22 December 2008, 61 days after the 2nd dose of PEDIARIX, 61 days after the 2nd dose of Hib-MenCY-TT, this six-month-old subject developed broncholitis. On 08 January 2009, 16 days after the 3rd dose of PEDIARIX and Hib-MenCY-TT, he developed dehydration. The subject was hospitalised. The events were unresolved at the time of reporting. The investigator considered that there was a reasonable possibility that the bronchiolitis may have been caused by PEDIARIX and Hib-MenCY-TT and that the events were possibly due to viral infection. The investigator considered that there was no reasonable possibility that the dehydration may have been caused by PEDIARIX and Hib-MenCY-TT. Relevant risk factors: sibling with asthma. Investigator comments: On 1/5/09 subject presented with 2 week history of cough, diagnosed with bronchiolitis and treated with ALBUTEROL. The subject returned on 1/7/09 with worsening symptoms and fever and was diagnosed with OM, brronchiolitis and treated with OMNICEF antibiotic and ORAPRED. Returned to clinic on 1/9/09, unable to keep his meds down and became dehydrated. Hospitalized for  for management of bronchiolitis and dehydration.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 04-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown demographics. On 16-FEB-2015, the patient received the second dose of MMR II. The nurse reported that on 16-NOV-2015, the patient was inadvertently administered a third dose of MMR II. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Pt received 1st dose of COVID-19 Moderna vaccine at 1:15 PM. While waiting in observation, pt got up to go to restroom at 1:35 pm and fainted. No injury noted. Pt assisted to sitting while in the restroom area, alert and talking. Upon assisting pt to standing, pt fainted a second time in the hallway. Assisted to wheelchair, noted to be diaphorectic  but alert and talking. Taken by wheelchair to ER with mother accompanying. Mother reports that the patient had a phobia of needles as a child and has done this before. Call to dad later that evening when unable to reach pt by phone. Dad reports that pt was released without incident. Diagnosed with syncopal episode.
pain, redness or swelling at the injection site, tiredness, headache, muscle pain, chills, low grade fever and nausea.
Aches; Lingering headache; Have a fever which was up and down up to 100.3F / went away and came back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), PYREXIA (Have a fever which was up and down up to 100.3F / went away and came back) and HEADACHE (Lingering headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PYREXIA (Have a fever which was up and down up to 100.3F / went away and came back). On an unknown date, the patient experienced PAIN (Aches) and HEADACHE (Lingering headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (Aches), PYREXIA (Have a fever which was up and down up to 100.3F / went away and came back) and HEADACHE (Lingering headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Contains non-significant information.
Systemic: patient expressed that blood work at doctor indicated incresed C4 levels in her blood-Mild, Systemic: Joint Pain-Medium, Additional Details: patient has expressed moderate pain in her hands
54-year-old female who presents with nausea and vomiting since yesterday as well as a fever as high as 102° with generalized abdominal discomfort to palpation which is non-peritoneal. Vital signs reviewed on presentation to the ED and patient had a mild fever but no other significant findings were noted. Physical examination obese with mild diffuse abdominal tenderness. Otherwise she was on her home O2 requirement of 3 L saturating well with no other significant abnormalities. In light of patient's symptoms full cardiac workup was obtained including CBC, BMP, troponins, urinalysis, hepatic profile and chest x-ray. Patient was also ordered a CT of her abdomen and pelvis to rule out any intra-abdominal pathology. Patient was given Zofran and IV fluids which she tolerated well. Laboratory results show an unremarkable CBC and BMP, hepatic profile showed no acute findings urinalysis. Chest x-ray showed some mild atelectasis and her CT of her abdomen and pelvis was noncontributory. She was noted to be positive for Covid. She is a vaccinated individual. I had an extensive discussion with the patient upon her findings. She did state she was no longer nauseous and will discharge her with a short course of Zofran for her to follow up with her primary doctor gastroenterologist after quarantine period. Patient verbalized understanding of her discussion agreed for close follow-up with her primary doctor after quarantine. We will give her pulse ox on discharge as well as; body infusion referral. Patient verbalized nursing discussion agreed for close follow-up verbalized understanding of return precautions.
Approximately 36 hours after injection parent noticed redness at injection site. Presented at clinic 48 hours after injection with area of redness, raised in right deltoid area approximately 70 mm X 55 mm. Temp 97.4 (ax).
Pfizer / BioNTech / COVID-19 Treatment; Pfizer / BioNTech / COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EL 1284), in left arm, on 05Feb2021 as dose 2, single (Lot number: EL 9264), in left arm, on 18Aug2021 as dose 3 (booster) single (Lot number: FA 7484) and on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing), notes: Diabetes (T1D). There were no concomitant medications. Past drug history included: Augmentin, reaction(s): "known allergies Augmentin". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset May2022, outcome "unknown" and all described as "Pfizer / BioNTech / COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid test approximately 8 days after completing Paxlovid; Unknown results. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Addition information: Return of minor Covid symptoms and positive Covid test approximately 8 days after completing Paxlovid. Start date of treatment for COVID-19 was 31Jun2022. Stop date of treatment for COVID-19 was 05Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The day after the shot, I developed noticeable upper air pain/redness/swelling, but I had been told this might be a side effect.  I also developed incredible fatigue - went to bed directly after the shot and was noticeably tired for 2-3 days after.  I recovered and went on with life. On Sunday 4/11, however, my L upper arm came up with an extremely hot/itchy/swollen rash AGAIN.  This is 4 days with no relief.  It is red to the width and length of my hand (think a hand-sized mosquito bite) and now, 4/15, there is a small, less-red area in the middle (rash looks like a bulls-eye).
Fever, Chills, Myalgias x 24 hours Intermittent shortness of breath
This spontaneous report as received from a nurse refers to a male patient of unknown age who in January 2012 was vaccinated with the first dose 0.5 ml of GARDASIL intramuscularly (lot number not provided). In November 2012, the patient received of second dose of GARDASIL (dose, route, lot number was not provided) and 06-FEB-2013, the patient received of third dose of GARDASIL (dose, route, lot number was not provided). No adverse event experienced. Additional information has been requested.
A few days after taken the vaccine are became swollen with a big knot under it and turning red
pt passed  out and fell to floor.  eyes were open but confused. sat him up and he seemed ok
Exceedingly bad headache and fever of 102 for 2 days following vaccination. After fever subsided, headache also subsided for several days, but then returned five days later. Headache has become recurrent and persistent since that time. This is lasted three months. The headaches are now chronic and they do not respond to typical pain medication such as ibuprofen. The headaches started at the time of the second shot, and are almost daily.
After receiving the vaccine my period became very irregular.  I was having it every 2 weeks for 4-5 days at a time.
The patient did not experience any adverse reactions; however, an additional dose of the Pfizer Bivalent Booster was given as he did not report that he received a Bivalent Booster on 10/3/2022 until a couple hours post vaccination.
Bell's palsy; nervous system was attacked; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lymphoma.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant) and NERVOUS SYSTEM INJURY (nervous system was attacked). At the time of the report, BELL'S PALSY (Bell's palsy) and NERVOUS SYSTEM INJURY (nervous system was attacked) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment: This spontaneous case concerns a 75-year-old, male patient with relevant medical history of Lymphoma, who experienced the expected AESI of Bell's palsy and the unexpected, non-serious event of nervous system injury following administration of the second dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. The patient was diagnosed with Bell's Palsy and reported that his nervous system was attacked. No further details were provided. The rechallenge was not applicable as no additional dosing will be given. The medical history of Lymphoma, which can mimick Bell's Palsy, remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.; Sender's Comments: This spontaneous case concerns a 75-year-old, male patient with relevant medical history of Lymphoma, who experienced the expected AESI of Bell's palsy and the unexpected, non-serious event of nervous system injury following administration of the second dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. The patient was diagnosed with Bell's Palsy and reported that his nervous system was attacked. No further details were provided. The rechallenge was not applicable as no additional dosing will be given. The medical history of Lymphoma, which can mimick Bell's Palsy, remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.
Felt very flushed, all-over red- took two Benadryl@ 08:20-  Through the day my lips and tongue were becoming increasingly numb- I was not short of breath, but maybe felt slightly tight- used my albuterol MDI three times between 0820 and 1600 2 puffs each time
My daughter received a Tdap and Meningococcal boosters. She immediately started having severe headaches and body aches that lasted about 2 months off and on. Feb. 1st she was diagnosed with Type 1 diabetes.
Mother called clinic, stated daughter began to feel "achy and had a headache while at school" went home crying because of discomfort. Had fever overnight temp 103 per report and still feeling the same symptoms day of report 9/26/2012. Patient also recieved Menactra MCV4, Influenza IM Fluzone, pres free, and HPV Gardisil (second dose) immunizations during this visit.
Cellulitis right leg 6cm x 5cm, Keflex 250 mg 1 tsp TID x 10d.
PATIENT RECEIVED VACCINE AT Pharmacy. CAME TO CLINIC WITH RASH UNDER ARMS. LESIONS UNILATERAL TO AFFECTED AREA, CAUSING PAIN ALONG THE NERVE ROOT. VALTREX 1 GRAM TABS THREE TIMES A DAY FOR SEVEN DAYS. IBUPROFEN 800 MG THREE TIMES A DAY FOR FIFTEEN DAYS. FOLLOW UP IN ONE WEEK. PHARMACIST GAVE LOT AS B334Y EXPIRATION 10/17/20. DILUTENT LOT D3L5G EX 11/29/20
was tested for COVID and she tested positive for the virus; was tested for COVID and she tested positive for the virus; This is a spontaneous report from a contactable consumer.  An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization.  Medical history included cancer, she had her stomach or whatever operated on.  The patient's concomitant medications were not reported.  The patient was tested for covid and she tested positive for the virus on 24Jan2021, she felt terrible, but she was still just in her home, with like a plastic covering over her door. She was instructed to just take paracetamol (TYLENOL) and Zinc. The outcome of the events was unknown. Information on lot number/batch number has been requested.