chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 3 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 05-JAN-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally with lot number M029252 and expiration date of 14-MAR-2018 (strength and dose were not reported) for prophylaxis. Also, on the same date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX with lot number M032649 and expiration date of 11-NOV-2018 (strength, dose, route of administration, anatomical location were unknown) for the same indication. Both vaccines were stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848.
Patient called on 09/27/17 stating that she was itchy all over, body aches, fatigue, site of injection was sore. There is rash on site of injection. Was to take BENADRYL 25 mg four times a day. Called back on 09/28/17, stating that couldn't sleep, itchy all over. Started to take ALLEGRA 180 mg one tablet once a day, ranitidine 150 mg one tablet twice. Patient was then seen on 10/09/17, rash had spread to her another arm, per Dr. patient is to use cool compress for 10-15 minutes every few hours as needed, restart BENADRYL 25 mg one capsule every day, cetirizine 10 mg one tablet by mouth daily. Was given referral to allergies as well.
Pt reported feeling "malaise" and having chills the evening of her immunization. She reported that she was completely recovered the following morning with no problems.
The patient received a MODERNA booster vaccine from a vail that had been expired. The original vial was punctured on 4/1 @ 0940 and the booster dose was administered from this same vial on 4/4 @ 1500.
injection site was also itchy; she noticed a red rash at the injection site; she noticed a red rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site was also itchy), VACCINATION SITE RASH (she noticed a red rash at the injection site) and VACCINATION SITE ERYTHEMA (she noticed a red rash at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (injection site was also itchy), VACCINATION SITE RASH (she noticed a red rash at the injection site) and VACCINATION SITE ERYTHEMA (she noticed a red rash at the injection site). The patient was treated with CORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (injection site was also itchy), VACCINATION SITE RASH (she noticed a red rash at the injection site) and VACCINATION SITE ERYTHEMA (she noticed a red rash at the injection site) outcome was unknown.
Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 17-SEP-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (strength and route were unknown; lot# N034558, expiration date 05-DEC-2019) and properly stored Merck Sterile Diluent (lot# N031941, expiration date 03-AUG-2020) for prophylaxis (incorrect product storage). No adverse effects were reported. The vaccine was stored at 14 to -10 Celsius degrees for 15 minutes, -9 to 8 Celsius degrees for 5 hours and 45 minutes and 9 to 25 Celsius degrees for 3 hours. Data logger was involved. The previous temperature excursions were -14 to -10 Celsius degrees for 30 minutes, -9 to 8 Celsius degrees for 25 hours and 9 to 25 Celsius degrees for 17 hours. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA009201.
Felt fine prior, had had no problems with prior Pfizer Vax, also got the Quad Flu at same time, Rt arm. I then had a nice hamburger and coleslaw at a place I frequently eat, felt fine, then sometime in the evening, maybe 7ish, I began to have symptoms typical of acute food poisoning with severe wrenching, vomiting, and mild diarrhea.  It was so severe that I basically lay on the bathroom floor for a full 24 hrs until I finally had massive deep vomiting for about an hour and it finally resolved. I was unable to keep any fluids or meds of any kind down for that time, and next step would have been ED. It took a full week to recover, and I initially  thought it was food poisoning until I began to hear of other friends having similar, but not as severe,  nausea, HA, weakness. I was profoundly weak, severe HA for a week, flu like aches and feverish feeling without actual fever. The restaurant had no other reports of illness.
Left upper arm erythematous with swelling spreading down arm. Concern for cellulitis-treated with Cefalexin.    Received two vaccines in same arm.
Client was given Moderna for 1st dose on July 14th 2021. Client was inadvertently given Pfizer for second dose after client reported verbally and written that client was given pfizer for first dose. Upon looking in OSSISS noted client was given moderna for first dose. No adverse affects noted at this time. Informed client of incident and notified to monitor any symptoms. notify PCP or Health dept if needed.
A report was received from a healthcare professional on 10/14/2003 concerning a vaccinee of unknown demography who received expired Fluvirin on an unspecified date. On an unspecified date the vaccinee received expired Fluvirin.  The vaccinee did not experience any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1. 22 December 2003. The expired Fluvirin was administered to three vaccinees.  No specific information was available on the vaccinees.  No adverse effects had occurred as a result, as the time of this report.  No follow-up pending.
Erythema, induration, mild itching locally 12 x 12 cm area of erythema/warmth over (L) thigh. Patient seen Dr 1-5-15.
stated that he felt more uncomfortable with the first dose; had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "stated that he felt more uncomfortable with the first dose"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had a sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The report was not related to study or programme.  The reason for no lot number of Covid shot was that caller was unwilling to complete the report. Patient history was not provided.  Caller stated that her spouse had both Covid as advised. Stated that he had absolutely hardly any antibodies after 7 months. Stated that this is very discouraging. Stated that she read as much as could before she called and there was no guarantee of immunity. Caller stated that it stated that an antibody count of 2500 is advisable. Stated that her husband had 64. Later clarified that she did not complete a report on her husband. Stated that he had a sore arm with both doses and felt more uncomfortable after the first. Nurse declined to provide further details about the adverse reaction. She wanted to know why it does not know why it does not provide more antibodies. She stated that she worked for 30 years as nurse.  Follow-up attempts completed. No further information is expected.
The pt experienced Type III hypersensitivity reaction, as well as, arm soreness, redness and swelling after vaccination with Pneumovax.
Sleeping a lot; Slight headache; Extremely high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Extremely high blood pressure), HYPERSOMNIA (Sleeping a lot) and HEADACHE (Slight headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B212A and 045B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes since 01-Jan-2014, Hypothyroidism since 01-Jan-1993, Latex allergy and Allergy to chemicals (Ethylenediamine). Concomitant products included ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE ACCORD [ESOMEPRAZOLE MAGNESIUM]) for Acid reflux (oesophageal), INSULIN DEGLUDEC (TRESIBA FLEXTOUCH) and INSULIN HUMAN (HUMULIN R) for Diabetes, VARENICLINE TARTRATE (CHANTIX) for Smoking cessation therapy.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced HYPERTENSION (Extremely high blood pressure) and HEADACHE (Slight headache). On an unknown date, the patient experienced HYPERSOMNIA (Sleeping a lot). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 01-Apr-2021, HEADACHE (Slight headache) had resolved. At the time of the report, HYPERTENSION (Extremely high blood pressure) and HYPERSOMNIA (Sleeping a lot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Blood pressure measurement: 135/85 mmHg (High) 135/85. On 28-Mar-2021, Blood pressure measurement: 143/86 mmHg (High) 143/86. On 30-Mar-2021, Blood pressure measurement: 141/87 mmHg (High) The blood pressure came down to 127/83 mmHg.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient took hot bath.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up was added on 13 May 2021 included other relevant history, concomitant medications, second dose details was added and event outcome of the headache and action taken was updated.
t102.4, bones aching, et h/a, malaise, 2AUG95 cont w/temp, h/a malaise has taken APAP & ASA w/no relief; rt arm w/swelling warmth et erythema 3AUG95;
Patient received a dose of  Pfizer vaccine 8.30.21 that was mixed with 1.8  sterile diluent (sterile water) instead of 1.8ml Normal Saline.
Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 27-MAR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
When questioned patient denied receiving a COVID vaccination. Patient even completed two consent form and signed, patient even checked had not received another COVID vaccination.   Upon entering vaccine information found patient had completed the Moderna vaccination in April 2020 in another state.  Patient not responsive to phone call, unsure why patient thought she needed the Pfizer vaccine as well as the Moderna.
After receiving each shot I had the typical symptoms of feeling very tired and sore and having headaches. However over 2 weeks ago I started tasting and smelling the same smell/taste all the time. All food, unless it had a very high sugar content, tasted the same and so do most smells.
Fatigue, loss of use of fine motor skills, variable ptosis, EMG results and neurology determined CIDP. Developed rash w/in days of vaccination.
Child had chills, (temp. not taken) then would get very hot. She was lethargic & nauseated. She did not have an appetite & would not eat; felt ill. Sx's lasted 4 days after injection.
Patient felt like fainting. We called 911. The EMT crew members took the patient's vital signs. The patient stated he was okay so the EMT crew left without taking him the the hospital
At 2-8-21 at approximately 1:00pm I recieved my 2nd shot. At 5:00am on 2-9-21, I woke up experiencing an extreme headache, nausea, body aches, and severe chest pain. I checked my heartrate with a PulseOximeter and found it to be elevated at 105-115. I called out of work and rested in bed for the day. On 2-10-21 most of my symptoms had subsided however the chest pain persisted through 2-11-21. On 2-11-21 at 2:00pm, I visited the Urgent Care. While there, the provider ran an ECG, Chest X-Ray, and bloodwork. Test results showed Troponin levels in my blood had reached critical levels of 7.72ng/ml. I was immediately transported to the ER at the Hospital, where upon arrival they did an EKG and bloodwork. I was then admitted and seen by a cardiologist, who ordered an CT Angiogram, more bloodwork, and an Echocardiogram. After I was admitted, my mother contact the nurses station to check on me and asked what was wrong. She was then told the hospital was treating me for an NSTEMI and Myocarditis. This resulted in a 3 day hospital stay where the results of the tests showed there was nothing wrong with my heart other than the increased Troponin levels. It should be noted that I have had ZERO previous cardiac issues, or any other significant health issues. I was discharged from the hospital with lower but still elevated Troponin levels, and told to follow up with my primary care doctor. I had no health issues and felt fine until I had my second dose of the Covid-19 vaccine.  I have copies of my hospital records detailing all of this.
Slight varicella-like lesions noted in few places. There are approximately 6 lesions.
Report 2001003541-1 describes joint pain in a 53 year old male who received Lyme disease vaccine (Lymerix). This report was received from the patient and has not been verified by a physician or other health care professional. The patient reported receiving injections of Lymerix in May 1999, June 1999, July 1999, May 2000, and June 2000; this is greater than the recommended number of Lymerix injections. At some later, unspecified date, the patient experienced bilateral knee joint pain. No redness, edema, or heat was noted in the knees. The patient has not sought medical attention. The outcome of this event was not provided. The adverse event of joint pain does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Headache, Arthralgia, Fever, NauseaVomiting, Sore right arm,chills, back and shoulder pain Narrative:
This solicited report has been received from a 44 year old female patient with chronic obstructive pulmonary disease (COPD) who participated in a market research and was reporting on herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown dates, the patient was vaccinated with a doses of PNEUMOVAX 23 for respiratory disease (reported as resp dis) (doses, frequency, route of administration, anatomical location, lot# and expiration date were not reported). According to the patient, every time she received PNEUMOVAX 23 for respiratory disease she ended up with symptoms of that disease which set off her COPD, (dates unspecified). She stated also: "the cure was worse than her disease". The outcome of the events was unknown. Causality assessment was not provided. Additional information is not expected as there was no consent to contact provided.
Day 1- sore arm Day 2 Temp 100.6, muscle aches, Headache Flu like symptoms & tired ness
45 mins p/vax pt c/o itching @ site near rt elbow; mom states site reddened elevated & hard like bite; pt has had spider bites in past; 1 hr later reddened pinpoint type rash noted on neck & upper back; pt believed to have fever;
shacking again this AM, and her shoulders too; she couldn't sleep; head was shacking; chills; fever; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered anatomical location not reported, on 08Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. The patient received the first dose of the vaccine on Monday 08Mar2021. On 08Mar2021, the patient had fever and chills. Last night (10Mar2021), she couldn't sleep. She said her "head was shacking". She went to bed at 09:00pm (21.00) and couldn't fall asleep until 03:00am. She started shacking again this AM (11Mar2021), and her shoulders too. The patient wanted to know if there were any reports of this and what she should do. The outcome of patient could not sleep was recovered on 11Mar2021 03:00. The outcome of head shaking, chills, fever, shaking again this AM and shoulder too was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Fever of 103 degrees and fussy after receiving 2 month and 4 month old vaccines, symptoms worse after 4 month vaccines. and lasted for 3 days.
big red patchy areas on stomach, hips, & arm area;areas itch;to see MD this PM;
On 4/6/21 @2.30 i had first dose and see no effect,next day (4/7/21) at work from 9am start feeling strange and could not finish my lunch and start  feeling like i am going to throw out,I left 3pm and at 3.15 I vomit and next one 4 when i get home ,no tempt,on 4/8/21,felt same way like I am going to Vomit,but no,at late night on 4/9/21 around 11am feel like I am about to vomit,but no and I went to bed,get up on 4/10/20,same way feeling that I am about to Vomit ,but  and it look like it is going to come out.Burp comes once a while.It is uncomfortable and worry situation..    What we can do to stop.Vomiting  is  one of side effect listed on this site   Thanks
Patient c/o feeling dizzy, SOB, chest pain , sharp pain to the heart, numbness to the face. BP 120/80 Pulse 76 taken by nurse on site. EMS was also called to the scene. Patient refused ambulance transport and signed refusal form. Patient is okay and left facility with husband. Advised to monitor conditions closely and call 911 if it gets worse.
On 12/14 I felt fatigue, headache, body aches and post-menopausal bleeding (12/14-12/24). I went to the doctor on 1/5.
Adverse Events: Throat grab (immediate), Throat swelling, ears popping, difficulty swallowing Treatment: Resident "self-medicated" and took 40mg prednisone, 50 mg Benadryl, 1 inhaler of Albudiral Outcomes: Parked at hospital, waited for reaction to subdue. Resident left the vaccine site unauthorized before her 15 minute waiting period.
Rash look like a burn; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash look like a burn) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHYROID), GABAPENTIN and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced RASH (Rash look like a burn). At the time of the report, RASH (Rash look like a burn) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       About 12 hours later the first dose patient developed a rash that now looks like a burn 10 days later 19 Mar 2021. Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: No new information.
For 2-3 days after the 2nd dose (given on 2/10/21), I had a sore arm, aching and weakness all over my body, tired, nauseous and no appetite. I remaining in bed off and on for about 36 hours and then worked my way back to eliminate most of the symptoms.  However, after that and continuing at this time, i continue to be achy, particularly in my joints and my hands, fingers and neck, and I find that my lower jaw seems to be moved forward when I awake in the morning.  The achiness is particularly acute when waking in the morning, particularly in my fingers..  The pain is by no means debilitating, but it is noticeable.  I would rate the pain 3 or 4 when waking and 2-3 throughout the rest of the day.     I have not sought any treatment.
Developed swollen legs tight and discolored.. had a massage to relieve pressure on Friday.. started noticing Thirsday and at present have very bad vision changes that isn't normal. I also have on and off cheat pains this morning with numbness in my left arm and tingling fingers. Pain move from my right under breast area to left side before subsiding. But vision problem persists with swollen face and headache.
1 month following the vaccine patient started experiencing extreme fatigue, started having shortness of breath.  PCP ordered echo and he has pulmonary hypertension on echo.  Has recently started having some chest pain and tingling in arms and legs.
I was post menopausal for 5 months prior to receiving injection. Began spotting consistently without having a normal period shortly after injection. This continued even after second dose.  My ob/gyn wanted to do exploratory surgery  to test for potential cancers since ultrasounds were inconclusive. Finally resolved about 1.5 months after second shot.  I had a period and then no more spotting occurred.  I have not had any additional spotting or period after May 2021.
Debilitating headache started 18 hours after administration and is still occurring 3 days post vaccination. I can not move my head without extreme pain. This also lead to nausea, chills, muscle aches and loss of appetite.
Patient presented to ED with history of 4 days of worsening abdominal pain (10/10, intermittent), nausea and vomiting. CT is suggestive of small bowel obstruction. Patient received ondansetron, morphine, metoclopramide and IV fluids, and had an NG tube placed while in the ED. Patient is being admitted to the hospital.
Severe sore throat, lethargy, body aches, headache, some nausea - symptoms are now abating.