chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient  is a 61 y.o. male patient of, MD with history of anemia, Asthma, COPD, Gout, Cocaine use, HTN presented to  Medical Center with flu like symptoms .   Sepsis-POA, resolved  Possible CAP Covid-19 pulmonary infection Acute asthma exacerbation Acute hypoxic respiratory failure/ Date of onset of symptoms: ~7/15 P/w fever, tachycardia Date of covid positive test: 7/17 Vaccination status: vaccinated Imaging: CXR bibasilar opacities  Oxygen requirements on admission: RA Current oxygen requirements: RA Medical therapy: steroids; Levaquin; initiated on remdesivir and already on steroid Consultants following: ID E-consult Anticipated special isolation end date: 7/27 Overall improving Finished steroid course and remdesivir with improvement Finish 7 days of Levaquin Hyponatremia Could be due to decreased oral intake Encourage solute intake Dry lung strategy Monitor DC IV fluid Improved     Mild anion gap metabolic acidosis Bicarb 15, etiology? Resolved     HTN Cont home Norvasc BP stable   Skin rash Over both ankles x1 week Pt attributes them to friction due to tight shoes Psoriatic look clinically Outpt f/up   ETOH abuse Drinks 'plenty of beer' but denies heavy drinking or dependence Was at facility earlier
This case meets vaccine breakthrough review criteria. SxS include weakness for 1 week PTA, some diarrhea
Information has been received from a physician concerning a 16 year old female who on an unspecified date was vaccinated with the first dose of HPV vaccine. subsequently the pt developed lower extremity weakness and was hospitalized for two days with Guillain [[name]]. The pt received treatment with gamma globulin during her hospitalization. At the time of this report, the pt was back to school and was 99% recovered having only some area of numbness to her lower extremities. The physician did not believe that the pt was on any other medications at the time and had no further details to provide. Additional information has been requested. Mild Guillane [[name]] Syndrome. EMG study on 10/10/2006: nerve conduction studies of right peroneal and tibial nerves were normal. F wave latencies were normal but some blocking was present. Conclusion: study consistent with mild Guillain [[name]] Syndrome.  12/12/06-records received from facility. DX Mild Guillain [[name]] Syndrome. 12/28/06-DC Summary received DC DX: Mild Guillain [[name]] Syndrome. 1.5 week duration of tingling below kness and above ankle bilaterally. Pain with walking. Office note for DO 12/28/06 from pediatric neurologist:continues to have tingling from elbow to hands, improving. On Neurontin 100 mg tabs 1 three times per day. Has pain across shoulders and neck also lower back. Will order labs.
Numbness lips,mouth; Was feeling bad; leg numbness/numbness in head, face; pain in head; increased BP; blood pressure was up and down; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) via an unspecified route of administration in left arm on 29Dec2020 6 am at single dose for covid-19 immunisation. Co-suspected drug amoxicillin;clavulanic acid (AUGMENTIN, Batch/lot number: KN4291, Expiry Date: Mar2022) by mouth from Dec2020 to 28Dec2020 at 875mg, 1 tablet twice daily for pain or infection; MOXIFLOXACIN HYDROCHLORIDE (AVELOX, strength:400mg) by mouth from 29Dec2020 and ongoing at 400mg, 1 tablet once daily for infection; fluconazole (DIFLUCAN, strength:200mg) orally (by mouth) from unknown date and ongoing at 200mg, 1 tablet once daily for Infection.The patient's medical history was reported as ongoing high blood pressure, ongoing pains in her fingers and toes and they thought she had an infection from 02Dec2020, white count went down on 09Dec2020, ongoing pain was up and down. No other vaccines given at that time and none given 4 weeks prior. Had a Flu shot back in Oct2020, but no problems. None diagnosed allergies and family medical history relevant to adverse event. The concomitant medications included unspecified blood pressure medication by mouth daily for high blood pressure. She had also started 2 antibiotics around the same time that she received the vaccine.  No further details provided Was on antibiotics at the time she was given the Pfizer COVID-19 vaccine. Patient experienced increased BP/ high blood pressure, pain in head, and leg numbness; all started 2 days (on 31Dec2020) after receiving the vaccine and persisted for 48 hours. First her blood pressure was up and they had to get it stable and had numbness in her head, face, and mouth for 48 hours. Her blood pressure was up and down and she has history of blood pressure and takes medicine. Was taken off work for a few hours and went to the emergency department on Fri night about 2am. Her blood pressure was 170/92 on 01Jan2021. Not sure if this was related to the vaccine, but the numbness in her head started from her upper neck to face to the right side of her check and she also had leg numbness. Wanting to know if this was related because she was worried about getting the second dose. Had a hard time for 48 hours. Weight was between 150-155 pounds. Stated everything improved after 48 hours. Her lip was also just a little bit numb, but it is feeling better. Patient was feeling bad from 01Jan2021, all Fri and Sat and much better by Sun. Events of increased BP/ blood pressure up and down, leg numbness, numbness in lips, head, face, mouth with emergency room visiting. Wanted to know if she should have the second dose. The action taken in response to Augmentin was permanently discontinued on 28Dec2020, for Avelox and Diflucan was dose not changed. The outcome of events was recovering.
A vein in my left arm where she injected turned almost neon blue.  The pharmacist noticed it and I kind of blew it off, but then later I realized how blue it had turned and realized it may have been an adverse event.  Right now only issue is my arm is extremely painful.
First Dose administered on 22-Dec-2020 and second dose administered on 12-Jan-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose administered on 22-Dec-2020 and second dose administered on 12-Jan-2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose administered on 22-Dec-2020 and second dose administered on 12-Jan-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose administered on 22-Dec-2020 and second dose administered on 12-Jan-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   This case was linked to MOD-2022-551251 (Patient Link).
This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced chills and a racing heart on an unspecified date. The outcome of events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Pt. states that after receiving the 2nd dose of Phizer 03/14/2021, started to experience pain in the right shoulder 03/14/2021 resulting in arm weakness. Pain has continued through the backside. Still continuing to experience Symptoms, no noted Primary visit.
9/16/98 pt recv 1st dose of vax & 9/23/98 pt exp headache, stomach ache, stomach ache described ``spasms of pain that come in waves'' also exp aches & cramps in legs, aches in neck, cramping in back/swollen gums, dizzy 9/25; mild rash
raised place on the right wrist/ a raised place on the right and then there is a smaller place on the left; This is a spontaneous report from a contactable consumer or Other Health Professional. A 69-years-old female patient received first dose of BNT162B2 (solution for injection: Batch/Lot Number: EL9265) via an unspecified route of administration at left arm on 28Jan2021 15:30 as single dose for covid-19 immunisation. The patient Medical history and concomitant medications were not reported. There is no prior Vaccinations within 4 weeks. The patient experienced raised place on the right wrist on 30Jan2021 with outcome of re-covering, a raised place on the right and then there is a smaller place on the left wrist on 31Jan2021with outcome not recovered. She had to bend her hand to see the one on the left. The place on her right wrist is a tad smaller now. The place on the right wrist is wider than a quarter. The left one is smaller than a dime. She is planning on getting the second dose but has not scheduled it yet.
Swollen, red arm at site of injection, enlarged, red painful lymph nodes on right collarbone and under right arm. Fatigue, fever, muscle aches
1-3 min after vaccine pt with fever - saying he couldn't breathe, no wheeze (? throat closing 5x). V - received epi 0.2 cc with resolution of sx in 1-2 min. Observed x 5 hrs - only feverish with tachycardia x 1-2 hrs.  11/27/2007 MR record received from vax provider for DOS 9/20/2007.  After receiving MMR pt began itching and hives appeared.  Pt reported difficulty breathing.  No wheezing noted.   Pt was sneezing and erythema and flushing of skin noted.  Epi given with resolution of symptoms
Strep pneumonia from blood, presumed strep pneumoniae pneumonia. RSV + Hosp 11/24/2006 - 11/29/2006 TX Antibiotics.  03/20/2007 MR received for a 5 day hospital admission for respiratory distress.  Child had cough and nasal congestion x 7 days with fever up to 102'F x 2 days.  Seen in pediatrician's office where O2 sats were found to be 89% and he was sent to the ER.  Child was admitted for tx and required supplemental O2, antipyretics, and antibiotics.  Discharged after 5 days. Final DX: Right middle lobe and left lower lobe pneumonia.  RSV infection.
I had covid19 last March 2020 and after I recovered I developed tinnitus in my right ear that is still a problem for me today.  The ringing level was at a 4-5 range before and immediately after the 1st Pfizer vaccine shot on 4/4/21, the ringing level went to a 9-10 and is still at that current level today after almost 3 weeks.  I am not going to get the 2nd shot because of this reaction, and wanted it to be documented,
a 5 year old patient  received Pentacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional (Reference number- 00436824) and transmitted to company on 19-Jan-2021.  This case involves a five-year-old male patient who received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination on an unknown date (Product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   This was a case of actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Loss of Breath after 5 days after both Vaccines  Urgent Care concerned about Blood Clot Hospitalize 3 days - New diagnosis -  Congestive Heart Failure
Patient fainted post vaccination sitting in chair, fell on floor, scraped facial area, brief LOC, EMS placed on stretcher, recovered and released.
Warmth, pain, redness, swelling, hardness. Patient received vaccine on 6/3/17 and symptoms were unresolved on 6/5/17. She was seen  by her MD who diagnosed her with cellulitis.
Arm and shoulder pain, headache, cough, fever 101-102, chills, body aches, nausea the day after
The patient received the booster vaccine 3 months early, booster was to received in March of 2022.
Reoccurring taste and smell of chicken soup dumplings  consumed day after vaccine when not eating/near said food.
From the 2nd week after receiving his 1st COVID-19 Vaccine until today, he has had horrible headaches; His blood pressure was kind of high in the mornings; This is a spontaneous report from a contactable consumer (patient). An 80-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FL9269), via an unspecified route of administration, administered in Arm Left on 15Feb2021 between 9:00AM-10:00AM (age at the time of vaccination 80-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FL9262), via Intramuscular route of administration, administered in Arm Left on 25Jan2021 (age at the time of vaccination 80-years-old), as a single dose for COVID-19 immunization. The patient's medical history included Blood pressure high, Neuropathy from Jun2020 (Stated he has neuropathy in his feet and sometime in his pinky finger, his feet sometimes burn, he was diagnosed with neuropathy in Jun2020 by a neurologist and has been taking Gabapentin pills), patient taking Lopressor 100mg approximately 4-5 years, and Amlodopine/ Valsaratan/ HCT 2.5mg tablets for 4-5 years (Manufacturer NDC Number: Provided 248607715395, Lot Number: BTT36, Expiration Date: Apr2022) stating that since he gets the medication in another country, it may be a different number used than the NDC Number. The patient's concomitant medications were not reported. On an unspecified date Jan2021, the patient experienced from the 2nd week after receiving his 1st COVID-19 Vaccine until today, he has had horrible headaches, and on an unspecified date His blood pressure was kind of high in the mornings. On an unspecified date Feb2021, the patient underwent lab tests and procedures which included Blood test: Normal; and on an unspecified date 2021 Blood pressure measurement was kind of high in the mornings. The patient visited to physician office for adverse event and treatment was received. The outcome of the events from the 2nd week after receiving his 1st COVID-19 Vaccine until today, he has had horrible headaches was not recovered, and His blood pressure was kind of high in the mornings was unknown.   No follow-up attempts are possible. No further information is expected.
On 9/22/00, pt went to ER with complaint of redness and swelling from right deltoid to right elbow. Benadryl and Cortisone given at time of visit.
Started sweating a lot and got very pale soon after injection. Hours after injection got chills, muscles aches, and a bad headache that lasted days. Lot appetite for days. Overall felt like I had the flu.
Soreness, warmth, and itchy skin at the injection site began on the evening of 5/19/22 (date of vaccination).  On 5/20/22, around mid-day (12:00-1:30pm) more severe adverse reactions occurred.  A headache progressed to migraine progressed and Sumatriptan was taken to alleviate the pain.  Joint pain throughout the body (all major extremities) which caused difficulty walking/ambulating.  Also severe, frequent, consistent muscle spasms and cramps (an inability to lay still for more than 30 seconds), fever, chills, and mild nausea.  The migraine subsided within 90 minutes of taking medicine.  The other symptoms lasted for approximately 2-3 hours.  Note, the spasm were predominately on the left side of the body.  The fever comes and goes, lasting  up to 45 minutes.  Ice packs on my body and a fan were used to quickly cool me down.  As of today 5/22/22, fever continues to come in less frequent waves and seems to be managed with Tylenol, the injection site is still warm to the touch, itchy, and sore.   *I refused to go to the hospital despite the concerns of my husband.
pt exp anxiety feelings & surge of adrenalin beginning suddenly about 8mins p/inj;hyperventilated & felt shaky-no wheezing or SOB;VS q 15mins WNL;tx reassurance given/pt watched until 3PM;
Left sided chest pain with heart palpitations/potential PVCs that were not present before. Still ongoing at this time, waxes and wanes. Was seen in the ED on 11/3 to be on the safe side when palpitations did not go away. Seem to happen 1-2 times and hour, possibly more frequent at times.
She thinks she already had Covid-19; cough; low temperatures; High heart rate; difficulty breathing; This case was reported by a consumer via call center representative and described the occurrence of suspected covid-19 in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2019, the patient received the 1st dose of Shingrix. On 8th March 2020, 110 days after receiving Shingrix, the patient experienced suspected covid-19, cough, body temperature decreased, heart rate increased and difficulty breathing. On an unknown date, the outcome of the suspected covid-19, cough, body temperature decreased, heart rate increased and difficulty breathing were recovered/resolved.   It was unknown if the reporter considered the suspected covid-19, cough, body temperature decreased, heart rate increased and difficulty breathing to be related to Shingrix.  Additional details were reported as follows: Customer was the patient and emailed on 6th May 2020 the following Shingrix.  The patient received first shot in mid- November 2019, and was due for my 2nd shot when the Covid-19 pandemic hit.  The patient asked my physician to write me a prescription to have my 2nd shot, but he is adamant that I wait until it was safe to do so. He says it was not yet safe (I live in a hot spot area, ). My question for you is this: how long could I really wait to get the 2nd vaccine shot (Shingrix)? was it okay if I wait 7-8 months to get the shot? Called customer on 5/7/2020 and while speaking she mentioned that she thinks she already had Covid-19. She stated that around March 8th or 9th 2020 she experienced cough, low temperatures of about 96 or 97 degrees F, high heart rate (heart rate 123), and difficulty breathing. She was not able to get tested for Covid-19 at that time because she did not qualify for a test (ie: she had not recently traveled). Her coworker tested positive for Covid-19. No indication that her coworker was using any GSK products.  She just told us this to indicate why she feels like she already contracted it]. She recovered after 2 weeks. Consented to follow up.
Facial twitching in left cheek, just left of mouth. It will either twitch or steadily pull my mouth to the left and make it appear I'm smirking. I have not sought medical treatment or seen a doctor at this point as I'm hoping it goes away. It started the morning after the second covid shot on December 3rd. I have no history of twitches, muscle spasms or ticks.
This spontaneous report was received from a licensed vocational nurse and refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date in 2015 (reported as "since 13-JUL-2015"), the patients were vaccinated with an unspecified number of improperly stored doses of VARIVAX (lot # K002916, expiration date 26-FEB-2016) (dose, strength and route of administration were not reported). There was no concomitant medication reported. Additionally, no adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Just before his first birthday he was more aware, he would baby talk and wave. He has few words, doesn?t wave anymore and doesn?t respond to his name like he would before. Things he would say before I don?t hear anymore.
6 month patient administrated with Kinrix; Kinrix was administrated instead of Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received DTPa-IPV (Kinrix) (batch number 3ks4f, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 4th October 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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: 06-OCT-2022 Reporter's Comment: The medical assistance reported that the patient received a dose of Kinrix instead of Pediarix.  No adverse event reported. The reporter consented to follow up. Additional Supportive Information: The 6 months old patient received Kinrix instead of Pediarix, which led to inappropriate age at vaccine administration and wrong vaccine administered.  This case had been linked with case US2022143284, US2022143286 and US2022143282 reported by the same reporter.; Sender's Comments:  US-GSK-US2022143284:Same reporter US-GSK-US2022143282:Same reporter US-GSK-US2022143286:Same reporter
Immediately following shot pain in arm, couple of hrs later swelling and redness. Following day, red swollen upper arm went to ER placed on antibiotics
w/in 15min of vax pt arm (including fingers) became numb;during the next 2hr pt had severe pain in lower back, followed by pain in leg;
This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received 1st dose on an unknown date and had outbreak). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The patient did not receive 2nd dose due to pandemic, which led to social problem. The patient stated that, 1st dose did not do so well.