chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's conditions and medical history were not reported. On 09-JUN-2016, the patient was vaccinated with VAQTA "10Pk 25U/0.5 ml SD LLok w Cap Ped", lot # L030442 with expiration date 19-DEC-2016, which was stored at -0.5 Celsius Degrees for 72 hours and at 1.11 Celsius Degrees for 384 hours. The type of excursion was refrigerator and the vaccine status was reported as "in excursion". There were no concomitant medications and adverse effects reported. No product quality complain was involved. This is one of several cases from the same reporter. Additional information has been requested.
numberless shoulder/extends numbness left leg weak when stood( felt numb)/numbness; This is a spontaneous report from a contactable consumer. A 49-year-old female patient (not pregnant) received bnt162b2 (BNT162B2, also reported as Pfizer-BioNTech COVID-19), via an unspecified route of administration on 18Dec2020 13:15, single dose (dose number 1) in left arm, for immunization. Medical history included allergies to food, perfumes, fragrance, smoke and residual odor. Other medical history includes asthma, OSA (obstructive sleep apnea), borderline DM, anxiety and depression. The patient previously took VICODIN and had drug hypersensitivity.  She had no other vaccines in four weeks but had other medications (unspecified) in two weeks. The patient reported that on 18Dec2020 at 13:30 she experienced left arm lateral numberless shoulder- last 3 finger, extended numb to pointer finger, extends numbness shoulder up left neck to lips midpoint the complete lips extended to right side of face and neck and then to right temporal, ear and down to clavicle; left leg weak when stood( felt numb). She developed asthma exacerbation by 0900 and started to resolve in ER. About 0018 numbness now in lips, around lips, tongue, and starting down neck. Treatment for the event were Epinephrine IM, Benadryl, Dexamethasone, ab. She also had CXR (chest x-ray), no results reported. The outcome of events was recovered with Sequel.   Information on the lot/batch number has been requested.
Since first vaccine, on 12/22, noted bilateral axillary lymphadenopathy. Had 2nd dose on 1/11/2021. On 2/11, pt called with persistent bilateral lympadenopathy without any improvement. Has not taken any medications for it. Non tender.
Myalgia & SkinRash patient seen in employee health with swelling and pain in the right deltoid that stated one day after immunization(2nd dose). Erethema and swelling present . Give ice and tylenol and ibuprofen. Followup 24 hrs later patient reported improving symptoms
Bell's palsy symptoms; A spontaneous report was received from a consumer concerning a 84-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy symptoms.    The patient's medical history was not provided. Concomitant products included losartan and amlodipine for drug use for unknown indication.  On 11 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 015M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 11 Mar 2021, the patient received his second dose of two planned doses of mRNA-1273 (lot number: 026A21A) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection.   On 15 Mar 2021, the patient experienced Bell's palsy symptoms (important medical event term).  Patient did not take anything to treat symptoms.   Action taken with mRNA-1273 in response to the event was not applicable.    The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Starting the afternoon of 1/14/21 patient stated the injection site started to feel itchy. When she looked in the mirror, there was an area of bright pink surrounding injection site. She reports the site felt swollen and she could not tell if it was warmer than her other shoulder. Early on the morning of 1/15/21, patient reports the area around injection site was bright pink and remained swollen. At this time it is less itchy, but remains lightly itchy intermittently. At 9am on 1/15/21, RN visited patient and was informed of her reaction. RN observed her L upper arm and she has an oval-shaped light pink area with injection site at the center. Oval measures 8.8 cm x 6.1 cm. The site is warm, slightly swollen, and feels indurated from the swelling. Patient is afebrile at 97.4 orally. Patient reports the light pink coloring at this time is less bright than it was earlier in the morning. Report is being made at 10 am 1/15 so outcome of reaction unknown at this time.
BAD SIDE EFFECTS FOR ABOUT A WEEK; NO STOMACH PAIN AT ALL; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: stomach ulcers. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included omeprazole for pain and issue.  On an unspecified date, the patient experienced bad side effects for about a week, and no stomach pain at all. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad side effects for about a week, and the outcome of no stomach pain at all was not reported. This report was non-serious.
3-4 days following the dose, tinnitus began quiety, then quickly increased in volume and intensity.  It sill occasionally subside if I massage the ears, but it never fully disappears.
diarrhea; a little soreness on my arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and MYALGIA (a little soreness on my arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea) and MYALGIA (a little soreness on my arm). At the time of the report, DIARRHOEA (diarrhea) and MYALGIA (a little soreness on my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information given. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received contains no new information.
Patient received Hep B #3 on 1/22/14; about 24 hours later she developed fever and body aches. Did not measure temp. Fever persisted for 4 days; developed chest congestion with cough - day 3 which continues and is productive. She has been afebrile x 2 days. She also reports nausea, vomiting and diarrhea x 1 day - on day 3 post immunization. She still has cough - no fever, and feels better.
Information has been received from a physician assistant concerning a 20 year old female with migraine, penicillin allergy and VICODIN allergy and a history of pneumonia (in November 2006) who on 15-AUG-2007 was intramuscularly vaccinated with the 3rd 0.5 ml dose of GARDASIL (lot #658556/1060U) into the left arm deltoid. The dates of the first two doses of GARDASIL were not available. Concomitant therapy included multivitamins (unspecified), ascorbic acid, vitamin E and unspecified over the counter medication for migraines. In August 2008, the patient experienced hypothyroidism and rheumatoid arthritis. The patient initially treated with prednisone. At the time of reporting, the patient did not recover. The patient had an office visit for medical attention. Hypothyroidism and rheumatoid arthritis were considered to be disabling. Additional information has been requested.  5/19/09 medical records received 4/9/07 to 4/16/09. FINAL DIAGNOSIS: Rheumatoid arthritis, hypothyroidism Post vaccination: Rheumatoid arthritis, hypothyroidism diagnosed. Candida.
Approximately after shot, had fever 104 and seizure for 1 minutes. Next day no fever and child happy.
The pt experienced swelling in the right ankle, pain on side of right foot, headaches, joint pain. The pt was dx with URI.
Guillain Barre syndrome; weakness in arms/ shoulders/ hands; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 27 May 2021 via medical record (case is now medically confirmed). As per the medical records plaintiff had received Shingrix first shot on 27 December 2018 for Prophylaxis. On 01 January 2019 patient experienced weakness in arms, shoulders and hands. Patient visited hospital for same reasons and admitted on 04 January 2019 where patient was diagnosed with GBS(Guillain Barre syndrome). The patient currently experiences weakness in arms and hands.
Fever (101), congestion, headache. Fever rose to 103.3 on 1/22/2013. On 1/28/2013 patient complained of severe pain in feet. On 1/30/2013 patient was hospitalized for 4 days with severe foot pain of unknown origin Treated with Toradol.
muscle aches, stomach tightness, swollen right eye with edema, headache, fever 99.8 (my normal is 97.2), hypertension 170/97 (my normal is 120/70 or less), general malaise.
102.5 fever which persisted for 2.5 days at which a measles-like rash then started and spread to entire body on 8/12/2013.
light headed; fainted; cold hot sweats; dry mouth; felt thirsty; flu symptoms; unbearable body aches; A spontaneous report  was received from a Consumer, concerning a female patient of 31 years-old-age, who received Modena's COVID-19 vaccine and she fainted and experienced cold hot sweats, dry mouth and felt thirsty.  The patient's medical history was not provided. Advil was the Concomitant products that was  provided by the reporter.  On 16Mar2021 at 8am, the patient received their first of two planed doses of mRNA-1273 (Unknown lot number) intramuscularly in her right non-dominant arm for prophylaxis of COVID-19 infection. After getting the dose at 8am, she had a bad reaction where 5 min later she fainted and experienced cold hot sweats, dry mouth and felt thirsty. On Tuesday night (16Mar2021) she had flu like symptoms with unbearable body aches.  She stated on 18Mar 2021 she is felling better but tired and felt like fainting, light headed and dizzy. The patient stated that she took Advil for flu like symptoms.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, was recovering and resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. No follow up is possible.
Pt. with hx of hypoxia, oxygen at night, CAD, seizure disorder. Started feeling light headed, SOB of 4-5 min. after injection. Pt.brought to procedure room.  Initial vs at 4:20, 118/78, p 105, r 18. O2 placed, sat up to 98% on 2l. 911 called. Started feeling better on o2.  SOB improved.  Due to hx of CAD, epi not given.  PE: heart rate reg 95, lungs cta, upper airway without stridor, swallowing well. Squad arrived. Repeat bp 120/80, sat 98%, r 16.  pt. exhibited some shakes and felt he might seize. Shakes stopped in 10 sec.  Transported in stable condition to ED.
This spontaneous report as received from a physician and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. Since 14-OCT-2016, the patients were vaccinated with a dose of improperly stored ROTATEQ orally, (which had a lot #of M019690 and an expiration date of 02-NOV-2017; however, dosage number and route of administration were not reported). Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 8 hours: 35 grades Fahrenheit. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.
Baby had immunization on 4/16/04 which included DTaP, IPV, ,HIB and Prevnar. On 4/19/04, she was seen in office for lethargy and . She was admitted to hospital and spinal tap, blood cultures; all were negative. Nurse follow up on 05/18/04: decreased intake, tremors.
Very swollen bottom right side of lip and tongue, itching on tongue and lip, pain in left arm muscle (where vaccine was given), hives on left arm morning of 09/23/2010. Called the doctor, they recommended taking Benadryl and calling if symptoms persist or get worse.
Heart palpations started about 5 days after 2nd dose.; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN3200) via unspecified route of administration in the left arm on 16Feb2021 at 16:00 (at the age of 73-year-old), as a single dose for COVID-19 immunisation. The patients medical history included asthma, spinal cord injury and vascular history. Concomitant medications included 1000 mg vitamin C (MANUFACTURER UNKNOWN), 500 mg calcium (MANUFACTURER UNKNOWN), 1000 international unit (IU) vitamin D3 (MANUFACTURER UNKNOWN). All the concomitant medications were taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9264) via an unspecified route of administration on 26Jan2021 at 16:00, as a single dose for COVID-19 immunisation. The patient was allergic to sulfa, naproxen sodium, shell fish and soy.  The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient experienced heart palpations on 21Feb2021, started about 5 days after the 2nd dose, lasted about 2 to 3 days. No therapeutic measures were taken as a result of adverse events. The clinical outcome of heart palpitations was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Vomiting 3 days after vaccine was administered  Low grade fever on the 4th- 7th days  Crabby, no appetite, not drinking, sleeping more than usual Day 8 rash beginning on neck  Day 9 rash covering entire trunk
Cold; Chest Pain; Coughing; Sore Throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization.  The following information was reported: NASOPHARYNGITIS (non-serious) with onset Dec2021, outcome "unknown", described as "Cold"; CHEST PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "Chest Pain"; COUGH (non-serious) with onset Dec2021, outcome "unknown", described as "Coughing"; OROPHARYNGEAL PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "Sore Throat".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Prolonged rash after MMR/HepA/Varicella/PREVNAR 13.  Fever/rash onset 13d after vaccines. Rash persisted x 4-6 wks.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date the unspecified number of patients were vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Anaphylaxis c/o chest tightness and "unable to breathe"-epi pen administered with immediate response. Narrative:  c/o chest tightness. epi pen administered with immediate response. "I can breath now," pt. stated. Monitored, d/c'd to home/released from work.
Body aches; This is a spontaneous report from a contactable other healthcare professional. A 54-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported), via an unknown route of administration on an unknown date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced body aches. It was reported that intermittent body aches since stop that may be due to recent covid-10 vaccination. MD aware and was changing medications. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Onset of Ulcerative Colitis including the passage of blood and mucosa. This is the first time in 18 years that I have had any real prevelant issue with colitis. It began Day 5 after the vaccination and grew progressively worse through Day 13 at which point the outward signs began to wane. By Day 11, I was using the bathroom up to 10 times per day. By Day 18 I had pretty much returned to my normal state. With some hesitancy, I received my 2nd dose on August 21, 2021
Red egg circle shape; Itching on left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red egg circle shape) and PRURITUS (Itching on left arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red egg circle shape) and PRURITUS (Itching on left arm). The patient was treated with HYDROCORTISONE for Itchy, at an unspecified dose and frequency. On 11-Mar-2021, VACCINATION SITE ERYTHEMA (Red egg circle shape) outcome was unknown and PRURITUS (Itching on left arm) had resolved.            No concomitant medications were given
Received call from mother stating pt crying inconsolable x 1 hr. Mother tried changing diaper, holding patient and feeding no success. TYLENOL susp 1.25 ml given. Patient fell asleep while mother was talking to provider at the office.
I went to give patient vaccination and as soon as I gave it I was not sure if I had drawn any vaccine into the syringe, I put into sharpes container before having a chance to inspect for traces of vaccine, I then decided to draw up remaining doses to see how many were left and there were 5 , I  thought she was second dose out of new vial so I felt confident she had not received the vaccine, I readministered vaccine but later in the day I was short 1 dose based on getting 6 doses per vial, so patient may or may not have received 2 doses. I contacted patient 3/25/21 to check on her and only adverse reaction she is reporting is a  moderately sore arm.
soreness in the arms; This is a spontaneous report from a contactable other healthcare professional (HCP). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for Covid-19 immunisation. Medical history included polyarthritis. The patient's concomitant medications were not reported. The patient experienced soreness in the arms on an unknown date. The outcome of the event was unknown.   The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up.
She added 2 days later, on Sunday, it was then itching like a "bee sting" then it continued to itch, and it now feels like a "mosquito bite".; Sleepy, Groggy, Slept for 12 hours; injection "site/arm was a little tender"; it was painful when she reached out to get something/ Right Arm Hurting, Sore and Tender; This is a spontaneous report from a contactable consumer (patient).   A 70-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, Lot number: EW0176), on 29Apr2021 at 14:00 (at the age of 70-year-old) via an unspecified route of administration, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Family medical history relevant to AE was none. The patient previously received historical vaccine included first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, lot number: EW0158 and expiration dates was not reported), via an unspecified route of administration, for COVID-19 immunisation and her arm was a little sore. On 29Apr2021 at 17:00, her right arm hurting, sore and tender, she felt sleepy, groggy, slept for 12 hours and on 02May2021, her right arm itching, like a mosquito bite and was a bee sting at first at injection site. the caller stated that she received her final shot on Thursday 29Ar2021. caller stated after the first one, her arm was a little sore. Caller stated this time, her arm in the site where she got the vaccine was tender and painful, so she stopped reaching up to do exercises. She added 2 days later, on Sunday, it was then itching like a 'bee sting' then it continued to itch, and it now feels like a 'mosquito bite'. She stated that the paper said to put a cold wet towel on the site, so she did that. The itchiness persisted. She asked if her symptoms were normal after getting the vaccine. Caller stated that she slept for 12 hours and when she woke up and she was still sleepy until another 8-9 hours, but she couldn't sleep longer, she had to go to the store, states it was a groggy sleepy. She further clarified that she went to reach up to get something and the arm pain worsened so she didn't want to cause any more pain, so didn't reach up. She asked what to do to alleviate her symptom from the Pfizer-BioNTech COVID-19 vaccine. The seriousness was unspecified for the events. On 30Apr2021, the outcome of the events sleepy was recovered, while outcome of the rest all events was not recovered.   No follow-up attempts are needed. No further information is expected.