chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she cannot move; waking up in the middle of the night due to pain; hives popped up on the injection site; fatigue; headache; fever; 3 inches wheal on arm of injection site- allergic and inflamed; feeling unwell; mild transient side effects; scratchy throat; This spontaneous case was reported by a physician and describes the occurrence of ADVERSE EVENT (mild transient side effects), OROPHARYNGEAL DISCOMFORT (scratchy throat), HYPOKINESIA (she cannot move), MALAISE (feeling unwell) and PAIN (waking up in the middle of the night due to pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced ADVERSE EVENT (mild transient side effects), OROPHARYNGEAL DISCOMFORT (scratchy throat), MALAISE (feeling unwell), VACCINATION SITE REACTION (3 inches wheal on arm of injection site- allergic and inflamed), PYREXIA (fever) and HEADACHE (headache). On 07-Apr-2021, the patient experienced VACCINATION SITE URTICARIA (hives popped up on the injection site) and FATIGUE (fatigue). On an unknown date, the patient experienced HYPOKINESIA (she cannot move) and PAIN (waking up in the middle of the night due to pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CIMETIDINE (TAGAMET [CIMETIDINE]) at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT (mild transient side effects), OROPHARYNGEAL DISCOMFORT (scratchy throat), HYPOKINESIA (she cannot move), MALAISE (feeling unwell), PAIN (waking up in the middle of the night due to pain), VACCINATION SITE REACTION (3 inches wheal on arm of injection site- allergic and inflamed), VACCINATION SITE URTICARIA (hives popped up on the injection site), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown. Not Provided      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  use was reported.
Swollen lymph nodes in left armpit.  (Vaccine was given in right arm)
About 5 minutes after administration, patient fainted. He was caught by father & I. We layed on floor with feet up. Regained consciousness in 1 minute. After 10 min sat in chair. Remained for 30 minutes till felt good & then left.
High blood pressure, 12:00AM till 7:00 AM on 10/09/2016. Smelly, foul diarrhea several times on 10/10/2016 and 10/11/2016.  Both diarrhea and vomiting on 10/12/2016.  Slow recovery with diarrhea still ongoing on 10/13/2016 and 10/14/2016. Noticeable swelling and pain at injection site. Gas pains and indigestion 10/09/2016 through 10/14/2016.
Chills and nausea started without warning at 8 pm..............................by 6 am all symptom were done
about 45mins to 1 hr p/vax pt lifted from car seat was pale, limp looked @ mom but not moving or responsive; then had 2 episodes of screaming, tensing fists, staring off with unusual scream x 5-10seconds, limp x 1 min then repeat of stiff
1. Nose bleeds, first one was constant for almost a minute, had a couple more and then also while sleeping woke up as felt a running nose but was also a nose bleed. Never had a nose bleed before until after getting the covid vaccine.  2. Tiredness feeling exhausted all the time. 3. Hot flashes every day. 4. Shoulder pain both side also since getting the vaccine.
11:45 Lips tingling/burning, "feels warm".  BP 156/111, HR 101, O298%.  Left observation area at 12:10p.
8 days after vaccination, developed large red rash at injection site.  Very itchy.  Resolved 8 days later.
Day 1 (of vaccine) I was ok, but tired. Chills started overnight. Shaking profusely. After putting on blankets, which worked eventually, woke up overheating. Day 2:  Whole body aches and tiredness. Nausea and headaches. Didn't eat much. Kept taking naps all day. Coughing or sneezing would make my head pound. Ate a late afternoon soup lunch. Went back to bed. By evening 8pm, when I woke up, the all over body pain had dialed itself down from 80% to 20%. On way to bed, noticed left armpit lymph nodes were swollen. Day 3: lymph nodes still swollen and painful.  Taking day off work due to brain fog and feeling a low grade fever / loss of temperature regulation even though the thermometer is measuring lower than usual.
Increased arthritic pain in fingers but not in the finger joints; This is a spontaneous report received from a contactable consumer (patient) reported for himself. A 66-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6208, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 11Mar2021 at 15:00 pm age at vaccination was 66 years as dose 2, single for COVID-19 immunization. The patient's medical history included type II diabetes from an unknown date. Concomitant medication the patient received within 2 weeks of vaccination included VYVANSE taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 10Feb2021 at 14:30 pm age at vaccination was 66 years as dose 1, single for COVID-19 immunization. The patient previously took codeine and egg based flu shots and experienced known allergies to it. The facility where the most recent COVID-19 vaccine was administered was Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 12Mar2021 at 13:00 pm, the patient experienced increased arthritic pain in fingers but not in the finger joints. The patient received treatment with Advil for the event. The patient underwent lab test which included SARS-CoV-2 test negative on an unspecified date. The device date was reported as 08May2021. The outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
Swelling, hardness and redness way beyond the injection site as well as warmth to arm vaccine injected at with itchiness noticed at home 6-2-16 morning.
She got the vaccine, the next day she had a headache behind her ears, pain behind the ear to the back of her head.  On 3/26/21 she started having severe headache and sharp pains in her head behind her ear, started feeling heaviness in her chest.  On saturday also had heaviness in her chest, headaches.  On Sunday she could not breath and felt the heaviness in her chest.  Sunday night she had bad sore throat and could not swallow.  On Monday she could not swallow, coughing, heaviness in her chest.  On Monday night she went to the ER and they did a chest x-ray, neck x-ray and all her tests were ok.  She lost her voice on Monday, and hasn't had it back since then.  She is coughing up phlegm, but not much but still having the heaviness in her chest.  She was diagnosed with COVID.  They told her to drink a lot of tea and to hydrate.  She then went to a different facility and got monoclonal therapy.  She was throwing up Wednesday night and she is feeling better, her throat still hurts, she can swallow better, but is still hoarse.  Her headache went away yesterday.
Patient tested positive for COVID-19 about 2 weeks after receiving the 1st dose of COVID vaccine; Patient tested positive for COVID-19 about 2 weeks after receiving the 1st dose of COVID vaccine; This is a spontaneous report from a contactable consumer reported that a male patient of unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date, at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient is a health care worker who works with COVID patients as part of his daily work duties. He tested positive for COVID-19 about 2 weeks after receiving the 1st dose of BNT162B2. Outcome of the events was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
The first bought of COVID-19 was a sore throat, runny nose and heavy cold. This lasted for 3-4days and I started Paxlovid right away for 5 days. I was then feeling good and tested negative on the 18th. Then on the 23rd I started feeling sick again and running 102 high fever, tested and it was positive again. The fever lasted about 3 days. I had a sore throat and a cough and felt really bad and I took OTC; symptoms were 10 times worst than the first time. After about 4-5 days I started feeling better.
high frequency hearing loss; Developed a hissing in ears; This spontaneous case was reported by a physician and describes the occurrence of DEAFNESS (high frequency hearing loss) in a 72-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (high frequency hearing loss) (seriousness criterion medically significant) and TINNITUS (Developed a hissing in ears). At the time of the report, DEAFNESS (high frequency hearing loss) and TINNITUS (Developed a hissing in ears) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was stated that patient was double vaccinated and had booster. After the 2nd vaccine in February (unspecified year), developed a hissing in ears, and high frequency hearing loss. Patient saw an ENT. It was stated that patient made a decision about getting the 2nd booster dose the day after the date of report and said that data on booster was spotty. HCP asked if there was any MI on measuring immune memory or degree of cellular memory.  No concomitant product was provided. No treatment information was provided.  Company comment: This spontaneous case concerns a 72-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) event Deafness, on an unspecified date after the second dose of mRNA-1273. The patient experienced high frequency hearing loss and hissing in the ears. The patient saw an ENT, but details not reported. At the time of reporting the event outcome was unknown. Elderly age of the patient could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-533147 (Patient Link).; Sender's Comments: This spontaneous case concerns a 72-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) event Deafness, on an unspecified date after the second dose of mRNA-1273. The patient experienced high frequency hearing loss and hissing in the ears. The patient saw an ENT, but details not reported. At the time of reporting the event outcome was unknown. Elderly age of the patient could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Upon mixing the Shingrix, I accidentally reconstituted with sterile water and not the adjuvant.  I followed up with the clinical team and was told it needed to be redosed.  Pt received the redosed injection mixed with the adjuvant on 7/31/2019.  Pt did not present with any symptoms on this date.
Flushing of face and forearms, lasting a few minutes at a time. Occurring intermittently, up to 3-4 times per day
2 days later, pt had gross hematuria and flank pain Pt was seen in ER and worked up for a kidney stone. No kidney stone was seen. Pt seen after for follow up in my office and has no gross hematuria but some abd pain persists.
3 days later, lost hearing in right ear, began losing balance, by next morning, severe vertigo, vomiting, full right ear hearing loss.
8 days after the vaccine I noticed a rash around the injection site. The area is slightly raised and red, it is not itchy but feels a little tender to touch. It covers an area about the size of a larger bandaid.
Information has been received from a physician concerning a patient (age and gender unknown) with a history of mononucleosis who in June 2007, was vaccinated with a first dose of Gardasil.  Subsequently, between the first and second dose of Gardasil (second dose yet to be given) the patient developed mononucleosis.  It was also reported that there "no adverse symptoms."  The patient sought unspecified medical attention.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Information has been received from a physician "who heard from a colleague" that a female (age unknown), who was vaccinated with a dose of GARDASIL. Subsequently, a few days after receiving the vaccination the patient experienced a tingling in her leg and she had GUILLIAN BARRE Syndrome. The patient may have had other vaccines that day (unsure of which vaccines). At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Upon internal review GUILLIAN BARRE Syndrome was considered an important medical event. Additional information is not expected.
EXPIRED DRUG USED; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXA81EZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 22nd February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received expired a dose of Bexsero, which led to expired vaccine used.  The reporter would like to know if the patient needed to be revaccinated and what were the next steps.  He reported that, he did not have any patient demographic information or contact information and the patient had not experienced any adverse events.  Consent was obtained to contact reporter for follow up questions.
Local reaction with 2" induration/redness to DTAP(4th dose). No such reaction to prior doses.
One of my children went to get her first COVID-19 vaccine dose and my other two children went to get their second dose of the COVID vaccine. The following day we were informed by the pharmacist that they were all accidentally given the adult dosage instead of the pediatric dosage. Within a week of this my oldest has now been diagnosed with a kidney disorder Nephrotic Syndrome- most likely as a result of this.
Patient called and reported hives on skin beginning the day of the injection, followed by extreme arm soreness at injection site, and swelling of the tongue that developed the next day.
Started as taste sensation,,,,,,,,,,continued with flu like symptoms (body/nerve pain, fever (101.9) headache, stomach issues. Site inflammation.
The mother described slight difficulty breathing before bed. Gave cough syrup. Upon waking in the AM, Mother noticed puffy face, eyes and bilateral hands. The pt was given Benadryl. Saw MD and assessment was normal.
Patient experienced shingles; inflammatory arthritis; This spontaneous report was received from a consumer via GlaxoSmithKline concerning a female patient of unspecified age. The patient's medical history, concurrent conditions and concomitant medications were unknown by the reporter.   On an unspecified date, reported as 10 years prior to receiving varicella zoster vaccine rge (cho) (SHINGRIX), the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) for prophylaxis (dose, route of administration, injection anatomical location, lot # and expiration date were not reported).   On unknown dates, when the patient was around 81 to 82 years old, she received two doses of varicella zoster vaccine rge (cho) (SHINGRIX) (dose, route of administration, injection anatomical location, indication, lot # and expiration date were not reported).  On an unspecified date, when the patient was 84 years old, she experienced shingles (Herpes zoster). Also, on an unknown date, the patient had inflammatory arthritis (Arthritis) and received low dose prednisolone as treatment.   The outcome of the events, and causal relationship between the events and the suspect therapies was unknown.
Muscle spasms in upper extremities. Reported jerking movement of upper extremities.  Nausea  Fever Headache
Patient was administered with an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 69-year-old female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 22nd June 2022, the patient received Havrix. On 22nd June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. The action taken with Havrix was unknown. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-JUN-2022 Reporter's comment: Nurse reported that today(day of reporting) a patient was administered with an expired dose of Havrix. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Havrix which was already expired, which led to expired vaccine used.
On 7/4 patient developed a painful rash on his face, vaccine was given on 6/30/21. He has no history of rashes like this occurring.
Developed left sided facial droop and unsteady gait with speech slowing.  CT scan of the brain revealed an acute right basal ganglia stroke.
Pt recv vax on unspecified day; on 1/22/99 pt exp blisters on face
Immunocompromised given booster dose instead of 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised given booster dose instead of 3rd dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Immunocompromised (severely immunocompromised with rheumatoid arthritis).   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised given booster dose instead of 3rd dose). In November 2021, ACCIDENTAL UNDERDOSE (Immunocompromised given booster dose instead of 3rd dose) had resolved.            It was reported that the doctor recommended the patient to get a third dose but she got the booster dose in Nov 2021.  Concomitant medications reported included medications for rheumatoid arthritis.  No treatment medications were reported.   This case was linked to MOD-2022-455548 (Patient Link).
slight soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 07Apr2021 18:15 (Lot number: ER8729) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hair health" (unspecified if ongoing), notes: Hair health; "Eye health supplement" (unspecified if ongoing), notes: Eye health supplement; "Dietary supplement" (unspecified if ongoing), notes: Dietary supplement. Concomitant medication(s) included: NUTRAFOL taken for hair disorder, start date: Apr2021 (ongoing); PUMPKIN SEED OIL [CUCURBITA PEPO OIL] taken for malnutrition, start date: Jan2021 (ongoing); OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL] taken for eye disorder (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "slight soreness at injection site". Additional information: The first two doses: Slight soreness at injection site. 2nd dose had slight chills. No other issues. Took no conmeds or treatments for it. Booster: My reaction was quite different then 1st 2 doses, so thought I' d report Vaccination was in the morning and on empty stomach. Symptoms listed in AE section onset with fever and rigor(slight) on evening of 28Nov2021.Increaed intensity by next morning. Felt quite weak so stayed in be and slept most of day. Late night 28Nov2021-onset of body aches and increased sweating. Intensity increased by next morning. Sweated to pint that clothes were damp as  was bed. Fatigued from early AM on 29Nov2021 increasing intensity by mid day and subsiding to resolution on 30Nov2021. All subsided by early AM on 30Nov2021. Took regular meals and hydrated throughout. No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant concerning a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 05-APR-2018, the patient was concomitantly vaccinated with a dose of VARIVAX (lot # M023379 with expiration date of 01-MAY-2018), and with a dose of PROQUAD (lot # M042502 with expiration date of 17-APR-2018), for prophylaxis (dose, route of administration and anatomical location were not reported). No adverse effects reported.
After his third anthrax vaccine, given in his left triceps area on 4/12/03, he reports waking up the next am with redness, increased warmth and swelling from his shoulder to his elbow, almost the whole circumference of his upper arm. He repots that his skin was stretched tight causing significant discomfort. He called his unit for instruction and was referred to his local VA Medical Center on 4/14/03. (No records of visit available.) Patient reports that he was instructed to elevate his arm, apply ice to the affected area, and to take Ibuprofen. After 2 days, the redness, warmth and swelling began decreasing and was completely resolved within the next week. PFC also reports experiencing a mild headache, generalized muscle aches and fatigue during the first few days following receipt of his third anthrax vaccine. He denies any persistent systemic symptoms. Symptom : edema at injection site 50-120 mm Start: 4/13/2003. Symptom: erythema start: 4/13/2003 Comment: surrounding vaccine site. Symptom: Pain start: 4/13/2003 Comment: at vaccine site