chrisvoncsefalvay/vaers-outcomes huggingface dataset:
20-year-old female presents to the emergency room complaining of right-sided chest pain, primarily located midclavicular approximately rib 2.  Patient states pain started this evening, feels sharp.  Patient states previously she has felt the same discomfort when she had COVID.  She states previous workup did not find anything significant at that time in March 2021.  She endorses shortness of breath, states taking deep breaths in makes it worse.  She also notes pain radiating through into the back.  Patient denies any fevers, chills, nausea, vomiting.  Patient got her Pfizer vaccine today in the AM.  Patient was seen in the emergency room recently, and diagnosed with mild pyelonephritis, treated with 1 g ceftriaxone and sent home with 5 days of ciprofloxacin.  Patient just completed this course.  Previous urine culture positive for staph saprophyticus ciprofloxacin susceptible."
Information has been received from a registered nurse concerning a male patient who on an unspecified date was vaccinated with a dose of PROQUAD (Merck) (Lot # not provided), "back to school dose required by the state", instead of VARIVAX (Merck). It was reported that the patient had not experienced any known symptoms. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
mom states that pt cried for 4 hrs p/vax; pvt MD called & advised no pertussis next shot; pt fell asleep so mom did not take to MD;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 11:06 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 11:06 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 54.04.  No concomitant medication was reported by reporter.  Batch number 031L20A underwent temperature excursion on 12-Feb-2021 with temperature 35 degrees Fahrenheit at 10:00 AM and 11:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 12-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken by using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Started with hives, general itching, shortness of breath less than 24 hours after administration of vaccine.
FLU LIKE SYMPTOMS; DIZZINESS; APPETITE LOST; NAUSEA; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced flu like symptoms, dizziness, appetite lost, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the flu like symptoms, dizziness, nausea and appetite lost was not reported. This report was non-serious.
Public Health nurse gave MD wrong dose/type of H1N1. Patient should have received 0.25 ml preserv.  and instead she gave MD 0.5ml H1N1 with free preservative. Sanofi UP013AA multi dose vaccine.
After vaccine I noticed I was having a horrible time sleeping, then I started having joint inflammation 10 days later. I was I excruciating down my legs, I had big knots on my as well. Days 12-14 the pain kept me up because it was bad. By day 15 I had extreme pain, water retention and I had to take something for pain. On 4/4 I had nausea and last Wednesday I was nauseated and started running a temperature and felt like the flu and chills. I went to get a covid test because of the way I was feeling and it came back negative.
7 month old male was administered Varicella vaccine and MMR vaccine; none of the patients developed symptoms of vaccine related viral illness;   This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 7 month old male patient. The patient's concurrent conditions included biliary atresia. His pertinent medical history included failed Kasai procedure. Information regarding the patient's concomitant therapies were not provided by the authors.   On an unspecified date, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and a dose of varicella virus vaccine live (oka/merck) (manufacturer unknown) both administered for prophylaxis (strength, dose, frequency, route of administration lot number and expiration date were not provided). The patient received these vaccine doses 11 and 12 days prior a schedule orthotopic liver transplant and a small bowel obstruction surgical porcedure. The patient did not develop symptoms of vaccine related viral illness.   This is one of several reports received from the same literature article   A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2107USA002514:Original Case : 2107USA005481
Feeling really fatigued and tired; A lot of muscle aches; Nausea; Arm really, really sore; A spontaneous report was received from a healthcare facility staff member concerning a 42-year old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced fatigue and tiredness, sore arm, muscle aches, and nausea.   The patient's medical history was not provided. Concomitant medications reported included bupropion hydrochloride.   On 31 Dec 2020 the patient received their first of two planned doses of mRNA-1273 (Lot number OZSLZ0A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 01 Jan 2021, the patient's arm was sore and she experienced fatigue and nausea that lasted a few hours.  On 03 Jan 2021 the patient began to experience muscle aches.   On 04 Jan 2020, the patient reported the soreness to be gone but the fatigue had gotten worse and not improved with rest. Treatment for the event included ibuprofen, which per the patient, alleviated some of the soreness and aches and pains.   Action taken with mRNA-1273 in response to the events was not reported.  The event, nausea, was considered resolved on 01 Jan 2021. The event sore arm was considered resolved on 04 Jan 2021. The outcomes of the events, feeling fatigued and tired and muscle aches, were unknown.; Reporter'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.
soreness in arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a slight soreness in arm after receiving 1st dose of Shingrix. Consent to follow up was provided.
After oral rotavirus vaccine, 2 month old baby has older GI discomfort, gas, bloating, trouble pooping. Disruption of ability to eat. Symptoms lasting over 2 weeks after administering vaccine. Probiotic drops seem to improve the situation.
pt recv vax 23FEB98 & pt come down w/chickenpox 25MAR98;home visit made 26MAR98 >100 lesions noted to entire body;spoke w/mom via phone 30MAR98-no new lesions 9APR98 mom states pt completely recovered;
RED RASH ABOUT TWO INCHES IN CIRCUMFERENCE NEAR INJECTION SITE.
was initially admitted to the hospital on April 23, 2021 because of COVID-19 infection for 3 days.  She received 3 days of Decadron followed by another 3 days as outpatient.  Initially the patient felt much better but since then her breathing has been deteriorating till she has been experiencing hypoxia with oxygen saturation 85 up to 88% on room air.  This time her chest x-ray shows some worsening of infiltration comparing to the previous 1 done on April 23, 2021.
Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced stored at 32 degrees Fahrenheit for a few days.  The patient received a dose on an unspecified date.  Relevant medical history was not provided.  Product was administered on an unspecified date.  Concomitant medications were not reported.  Approximately 5 patients received the PREVNAR vaccine the was stored at 32 degrees Fahrenheit for a few days.  No adverse events were reported at this time.  No additional information was available at the time of this report.
After receiving her vaccine, client stated that she has numbness in both hands.  Vital signs obtained by EMS B/P 158/68, HR 60, o@ sat 97%.  Client stated she is feeling better.  Client discharged home by EMS.
Moderna COVID-19 Vaccine EUA  Joint aches, hot flashes, headache, mild dizziness, difficulty concentrating
NO ADVERSE EVENT. THE VACCINE WAS AT ROOM TEMPERATURE TOO LONG HAD BEEN MORE THAN 24 HOURS.  BOTTLE HAD BEEN TAKEN OUT DAY BEFORE AT 10AM
Almost immediately felt flush and light-headed. That passed within 60 - 90 seconds. Experienced some transient pain when walking, primarily in my hips. Within a half-hour, I experienced uncontrolled shivering. That evening I was unusually tired. I experienced another period of chills/shivering about 7 hours after the injection. I slept 11 hours, got up, and immediately went back to bed, too tired to stay up. I slept another 4 hours. 24 hours post-injection I feel fine.
Submental (midline) lymph node, 2 cm, tender.  Lasted for 48 hours, starting on day 4 after vaccine.
Stroke due to blood clot in right side of brain. Severely affected speech, mildly affected left hand. Is currently going through speech therapy.
Migraine headache; Intense chills for 36 hours; Fever of 103 for approx 18 hours; Muscles and joint pain; Muscles and joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301458A) via an unspecified route of administration in the left arm on 22Sep2021 at 16:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 23Sep2021 at 07:30, the patient experienced intense chills for 36 hours, migraine headache, fever of 103 (unspecified units) for approx 18 hours, muscle and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event intense chills was resolved on 24Sep2021 at 19:30, after a duration of 36 hours whereas the event fever of 103 (unspecified units) was resolved on 24Sep2021, after a duration of approx 18 hours. The clinical outcome of event migraine headache and muscle and joint pain was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Patient experienced dizziness and giddiness . Onsite EMS was called vitals BP 137/91  98% O2 room air HR 78   Patient refused evaluation/care  released against medcial advice.
Pt c/o polyarthropathy with arm swelling. Pt c/o that in the first whole week after vaccine, pt c/o  L arm pain with pain in L ring finger and could not straighten the finger out.   Pt reports all symptoms have resolved completely per patient on 6/15/21 and she is scheduled for her 2nd vaccine 6/18/2021 and does plan on having the vaccine. Pt will contact office with any adverse effect.
suspected clinical vaccination failure; COVID-19 infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220438211 (Janssen).  A 32-year-old female patient received BNT162b2 (BNT162B2), on 05Feb2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 12Apr2021 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 19Apr2022, outcome "unknown", described as "COVID-19 infection"; DRUG INEFFECTIVE (medically significant) with onset 19Apr2022, outcome "unknown", described as "suspected clinical vaccination failure". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Positive. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Clinical course: Case level outcome was unknown. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint, and reference number was requested. Company Remarks (Senter's comments) included VO: 20220438211-COVID-19 VACCINE AD26.COV2.s- suspected clinically vaccination failure. The event (s) has compatible/ suggestive temporal relationship is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with event (s) than the drug. Specifically special situation. Therefore this event (S) is considered not related. Suspected clinical vaccination failure (vaccination failure) causality as per reporter (drug/vaccine) was possibility. Causality as per Mfr (drug/vaccine) was possibility. Suspected Covid-19 infection (Suspected Covid-19 infection) causality as per reporter (drug/vaccine) was possibility. Causality as per Mfr (drug/vaccine) was possibility.  No follow-up attempts are possible. No further information is expected.
Pt cried from 9 PM - 5AM after last Imm - no fever.
Approx. 20 minutes after injection began a profound ringing on right side ear (tinnitus) .  Noise is continuous and loud.   Then approx. 3 weeks later began having, now diagnosed  as cluster headaches.  Penetrating knife like pain through right eye lasting approx. 20 minutes however; one episode was lasting 1.5 hours and went to ER for pain.   I have had 21 attacks in last 40 nights.   Have discovered high flow oxygen helps subside pain.
Headache, nausea, vomiting, diarrhea, flu-like rxn (w/in 24 hrs of injection); exacerbation of underlying condition;
Headache, body aches, nausea, fatigue, loss of appetite, abdominal pain
Sore injection site right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site right arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Irritable bowel syndrome.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site right arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site right arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-076358 (Patient Link).
BODY ACHES; CHILLS; This spontaneous report received from a consumer via a company representative concerned a 41 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced body aches, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and body aches was not reported. This report was non-serious.
the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms); the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms; in the left arm it was cold and tingling; in the left arm it was cold and tingling; experiencing contractions and cramping in her arm and the left side of her torso in the ribcage area that continued for 24 hours; diarrhea on the weekend; strong cramps  in her stomach (stomach flu-like symptoms); This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via an unspecified route of administration in Arm Left on 23Mar2021 (Lot number and Expiry date was not reported) as single dose for covid-19 immunisation. Medical history included ischemic colitis in the past and she thinks that maybe the cramping started triggering it again. The patient's concomitant medications were not reported. On 02Apr2021 strong cramps in her stomach (stomach flu-like symptoms) and on an unspecified date, the patient experienced the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms), in the left arm it was cold and tingling (vaccination site coldness), (paraesthesia), experiencing contractions and cramping in her arm and the left side of her torso in the ribcage area that continued for 24 hours (muscle spasms) and diarrhoea on the weekend. Her second dose is scheduled on 13Apr2021, she would like to know if there are recommendations for her second dose because she heard that with the second dose the side effects are worse, she would like to know if someone else has reported these symptoms. She would like to know if she should possibly receive the vaccine in her thigh instead of her arm and if that would be helpful. The outcome of the events diarrhoea was recovered on 05Apr2020 and outcome of contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms) was not recovered and rest of the events was unknown.  Information on the Lot/Batch number has been requested
experienced dizziness; feel headache; muscle pain in his back; cough too much, it was white mucus; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6200 and expiry date: not reported), via an unknown route of administration on 24Feb2021, as dose 1, single (Age at vaccination: 54-year-old) for COVID-19 immunization. Medical history information included: The patient had COVID-19 on 26Jan2021 with very mild symptoms. The patient was losing the senses such as loss of smell. He got well after 3 or 4 days and went back doing activity and also had ongoing Diabetes Type II. Concomitant medications included: Ongoing Metformin extended release at 500 mg, twice a day (morning/evening) for type 2 diabetes mellitus and it was controlled. The patient had the first dose of COVID-19 vaccine on 24Feb2021 by 4 o' clock or 4:15 afternoon and had some symptoms, the patient had dizziness after 2 mins of getting the vaccine. The patient was given some 'Motrin' (not clarified) and some stuff, and he left after like an hour because before that he could not drive. The patient went back to house, 3-4 hours later had headache and muscle pain in his back and hurtled him on left side and can't move for 2-3 days as it was really painful. The patient had been like 12 days for some symptoms, and I do know that happened to me because I had or I have too much antibodies. The patient stated that, it was the feeling like when somebody pulls the arm strongly, like some kind of, and cannot turn around and back was like really painful. It went like that for 24 hours and patient started using some Voltaren and took a pill of Feldene in home, of course made by Pfizer. The patient noticed them as like inflammatory pills, so he took one Feldene 20 mg at bedtime. It was so helpful. It was having some kind of inflammatory, muscle pain and also was hard for him 'doing the COVID-19 to tell' (not clarified). 3 or 4 days later started feeling cough, cough was with mucus, was white but strong. The patient laboratory tests included: A1C test was 6.5 on an unspecified date, and Covid 19 tested positive on 26Jan2021. Outcome of dizziness was recovered on 24Feb2021. Outcome of other events was unknown.  No follow-up attempts are possible. No further information is expected.