chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an employee at a physician's office concerning a 4 year old male patient with no pre-existing allergies, birth defects or medical conditions who on 10-AUG-2000 was vaccinated IM in left anterior thigh with a first dose of VARIVAX (Oka/Merck) (LOT# 632612/1851J) and was vaccinated IM in right "VL" with a third dose of ENGERIX-B (LOT# 3142AZ). Concomitant therapy included BENADRYL and mejoralita. On 25-JAN-2004 the patient developed zoster, left leg and cellulitis. It was to late for Acyclovir. Cephalexin 250/5 (KEFLEX) was prescribed. At the time of the report, it was unknown if the patient had recovered. Additional information has been requested.
This is a non serious spontaneous case from a consumer requiring an ER visit due to periorbital cellulitis. The reporter causality to FluMist is not provided.  A consumer reported a case of periorbital cellulitis in a female neighbor. Pt's demographics and past medical history were not reported. The pt received FluMist on or about 05Nov04. On 05Nov04, the reporter stated the pt had swelling and pain around one eye. The events continued over the weekend. On 07Nov04, the pt presented in the ER and had a CT scan. The pt did not have an infection behind her eye and the documented contition was periorbital cellulitis. She was sent home with a three day antibiotic regimen. As of 08Nov04 the reporter stated the pt was feeling much better. Follow up 03/07/05: Several attempts had been made to obtain vaccine lot number and patient's date of birht and age. As of 03/07/05 no information was received. A letter requesting addtional information will be sent to the reporter.
For the last few weeks I have been having shortness of breath and it feels like I have a hole in my diaphragm. It feels like air is leaking out of my diaphragm when I take a breath. I have been getting really dizzy as well. It feels like my internal cavities of my body don't have the right pressure. My legs feel like led as well.
extremely lightheaded; like he was about to fall down; This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients. This is the 1st of 2 reports.  An 89-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL0140), intramuscular on the right arm on 30Dec2020 10:10 at single dose for vaccination.  Medical history included covid-19 on Jul2020 and had it fairly severe and almost died and he mentions he was overweight.  There were no concomitant medications.  The patient previously took flu shot (INFLUENZA VACCINE), a couple of months ago. He mentions he was in the military so he had a lots of shots in his life but he has never had a reaction like this.  The patient stated that on 30Dec2020 10:30, "he became extremely lightheaded, like he was about to fall down. He sat down and is currently sitting down. This lightheadedness started about 20 minutes after the injection. When probed for the outcome, the caller explains it might be improving a little. The lightheadedness is not still not gone, but it has not worsened.  When probed for seriousness criteria, the caller explains he is just resting and sitting. He would say its not serious but it could be medically significant. He states he isn't sure if this is something that happens to just people who have had COVID before. He states none of his friends or relatives have this type of reaction. He lives in a retirement home and everybody is getting the injection. This is the second day of injections. He doesn't know if anybody had a reaction to the COVID-19 vaccine here". The outcome of the events were recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of lightheadedness and pre-syncope due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520862 same reporter/drug, similar event, different patient.
Pt recv vax on 12/7/98; on 12/8/98 pt exp redness, swelling of vax site; dx=cellulitis; tx=Keflex
First, the injection was far more painful than anticipated (and it bled down my arm).  My arm immediately ached intensely.  Approximately 10 minutes after injection, I began to sweat profusely, followed by intensifying extreme lightheadedness. I could not stand, or lift my head, as I would have definitely passed out.  My shoulders and neck became extremely painful, as if ?frozen?, also preventing me from lifting my head.  After about 35 minutes I very gradually began to recover. It was about an hour before I began to move around normally.   Pharmacy and store staff  debated calling the paramedics, but I refused.  FYI, I had not been especially anxious about the vaccine, and I have never experienced such a reaction to anything in my life. It was a traumatic experience I would not wish to repeat.
A physician reported that a 10 month old female received Prevnar and within 24 hours, post vax, developed a fever of 102F to 103F and an injection site reaction characterized by a 3cm to 4cm area of redness and induration. The infant was taken to the ER for further evaluation. No further information was available at the date of this report. The reporter indicated that 4 pts experienced this event following receipt of Prevnar lot 475383; however, 3 are not presently identifiable. Additional reports will be generated when identifying information is provided.
12/9/21  57-year-old female presents today for Covid testing.  Patient states that she has been having cough, low-grade fever, headache and body aches x1 day.  Patient states that she was exposed to coworker who tested positive today for Covid.  No prior history of Covid.  She is fully vaccinated against Covid.  Has been taking Tylenol over-the-counter and nasal saline sprays for her symptoms at home.  No chest pain or difficulty breathing
Pain at injection site, large swelling on arm at injection site, fever 99 degrees, itchy rash on arm at swelling site, 7 days time course until stopping.
Hives, Benadryl and Allegra, itchy, red welts all over my body except for my back, hands, face, lower legs, and feet.
I have been having heart population, I was running a race this Sunday. I dizzy and lightheaded and had an EKG. I saw the doctor on 10/3/22. They diagnosed me with Arrhythmia.  I haven't got any treatment yet.
(R) arm redness, swelling, hot and painful following vaccination x 2 days.
malaise; itching on the side of his neck (From under the ear to shoulder); Rash on the side of his neck (From under the ear to shoulder); This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), PRURITUS (itching on the side of his neck (From under the ear to shoulder)) and RASH (Rash on the side of his neck (From under the ear to shoulder)) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced MALAISE (malaise), PRURITUS (itching on the side of his neck (From under the ear to shoulder)) and RASH (Rash on the side of his neck (From under the ear to shoulder)). At the time of the report, MALAISE (malaise), PRURITUS (itching on the side of his neck (From under the ear to shoulder)) and RASH (Rash on the side of his neck (From under the ear to shoulder)) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medication was not reported.  The patient had a rash and itching on the side of his neck (from under the ear to shoulder) which looked like shingles. The patient used a Steroid cream that he had at home and it looked better.
Pain site; Tiredness; Headache; Muscle pain; Feeling unwell; Arm pain; Nausea; Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on an unknown date in 2021, as a single dose for COVID-19 immunisation. Medical history of the patient was reported as none. The patient had no known allergies. Concomitant medications included anxiety medications (MANUFACTURER UNKNOWN), on an unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on an unknown date in 2021 at 14:00, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Jun2021 at 00:00, the patient experienced pain site, tiredness, headache, muscle pain, feeling unwell, arm pain, nausea, fever and chills. . Therapeutic measures were not taken as a result of these events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain site, tiredness, headache, muscle pain, feeling unwell, arm pain, nausea, fever and chills was not recovered at the time of this report.   The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
Information has been received from the mother of a 4 year old male with no medical history and no drug reactions/allergies who on 27-FEB-2007 was vaccinated with a 0.5 mL dose of Attenuvax (Enders-Edmonston).  There was no concomitant medication.  On 28-FEB-2007 the patient developed a fever of 104 after vaccination.  On 01-MAR-2007 the patient had glassy eyes and a temperature of 102.  On 02-MAR-2007 the patient had a temperature of 103.  On 05-MAR-2007 during the weekend, the patient's glands were swollen, he experienced a dry cough and a runny nose.  The mother reported that her son's eye hurt on 05-MAR-2007, he is sensitive to light and his glands are still swollen.  The patient sought unspecified medical attention.  The mother reported that the son's physician believes it is a "second viral infection."  The patient's status was reported as not recovered.  There was no product quality complaint.  Additional information has been requested.
Expired ROTARIX vaccine given( exp. 7/3/18). Remainder of Lot removed from stock. Mom/client had left clinic when event realized. Phone call to mom 9/13/2018 to notify of need to repeat dose. Arranged to RTC 10/3/2018 for this.
Patient received 2nd covid Bivalent vaccine. No adverse reaction was noticed. Contacted HD to report.
Bell's Palsy started 12/24 or 12/25/2020 Narrative:  Currently being treated by her Primary Care Provider with prednisone
Moderna Covid Vaccine EUA: Patient developed sensation of throat tightness approximately 15 to 20 minutes after administration of vaccine while in observation area for 30 minute observation.  Evaluated by physician on site.  No visible swelling of neck, lips, mouth, face, tongue; no palpable swelling of neck; breath sounds and heart rate normal.  Single hive noted on frontal neck above collar bone.  Patient took oral diphenhydramine 25 mg and oral famotidine 20 mg.  Observation period extended with one on one monitoring.  Symptoms resolved within 15 minutes.  Total observation of 1 hour after vaccination.  Patient and family instructed on management of possible recurrent symptoms.  They have managed multiple allergic reactions in past and are comfortable with returning home.
got a rash on the right side of my body, neck, chest, my back, my arm; Shingles and they are very painful; This is a spontaneous report received from a contactable consumer (Patient). An 83-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch number: EL9265), via an unspecified route of administration at the left upper arm on 08Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she believes she got bad reactions because the following week on 15Feb2021 got a rash on the right side of my body, neck, chest, my back, my arm. It was reported that on unspecified date of 2021 she got shingles and patient felt it was from vaccine. The patient stated that went to doctor again and she definitely said that shingles and gave medications. she was very bothered as she got rash and shingles. she supposed to get the second dose on 01Mar2021, but she can't get it because she was afraid. Patient was fine and feeling good, and stuck with the shingles and they are very painful. Patient received treatment for Shingles. The outcome of events was unknown.
Left arm is swelling and redness, and the next day arm continued to be red (for 2 weeks)  The skin on site is discolored as of today.
Arm doubled in size\ Expansion of the inflammation to the lower arm; Loss of mobility in the arm; Sore arm/ pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Loss of mobility in the arm), VACCINATION SITE PAIN (Sore arm/ pain in the arm) and VACCINATION SITE SWELLING (Arm doubled in size\ Expansion of the inflammation to the lower arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Loss of mobility in the arm), VACCINATION SITE PAIN (Sore arm/ pain in the arm) and VACCINATION SITE SWELLING (Arm doubled in size\ Expansion of the inflammation to the lower arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Loss of mobility in the arm), VACCINATION SITE PAIN (Sore arm/ pain in the arm) and VACCINATION SITE SWELLING (Arm doubled in size\ Expansion of the inflammation to the lower arm) outcome was unknown.            Concomitant drug was not reported. Treatment medication was not reported.
I had knee replacement about 4-5 weeks before testing positive for COVID-19 so some symptoms may have been from that but I headache, pressure and pain in lower back, all of my joints hurt, my skin hurt, I had an increase in asthma symptoms, not shortness of breath, coughing, congestion, fatigue, mild sore throat, and brain fog.
no additional AE; a dose of PROQUAD was administered to an adult today; This spontaneous report was received from a registered nurse and refers to a 52-year-old female patient.  The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 23-AUG-2023, an adult patient (product administered to patient of inappropriate age) was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) 0.5 milliliter, lot # reported and confirmed as: W034209, expiration date was reported and confirmed as: 24-APR-2024 (dose number, site and route of administration were not provided) for prophylaxis. The patient needed varicella and measles, mumps, rubella (MMR) vaccination for nursing school. No side effects or symptoms reported. There was no additional adverse event.
Cellulitis Originally unsuccessfully treated with BACTRIM. Successfully treated with Doxycycline 100 mg.
given HIB had cry gave DTP IM & no cry; pt rocked around to stimulate no resp used ambulance; had gag reflex when paramedic tried to intubate; CPR given;
6PM 1JUN fast breathing, clenched fists locked jaw, eyes rolled, shaking/stiff body then stopped breathing per mom; has had 5 other sz since then; no hx of sz a/; mom says pt has t99-100 during sz;
chest pains; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pains) and PAIN IN EXTREMITY (sore arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A, 027821A and 027H21B) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery. Concomitant products included TERAZOSIN, METOPROLOL, HYDRALAZINE, ATORVASTATIN, ISOSORBIDE and IBUPROFEN for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced CHEST PAIN (chest pains) and PAIN IN EXTREMITY (sore arm). The patient was treated with GLYCERYL TRINITRATE (NITROGLYCERINE) for Chest pain, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (chest pains) had not resolved and PAIN IN EXTREMITY (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported taking nitroglycerin after the chest pains and still experiencing the chest pains.  Patient passed his stress test.
Possible grand mal seizures about 5 mins after vaccination lasting for 2 minutes.  Eyes rolling, toniclonic movements, pt afebrile.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 03-DEC-2015, the patient was accidentally vaccinated with an expired dose of PNEUMOVAX 23 lot # K007824, expiration date 05-NOV-2015, (dose number, route, and anatomical location were unspecified). No adverse effects reported. Additional information has been requested.
Aches; chills; fever; fatigue; diarrhea; dizzy; mental fog; Injection site pain; Injection site swelling; arm rash; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 13:00 (at the age of 45-year-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 13:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, ulcerative colitis, ADD (attention deficit disorder) and sickle cell trait. The patient was allergic to adhesive and latex. Concomitant medications included paracetamol (TYLENOL ARTHRITIS). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 13:45 the patient experienced aches, chills, fever, fatigue, diarrhea, dizzy, mental fog, injection site pain, injection site swelling and arm rash. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department, or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events aches, chills, fever, fatigue, diarrhea, dizzy, mental fog, injection site pain, injection site swelling and arm rash were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
left arm is sore; headache; nausea; Threw up once; tired; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (Threw up once), FATIGUE (tired), VACCINATION SITE PAIN (left arm is sore) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced NAUSEA (nausea), VOMITING (Threw up once) and FATIGUE (tired). On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (left arm is sore) and HEADACHE (headache). On 04-Feb-2021, VOMITING (Threw up once) had resolved. At the time of the report, NAUSEA (nausea), FATIGUE (tired), VACCINATION SITE PAIN (left arm is sore) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Initially on March 31 (one week after the vaccine) I had some redness around the injection site but that resolved within a few days.  Then on April 3rd (11 days following the COVID vaccine), I felt very sick. I had chills, nausea, felt very fatigued. Later that day I was feeling very flushed and had diarrhea and felt like I was going to pass out. This happened throughout the afternoon. Symptoms improved by that evening. The following day I had similar symptoms but they were more mild. I had no measured fever at home during this time. My symptoms completely resolved by 4/5/21. On 4/6/21 a new rash started on my left arm around the injection site. It was very warm to touch, uncomfortable but not painful.  Red area is increasing in size and it is raised around the edges. No fevers or chills. I went to the doctor on 4/6 for my symptoms. She prescribed Cephalaxin (Keflex) and ordered a Covid test for me, which was negative.  This description was taken mainly from that after-visit summary.