chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 29SEP97 & the next day pt exp site redness (30mm), swelling, warmth & inflammation;
Headaches; This is a spontaneous report from a Pfizer. A contactable nurse and a contactable 71-year-old male consumer (patient) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at dose number unknown, single for COVID-19 immunisation and started to receive tofacitinib citrate (XELJANZ 5 mg, tablet; lot number: ED8423) via an unspecified route of administration from Mar2021 and ongoing, at 5 mg with unknown frequency for an unspecified indication. The patient medical history and concomitant medications were not reported. On unknown date, the patient reported he got headaches every time he took the medication. Patient stated it took about 3-4 hours. The patient reported since starting on tofacitinib citrate 5 mg tablet he had been experiencing headaches and had also received the COVID-19 vaccine. The adverse event was reported as non-serious. The action taken in response to the event for tofacitinib citrate was unknown. The outcome of the event was not recovered. No further information provided. Reporter considered the event caused by suspect product.  No follow-up attempts are needed. No further information is expected.  Follow-up (21May2021): New information reported from a Pfizer the same contactable nurse included: additional suspect drug (BNT162B2), tofacitinib citrate formulation and lot number, information about the event previously reported.   No follow-up attempts are needed. No further information is expected.
Shortness of breath, sore throat, fatigue muscle aches headaches congestion after doxycyline and amoxicillin still congested and fever. The date of the vaccine was Oct. 25 2007 Temperature 104.F.
This spontaneous report as received from a pharmacist via field employee refers to three female unspecified patients of unknown age. On an unknown date approximately October 2013, reported as within the last month, the three unspecified patients were vaccinated with ZOSTAVAX (dose, lot, expiry date and route were unknown). On an unknown date approximately October 2013, reported as within the last month, the patients developed redness and inflammation at the injections site after the vaccine was administered. No rashes developed in any of these cases. The outcome of events redness and inflammation at the injections site was unknown. All patients had contacted pharmacist to seek medical attention. Additional information has been requested.
Rt eye swelling, myalgias, hepatic decompensation, flushing, inc abdo discomfort, bloating, icterus, drowsiness, nasuea, ascites;
Headache after second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache after second dose of vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  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, the patient experienced HEADACHE (Headache after second dose of vaccine). At the time of the report, HEADACHE (Headache after second dose of vaccine) outcome was unknown.      No concomitant drug details were reported. No treatment details were reported.
Headache, severe aches, severe pain at injection site, red rash on upper arm not at injection site (still have) not painful or itchy.
Narrative:  Symptoms gradually improved over the next two weeks. Lack of energy, Slept 18 hours in the first 24 after injection. Confusion, Dizziness, Headache, Myalgia, Arthralgia, Fever,
COVID arm, no treatment, large red patch around injection site, pain, itching, lasted 4-5 days. Same reaction with second shot on 4/15/21.  Also had significant lymph node swelling in armpits for both shots. Second shot in right arm.
Urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported by reporter.  Concomitant products included SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Urinary tract infection.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.            The action taken with mRNA-1273 with the events was considered as not applicable. No treatment medication reported by reporter. Patient informed vaccine has something to do with her Urinary Tract Infection, and wants to know if she will continue the antibiotic.
Information regarding PREVNAR was received from a pediatrician regarding a 2-month-old patient who received a dose in 2007 and experienced irritability and excessive injection site redness. Relevant medical history was not provided. Product was administered in 2007. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. During 25-Nov-2007 to 18-Dec-2007, the patient developed irritability and excessive injection site redness. Treatment included BENADRYL. The patient had not recovered from the event. No additional information was available at the time of this report.
Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Naproxen) and Drug allergy (Ibuprofen).    On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period). On 22-Aug-2021, PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) to be not related.    No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   This case was linked to MOD-2021-313106 (Patient Link).
Primary malignant neoplasm of left lung metastatic to other site - patient is currently admitted to hospital for treatment (4/6/2022). Hospital admission within 6 weeks of receiving the COVID vaccine.
I experienced a fast heartbeat at about 10 minutes after the shot. I did a few deep inhale/exhale repetitions to calm it down. I think this lasted less than 1 minute. I did not have other symptoms.
Anterior Uveitis in the Left Eye; blurry vision, injected sclera in left eye started on 1/3/21; evaluated for and diagnosed with Anterior Uveitis of Left Eye at Hospital Emergency Department on 1/4/21, and prescribed topical steroids upon same-day discharge.
Likely Pericarditis or Myocarditis:  Poking/stabbing chest pain on left side, Trouble breathing when lying down, arrhythmia  Lasted about two days, feeling better today
injection site arm soreness; Extremely tired the remainder of the day and also the next day; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613), via an unspecified route of administration in the left arm on 23Mar2021 at 09:00 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient was allergic to penicillin. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN), thioctic acid (ALPHA LIPOIC ACID) and Co-Q10 (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 at 11:00, the patient experienced injection site arm soreness, extremely tired the remainder of the day and also the next day. The patient did not receive any treatment for the reported 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 vaccination site pain and tiredness was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient reported feeling warm all over and developed a red rash.  No difficulty breathing or swallowing noted.
Given DTAP/IPV at 5 year well visit on 01/28/2004 yesterday.  Noticed 3 inch red area raised hot at injection site on left arm.  Today a little less red.  No temperature.
Urticaria and dermatographia beginning on 12/21/2021 (day 13 following booster) and continuing until today (2/2/2022).
Headache; This spontaneous case was reported by a consumer and describes the occurrence of 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 information was reported.   On 25-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided          The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable No concomitant medications were reported No treatment drugs were reported
Patient received Moderna Spikevax 2023-2024 Formula on 10/30/2023. Our time was given some training before administering the vaccine, but we did not know that the vaccine needed a thaw time and Medical Assistant was applying heat to the Frozen vaccine with her hands for up to 15-20 min max until it turned into liquid. Patient has been called and stated she had fever for less than 2 days and noticed that a little bump was on the site where she received the vaccine (left deltoid), pt did not went to urgent care/ hospital/ emergency room. Patient was informed about the administration error of the vaccine, I did explain to her that we are submitting a VAERS report. After a week receiving the vaccine, patient states she has been feeling very well and no other concerns.
sharp pain in left breast; swelling of the left breast on the outside; fatigue; joint pain; This case was reported by a consumer via call center representative and described the occurrence of breast pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lymphangiectasia (below the breasts across upper ribcage).   On 8th July 2019, the patient received the 2nd dose of Shingrix. In July 2019, several hours after receiving Shingrix, the patient experienced breast pain, breast swelling, fatigue and joint pain. On an unknown date, the outcome of the breast pain, breast swelling, fatigue and joint pain were unknown.   It was unknown if the reporter considered the breast pain, breast swelling, fatigue and joint pain to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccination on her left arm. The patient received Shingrix and awakened in the night by sharp pain in left breast. There was swelling of the left breast on the outside. The patient had experienced fatigue and joint pain also.  The patient asked should she be concerned or would this just go away in a couple of days.
immediate tingling; redness progressing to vesicles in area of inject over 24-48 hrs; resolved w/in days;
hepatocellular carcinoma; hepatic cirrhosis; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 at 17:30 as dose 2, 0.3 ml single (Lot number: FF8839, Expiration Date: 31Dec2021) at the age of 61 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (ongoing); "Chronic hepatitis C" (ongoing). Concomitant medication(s) included: HYDROXYZINE oral; ONDANSETRON oral; FAMOTIDINE oral; TRAZODONE oral; LIDOCAINE oral; FUROSEMIDE oral; KCL oral; SPIRONOLACTONE oral; ALBUTEROL [SALBUTAMOL]; BACLOFEN oral. Vaccination history included: BNT162b2 (DOSE 1, 0.3 ML SINGLE;  Lot number: FA6780), administration date: 02Sep2021, when the patient was 61-year-old, for COVID-19 Immunization. The following information was reported: HEPATIC CIRRHOSIS (medically significant) with onset 26Jan2022, outcome "not recovered"; HEPATOCELLULAR CARCINOMA (medically significant) with onset 26Jan2022, outcome "not recovered". Therapeutic measures were not taken as a result of hepatocellular carcinoma, hepatic cirrhosis.  Clinical information: It was reported that family history of cancer, diabetes and heart disease. The patient received third vaccine on 14Mar2022 (Lot: FF8839) and fourth dose booster on 11Aug2022 (Batch/Lot no.: FK9894). He received third booster subsequent dose. Booster dose due to a weakened immune system: checked. If the reason was a weakened immune system, the conditions below: Current or recent cancer (including blood cancers such as Hodgkin's disease, leukemias, and myelomas): Checked Booster dose (other). He received concomitant trazodone 50 and baclofen 10 (unit not reported).; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.
(R) arm - swollen inflamed red area. Also has fever blister on lower lip.
45 y/o female with known history of allergies c/o itchy all over rash 30 mins s/p receiving second dose of Moderna @10:20am(vaccine given at @9:50am). Pt immediately brought to medical bed and assessed. Denies SOB/lip swelling/ N/V/HA/stridor/wheezing. Pt notes that she has had two allergic reactions in the past 3 weeks to an unknown IV infusion treatment which both had to be treated with benadryl and steroids. States did not have a previous reaction to first dose of moderna, at that time had not had IV treatment. Therefore 50mg IM Benadryl given @ 10:20am. Pt reports relief of rash/itchiness 8mins after meds given. Pt monitored for total of 1 hour after vaccination and reports improvement of symptoms.  Vital Signs:  Time: 10:20am BP: 131/87 P: 79 O2 Sats: 100 %  Time: 10:55am BP: 154/92 P: 80 O2 Sats: 100%     Medications given:  Time: 10:20am Medication: Benadryl 50 mg IM        Outcome of the adverse event (if paramedic please list hospital taken to): Pt discharged after monitored for an additional 30 mins s/p receiving Benadryl for allergic reaction. Reports improvement of symptoms 1 hour after vaccination. STRICT ER precautions discussed, pt is to call 911 if symptoms return or has any new or worsening symptoms such as lip swelling, abnormal throat sensation, SOB, wheezing. Upon d/c pt lungs CTAB, no wheezing/stridor on exam. No lip swelling/eyelid swelling. Rash improved, almost resolved.
An 18 week old female was vaccinated with a second dose of Comvax IM on 24-JUN-1999 at 10 AM. Concomitant vaccinations that same day included the second dose of Rotasheild PO, the second dose of ACEL-IMUNE IM and the second dose of IPOL SQ. On 28-JUN-1999, the pt developed projectile vomiting, diarrhea and was inconsolable. It was noted that four and five days post vaccination, the pt developed a fever 101 F, vomiting, diarrhea and fussiness. The diarrhea was described as "foul, explosive mucoid green".The pt was reported to have gastroenteritis. The fussiness resolved after 3 weeks. Four weeks post-vaccination, the pt continued to have "green/mucous" stools. The diarrhea resolved after6 weeks. The pt was reported as recovered. Additional information ha been requested. This was originally reported by a physician. Upon follow up, the physician stated "I have had no adverse event." No further info is available.
53yo woman rec'd immun on 13DEC89, on 19DEC developed a large hive @ inject site - raised, warm & red, Tx DPH;
Information has been received from a 63 year old female patient with penicillin allergy, CIPRO allergy, HYCODAN allergy, SUPRAX allergy, hypertension, asthma and allergy who on 09-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included losartan potassium (manufacturer unknown), NASALIDE, AEROBID, albuterol, CARAFATE, famotidine and CITRACAL + D. On 10-FEB-2011 the patient developed pain at the injection site of left upper arm. On 11-FEB-2011 the patient was evaluated by her unspecified pulmonologist and was found to have a 4 inch by 5 inch area of redness, warmth, and swelling at the injection site. She was diagnosed with cellulitis and prescribed oral CECLOR. On 12-FEB-2011 the patient developed a fever of 101.8F. She was evaluated in the emergency room of hospital. Chest X-ray, X-ray and ultrasound of the left upper arm, and complete blood count were ordered. The X-rays and ultrasound were normal but the neutrophil count was elevated. The patient treated with intravenous clindamycin. The patient was release from the emergency room on oral clindamycin and she was currently recovering. Follow up information has been received from medical records and a physician concerning a 63 year old female patient who on 09-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck). On 12-FEB-2011, the patient was evaluated in the emergency room for cellulitis of her left upper extremity. The patient was given acetaminophen oral, 1000 mg, once by mouth and clindamycin HCL injection, 600 mg intravenous piggyback in dextrose 5 percent water over thirty minutes for a total of four doses. On 13-FEB-2011, the patient had the following diagnostic tests performed: left humerus X-ray that showed no acute osseous abnormality, no abnormal periosteal reaction or erosive changes; chest X-ray that showed no acute cardiopulmonary disease; sonogram of her left upper extremity that showed left upper extremity edema without focal fluid collection; and laboratory test that showed high neutrophil percent auto (87.7%), low mean platelet volume (7.1 fL), high neutrophil absolute (6.0 uL), high urea nitrogen (22 mg/dL), high random glucose (126mg/dL), high aspartate (66 IU/L), high alanine aminotransferase (85 IU/L), high activated partial thromboplastin time (52.2 seconds), moderate blood in urine, and trace levels of leukocyte esterase U in urine. On 13-FEB-2011, the patient was discharged from the emergency room with the following instructions: stop taking cefactor and clindamycin. Patient was instructed to return to the emergency room for persistent, worsening, or new symptoms, including: fever, worsening pain or swelling and to follow up with her primary physician. All available medical records will be provided upon request. Additional information has been requested.
Child was given combination vaccine pentacel (dtap,hib,ipv) and also given separate Haemophilus conjugate vaccine
Erythematous indurated rash about 4 cm round, Painful to touch. Suggested ibuprofen and cold compresses to follow up  if symptoms persist.
Patient with 3 COVID vaccines (but not up to date) who admitted to hospital with positive COVID PCR and non-STEMI.  No complications from COVID noted.
On 2/15/2021 I had a blood pressure of 156/93 and 169/112. I saw a heart specialist on 3/19/2021, my doctor on 3/23/2021, and a vascular surgeon on 3/24/2021. My doctor told me to keep taking a record of my blood pressure. Some of my blood pressures were 161/103, 163/105, 180/108, 161/105, 168/102, 136/81, 179/116, 186/120, 172/108, 140/81, 139/90, 164/104, 136/82, and 154/90. My doctor prescribed me with amlodipine in May 2021. Also, both of my legs and feet were swollen around that time in May 2021. I gained 5 pounds because of the swelling. The doctor increased my Lozol from 1.25mg to 2.5mg. My eye doctor also said I had a stroke in my left eye. They said I had a central retina vein occlusion. One day when I closed my right eye, I couldn't see anything out of my left eye. I went to the doctor and seen a retina specialist. They increased my aspirin from 81 to 325 mg. I also had stopped taking my anxiety medication. My vision has improved. I got a retina injection on 2/16/2022, and I am going to get another retina injection on May 11, 2022. I don't have an appointment for cataract removal surgery yet. I also had trouble seeing on my phone. When the doctors took an internal picture of my left eye it looked like a fresh tomato that was smashed. Around the time of getting the 2nd dose of COVID vaccine, which was given on March 4, 2021, I started seeing floaters in my vision as well.
Patient complained of muscle soreness and inability to move her left arm, with body aches. Patient took TYLENOL and symptoms have improved throughout the day, but still with muscle soreness at the moment and some nausea. She is calling the pharmacy back in the morning on 9/27/18.
patient fainted about 5 minutes after receiving the vaccine. First aid was administered with only a small laceration in the left eyebrow
Pt was in office and mother requested Flu shot for pt. Pt was given vaccine for 3 years plus but pt was 2 years old. Incident was discussed with MD and mother to be informed.
Received in left arm pneumococcal vaccine 9-12-14. Came to primary care clinic to assess swelling (local), pain, and rash (general) and itchiness. Stated rash occurred 9-26-14. Itchiness 9/25 evening. Sent to emergency room. He received liquid BENADRYL, prednisone and antibiotic.
8/31/21 Pt with h/o osteoporosis, CAD, previous MI, HTN presents with recent syncope, anorexia, nausea, and generalized weakness
After injection, the patient reported having difficult breathing. She remained in the pharmacy to rest and being observed for 30 minutes. During that time, she drank some water and felt better and was taken home by her mother with advice to seek emergency medical care if symptoms got worse. The next day follow up call, her mother reported that the patient had some fever and difficult breathing over night. She was given Tylenol and got better in the morning. We advised the mother to continue giving her Tylenol along with Benadryl every 6 hours for the next 2 days and if symptoms get any worse then seek emergency medical care.
Vaccines was given to wrong sibling because parent wrote last name as the first name on the consent form. Name on the consent form was listed. When called the wrong sibling sat in the chair; thus, the wrong vaccines were administered. Mistake was identified after administration and informed the parents. Informed regarding possible side effects and it would not harm child. Correct vaccines were administered to the child after identification of mistake. PCV-13 was administered to this 6 yr old child which is outside the recommended age range.
Patient given a 3rd booster dose when it is not approved for a 17-year-old. No adverse event reported by the patient.
Patient given FLUMIST incorrectly - only given in one nostril on 10/8/09. Patient revaccinated on 10/22/09 with no adverse effects