chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left (left shoulder) on 09Feb2021, early afternoon 15:20 (Batch/Lot Number: EN6201) as single dose for COVID-19 immunisation. Medical history included Bell's Palsy in the past, but not for years. He doesn't know, but probably 15 years since he last had it. Family Medical History Relevant to AE(s) included his brother had Bell's Palsy after his COVID shot. His brother had Bell's palsy before also. There were no concomitant medications. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. The patient had no additional vaccines administered on same date of the pfizer suspect. The patient did not receive any prior Vaccinations (within 4 weeks). He normally doesn't take vaccines. The patient had no AE(s) following prior vaccinations. Patient wanted to report Bell's Palsy is directly caused by Pfizer COVID shot. Caller clarified that he is the patient that experienced Bell's Palsy. He understands that Pfizer has denied that. He was not sure of the date. It was the date he got the shot. It happened the same date got first COVID shot. He did not get second COVID shot. Facility called him today to follow up because he didn't get second shot and they told that's what it was and gave him Pfizer's phone number. When caller got his vaccination card, he states the date was 09Feb2021 that he got the shot and developed Bell's Palsy. Immediately afterwards, the patient experienced Bell's Palsy. The next day his wife noticed it. The patient clarified the date Bell's Palsy started was 09Feb2021. It was bad enough the next day, 10Feb2021, that his wife noticed it. The patient just went directly to the doctor and did not go to ER. He would have gone to the ER to get the thing he needed for Bell's Palsy, but he went to the doctor instead. The doctor gave him the medication he needed. He went to the doctor because the doctor had treated his brother. His brother had the same reaction. That is how caller knows it was caused by the Pfizer COVID shot. Caller clarified that his brother got Bell's Palsy immediately too but didn't recognized it until after he had the second shot. That is how they know for sure it was caused by Pfizer COVID shot. The outcome of the event was not recovered.  Follow-up attempts are needed, Other additional information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021725674 similar report from same reporter
Extreme skin sensitivity, body aches, headache, fever, chills, nausea and fatigue as well as swollen lymph nodes in my left under arm. This lasted 24 hours. Since those extreme symptoms dissipated, i have minor pain in my ears and jaw, a continued headache and continued swollen lymph nodes
Patient reports bleeding immediately at the site at time of administration. This was not usual for her and was concerned. After several moments of stopping the bleed, she reportedly went on with her day. However, she reports daily that her arm has been hurting with limited ROM and pain/tenderness at the site. She has attempted to use compresses in the beginning stages of pain however the daily pain has become more bothersome.
No adverse effect reported; patient received improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 09-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # S002494, expiration date: 23-JUL-2020 (exact dose, injection site and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MERCK) injection (exact dose, injection site, route of administration, indication, lot # and expiration date were not provided). Administered dose experienced the temperature excursions of 6 degrees Fahrenheit to 14 degrees Fahrenheit (10.2 degrees Fahrenheit, multiple) for 50 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was subarachnoid hemorrhage.
I felt tingling in my left arm at the injection site; it was swollen under arm.; I felt tired; had chills; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PARAESTHESIA (I felt tingling in my left arm at the injection site), PERIPHERAL SWELLING (it was swollen under arm.), FATIGUE (I felt tired) and CHILLS (had chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced VACCINATION SITE PARAESTHESIA (I felt tingling in my left arm at the injection site), PERIPHERAL SWELLING (it was swollen under arm.), FATIGUE (I felt tired) and CHILLS (had chills). At the time of the report, VACCINATION SITE PARAESTHESIA (I felt tingling in my left arm at the injection site), PERIPHERAL SWELLING (it was swollen under arm.), FATIGUE (I felt tired) and CHILLS (had chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment mediations were reported.    This case was linked to MOD-2021-403270, MOD-2021-403276 (Patient Link).
Admitted to hospital 10/25 for oxygen (max 4.5 L) and Albuterol treatments. Presented with 3-4 days of cough, congestion. Developed fever 10-25 and had increased resp difficulty on day of admission.  10/28/09 Medical records received for DOS 10/25. CC: Cough and increasing work in breath  11/2/2009 MR for 10/25/2009 admission. Tx: IVF, Rep tx's, Tamiflu     Presents in ED with acute respiratory distress. Pale and lethargic. Cough, hypoxemia. Fussy but consoled. Dark circles under eyes. Some upper airway congestion. Occasional emesis.  Decreased appetite.   Lymphadenopathy neck. Mild sub costal retractions, tachypneic, nasal flaring. Decreased breath sounds at bases bil, R greeter than L.  CXR abnormal suggestive of bilateral pneumonia. Possible viral process s/to H1N1.
Single shingles blister on the inside of the left arm developed 24 hours after vaccination, blister burst 48 hours after vaccination. Patient contacted pharmacy with information 72 hours after vaccination, pharmacist observed. Patient reports localized pain, redness, and irritation.
Patient left the institution with mother before the mandatory 15 minutes wait after vaccine administration. Patient had a vasovagal syncope, resulting in forehead injury and left ear abrasion due to fall. Patient did not lose consciousness at anytime, and responded well.
injection site soreness 1-2 days, fatigue 3-4 days; stated same reaction after both injections
Patient complained of feeling warm and had a "metalic taste" after receiving influenza vaccine.  Oral Benadryl administered. Blood pressure 146/86.  HR 94, Respirations 21.  Patient stated blood pressure reading was high for her.  Became anxious, stated "feels tight" and pointed to neck. EMS called to transport patient to the Emergency Department.  Patient walked with escorts to door to meet ambulance.  Ambulance departed with patient at 11:28 a.m.
dose 1 start date : 27Feb2021 dose 2 start date : 03Mar2021; twitching on the left side of my face; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 03Mar2021 14:30 (Batch/Lot number: unknown) at the age of 66 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "facial numbness" (ongoing), notes: Still have periodic facial numbness without facial drooping.; "Bell's palsy" (unspecified if ongoing). Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]; ANTIVERT [DIHYDROERGOCRISTINE;LOMIFYLLINE]. Vaccination history included: BNT162B2 (DOSE 1,SINGLE ; lot number: unknown; anatomical site :left arm; administration time: 14:30), administration date: 27Feb2021, when the patient was 66 years old, for COVID-19 immunisation, reaction(s): "numbness around my mouth", "Numbness facial". The following information was reported: MUSCLE TWITCHING (non-serious) with onset Mar2021, outcome "recovering", described as "twitching on the left side of my face"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 03Mar2021 14:30, outcome "unknown", described as "dose 1 start date : 27Feb2021 dose 2 start date : 03Mar2021". Therapeutic measures were not taken as a result of muscle twitching.  Additional information: The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient administered vaccine after the manufacture's date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The vial did not undergo any temperature excursions. Date the vial initially stored in the refrigerator was unknown.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received reporter's address updated.
Hallucination while at home:  "saw" two other men arguing in his room but they were not actually there. Duration a few minutes, resolved spontaneously.
Metallic taste in mouth after injection. Then 45 minutes later, had rapid heart rate and itching over the injection side. Later that night had itching throughout body. She has since had a HA.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 12-NOV-2015 at time- 14:20, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L004754 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.6 and 2.5 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
hot flashes; sweats; back pain in the lower spine; dehydration; Deep libido; joint pain; exhausted and tired more quickly.; This spontaneous case was reported by a patient and describes the occurrence of HOT FLUSH (hot flashes), HYPERHIDROSIS (sweats), SPINAL PAIN (back pain in the lower spine), DEHYDRATION (dehydration) and LIBIDO INCREASED (Deep libido) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 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 HOT FLUSH (hot flashes), HYPERHIDROSIS (sweats), SPINAL PAIN (back pain in the lower spine), DEHYDRATION (dehydration), LIBIDO INCREASED (Deep libido), ARTHRALGIA (joint pain) and FATIGUE (exhausted and tired more quickly. ). At the time of the report, HOT FLUSH (hot flashes), HYPERHIDROSIS (sweats), SPINAL PAIN (back pain in the lower spine), DEHYDRATION (dehydration), LIBIDO INCREASED (Deep libido), ARTHRALGIA (joint pain) and FATIGUE (exhausted and tired more quickly. ) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient had two Moderna vaccinations against corona and haven't felt the same since then. The patient was not acutely ill, just exhausted and tired more quickly. Mild sweats/hot flashes sometimes. joint pain and back pain in the lower spine. The patient had deep libido. Sometimes there was a feeling of dehydration. Not extreme or short, but the patient felt like the patient had been aged a bit too much. Cancer and things like that have been examined by a family doctor and are luckily negative.  No treatment medication was reported.
Felt burning right after vaccination was administered, 7 days later area started itching, and a larger size round area of  induration and with erythema
Lt deltoid area w/red discoloration, mild pain & itch; 1 episode of fever;
Information has been received from a RN concerning a first grade female pt who on 04/24/98 was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt developed chickenpox. Unspecified medical attention was sought.  There was no product quality complaint involved. Additional information has been requested. It was noted that pt's from the same source had a similar experience (WAES # 0403USA02109, 0403USA02110, 0403USA02111, 0403USA02112, 0403USA02113, 0403USA02114, 0403USA02115). ** Follow up information was received from the registered nurse who indicated that the patient was diagnosed with chickenpox on or about 01/17/2004. No further information is expected.
This case was reported by a nurse via sales rep and described the occurrence of chills in a 57-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of myalgia (1st dose received on 3rd April 2018, for tolerance see case US2018GSK162440). On 24th August 2018, the patient received the 2nd dose of SHINGRIX. On 25th August 2018, 1 days after receiving SHINGRIX, the patient experienced chills, tremor, fever, abdominal pain and constipation. The patient was treated with FAMVIR, gabapentin and LORTAB. On an unknown date, the outcome of the chills, tremor, fever, abdominal pain and constipation were unknown. It was unknown if the reporter considered the chills, tremor, fever, abdominal pain and constipation to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX and went to emergency room (ER) on Saturday (25th August 2018) and Sunday (26th August 2018) for shaking, chills, fever over 100 and abdominal pain. The physician treated the patient with LORTAB on Saturday and gabapentin PERCOCET and FAMVIR on Sunday. The patient was back in physician office on Monday (27th August 2018) to be treated for left side abdominal pain. On the day of reporting the patient called back with abdominal pain. The physician gave him medication for constipation. This case has been linked with case US2018GSK162440 (same patient) reported by the same reporter. The reporter agreed to be contacted for follow up.
Pt had a vasovagal reaction. Pt felt lightheaded, had an episode of semi-consciousness. Pt skin was pale, clammy, and diaphoretic. Pt was laid back in chair. Episode lasted around 15-20 seconds then pt came to. Pt did not fall or sustain any injuries. Pt was given an ice pack behind his neck and put a fan on him. Pt was given water and told to take small sips. Got 4 sets of vitals signs every 5 minutes as follows: 79/36 HR-43, 87/36 HR-45, 123/59 HR-53, 122/62 HR-53.
5 minutes after injection, face red, sudden onset of flushing sensation in chest followed by dizziness and a feeling of rapid heart beat.  Throat tightness and difficulty swallowing.  Flushing sensation and feeling of rapid heart beat resolved within a few minutes, but left with nausea, flushing and difficulty swallowing/throat tightness.
Pt. reports about a week after getting the Pfizer covid vaccine, pt developed colitis which is still an ongoing problem.
Injection site is red, swollen, warm, and tender again. It was like that for a few days after the injection, but symptoms had subsided. Now they?re back.
DTAP given at (R) thigh at the village clinic by PHN on 12/4, & then child developed fever 101.4 degrees F & red, swollen (R) leg -> was seen at clinic 12/6 1030 pm & released to home.
Severe vertigo and headache the next day.  Vertigo has improved, but headache continues although lessened.  Ibuprofen helps.  Patient knows friend who had similar effects.
Information has been received from a physician concerning an approximately 10 year old female patient (Now 20 year old) with morbidly obese and no drug reactions or allergies who on 02-MAY-1991, was vaccinated with a dose of MMR II (Lot# not reported) and on 03-AUG-2001, the patient was vaccinated with a another dose of MMR II (Lot# not reported). On 26-AUG-2010, a MMR titer test was done and showed lack of immunity to rubeola. It was unknown if the patient sought medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Upon receiving a dose of flu vaccine at 1500 hours on 09/29/2016 I had broken out with an extreme case of hives and rash over my back torso thighs and crotch area and proceeded to the ER for treatment. I was given a Cortisone shot and prednisone tablet which had relieved the symptoms. Since then I have been to allergists oncologist dermatologists receiving shots of cortisone again. I have had blood work done which all effects have come back negative for indication of any blood-liver and or kidney maladies as of this week I have been to an allergist with some indication of allergies to certain manmade byproducts (formaldehyde), which still leaves me in limbo on why I had the outbreaks throughout the year.
large mass at injection site. Grown from the size of a quarter 12 hours after administration to the size of the lid of a standard can 24 hours after administration. The skin is erythematous and warm to the touch. Symptoms: lethargy, myalgia,  and mild fever symptoms. Has not resolved yet and do not feel like I need to see a doctor.
vaccine was administered in error as subcutaneously rather than intramuscular pt did not report any adverse effects
Within 10 seconds of administering Hepatitis A patient had syncopal episode and stopped breathing - responded with first rescue breath.  Complained about stomach and head pain prior to passing out. Apnea. Syncope.
Fever (on and off for 48 hours, as high as 101.3 degrees F) Chills Headache
pt recv vax 10AM 14OCT98 & 11AM had pain to let side of head, dec jaw & to lt side of neck;woke up 4AM 15OCT98 had diff w/gait (couldn't put lt leg forward);also c/o weakness to lt arm & hand;diff making tea;lt leg/knee still weak;
Vaccines went into 2-8 C thaw state on or about 20-Dec-2021; Received vaccine past  its 30-days Exp date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past  its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 20-Dec-2021) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2022 at 8:14 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Feb-2022 at 8:14 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past  its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 20-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past  its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 20-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. On 04-Feb-2022 at 8:14 AM, patient received an expired booster dose.
pt recvd vax & next day devel t102, lethargy, dec appetite;inconsolable crying, shivering, shaking, high pitched cry x 3-4hrs devel 2hrs p/vax;also devel red tonsils, rhinitis;seen by MD, tx ATB inj;MD advised to postpone next DTAP to 15mo
FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu-like symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20210843021, 20210843411 and 20210842933.