chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information regarding PREVENAR was received from a healthcare professional regarding a 28-month-old female patient who experienced pneumococcal pneumonia, significant intraparenchymal cavitation and lung necrosis. The patient received the fourth dose on 23-Oct-2006. The patient experienced pneumococcal pneumonia with significant intraparenchymal cavitation and lung necrosis on 31-Aug-2007. The patient was hospitalized. The patient recovered. No additional information was available at the time of this report.
Full out shingles rash as reported by provider. Rash on rib cage/torso. No injection site reaction.
Information has been received from a registered nurse concerning a 7 year old female whose mother reported to the nurse that at 18 months of age in approximately 1996 her daughter was vaccinated with the MMR II. It was reported that the pt developed a fever of 105 F. Unspecified medical attention was sought. Subsequently, the pt recovered from the fever. Additional info has been requested.
Initially I was fine, but after 2 hours I started feeling joint pain. The next day the pain got worse and caused me to limp at work. I started feeling down. That night, I went home and had chills and fever. I was sweating in my sleep. I was fine on Christmas and now I have bronchitis like symptoms. I've seen 3 different providers at urgent care and was told that they don't know much about the vaccine. They told me to use Albuterol and go to the hospital if I get worse. I was told that I still have the antibodies from already having COVID twice and it may be causing me to have problems now. The first time was really bad and I developed pneumonia, but didn't go to the hospital due to all of the deaths occurring in city.
Focal Seizure on 1/23/2021 followed by extreme difficulty with cognition, thought processing and memory
Left shoulder and chest pain; shortness of breath starting at 6:00 pm September 21.  Rest of day felt fine - had dental appointment and worked normal work day.  Early morning September 22, woke about 3:00 am and went to ER with difficulting breathing and increased chest and shoulder pain.
Received vaccines Thursday morning. Pt noticed swelling to left upper arm Thursday night. Friday morning left upper arm with swelling, redness and warmth. Walk in clinic Friday morning recommended ice to area. ER Friday evening recommended BENADRYL and antibiotic.
pt went to urgent care due to Bells palsy 7 days post vaccine, they informed her to report to pharmacy so that we could report reaction to vaccine
10Mar97 Pt recv 1st dose vax. 28Nov97 Pt devel fever,vesicles & rash which started on penis & spread to trunk,neck & back. 03Dec97 Pt recovered.
Pt Indicated Sx:rash on his shoulders and antecubital areas. He would get intermittent sharp pains on his shoulders and ankles. He also got headaches. This lasted for a week. Although the rash lasted a month. He kept applying OTC remedies and it finally went away.
Pfizer-BioNTech COVID-19 Vaccine : During vaccination administration, the vaccine recipient pulled away and none of the vaccine dose was injected into the arm. This was a vaccine administration error.  Vaccinator completed the vaccination with a new dose
Patient came in with stiff joints all over body. Complaining about difficulty breathing and swallowing. Fever 100.6 Family states hx of anxiety attacks. B/p 140/90, pulse88. Immunization arm very sore. No redness noted.
LEG PAIN; SEVERE HEAD PAIN; This spontaneous report received from a consumer via a company representative concerned a 20 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced leg pain, and severe head pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe head pain, and the outcome of leg pain was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
rash; This is a spontaneous report from a contactable consumer via Pfizer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  Historical vaccine includes dose1 of BNT162B2 received on 24Feb2021. The patient experienced rash on 03Mar2021 with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt c/o numbness in (L) arm. Feels radiating "hotness" up and down arm. No visible changes noted. Arm strength equal bilaterally.
This was my second dose of the Moderna vaccine. I felt soreness starting in my arm almost immediately. The arm soreness grew in intensity the rest of the day. Around midnight that night, I became extremely warm and was very hot. (I generally run cold.) The next day, my temperature reached 99.7, and I felt stuffed up on one side of my nose for a few hours. Also, I was very tired and still felt overheated. My arm hurt even to lift it above my head. I woke up the following day feeling better, though the arm soreness did linger a bit still that day.
Severe fatigue, coldness, shivering, but NO fever -- for about 1 week.  Followed by onset of painful full body shaking / trembling (arms and legs).  Treated with Lorazepam / Clonazepam to control shaking.  However, continuing issues with poor sleep, anxiety, and periodic extreme fatigue continuing to the present (11/23/11).  Clonazepam continues to be necessary daily to control shaking / tension.  MRI has ruled out structural brain issues.  Multiple blood tests (CBC, nutrient studies, thyroid, and more) have yet to identify a cause for symptoms.  EEG verified no epileptic activity.  Cardiac studies (stress test and echo-cardiogram) showed no abnormal heart conditions.
Patient was given wrong vaccine. Patient received Pedvax HIB instead of Prevnar. There was no adverse reaction report by patient's mother. Patient will need to return to clinic to receive Prevnar vaccine.
Pt reported that minutes after taking her first dose of oral Typhoid she began to "feel funny", her tongue began to feel thick, her skin turned beat red, her hands and arms began to itch, she had facial swelling, pt was taken to the local ER room where she was treated with oral Atarax and released within 24 hours.
Mild flu like sym. that started approx. 8 hrs after injection and lasted approx. 8 hrs.
Narrative: COVID infection following COVID vaccine series 02/12, Pfizer, dose #1 03/12, Pfizer, dose #2 08/16 pt cc: No symptoms exposure: unknown 08/16 COVID swab, result: detected
She got DTaP #4 and Hib #4 at 10 A.M. At 11:30 AM swelling of eyelids (upper) R>L was noted - returned to clinic was seen.
Symptoms lasted 4 weeks and included muscle and body aches, fever <100 deg F(2 weeks), loss of appetite, fatigue,  vomiting and diarrhea (1 day),
This spontaneous report was received from a health professional refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with unspecified doses of PROQUAD (Merck) (routes, lot numbers and expiration dates were not provided). On an unknown date, an unspecified number of patients received improperly stored PROQUAD (Merck), so there was an incorrect product storage. No adverse event was reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status' was unknown. This is one of several reports received from the same source. Additional information has been requested.
Scheme not completed on time; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 15th June 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-JAN-2023 Reporter's Comments: A medical assistant called to inform that a varicella vaccine was administered to a patient by accident instead of the Shingrix vaccine, also informed that due to this event the scheme of Shingrix was not completed on time. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Details were reported for non-gsk product.
aware of 6 cases of Bell's Palsy by the companies making these vaccines; This is Spontaneous report from a contactable Other HCP. This Other HCP reported similar events for 6 patients. This is 4th of six reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter reported since the use of modified RNA in covid vaccines, he/she had aware of 6 cases of Bell's Palsy by the companies making these vaccines since an unknown date. The outcome of the event was unknown.  Information on the Lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between event Bell's Palsy and BNT162B2 vaccine cannot be excluded. 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-2021007605 same reporter, same drug, same event, different patient
This spontaneous report has been received from a pharmacist concerning a female patient of approximately 75 years old. Patient's pertinent medical history and concurrent conditions were unspecified by the reporter. No previous drug reactions or allergies were reported. On 09-JUN-2015 the patient was vaccinated with ZOSTAVAX (0.65 mL, subcutaneously, left deltoid0 lot # K018176 with an expiry date of 10-JAN-2016. No concomitant medications were reported. On an unknown date in June 2015 the patient experienced shingles. The patient filled a prescription at the pharmacy on 22-JUN-2015 for gabapentin 100 mg two capsules twice a day as needed for shingles pain and acyclovir 800 mg three times a day for 10 days. THe pharmacist states that she does not know when the patient began to experience shingles. The patient filled another prescription on an unspecified date after 22-JUN-2015 for gabapentin for shingles pain, and the patient reports that she is still experiencing post herpetic neuralgia. The pharmacist believes that the patient's lesions are healing. The outcome of the events shingles and post herpetic neuralgia were reported as recovering. The reporter did not provide the causality between the events and the suspect therapy. Additional information has been requested.
COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a female of unspecified age.  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000241343.
Tiredness; Muscle pain; Injection site pain; Feeling unwell; Feeling Feverish (but no fever); This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 10Apr2021 at 09:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included reactive airway disease, ARDS (acute respiratory distress syndrome) survivor and mild latex allergy (rash/hives). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 20Mar2021 at 15:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 10Apr2021 at 18:00, the patient experienced tiredness, muscle pain, injection site pain, feeling unwell and feeling feverish (but no fever). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tiredness, muscle pain, injection site pain, feeling unwell and feeling feverish (but no fever) were resolved on an unknown date in 2021 at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The pharmacist reported that the patient was vaccinated with a dose of RECOMBIVAX HB injection (10Y) on 14-NOV-2014 and the second dose on 07-AUG-2014. No adverse effects reported. No further information provided. No PQC. Outcome of the event was unknown. Additional information is not expected.
Patient lost full range of motion after receiving vaccination. He was unable to lift his arm to dress and was unable to sleep do to the pain.  Pt sought medical from primary care provider and was told the flu shot was administer too high and went into the shoulder joint.  Patient was prescribed pain medication for the pain.  Patient has improved arm function but not back to normal yet.
Slight swelling - pain 2 hours after - next day pain, discoloration black and blue 6 inches by 3 inches. Pain gone after 2 weeks. Discoloration still exists about 3 inches by 2 inches.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 07-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) dose, route and anatomical location were not provided. There was no concomitant medication provided. On unknown dates, the PNEUMOVAX had temperature excursions for 72 hours with the lowest recorded temperature of 28F (-2.2 Celsius) and 40 hours with the highest recorded temperature 47 F (8.3 Celsius). The vaccine status was reported as "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved and no adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Systemic: Dizziness / Lightheadedness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Additional Details: 911 was called and responded to pharmacy. Patient was hypotensive. Patient's husband was called and arrived on scene to transport patient home.
I had my 2nd Shingrix 50mcg Injection on 9/26/19. On 9/27 I was extremely tired and weak. Slept through most of the day, unable to even eat. On 9/28 I was still exhausted and now covered in a rash from my neck down to my waist and down both arms. I took Benadryl for this. Only able to eat a waffle, still no appetite. On 9/29 still covered with rash and now had diarrhea. Today, 9/30 diarrhea is mild. Still tired I went to my doctor today just to have her check me out.
pt reported to RN that he "felt like he was going to pass out" pt was very pale, diaphoretic, had brief syncopal episode lasting about 15 seconds. carotid pulse weak and about 40-60bpm pt regained consciousness spontaneously, after about 30 seconds pt reported feeling better. pt ambulated to EMS area for vital signs and evaluation. Time - BP - HR - SPO2 - RR 19:11 - 121/55 - 64 - 97% - 16 19:15 - 125/81 - 75 - 99% - 18 pt feeling much better at this time. pt is refusing transport to the hospital. pt given water to drink, at this time 19:27 has no complaints.
I woke up extremely fatigued, feverish with a headache, chills and dizzy.  I spent the day sleeping and had to cancel the plans I had made for the day.  I was too weak to do anything.  At one point, I felt sick to my stomach, but I did not vomit.
08/23/2002 Pt come by the clinic complaining of pain, swelling, itching on left upper arm. Pt had TD shot last 08/16/2002. Observed swelling, redness on left upper arm, deltoid area. Pt stated back four years had antibiotic on arm, had some reactions. Advised pt to elevate arm and apply cold compresses on the site where redness and swelling. Advised pt if symptoms get worse see PMD for evaluation.
Syncope immediately after vaccination-Vital signs stable throughout at 2 min intervals (BP L arm sitting 108/58, pulse 82 regular, 102/60, 84 regular, standing: 104/60, pulse 84 regular).  Recovered on his own within 15 minutes
Muscle weakness, extreme fatigue, irregular gait, arm and hand pain, numbness and burning, leg and feet numbness, pain and burning. Hand, arm, feet and leg neuropathy, 47/49/67/69%.  Bell?s palsy left side of face, inability to blink left eye, flickering vision, bright flash sensations making it impossible to drive (migraine like blindness) left side, inability to drink water. Leaks out of left side of mouth.  Inability to sense cold or hot water in hands arms legs and feet. Inability to lift even routine items. Inability to stand for more than a few (2-3) minutes. Inability to tolerate pressure to arms such as arm rest in planes, or arm rest on chairs. Pressure in calves and feet. Inability to tolerate crossed legs pressure. Inability to walk even 1 block without resting or sitting down.  Inability to lift a carry on suitcase to over head bins.  Severe Headaches, inability to sleep more than 1-2 hours due to body aches and pain in extremities.  Pain in hands holding everyday items like smart phone, smart device, etc.  Inability to lift or carry groceries.  Severe thirst.  Ringing in ears and up the back of  head and neck. Severe Neck pain.  Jaw pain and some lockjaw symptoms when eating. Jaw will lock open when trying to bite or eat.  Inability to hold lawnmower handle, paint brush, bottle of water, coffee cup etc.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 17-FEB-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23, intramuscular, lot number L035687 with expiration date 16-FEB-2017 (dose and anatomical location were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
I have had idiopathic angioedema, since 10/21.  This bivalent booster made it so much worse.  Lip and tongue swelling are unpredictable.
a palpable supraclavicular mass on my left collarbone; got worse a few days after 2nd injection (bigger and moreuncomfortable); got worse a few days after 2nd injection (bigger and moreuncomfortable); This is a spontaneous report from a contactable female consumer (Patient). A 31-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration in arm left on 05Feb2021 14:15 (at the age of 31-years-old) as second dose, single for COVID-19 immunization. The patient medical history included polycystic ovarian syndrome, shortness of breath, heart palpitations, vitamin D deficiency, seasonal allergies, allergy to horse serum and cats. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EL8982) via an unspecified route of administration in arm left on 15Jan2021 as first single, dose for COVID-19 immunization. The patient received unspecified medications with 2 weeks of vaccination. The patient received COVID-19 vaccine Pfizer/BioNtech (dose 1) prior to the COVID second dose within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not tested for COVID-19 post vaccination. On an unspecified date in Jan2021 (10-days after receiving first dose COVID-19 vaccine), patient experienced a palpable supraclavicular mass on my left collarbone. Patient had reported to PCP, he ordered ultrasound and LDH/CBC/CMP labs. Then followed up with ENT Head/Neck Specialist for further follow-up. Mass varied in prominence over about 6 weeks and got worse a few days after 2nd injection (bigger and more uncomfortable). Now much smaller and less prominent but still noticeable upon examination. The patient did not receive any treatment for the events. Patient had doctor or other healthcare professional office/clinic visit for the event. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
This infant had DTaP and Prevnar injected at separate sites of the right upper arm. No sterile abscess, but muscle swollen, slightly tender, red blotches on upper arm 7 cm x 2 cm around the injection site, 3; 1 x 1 cm 65 inch posteriorly upper arm and 2 smaller blotches below the injection site. 3 x 2 cm and 1 cm diameter not warm or indurated, no hives.
According to records in electronic system, first dose of Moderna was provided on 03/31/2021 and second dose on 04/20/2021. This makes the second dose invalid as it was provided too early. Patient notified and true second dose was provided after consulting with a physician.
FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not 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 subject 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.