chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INSUFFICIENT DOSE GIVEN; This spontaneous report received from a pharmacist concerned a 40-year-old female. The patient's weight was 145 pounds, and height was 177.8 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number:1808982 expiry: 31-JUN-2021) dose was not reported, 1 total administered on 10-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  It was reported that on 10-APR-2021, during the process of injecting the vaccine to the patient, reporter noticed that the tip of syringe was leaking that caused to inject an insufficient dose (approximately 0.1 ml had leaked) of JANSSEN COVID-19 vaccine. Repetition of dose will depend on patient's clinical judgement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of insufficient dose given was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210420047-covid-19 vaccine ad26.cov2.s-insufficient dose given. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
A pre-diluted grey-top Pfizer covid vaccine vial (adult) was further diluted with 1.8 mL of normal saline. Subsequently an over-diluted 0.3 mL vaccine was administered to the patient for her booster. The patient was notified of this, and informed that the CDC recommendation is to receive an additional dose of the vaccine immediately. She was not able to return to the clinic the same day, and a follow-up phone call was made to check on the patient and her vaccination status. During this phone call she stated that she is planning to go to a pharmacy near her home to receive the booster. There were no adverse events or clinical consequences reported.
allergic reaction; experienced flushed skin, lightheadedness, tingling, SOB. Observed in ED and released when symptoms resolved
lung capacity diminished to 67% by Oct 20, 2021 down to 60% by Feb 3 ,2021  tested covid positive Dec 18, 2021  received antibodies on Dec 20, 2021. Oxygen drops to low 80s when exerting small amount of enery PT now has oxygen in home
PT STATED EXPERIENCED RASH, AND BUMP AT INJECTION SITE (SIZE OF A LIME). NOT PAINFUL, SHE JUST NOTICED IT WHEN SHE TOUCHED HER ARM. ADVISED PT TO ICE THE AREA, AND CONTACT MD FOR FOLLOW UP.
Patient received the vaccine on 08/21/2018 and started feeling pain in her back, Upon checking she found blisters, bumps and rash on her back. She came to pharmacy today and mentioned about the same on 8/26/2018. I have advised her to call her Dr. and see him ASAP for a proper diagnosis.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose (lot # 657143/0380U). Subsequently, the patient developed erythema at the injection site within one day. The erythema was described as swollen, painful and warm from the injection site to the elbow. The painful and swelling prevented the patient from using her arm. Unspecified medical attention was sought. At the time of the report, the outcome was unknown. The physician requested a lot check. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of Center for Biologics Evaluation and Research and was released. Additional information has been requested.
adverse reaction to the first dose, and was systemically sick for 3 day with  high fever, myalgia, arthralgia, chills, headache, massive lymphadenopathy etc.
2/23-Lost appetite, developed low grade fever 2/23 PM-spiked temperature of 103.6 2/23-2/27- Continued low grade fever and loss of appetite 2/27-developed measles like bumps/rash on torso, neck, and face Incredibly lethargic
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (loss of smell and taste, had a fever, and aches and pains.) in March 2020.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown.            Concomitant medications reported included Flu Shot. Treatment information was not provided by the reporter. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-376660, MOD-2021-375104 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Sore head; Felt a little hot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt a little hot) and HEADACHE (Sore head) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced FEELING HOT (Felt a little hot). On 29-Jan-2021, the patient experienced HEADACHE (Sore head). On 29-Jan-2021, FEELING HOT (Felt a little hot) had resolved. At the time of the report, HEADACHE (Sore head) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Additional information received included no new information.
Injection site redness; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Injection site redness), NAUSEA (Nausea) and VOMITING (Vomiting) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Injection site redness), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, INJECTION SITE ERYTHEMA (Injection site redness), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received booster dose COVID-19 Vaccine manufactured by Moderna.  The reporter's causality for the event(s) of INJECTION SITE REDNESS, NAUSEA and VOMITING was not provided.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
About 12 hours after the shot I had a migraine and fever where I was sweating like crazy for another 14 hours
Fever; Chills; Bodyaches; Sleepiness; This is a spontaneous report from a contactable consumer or other non HCP (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Caller reports her husband got second dose two and a half or three weeks ago, and on an unspecified date, he experienced the fever, chills, body aches, and sleepiness, he had typical effects. The patient's wife didn't remember feeling sleepy from it, where as her husband slept, and he had the common effects to where he knew his body responded to it. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Information has been received from a physician concerning a 23 year old female consumer with a history of migraine who on 26-SEP-2006 was vaccinated with a dose of Gardasil.  On 26-SEP-2006, it was found out that the patient became pregnant.  Gardasil therapy was discontinued.  On 20-JUN-2007, client gave birth to a full term live male healthy child.  Patient developed eclampsia post partum.  The patient recovered.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Initial and follow up information has been received for the Pregnancy Registry for GARDASIL vaccine from a physician concerning a 23 year old female house wife with anaemia and a history of migraine headaches, chickenpox and cervical dysplasia who on 26-SEP-2006 was vaccinated with a first dose of GARDASIL vaccine. Concomitant therapy included prenatal (vitamin uspecified), REGLAN and iron (unspecified). Subsequently, she became pregnant. On 29-SEP-2006 the patient experienced drug exposure during pregnancy. On 01-FEB-2007 an ultrasound was done for anatomy and fetus ratio was 0.89. On 22-JAN-2007 maternal serum alpha-fetoprotein test was done which had normal result. In 20-JUN-2007, the patient experienced post partum eclampcia and hemolysis elevated liver enzymes and low platelet count (HELLP) syndrome. Subsequently, the patient recovered from post partum eclampsia and HELLP syndrome. Additional information is not expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: It was reported that patient got COVID 19 and for that Paxlovid treatment was given from 25Nov2022 to 29Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID arm. On the Tuesday after I got my 2 Moderna vaccine, the  site of injection got hot and red in the morning, and by the end of the day the skin that was red was raised and started to itch. It went away by Friday. I've felt nausea starting the day after the vaccine, but it is not all the time. Today is my 8th day since the vaccine and I still get nauseas every now and then after I eat.
Pt c/o pain in right arm/hand and swelling in right hand for the past 3 wks. Pt states she received vaccine 4/2021 and pain started 7/2021.
5/20/14  - MALAISE, 5/21/14 - FEVER, 5/24/14 - ITCHY SPOTS, STINGY, SORE MUSCLE IN LEGS (COMES & GOES).
Patient states she experienced flu-like symptoms for 2 weeks after being immunized (8/27/19) with Shingrix. Aching, chills. Then she felt better for a while until 9/23/19. On the evening of 9/23, she states she starting experiencing facial drooping, difficulty talking. She went to ER, and after extensive tests, diagnosed her with Bell's Palsy.  She stated on the phone today that they discharged her last night, and she is on prednisone. Some of the symptoms have improved, but she still has some drooping and difficulty talking.
patient slept fine through the night, but woke up experiencing cough and trouble breathing as well as a muscle spasm/soreness between her shoulder blades.  She also thought her tongue felt as though it might be swollen.
Pt received second Moderna COVID-19 immunization in L deltoid at 1020. Pt had reported hx of anaphylaxis to sesame, wait time was increased to 30 minutes. At 1026 pt alerted nurse in observation area of tightness in her throat, an itchy throat, and shakiness. Denied any change in breathing or tongue swelling/tingling. Pt was moved to a more private area with FNP and 2 RNs. At 1035 administered 50  mg IM diphenhydramine in L deltoid. Symptoms started to improve within 5 minutes. Between 1030-1100, BP 138-140/80-84, P 72-88, RR 18-22, O2 sats 98-99% throughout. Symptoms had improved by 1115 and pt was sent home with colleagues. Advised if symptoms worsened or if she had any difficulty breathing to call 911 or get to the closest ER immediately. Pt verbalized understanding and agreed with the plan of care.
Dizziness, extreme muscle cramps, heart racing, esophageal spasm, fatigue, heart skipping beats.
Started shaking violently at 8 p.m., Cold but not feverish. Went to bed and slept for next 24 hours. Got up with help to go to bathroom. Very weak. Had bowl of soup next day at 8:00 p.m. and returned to bed. Slept another 12 hours. Felt better. Gradually regained strength. No further reaction.
VACCINE ADMINISTERED AFTER 2 HOUR ROOM TEMPERATURE STORAGE RANGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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: Not reported) 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 vaccine administered after 2 hour room temperature storage range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered after 2 hour room temperature storage range was not reported. This report was non-serious.
fever, chills, shaking, SOB, chest pain, anxiety, muscle aches, back pain, leg weakness, difficulty standing and walking
headache; Unable to fall asleep; feel achy; swelling under the arm of injection site; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 17 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; POOR QUALITY SLEEP (non-serious), outcome "unknown", described as "Unable to fall asleep"; PAIN (non-serious), outcome "unknown", described as "feel achy"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swelling under the arm of injection site".  No follow-up attempts are possible. No further information is expected.
I in same night when I wake up I found my right foot inflated, red color, and very painful. I could not walk next day, because my food joints were every painful; I in same night when I wake up I found my right foot inflated, red color, and very painful. I could not walk next day, because my food joints were every painful; I in same night when I wake up I found my right foot inflated, red color, and very painful. I could not walk next day, because my food joints were every painful; I in same night when I wake up I found my right foot inflated, red color, and very painful. I could not walk next day, because my food joints were every painful; I in same night when I wake up I found my right foot inflated, red color, and very painful. I could not walk next day, because my food joints were every painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Jun2021 (Lot number: ew0180) at the age of 35 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious), PAIN IN EXTREMITY (non-serious), GAIT DISTURBANCE (non-serious), ARTHRALGIA (non-serious) all with onset 17Jun2021 10:00, outcome "not recovered" and all described as "I in same night when I wake up I found my right foot inflated, red color, and very painful. I could not walk next day, because my food joints were every painful". Therapeutic measures were taken as a result of peripheral swelling, erythema, pain in extremity, gait disturbance, arthralgia.  Additional information: The patient did not receive other vaccine in four weeks. The patient had not covid prior vaccination. The patient had not covid tested post vaccination. The patient received colchicine 0.6MG and prednisone 10MG as treatment medication.  No follow-up attempts are possible. No further information is expected.
Right deltoid area with erythema, tenderness, small pinpoint dot at injection site. right axillary lymph node palpable 2cm round mobile with erythema and tenderness. Instructed ice, Motrin PRN, ENC movement. Call with increased S/S. no UMP and PRN.
Information has been received from a health professional concerning a 5 month old female who was vaccinated with a first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information is not expected.
This spontaneous report as received from a mother refers to a 21 year old patient. The patient was vaccinated respectively with first and second dose of GARDASIL in August-2011 (reported as "a year ago") and on 08-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patient had sought medical attention. Additional information has been requested. This is one of several reports received from same source.
MEDICATION ERROR  Given to 17 y/o pt.  Vaccine licensed for 18 yrs and older.  Pt contacted and informed that he could not receive dose #2 until he is 18 y/o
sensation of warmth all over mostly face both arms, neck & shoulders ache all the time; exp severe flu like episode, poly arthritis, aches in arms, shoulders, neck & to a lesser degree in legs; Aches from tip of fingers up to neck;
Synovial cyst. Ibuprofen 800 TID, cold compress.
COVID-19 symptoms started 06/23/22; test positive on 06/25/22. I had cough, lots of sinus drainage, tiredness, fever, and malaise. I went to urgent care on 06/25/22 and tested positive, and on the 26th I started 5 days of PAXLOVID. I tested positive again on 07/01/22 and negative on 07/03/22. I'm still experiencing symptoms depending on the level of activity, and I have become very tired and my cough is worse. I've had a continuous cough but today it is worse. Occasionally I'm 97 and sometimes I hit 99 and I walk and exercise and house cleaning and it has definitely impeded my activities. My highest fever was 100.1 ad that lasted a couple of days and the 99 lasted a few more days and I was afebrile for a couple days after I hit 99.
Information has been received from a Licensed Practical Nurse for GARDASIL, a Pregnancy Registry product, concerning a 21 year old female patient who in May 2008, was vaccinated with the second dose of GARDASIL (dose, route and lot # unspecified). The nurse reported that the patient stated she became pregnant after receiving her second dose of GARDASIL and then had a miscarriage. The patient sought medical attention (office visit). Upon internal review miscarriage was considered to be an other important medical event. Additional information has been requested.
Seizure (no description of seizure was provided) Did not see physician until 48 hrs after incident
Site: Pain at Injection Site-Medium, Additional Details: Patient reports the pain is getting less. Will see MD if doesnt resolve.
No adverse effects reported; The patient received an improperly stored dose of VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not reported.    On 26-JUL-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R030485 and expiration date 22-OCT-2020 (strength, anatomical location, dose and route were not provided) for prophylaxis (product storage error). The vaccine was reconstituted with sterile diluent (DILUENT MRK) lot # R000561 and expiration date 30-AUG-2020 (strength, dose and route were not provided). No adverse effects reported. The vaccine and the diluent was stored at the following temperatures: from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 9 hours and  from 15 degrees Fahrenheit to 46 degrees Fahrenheit (mainly at 24.3 degrees Fahrenheit) for 21 hours and 30 minutes. There was a digital data logger involved, but there was no previous temperature excursion.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-SEP-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K004281, expire date 22-MAR-2015; dose and route unknown). The total cumulative excursion time was 1176 hours with the lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Caller stated a pharmacy technician mentioned to her that when both the pharmacy technician and the pharmacy technician's daughter received the GARDASIL9 vaccine, they both experienced injection site pain; This spontaneous report was received from a pharmacist technician and refers to her daughter, a female patient of unknown age.  On an unknown date, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dosage regimen, lot #, expiry date, and route of administration were not provided).  On an unknown date, the reporter stated that both the pharmacy technician (reported in MARRS# 2308USA005260) and the pharmacy technician's daughter, experienced injection site pain (vaccination site pain.)  The causal relationship between vaccination site pain and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.; Sender's Comments:  US-009507513-2308USA005260:
Pt has immunization of left arm --now has a diffuse erythema in upper arm and into left shoulder. There is mild erythema in right axilla. A/p allergic rxn to flu shot most likely- - will give BENADRYL and steroid taper--60/40/20. Rash, erythema multiforme.