chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Facial swelling; Headache; This spontaneous case was reported by a dentist and describes the occurrence of SWELLING FACE (Facial swelling) and HEADACHE (Headache) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037k20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Facial swelling) and HEADACHE (Headache). At the time of the report, SWELLING FACE (Facial swelling) and HEADACHE (Headache) had not resolved. 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Additional information added on 18JUN2021 contains no significant information
Patient complaining of hoarseness.  Assessed and monitored for 30 minutes.  symptoms subsided on site.
This spontaneous report as received from a physician refers to a 15 month old patient. On 23-AUG-2017, the patient was vaccinated with PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 23-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.
2nd dose was administered  Pfizer in his left arm and immediately looked pale. Mother indicates that usually when he sees needles or blood that happens to him. Paramedics were called and provider was notified. Paramedic and supervisor were notified. Vitals were taken. temp 36.3, Sat 96, P72, BP90/860
11:40AM client walked into school clinic for Tdap imm. Rec'd imm. and walked back to classroom 5 mins later. Teacher noticed client put head down on desk as if she "passed out". Teacher summons assistance. Staff member escorted client to clinic. While en route in hallway, student fainted. Staff member witnessed and guided to floor. Summoned nurse. Assisted student. No apparent injury. Awake and alert but sluggish. PERLA. Skin pale, dry. Taken to clinic via w/c to cot. Quickly responded with cool cloth and supine position. 2:00 Pt. was picked up by parent and taken home.
experienced vertigo after both first and second doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "meniere disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "experienced vertigo after both first and second doses". It was unknown if therapeutic measures were taken as a result of vertigo.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Parent picked up student at dismissal from school and noted bilateral upper arm raised welts/hives.  Skin surrounding hives, warm to touch.  Took child to clinic, however upon arrival hives disappeared.  Hives reappeared later that evening and the next day 10/5/13 to other areas of the body.  Benadryl given through the weekend.
Moderate to severe headaches, bodyaches particularly in the neck shoulder and upper arms. Heaviness and burning sensation in the same area. Lethargy.  No treatment has been received I just contacted my doctor today but have not got a return call. I have had these adverse effects for 12 days
Pruritus has resolved since receiving both doses; Received second dose 38 days after first dose; This spontaneous case was reported by a dentist and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Pruritus has resolved since receiving both doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 38 days after first dose) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Lymphadenectomy (No lymph nodes in right armpit due to removal of melanoma 50 years ago) and Thyroidectomy (Removed thyroid). Concurrent medical conditions included Pruritus since 16-Nov-2019, Allergy to antibiotic (Cipro), Drug allergy and Drug allergy. Concomitant products included MULTIVITAMIN [VITAMINS NOS], ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), FAMOTIDINE (PEPCID [FAMOTIDINE]), LEVOTHYROXINE SODIUM (SYNTHROID) and ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 38 days after first dose). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Pruritus has resolved since receiving both doses). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Pruritus has resolved since receiving both doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 38 days after first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2021: Follow-up information received captured allergies reporter details and patient demographic details and patient reported not experiencing adverse events.
Day of: Arm pain, 2am fever 101.7, March 2 -chills, body aches,  headache, loss of appetite. 9am fainted,  Mar 4th started with left sided weakness Mar 5 taken to ER for increased weakness Diagnosed with encephalitis in the hippocampus area related to vaccine
suspected vaccination failure; shingles break out; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 58-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had when was young) and shingles (had shingles break out in one place by buttocks (common in women) when in late 30's).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient had chicken pox when the patient was young and had shingles break out in one place by his/her buttocks which was common in women when in his/her late 30's. The patient had them chronically in that area for over 24 years, also had 2 of the Shingles vaccines with no results. At the time of reporting, the patient was 58-year-old and had to take an antiviral for them to stay under control. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
On late Monday night around 11 pm, Patient laid down to go to sleep after taking her regular spray of Fluticasone in each nostril shortly before, and immediately when she laid down, she felt blood going down the back of her throat and sat up and her right nostril was bleeding. It was a constant flow and so we had her lean slightly forward and applied pressure to her nose for about an hour, every 10 minutes releasing pressure to see if it had stopped. It wouldn't stop so I placed a call to the doctor's office after hours service and a nurse walked me through other tactics we could try to get it to stop. We tried repositioning the pressure on the nose and also tried a piece of gauze with a couple drops of water on it to place it in the nostril to put pressure on it once again and eventually, after 2 and a half hours, the bleeding stopped. The next morning, Tuesday 1/11/2022, I made an appointment for Patient to be checked out at her pediatrician's office with Dr. She checked Patient's nose and saw it looked raw inside and also a scab over a capillary (I think that is what you call it) which is where the bleeding was coming from. Dr. recommended an ENT referral for further treatment but also recommended Patient not use Fluticasone right now until the nose heals and also to use just a saline nose spray to humidify the nose, use a q-tip to apply vasoline to inside of nose 2 times a day, and also to use a humidifier in bedroom at night. We have been able to manage to keep Patient's nose moist so that the nosebleed has not reoccurred. She has been weak since the nosebleed and has gradually gotten strength back but her nose is very irritated and when wearing a mask at school today, she could not breathe well due to her nose irritation.
Rashes with spots on underside of arm, spots on face near lips, next day spread to hands, legs, hips, back with mild fever. Saw physician on 12/31/2015 who suggested optional 1% hydrocortisone cream with Motrin to manage fever if returned.
Developed 3 blood clots in leg and was placed on Eliquis then while on Eliquis for a month or longer developed a Pulmonary Embolism  plus increased edema to legs
Patient had red wheal approx. 2 inches across and surrounding area was red and hot and swollen about 6 inches across. Pt symptoms started in 24 hours and lasted about 4 days, increasingly getting better each day. Pt did not seek medical care.
This spontaneous report was received from a pharmacy student who noted that an unspecified number of unspecified patients had experienced injection site reactions after being vaccinated with ZOSTAVAX (lot # not reported) on an unspecified dates. The outcome of injection site reactions was unknown. Additional information has been requested.
The pt experienced left deltoid with pink, well circumscribed, warm, swollen and slightly tender area 4-6cm.
1st dose 2013, 2nd MArch 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a adult female patient who received HAB (Twinrix) (batch number 327E3, expiry date 14-MAY-2025) for prophylaxis.  Previously administered products included Twinrix (1st dose was received as Twinrix pre-filled syringe in 2013).  In MAR-2023, the patient received the 2nd dose of Twinrix. In MAR-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 2013, 2nd MArch 2023). The outcome of the drug dose administration interval too long was unknown.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 27-APR-2023 Pharmacist reported that, a patient had received their first dose of Twinrix in 2013 and their second dose in March of 2023. The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up via mail. The patient had received the second dose later than the recommended interval, which had led to lengthening of vaccination schedule.
Tinnitus, continuous since onset. It has never improved. No treatment yet but will begin looking for options soon. Difficult to function with it sometimes, but I'm managing okay.
Took 1st pill at 5:30PM, awoke at 3AM with head and face itching, severely swollen face, esp nose, right eye, and mouth. Took Benadryl 50mg, swelling was almost gone by 5/9/05. Did not take the last 3 pills of the vaccine.
lumps appear in my breast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BREAST MASS (non-serious), outcome "unknown", described as "lumps appear in my breast". The event "lumps appear in my breast" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received the vaccine and shortly after receiving it the patient had lumps appear in the patient breast. The patient's physician sent the patient for a mammogram because the patient had missed their mammogram the previous year because of Covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
patient complains of ongoing pain in right arm starting 2 days after vaccination given.  Pain originates in shoulder, goes down right side, to the hand.  Pain is constant, intensity varies. Patient has not visited his doctor for this complaint.
Information has been received from a healthcare professional concerning a 28 year old Indian male pt who on 5/7/99 was vaccinated 1 dose of MMR. On 5/31/99, the pt presented to a physician with parotitis, a fever of 102.2F, a  headache and a questionable purulent discharge from his buccal mucosa and a general chilled feeling. The pt's physician felt that the experiences were related to the vaccine. No further information is available.
Within 24 hours, pain in arm, dizzy, headache, fatigue, fever 100.9. Seen in office - ED - back in office. Labs are normal.
I was running a low grade fever and I had a pretty bad cough. Due to the 1st stage emphysema, my family members encouraged me to go to the hospital. Later that night, my fever really spiked and I ended up with 3rd stage sepsis. I was treated with antibiotics around the clock via IV which I remained on the entire time I was hospitalized. I was pretty out of it due to the fever which lasted for 2 or 3 days. I am unable to recall any of the events of those 2 to 3 days. I was released from the hospital and still recovering and then found out I was positive for COVID. My doctor gave me a medication for high risk patients. I am unable to recall the name of it. I am currently still experiencing extreme exhaustion and low energy. I have to stop walking frequently to catch my breath. My doctor completed paperwork for a handicapped decal.
This is a spontaneous report obtained from a contactable physician. A patient of unknown age, gender, and ethnicity received, on an unspecified date, PREVAR13 single dose. Relevant history and concomitant medications were unknown. Vaccines given on the same day and vaccines taken within the last four weeks were unknown. On an unspecified date, in SEP2013 or OCT2013, the patient had some sort of reaction. Relevant laboratory data was unknown. At time of this report, clinical outcome of the event was unknown. Causality between the event and PREVNAR13 was unknown. Follow-up (14NOV2014): Follow-up attempts completed. No further information expected.
5 hours after PEDIARIX, HIB, PREVNAR and ROTATEQ developed respiratory distress-grunting with cyanosis. Subjective fever. Req EMS trip to ER. CXR, CBC nl. RR 50-60. Received DECADRON and MOTRIN. SAT'S 98%. No further tx
The side effects I had back pain and pain in my neck. I also had side effects in my arm.
patient rec'd 1st dose of moderna on 3/18/21, 2nd dose on 4/7/21. 21 days of gap instead of 28 days. no adverse rxn noted.
Unconsolable crying for 5 hours, fever of 103, swelling, redness and pain at the injection site - called Facility twice and scheduled an appt and they said the fever wasn't related even though it started a couple hours after injection.
He got the vaccine, and when he woke up the 2nd day his throat felt dry and felt like it was sore.  His arm felt sore as if somebody hit him several times, very sore.  I felt sick, felt queasy, nauseous wanting to vomit but did not.  He felt really tired, fatigued because he didn't get any sleep that night.  He went all day feeling terrible, nauseous, felt like being through the ringer an flushed, which went on for 2-3 days.  He now feels a lot better, but felt like he was getting the flu.  He did not take anything for it and did take some medicine to help him sleep and did get a lot of rest and sleep.  He did drink a lot of liquids to keep his throat lubricated.  He also did have a throbbing headache, which he normally does not get headaches and felt terrible.  He did take some aspirin for that.  The symptoms have all resolved and feels perfectly fine now.     Stated that he has never felt so bad in his life.
Pt. called on 9/26 stating pt. had life threatening rxn to FLUZONE HD. Called pt. 9/30 to follow up, stated muscle pain, fainting, nausea, HA, cough, trouble swallowing. Took BENADRYL, went to doctor. Had flu shot before, not HD. 9/30 pt. stated feeling better but not 100%.
This case was reported by a nurse via sales rep and described the occurrence of redness of legs in a patient who received KINRIX (batch number 7559R, expiry date unknown). On 29th December 2017, the patient received KINRIX. On an unknown date, less than a month after receiving KINRIX, the patient experienced redness of legs and pharmaceutical product complaint. On an unknown date, the outcome of the redness of legs and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the redness of legs to be related to KINRIX. Additional details were provided as follows: The Patient experienced baseball size redness on thigh then the redness got bigger and was now covering the entire thigh. This case has been linked to the case US2018005860 and US2018005861 reported by the same reporter.
Mild fever (between 98 & 99) for 2 weeks now. Sleeps through his nap into the next day for 2 weeks now (Sleeps about 18 hours a day).  Loss of appetite.  Soft smelly stool.  Loss of energy.  Black & red circles under eyes even after sleeping 18 hours a day.  Nervous tick (on & off again).  This happened in the past when hes received vaccines.  Only that in the past these symptoms were only 1 week long.  Now its extending 2 weeks long.  I always take him back to the doctor to tell him whats going on & his answer is always the same.............these symptoms are not caused by the vaccines, its just a bug he has!
Muscle pain; Dizzy; face swelling; Dry heaving; Neck swelling; hip pain, soreness, and his back and shoulders are sore as well, joint achiness; hip pain, soreness, and his back and shoulders are sore as well; hip pain, soreness, and his back and shoulders are sore as well.; brachial plexus origin there was a sharp stabbing pain shooting down; rash was all over his body, but mostly on his back; drowsy; injection sight swelling in his arm; he did kind of feel like something was sitting on his chest; This is a spontaneous report from a contactable consumer. This 36-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunisation. Medical history included pre-existing back injury that caused neuropathy, damaged nerves, and chronic sciatica, all in 2009. There were no concomitant medications. On 05Jan2021, the consumer experienced muscle pain, joint achiness which got painful. He was dizzy. His girlfriend noticed a rash on his body. It was welted, but not itchy. His face and neck swelled up. He was dry heaving and couldn't throw up. He was given diphenhydramine hydrochloride (BENADRYL) and steroid shots in the ER. About 4.5 hours after the vaccine, the same day was when it all came on. At 8 o'clock, it got worse. The consumer had hip pain, soreness, and his back and shoulders are sore as well. He was dizzy and drowsy. At 11pm that night, his face was swollen and his neck was swollen. The rash was all over his body, but mostly on his back. He had injection sight swelling in his arm. At his brachial plexus origin there was a sharp stabbing pain shooting down his arm. It did go away. He recovered completely. That stabbing pain lasted from the 5th-6th. He has hip pain, soreness, and his back and shoulders were sore as well. They are ongoing, but improving. He has taken diphenhydramine hydrochloride (BENADRYL) and ibuprofen (MOTRIN). He has not had a fever. His neck still has a little swelling. He didn't have difficulty breathing. But he did kind of feel like something was sitting on his chest. He received a steroid. The consumer had to go to the ER visit. He was there over night from 05Jan2021 to 06Jan2021. The consumer went to get a free COVID test, and they had the vaccine available. The outcome of the event dizzy, face swelling, dry heaving, brachial plexus origin there was a sharp stabbing pain shooting down his arm was recovered on 06Jan2021. The outcome of muscle pain, neck swelling, hip pain, soreness, and his back and shoulders are sore as well, joint achiness was recovering. The outcome of other events was unknown.
Patient experience Bell's Palsy like symptoms on face 3 weeks after receiving SHINGRIX vaccination.
Pt was hospitalized on 7/15/00 through 7/19/00 for fever, nausea, myalgias, rash, diarrhea and swollen, achy joints. Treated with doxycycline 100mg IV while in the hospital. Diagnosed also with aphasia.
Fever that started next morning (as with 2 month and 4 month shots). This fever has persisted for 4+ days and continues at a level of 102-103 when not on TYLENOL or ibuprofen.
Have a lot of stomach issues; stomach kind of bothering me; Heart palpitations; elevated heart rate; I wasn't very hungry and then I had severe like lot of diarrhea; Joints sore; heart rate increased; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: ER8732, Expiry date: Unknown) via an unspecified route of administration in Arm Right on 05Apr2021 16:30, as dose 1, single (at the age of 37-years-old) for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On an unspecified date in Apr2021, the patient had a lot of stomach issues; stomach kind of bothering me, heart palpitations, elevated heart rate, patient wasn't very hungry and then patient had severe like lot of diarrhea, joints sore. Patient didn't receive any treatment for the events. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.