chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cytomegalovirus infection; generalized weakness; fatigue; hypotension; This is a literature report for the following literature source(s):   A 73-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Kidney transplant" (unspecified if ongoing), notes: Time since transplant-18 mo,  deceased donor kidney transplantation (D+/R-); "Diabetic nephropathy" (unspecified if ongoing); "end-stage renal disease" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "uncomplicated surgical recovery" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tacrolimus for Immunosuppression; Prednisone for Immunosuppression, notes: 10 mg. Vaccination history included: Bnt162b2 (DOSE 1,SINGLE), for COVID-19 immunisation. The following information was reported: CYTOMEGALOVIRUS INFECTION (medically significant), 18 days after the suspect product(s) administration, outcome "unknown"; ASTHENIA (non-serious), 2 weeks after the suspect product(s) administration, outcome "unknown", described as "generalized weakness"; FATIGUE (non-serious), 2 weeks after the suspect product(s) administration, outcome "unknown"; HYPOTENSION (non-serious), 2 weeks after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood creatinine: 1.6 mg/dl, notes: elevated; 1.1 mg/dl, notes: baseline; Blood immunoglobulin G: None of the recipients developed, notes: SARS-CoV-2 in response to vaccination; Blood pressure measurement: hypotension; DNA antibody: 41000 IU/ml, notes: after 3 wk; Lymphocyte count: 0.67, notes: Admission; Polymerase chain reaction: 3.11 IU/ml, notes: million; 415 IU/ml, notes: 1 wk later; 3110000 IU/ml, notes: CMV highest; SARS-CoV-2 antibody test: Negative; White blood cell count: 5.2, notes: Admission. Therapeutic measures were taken as a result of cytomegalovirus infection, asthenia, fatigue, hypotension. He was transitioned to oral valganciclovir and his blood CMV PCR was 415 IL/Ml one week later. The patient remains on prophylactic valganciclovir with undetectable blood CMV DNA PCR. The lot number for the vaccine, [BNT162B2 ], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case, an association between the reported event and the suspect product BNT162B2 cannot be ruled out.  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-PV202200004629 Same article/ drug/event and different patient;
Patient was given Prevnar-20 IMZ on 6/5/22. It was later discovered that she had previously received Prevnar-20 on 4/28/22. Only 1 dose of Prevnar-20 is recommended. Patient has had no adverse reaction and is feeling fine.
After my 2nd shot on 2/17/21, my L arm hurt as with my first shot on 1/27/21. Similarly I took Tylenol. [And, very grateful that arm soreness was the only after-effect after 2nd shot.] [No arm soreness past a few days with 1st shot.] HOWEVER:10 WEEKS! after my 2nd shot on 2/17/21, my arm is STILL SORE. Advice has been: try heat, try ice, try movement, try stretching, try Voltaren [Diclofenac]... info from any doctor I could ask, from nurse help-line, any nurse or anyone who might have an answer. I TRIED EVERYTHING THAT WAS SUGGESTED, and soreness is still there.  CAN YOU HELP??
At about 3:30pm the day, Friday,  I received the second shot of Moderna I felt like I had the flu. It hit me out of no where. From Friday afternoon until Sunday afternoon I felt like every muscle and bone aches, had a headache, felt like my head was heavy and full. No fevers.
pt recv vax 23APR97 & it was reported that about 423AM on 24APR97 pt was found expired in crib;pt reportedly had unremarkable med hx & had a nl develop;MD felt was instance of crib death (SIDS);
heart failure; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FAILURE (medically significant), outcome "unknown", described as "heart failure".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: On the basis of the limited information available in this report, a medically meaningful assessment of the case cannot be made. Details regarding the drug-event temporal relationship and clinical course are not provided. However on conservative basis, the possible causality 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.
Rash, pain, loss of eye sight for 2 weeks. Nerve pain. Experience - still being treated for nerve pain in head.
Fingers and toes will stiffen up, cramp like and can?t move fingers or toes at times.  Joint pain all through out body.  Never really goes away now. Worst at night.  Tried all the time no energy.  My treatments have been eating more vegetables and fruit.  Exercise more weekly trying to keep muscle and joint mobility. Ibuprofen up to 600-800 mg  daily. Up to 5-7 days and take a break for a few day . Ibuprofen messes with stomach. (Constipation) my whole body ache. Am continually doing  stretches 10-15 minutes 2-3 times a week  and walking 2-3 times a week about a mile or mile  an half .  Headaches all the time thought it was allergy related it is not going away. Menstrual cycle is regularly but now heavy heavy flow more than ever in my entire life! That started right away after vaccination.
Client reports that 12 hours after his first dose of Pfizer he had blurred vision that cleared on its own in 2 hours and also started with ringing in his ears.  Client still has ear ringing.  Two days later he felt like he was going to fall.  Client was approved by medical team to get 2nd dose.  Client waited 30 minutes and had no reaction.
On 6/1/2021 at about 1:00PM, I was on a bike ride with my wife. I had a lack of energy, and I had mild pressure in my chest. It wasn't painful, but it felt irregular. I didn't feel well, but I continued riding, because I didn't think my symptoms were serious. Later that evening, I went to a barbecue. I was able to socialize, but I felt mildly nauseous and achy; I thought that maybe I was coming down with something. At 1:00 on 6/2/2021, I woke up feeling hot, nauseous, and a little disoriented. I had pressure in my chest. I checked my blood pressure, which was elevated, and I decided to go to the ER hospital in city. The ER personnel noticed my troponins were elevated. They admitted me as an inpatient and ran a series of tests that included an EKG, a cardio catheter, a chest scan, and an ultrasound. They found that my heart was functionally and structurally sound. However, when they did an MRI, they discovered that the soft tissue of my heart my inflamed (myocarditis). They also discovered a 40-50% blockage in the left anterior descending artery. I was released from the hospital on 6/4/2021, and I was given atorvastatin and an aspirin. I was also advised to not physically exert myself for 2 months. On 8/1/2021, I went back to same ER for the same symptoms as before. The troponins were elevated, but not as much as the first time. I was prescribed colchicine and advised to continue resting.
This is an initial report of an AE, received on 01 Feb 2017, for Protein Sciences FLUBLOK. Subject, a 70 year old female received FLUBLOK Intramuscular on 05 Jan 2017. On an unspecified date in 2017, after receiving FLUBLOK, the subject reported having an allergic reaction to the left side of her face and nostrils that included redness and swelling. It was unknown if any corrective treatment was provided. At the time of the report, it was unknown the outcome of the event. Medical history for the subject included egg allergy. The subject had received FLUBLOK in the past with no events. Concomitant medications were not reported.
evening after vaccine (approximately 8 hours later) dizziness and vertigo set in - continued in to the morning to the point the patient could not get out of bed
Information has been received from a consumer concerning her/his daughter, a 14 year old female patient who was enrolled in a market research. Since an unknown date in 2015, the patient completed 3 dose series of GARDASIL (dose, route, and lot# were unknown) within 12 months on unknown dates, rather than the 6 month indication (onset date reported as "sometime in 2016"). The reporter also stated that the patient received multiple vaccines on that day (unspecified date). The reported considered the event to be related to GARDASIL. Additional information is not expected since the reporter did not wish to be contacted.
10:00pm arm feels sore  11:00pm fever, lethargy  1:00am Chills, fever, muscle pain
headache on one side of her face; heavy pressure over the right eye; her vision is blurry; dizziness; feeling tired; fever; A spontaneous report  was received from a other hcp concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache on one side of her face, heavy pressure over the right eye, her vision is blurry.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 047A21A) via unknown route for prophylaxis of COVID-19 infection.  On 16 Mar 2021, the patient experienced the event(s) headache on one side of her face, heavy pressure over the right eye, her vision is blurry.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache on one side of her face, heavy pressure over the right eye, her vision is blurry was unknown.
HEADACHE; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1850220, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Some swelling, redness, warm to the touch, soreness, by next morning swelling spread, redness spread, hot to touch, pain, low grade fever, by Wednesday morning arm had gotten 3 inches larger, redness from shoulder to elbow and almost completely around arm, very painful to touch, unable to use arm much at all. Went to Dr. Was given a shot of steroids and follow up tomorrow 10/22/2015 at 11:00 AM CST.
Small 2 cm lump in upper outer right thigh, not tender to touch, mobile.
This spontaneous report was received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, the patients were vaccinated with doses of improperly stored VAQTA (lot # K019560 and expiration date 02-JUN-2017, lot # L002717 and expiration date 02-JUN-2017) (dose and route were not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
inflammatory arthritis process.  pain and weakness in arms and legs.  seemed like PMR but negative inflammatory markers.  responded well to steroids (started 10/20/2021) but symptoms returned when steroids were stopped.  had another round of steroids 11/15/2021 and symptoms again improved.  symptoms returned when steroids were tapered.  steroids increased and symptoms improved.  was referred to rheumatologist and again improved with restarting steroids.  going to try hydroxychloroquine soon.
Information has been received from a female consumer concerning her approximately 40 month old daughter who in December 2011 (reported as one and a half year ago) was vaccinated with a dose of MMR II, (dose, route and Lot# not reported). In December 2011 (reported also as about a year and a half ago) within about 24 hours of receiving the vaccine the patient experienced uncontrollable shaking, throwing up, seizure, convulsing and fluctuating temperature. The patient went to ER and received unspecified treatment. The patient was not admitted to the (unspecified) hospital. Subsequently in December 2012 (reported also as about a year and a half ago) the patient recovered from uncontrollable shaking, throwing up, seizure and convulsing and fluctuating temperature. Upon internal review, seizure and convulsing were determined to be important medical events. Follow-up information has been received from a registered nurse, who stated she had already reported all the information. No further information is available.
8-10 days after DTaP given in left vastus lateralis a honey-crusted, irritated, tender, nodular area developed.  There had been a hard painless lump present within 2 days or so.  Augmentin ES 3/4 tsp bid x 10 days.
Patient fainted for few seconds  Breathing and pulse was okay and was conscious right after I elevated his head, gave him water and monitored him for 20 minutes
CHILLS; This spontaneous report received from a patient 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, intramuscular, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced chills. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.1 F.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious.
Patient was given a second dose of the pneumovax 23 vaccine 3 years after initial. No adverse reactions but she was not due for the vaccine.
3 pretty nasty nosebleeds; Runny/ wet nose; Felt like he needed to curl up into a ball on bed; Massive, excruciating pains in both his arms and legs; Headache; Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (3 pretty nasty nosebleeds), RHINORRHOEA (Runny/ wet nose), MALAISE (Felt like he needed to curl up into a ball on bed), PAIN (Massive, excruciating pains in both his arms and legs) and HEADACHE (Headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, CARVEDILOL, LISINOPRIL, PREGABALIN, ATORVASTATIN and INSULIN GLARGINE (LANTUS) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced EPISTAXIS (3 pretty nasty nosebleeds), RHINORRHOEA (Runny/ wet nose), MALAISE (Felt like he needed to curl up into a ball on bed), PAIN (Massive, excruciating pains in both his arms and legs), HEADACHE (Headache) and ARTHRALGIA (Sore shoulder). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 11-Mar-2021, EPISTAXIS (3 pretty nasty nosebleeds), RHINORRHOEA (Runny/ wet nose), MALAISE (Felt like he needed to curl up into a ball on bed), PAIN (Massive, excruciating pains in both his arms and legs), HEADACHE (Headache) and ARTHRALGIA (Sore shoulder) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient received his 1st dose of PFizer vaccine and about 10 minutes after the injection he got pale, diaphoretic , and lighteaded and dizzy. He was removed from the cell and taken to medical observation. he  stated that he had this before when he got a shot for yellow fever . he stated that he also did not have breakfast, patient blood pressure on arrival was 119/82 HR 65 and oxygen on room air was 93%. He was observed for an additional  He denied nausea, follow up blood pressure was 123/80 laying, sitting on the edge of the bed he was 105/78  HR, 72.. he then stood for 1 minute and follow up blood pressure was 133/68 HR 77.  Patient reported that his symptoms have resolved . His color  had  returned as well and was reporting feeling better.
uncomfortable side effects; This case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was unknown.   It was unknown if the reporter considered the discomfort to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the first shot, but had a bunch of side effects.  The patient stated that it was sure this was great for most people but to be aware that there could be some pretty uncomfortable side effects.
gut wrenching nausea; stomach ache; flushed; dizzy; Headache; This is a spontaneous report from a contactable other HCP(patient). A 51 years old female patient received first dose BNT162B2(lot number EL0140), via an unspecified route of administration on 29Dec2020 08:00 at the 51 years old at Arm Left at single dose for COVID-19 immunization. The patient medical history was none. The concomitant medications were none. The patient had her first dose on 29Dec2020, she had no fever or chills and she got it at 8AM, and she woke up on 30Dec2020, and for the last 9 days when she wakes up, she was gut wrenchingly nauseated. It lasted like up to sometimes until noon, she still had a little nausea now, and it is almost noon there, and this comes along with being so nauseated. She was having a pretty moderate stomach ache on 30Dec2020, especially after eating, then she was really felt flushed and dizzy on 30Dec2020, but she thought because the nausea was so bad. She had a headache on 30Dec2020 and lasted for 5 days. She was not sick prior to the COVID vaccine. The outcome of the event Headache was recovered on 04Jan2021, the other events was not recovered.
Injection site pain, headache, and muscle pain. Muscle pain was mainly in the shoulders (more on the side of the injection), lower back, and in the legs. Lasted through the night and took a Tylenol 500mg tablet that next morning (3/18). Symptoms improved slightly, but did not got away and got a little worse as the day progressed (but still improved from the morning). Took another Tylenol that evening, felt better by bedtime, and feel much better today (3/19). Still have some arm soreness when I lift the arm my injection was placed in, but not too bad.
Patient said arm was really red at injection site about 4 inches in diameter. She said it hurt or was sore also. Patient stopped by on 2-6-14 to show me. She also said it was a little swollen.
Patient had first vaccine in April and said he had a sore arm and a little redness across his chest for several days after the vaccine. Patient called the pharmacy complaining of painful sore rash across upper chest and around his shoulder area. He thought it felt the shingles he had several years back. I instructed the patient to contact his Dr. Patient went to the Dr on Monday 10/15/18 and Dr prescribed Prednisone and VALTREX. During his exam, the patient said his Dr was not 100% sure of what rash was but to please document that he had both series of the SHINGRIX vaccine. Patient is healing and asked we please document his reaction.
Have Autoimmune disease. Was starting to feel weird and off. Regularly go to get antibodies tested, which averages at 300, this time it was over 3500.  Is going back for testing in 05/2023.
Initial and follow up information has been received from a physician concerning a 10 year old child who, on an unknown date between July 2006 to 05-MAR-2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot number 656077/1491F). Subsequently, within two to three days post vaccination, the patient developed a 10 cm area of redness and/ or 6 X 6 cm area with a circular pattern with redness, warm to touch and pain. The reaction lasted approximately 1 week. Unspecified medical attention was sought; no treatment was required. The outcome was reported as recovered. No additional information to report. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information is not expected.
given the 2nd moderna shot on day 22 after the 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given the 2nd moderna shot on day 22 after the 1st dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 004B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given the 2nd moderna shot on day 22 after the 1st dose). On 01-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given the 2nd moderna shot on day 22 after the 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable   This case was linked to MOD-2021-200299 (Patient Link).
Patient reports when she is lying down within 3 days of being vaccinated a feeling of "head floating" and "feeling dizzy". This subsides as the day goes on and gets better until late night.  Patient reports this has been ongoing since the 3 day. She will follow-up with PCP for further testing and evaluation.
COVID-19 Infection - Supplemental oxygen to maintain SpO2>92%.  Encourage self-proning.        - Current O2 req: Room Air.  Baseline: Room Air.                - O2 change in past 24h: No        - Sx onset: NA.  Positive Test: 2/17.  Severity: Moderate.  Immunocompromised: Yes.