chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hard for him to talk to me; he got Bell''s palsy; This is a spontaneous report from a contactable consumer (reporter's husband). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 50-years-old, via an unspecified route of administration, administered in Arm Left on 18Sep2021 (Batch/Lot Number: FF8839) as dose 1, single for COVID-19 immunization. Medical history included blood pressure high, which is under control, halfway under control, blood cholesterol abnormal and blood pressure abnormal. Concomitant medications included atorvastatin calcium (LIPITOR) taken for blood cholesterol abnormal; and lisinopril taken for blood pressure abnormal; both start and stop date were not reported. The patient got Bell's palsy less than 24 hours after the first shot, they recommended that he doesn't get the second shot. It was on the 19Sep2021 right when he got up off bed the reporter thought he had a stroke, because his face completely looked like he had stroke. He got a pretty bad case of Bell's palsy. He has had it for almost 2 weeks, he has called the doctor, they put him on pills twice and he was advised not to get the second shot or anything else until the doctor says okay. He was supposed to get the second shot on 09Oct2021, but the doctor said no and so did the pharmacist, she said if the doctor said no, they cannot give it until he is clear to get it. He has got two physical exam, has got blood work done and everything came out fine. The doctor did a lab test for the first day he was in to get it checked out, his cholesterol was fine, his blood pressure was perfect, the doctor gave him prednisone (treatment) and some antibiotic (treatment) that he had to take for seven days and then he just put him on another week on prednisone again. The patient was still experiencing the event, he was on his second week. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
On January 5th, the day after my first COVID vaccine, I awoke to a small rash on my forehead.  I also had a bad headache.  Knowing I'm prone to migraines, I ignored it at first.  The headache and rash got worse, and the rash started to  be very painful.  The rash was bumpy and weepy - almost like poison ivy.  The inflammation in the rash made it bulge out about 1/2  inch high bump and I got  periorbital edema  in both eyes for about 4 days - almost to the point where I couldn't see because my eyes were so swollen.  I went to the doctor on January 11th and he and two other doctors diagnosed it as Shingles.  Their best opinion was that while it wasn't caused by the COVID vaccine, the stress on my body from getting the vaccine triggered the shingles virus and made it active.  I was given Valtrex to take for 10 days.  I also  got some CBD pills and oil to help lessen the rash.  I went back for a recheck on  January 26th.  The rash was going down by that point and had stopped being painful.  As of this writing (3/1/2021),  while the main inflammation I still have discoloration and pockmarks on my forehead where the rash was.
Ear clog and difficult to hear, medicine did not seem to help. With 2nd vaccination, worsening condition, loss of hearing, tinnitus (mostly left ear) lessened but has flare-ups. 01/31/2021 Astelin aerosol, Claritin, Sudafed for 5 days. 2/5/2021 PC gave antibiotics. Dizziness, vertigo, vomiting occurred after second dose. 2/23/2021 prednisone for 4 day, helped a little 04/01/2021 Hearing test, within normal limits but issues with high and low freq in left ear. Appointments pending w/ENT with specializing in ears. Symptoms are lessened as of 9/17/2021 it is ongoing.
little Itching; Belly ache; Lot of gas; Joint pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (little Itching), ABDOMINAL PAIN (Belly ache), FLATULENCE (Lot of gas), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 001A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ALPRAZOLAM for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PRURITUS (little Itching), ABDOMINAL PAIN (Belly ache), FLATULENCE (Lot of gas), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PRURITUS (little Itching), ABDOMINAL PAIN (Belly ache), FLATULENCE (Lot of gas), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-167261 (Patient Link).
Information has been received from a registered nurse concerning a 53 year old female with hypertension, diabetes mellitus insulin-dependent and goitre who on 03-OCT-2007 was vaccinated intramuscularly in the left deltoid with a 0.5 mL dose of PNEUMOVAX 23 (lot # 655765/0061U).  Concomitant therapy included unspecified influenza virus vaccine (Novartis) on 03-OCT-2007 administered in the right arm, aspirin, lorazepam, losartan potassium (MSD), SYNTHROID, diclofenac Na, insulin aspart, NOVOLOG MIX 70/30 and LIPITOR.  On 03-OCT-2007 the patient experienced "severe localized reaction" after vaccination with PNEUMOVAX 23.  The site was described as large, red and swollen.  Symptoms were located from the injection site down to the inner aspect of the elbow of the left arm.  The patient was instructed to contact the doctor's office with any symptoms.  On 05-OCT-2007, the patient reported that symptoms improved, using a warm compress.  The site was described as "red".  On 08-OCT-2007, the symptoms resolved.  No laboratory diagnostic tests were performed.  There was no product quality complaint.  Additional information has been requested.
Recipient broke out in Hives anywhere covered with clothes and in their throat on 10/07/2022 - 10/12/2022 a 50 mg dose  of Benadryl, alcohol baths, and cold showers were needed to relieve the rash and itching
unspecified "health problems"; where someone got a flu shot the flu administrator stuck it in the arm wrong; Initial information received on 25-Nov-2020 regarding an unsolicited valid non-serious case from a non-healthcare professional via social media.  This case involves an adult female patient who experienced unspecified health problems (unevaluable event) and where someone got a flu shot the flu administrator stuck it in the arm (wrong technique in product usage process), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency) reporter stated that the patient developed unspecified health problems (unevaluable event) and side effects as a result of a female patient being administered a flu vaccine. Reporter also reported that when the female patient had contacted the Centers for Disease Control, no action was taken. It was reported that there was a story about the side effects of that and she don't know if it dealt with medications and side effects and doctors they basically do nothing for anyone if have problems, even seen where someone got a flu shot the flu administrator stuck it in the arm wrong (wrong technique in product usage process) caused all kinds of health problems when the girl called the place where they gave her the flu shot they were further to Centers for Disease Control did nothing for her.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown for unevaluable event and not applicable for wrong injection technique.   Disclaimer: this suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module VI of the good Pharmacovigilance practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Chills, Fever (99.9), muscle aches, headache, extreme tiredness, nausea for 18 hours after onset.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. Since 01-OCT-2014, the unspecified number of patients had been vaccinated with doses of LIQUID PEDVAXHIB (lot #, dose, route and frequency were not provided), which had underwent supported and unsupported temperature excursions (on unspecified dates of 2014). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
vaccine was given lower in the arm -- bicep area (?) vaccine did not feel cold like the first dose did reaction: red rash, approximately 4x3,, warm to the touch one week later, area looks a little less angry but still warm to the touch
Patient states the day after receiving the vaccine her arm became red, swollen and itching which decrease over time.
1/6/21: developed dull shoulder pain 2/7/21: initial shingles rash appeared 2/12/21: shooting pains in shoulder and underarms begin in addition to shoulder pain  2/16/21: treated with valacyclovir and ibuprofen, rash and shoulder/underarm pain still present
pt recv vax 4DEC96 & 6DEC96 pt exp 6 fluid filled lesions on back;
Heart issues, palpitations, shortness of breathe. Seeing physician. reported this on 1/27/2021.
knot in the stomach; Puking; Diarrhea; Hot flash from waist down to the upper thighs; Patient decided not to get second dose; Tingling of fingers; soreness of the left arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (knot in the stomach), VOMITING (Puking), DIARRHOEA (Diarrhea), HOT FLUSH (Hot flash from waist down to the upper thighs) and PARAESTHESIA (Tingling of fingers) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced PARAESTHESIA (Tingling of fingers) and PAIN IN EXTREMITY (soreness of the left arm). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (knot in the stomach), VOMITING (Puking), DIARRHOEA (Diarrhea), HOT FLUSH (Hot flash from waist down to the upper thighs) and PRODUCT DOSE OMISSION ISSUE (Patient decided not to get second dose). On 28-Mar-2021, PARAESTHESIA (Tingling of fingers) had resolved. On 03-Apr-2021, PAIN IN EXTREMITY (soreness of the left arm) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (knot in the stomach), VOMITING (Puking), DIARRHOEA (Diarrhea), HOT FLUSH (Hot flash from waist down to the upper thighs) and PRODUCT DOSE OMISSION ISSUE (Patient decided not to get second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Morning of 9-7-11; pt experienced pain to (L) arm. Per pt. report, the pain progressed throughout the day seen by PCP on 9-8-11 & treated with KEFLEX. Per pt report, quarter sized redness at injection site occurred later that same evening. By the am of 9-9-11, redness had doubled in size per pt report. Seen again by PCP on 9-9-11 due to worsening & in ER on 9-10-11.
Trunk, lower abdomen, pelvic region, lower back, under arms itchy, red "welts", "rash" no fever. Mom administered BENADRYL 12.5mg 9/8/10 - does not remember if 1 more dose was given 9/9/10 "cleared up" - has not reoccured.
12 hours after vaccine around 3:30am on Saturday I woke up with sever chills, shaking uncontrollably for an hour or 2. I fell back to sleep and woke up about an hour later burning up and sore head to toe. I threw up and had a migraine that lasted the rest of the day. I was able to fall asleep around 6:30am and when I woke up around 9 I was just exhausted, sore all over, nauseous, with a headache. This lasted about a day. On sunday afternoon my toddler lightly hit my right arm where the vaccine was and it became sore, red, and swollen. By the late evening that day the soreness and redness increased. Monday-Thursday the redness and swelling increased to about 2 inches round and felt very tight with a lump in the swelling and it was warm to the touch. By friday the redness and swelling reduced to about an inch, but there is still an inch small lump at the injection site and hurts when anything touches it. The redness has faded and there is no visual bruising.
pain in extremity; 3 by 2 in. red rash around injection site with random edges; Raised a little around injection site; Shoulder sore; Injection site feels warm to the touch; A spontaneous report was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Injection site warmth, 3 by 2 inch red rash around injection site with random edges/vaccination site erythema, raised a little around injection site/injection site swelling, shoulder sore/arthralgia, arm sore/pain in extremity  The patient's medical history was not provided. Concomitant medications reported were metoprolol, lisinopril,  alprazolam for drug use for unknown indication.  On 29 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 027L20A) Intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 8 Feb 2021, the patient experienced the events Injection site warmth, 3 by 2 inch red rash around injection site with random edges/vaccination site erythema, raised a little around injection site/injection site swelling, shoulder sore/arthralgia, arm sore/pain in extremity.Treatment details included Benadryl oral and cream.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, Injection site warmth, 3 by 2 inch red rash around injection site with random edges/vaccination site erythema, raised a little around injection site/injection site swelling, shoulder sore/arthralgia, arm sore/pain in extremity were considered not resolved.  Based on MSA comment, Injection site swelling is coded to Vaccination site swelling
Patient came in to office on 07/14/2021. Patient came up to vaccine table and presented her Covid vaccine card to care person. Patient?s vaccine card was given to care person. Once care person saw patient's Covid vaccine card we saw the card had the first and second dose of the Moderna covid vaccine was documented on the card from facility; the card was stamped twice from said facility. Patient was asked by care person if she had in fact received both covid vaccnine doses. Patient stated the vaccine stamps for both doses were done on the same day. Patent stated she had her first vaccine shot back in march and was not able to get second shot due to forgetting that the she had to go back. Pateint asked if she had to start all over with getting the vaccine administered. I and care person informed patient that if she had ?only one shot she did not have to start over, we can administer second shot today?. I asked patient ?if she was sure that she was administered only one shot from previous facility even though her card stated she was given both doses.? Patient stated she only received one shot, so  we  stated we could administered the second shot. After second shot was administered, patient?s original vaccine card was returned. We then also gave patient a new card showing that we administered her second  dose of the Covid Vaccine Moderna. Patient was then informed to wait the 15 minutes in room to be monitored.  After all shots were given for the clinic was completed.  I then started entering information into system. I looked up patient and saw that two doses of the covid vaccine was already inputted into system showing patient had received both covid vaccine shot previously before coming into clinic today.  I noticed system entry for both shots were from the same facility patient had on her original vaccine card. I told care person we discuss it and decided that our plan was to wait for coordinator to come back to office to discuss further action.   COVID coordinator  I called patient to confirm story, the patient expressed the same details as noted above. I requested for the patient to e-mail me a copy of her original card for documentation and the patient said she was on her way out she would stop by the office. When the patient got here, she showed me her card and all dates and lot numbers on card matched what was in system. I expressed to patient that if this were incorrect documentation by the facility, we would need to call them and have them fix it so that we may document her second vaccine. As I was giving the phone number to the patient, she begins to tell me that she does have a bad memory and she may have received the second dose already. I asked patient how she was feeling and requested to see the injection site. I did not see anything out of the ordinary, a little redness and warmth at the site. Patient stated that she was feeling bad on 07/15/2021 the day after vaccine administration, took some Tylenol and rested the rest of the day. Feels much better today. I expressed to patient that if ANYTHING changes, she needs to go straight to the ER and to call me after she was taken care of. Patient understood.
Fever 102, chills, vomiting, body aches, severe head and face pain, joint pain
Febrile seizure, generalized < 15 min, probable time < 5min;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 22-DEC-2014, the patient was inoculated with ZOSTAVAX at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-JUN-2016, she was treated by a physician at the office for a blistering outbreak and stabbing pain in her ears which was then diagnosed as severe herpes zoster, or shingles. The patient was prescribed valacyclovir (VALTREX) and acetaminophen-codeine in attempts to curb her painful symptoms. As a direct and proximate result of these malfunctions, she suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
12 cm x 11 cm erythema 9 cm x 10 cm induration at site of injection.
7-10 minutes after vaccine administered, 1 inch hive developed at injection site with 3 inch of redness. No other hives or signs and symptoms of respiratory distress. Sent to physician for follow up, was given oral antihistamine. 09/02/04, called mother, fine today.
Marked erythema and induration developed at the injection site. At its worst 3-4 days after took two weeks to completely resolve. Recommended cold packs, ibuprofen. Treated with course of KEFLEX in case cellulitis component.
Complaints of constant chest pain after 2nd COVID vaccine. No known history of any health conditions.  Pain does not radiate but is worse with exertion and movement.  He reports dizziness, fever, HA and cough.  He tried ibuprofen and tums without improvement.  pain is a 7 out of 10.  Admitted to the hospital 5/16/21.
Feeling of overall not feeling well. Then I felt angry and scared at the same time. Bad heat around my heart. Then I started getting tingling down my left arm. Then heart palpatations.  Then numbness in my left are and left side of my face with slight drooping on left side of face. I forgot to tell the nurse that my face felt numb on my left side. I had a mask on the entire time of my appointment.
Burning tongue; Dry mouth; This is a spontaneous report from a contactable other Health Professional (patient). A 27-year-old female patient received the first dose of bnt162b2 (Lot/batch number and Expiration date were not provided), intramuscular in left arm on 15Jan2021 12:00 at single dose for covid-19 immunization. Medical history included Asthma. Concomitant medication included ibuprofen (ADVIL), cetirizine hydrochloride (ZYRTEC). The patient previously took amoxicillin and experienced allergies. The patient experienced burning tongue, dry mouth on 15Jan2021 13:30. No treatment received. The patient was not pregnant. The outcome of the events was recovered on Jan2021.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
body aches; headache; fever; body chills; wasn't able to sleep; pain throughout her arm/injection site was extremely sore; This is a spontaneous report from a contactable healthcare professional. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number ek9231/expiration date unknown), dose number 1, via an unspecified route of administration on 03Jan2021 14:15 at a single dose on the left arm for COVID-19 immunization. Medical history included migraines. Concomitant medications were not reported. The patient was fine the day she got the vaccine, but when it came to the night of 03Jan2021, she wasn't able to sleep due to the pain throughout her arm. On 04Jan2021 04:00, she woke up with a headache that was intense, fever, and body chills. The injection site was extremely sore to the point where she took some Tylenol and slept it off. On 05Jan2021, she felt a lot better, but still with mild body aches. The patient was not diagnosed with COVID-19 prior to vaccination. She was not tested for COVID-19 since the vaccination. The vaccine was received in a hospital. No other vaccines were given in four weeks. The outcome of the events was not recovered for body aches, and recovering for the other events.
Within an hour I experienced inflammation and aching in the site of the vaccine. Later that night I started to feel lethargic and my legs were a little weak. The morning after the vaccination I experienced strong flu-like symptoms including fever, chills, lethargy, malaise, muscle aches, strong headache, coughing and phlegm.