chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional Aaverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 18-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007: US-009507513-2001USA009210: US-009507513-2001USA009216: US-009507513-2001USA009217: US-009507513-2001USA009219: US-009507513-2001USA009211: US-009507513-2001USA009212: US-009507513-2001USA009213: US-009507513-2001USA009214: US-009507513-2001USA009215: US-009507513-2001USA009200: US-009507513-2001USA009201: US-009507513-2001USA009202: US-009507513-2001USA009203: US-009507513-2001USA009204: US-009507513-2001USA009205: US-009507513-2001USA009206: US-009507513-2001USA009207: US-009507513-2001USA009208: US-009507513-2001USA009209: US-009507513-2001USA009220: US-009507513-2001USA009221: US-009507513-2001USA009222: US-009507513-2001USA009223: US-009507513-2001USA009224: US-009507513-2001USA009225: US-009507513-2001USA009226: US-009507513-2001USA009227: US-009507513-2001USA009228: US-009507513-2001USA009229: US-009507513-2001USA009230: US-009507513-2001USA009231: US-009507513-2001USA009232: US-009507513-2001USA009233: US-009507513-2001USA009234: US-009507513-2001USA009235: US-009507513-2001USA009236: US-009507513-2001USA009237: US-009507513-2001USA009238: US-009507513-2001USA009239: US-009507513-2001USA009189: US-009507513-2001USA009240: US-009507513-2001USA009241: US-009507513-2001USA009242: US-009507513-2001USA009243: US-009507513-2001USA009244: US-009507513-2001USA009245: US-009507513-2001USA009246: US-009507513-2001USA009247: US-009507513-2001USA009248: US-009507513-2001USA009249: US-009507513-2001USA009190: US-009507513-2001USA009191: US-009507513-2001USA009192: US-009507513-2001USA009193: US-009507513-2001USA009194: US-009507513-2001USA009195: US-009507513-2001USA009196: US-009507513-2001USA009197: US-009507513-2001USA009198: US-009507513-2001USA009199: US-009507513-2001USA009250: US-009507513-2001USA009251: US-009507513-2001USA009252: US-009507513-2001USA009253: US-009507513-2001USA009254:
had right arm tingling / tingling in his right arm again; abdomen hurt / he was hurting in his abdomen; This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose of shingrix on an unknown date). Concurrent medical conditions included chronic bronchitis, allergic reaction (to the IV contrast dye) and sinus disorder. Concomitant products included COVID-19 MRNA-1273 VACCINE (COVID 19 VACCINE MODERNA), fluticasone propionate, salmeterol xinafoate (Advair), salbutamol (Albuterol), budesonide and ipratropium bromide, salbutamol sulfate (Duoneb).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced tingling of extremity and stomach pain. On an unknown date, the outcome of the tingling of extremity and stomach pain were unknown.   It was unknown if the reporter considered the tingling of extremity and stomach pain to be related to Shingrix.  Additional details were provided as follow: The case was reported by the patient. The patient had last Moderna  shot  was 2 and 1/2 weeks  before the 2nd shingrix dose and he noted that the second Moderna shot caused  low grade fever,  chills and he hurt all over for about 36 hours then it resolved. The patient received his last Shingrix dose, 3 weeks before his first injection of Nucala, which was on 26th March 2021. He noted after the second Shingrix dose, he had right arm tingling and his abdomen hurt. He did receive both Shingrix and Moderna in the right arm. The patient also received Nucala and had adverse events, for tolerance refer case US2021AMR080126. The reporter consented to follow up.
Fever/chills, shaking, muscle aches, abdominal pain. Severe chills and sweating, I couldn?t get warm even with all of my blankets and heat set to 77 and woke up multiple times drenched in sweat.
1 week and 1 day after the injection a red rash appeared around the injection site. It is itchy, red, and slightly hot to the touch. No such rash was present prior to this day. It is about 2 inches in diameter and not growing or shrinking since it appeared on 2/6/21 at about 7am
Mild arm ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Mild arm ache) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L208 and 031L20A) for COVID-19 vaccination.     No medical history was not reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (Mild arm ache). On 07-Feb-2021, VACCINATION SITE PAIN (Mild arm ache) had resolved. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  Relevant concomitant medications included, multivitamin was reported.   Treatment information was not provided.    This case was linked.
huge blood clots; Period is two weeks early; Period is two weeks early with major cramping; brain fog; extreme bloating; extreme fatigue; headache; arm pain at injection site; weight gain; chest pain; thick sputum; This is a spontaneous report from a contactable Other HCP (patient).   A 37-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 04Aug2021 13:00 (at the age of 37-year-old) (Batch/Lot Number: Fc3180) as single dose for COVID-19 immunisation, administered at Pharmacy or Drug Store.  The patient medical history was not reported. Known allergies: Iodine, codeine. The concomitant medications in 2 weeks were none. The patient previously received bnt162b2 dose 1 at right arm on 28Jan2021 16:00 (Lot number: El9265) as single dose for COVID-19 immunisation. No other vaccine in four weeks. Patient was not pregnant. No COVID prior vaccination. On 08Aug2021 14:30 the patient experienced huge blood clots (medically significant) with outcome of not recovered, period is two weeks early (non-serious) with outcome of not recovered, period is two weeks early with major cramping (non-serious) with outcome of not recovered, brain fog (non-serious) with outcome of not recovered, extreme bloating (non-serious) with outcome of not recovered, extreme fatigue (non-serious) with outcome of not recovered, headache (non-serious) with outcome of not recovered , arm pain at injection site (non-serious) with outcome of not recovered, weight gain (non-serious) with outcome of not recovered, chest pain (non-serious) with outcome of not recovered, thick sputum (non-serious) with outcome of not recovered. The course of events was as follows: Period was two weeks early with major cramping and huge blood clots, brain fog, extreme bloating, extreme fatigue, headache, arm pain at injection site, weight gain and chest pain with thick sputum. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Sars-cov-2 rapid test (nasal swab): negative on 18Aug2021. Therapeutic measures were taken as a result of the events: antibiotics.  Information on the lot/batch number has been requested.
One month after booster, sudden Fullness in ear and Tinnitus and discomfort to eardrums.
ended up in the hospital with the flu for a week; Suspected vaccination failure / got the flu shot and ended up in the hospital with the flu; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received dose on an unknown date and experienced shingles, refer case US2021AMR202752).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Flu shot and ended up in the hospital with the flu for a week.  The patient stated that this was why the patient would not get the Covid vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202752:Same reporter
pt received vaccine waited 15 minutes went to car and noticed she was all red in face/neck took a benadryl 25g and came back in store . Gave ice pack & water. She sat for 30 more minutes then went home.
Less than 20 minutes following administration of influenza vaccine, individual complained of feeling funny in the head, face and arms became rosy red and small hives began appearing. Gave epinephrine  in left arm SC. Took to ER for evaluation. Per ackn. letter: took to ER as precaution, but when family members advised they took him home woithout being seen by ER physician.
shortness of breath whenever I exercise/can't breathe very well; tightness in my chest; pain in chest whenever I exercise; This is a spontaneous report received from a contactable consumer (patient). A 26-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:00 (at the age of 26-years-old) (Batch/Lot Number: EP7533; Expiration Date: Jul2021) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported. The patient had not received prior vaccination. The patient heard this, if she needs to report an adverse side effect. She states if she looking to report a side effect, can she do on website or you,she got shortness of breath and pain in chest whenever she exercises. It's Pfizer Covid 19 Vaccine. She wanted to report any time she exercises, she gets tightness in her chest and she can't breathe very well, and it started today when she got her first dose and that's in April and it still hasn't gone away on 09April2021. The patient had not tried anything as treatment in response to events. The patient underwent lab tests and procedures which included allergy test: unknown on unspecified date in Jul2021. The clinical outcome of all events was not recovered.
Patient's upper lip started swelling the day after HPV #2; associated cough without throat-closing or dyspnea. He previously had lip swelling the day after HPV#1, but was attributed to Amoxicillin prescribed the same day.
Symptoms started with a headache at approximately 2:30PM. By 3PM, I had a severe neck ache, generalized aches in all joints, and shaking chills. I took Tylenol Extra Strength at 3:45 and had a temperature of 100.4. By 6:30, my temperature was 102.4. Symptoms continued as above, except for chills at that time. I called Dr on call and he felt I was having a severe reaction to the shot and thought I'd fell better within 24 hours. He suggested I alternate Tylenol with Ibuprofin. Temperature was normal this morning, however symptoms such as aching in joints and headache persist.
Itchy rash about 3 inches in diameter at injection site and swelling, only appeared one week post shot.
she had redness across her chest; it was itchy and really red and about an hour later it subsided; It was like a dry skin type itch; This is a spontaneous report from a contactable consumer. This female consumer (Patient) reported for herself that: A 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0150) via an unspecified route of administration on 06Apr2021 10:45 (44-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The concomitant medications were reported as none. On 06Apr2021, the patient experienced redness across her chest, it was itchy and red, and it was like a dry skin type itch. The patient stated that she got the first dose of the vaccine yesterday and waited there about 20 minutes. Around 4:00, about 5 hours later, the patient had redness across her chest and it was itchy, but it was not hives and really red and about an hour later it subsided. The patient does not have discomfort in breathing or anything. Around 9:30 last night the patient's arm was itchy, both arms and her chest but there was no rash, so she knew in her little it was symptomatic reactions but she was trying to find out if she would take the second dose, but it wasn't on 'CDC'. It was like a dry skin type itch. The patient took a Benadryl, which helped. The patient asked if this was normal and if it was okay to take the second vaccine after these symptoms. Therapeutic measures were taken because of the events. The outcome of the events were unknown.   No follow up attempts are possible. No further information is expected.
This case was reported by a consumer and described the occurrence of morphea in a female subject of unspecified age who was vaccinated with HAVRIX, GlaxoSmithKline, (non-gsk) FLUZONE vaccine. Concurrent medical conditions included seasonal allergy. On 9 August 2005 and 16 august 2006 the subject received 1st dose and 2nd dose of HAVRIX (unknown, left thigh). On 4 September 2007 the subject received unspecified dose of FLUZONE (unknown). At an unspecified time after vaccination with HAVRIX, the subject experienced morphea, and scleroderma. At an unspecified time after vaccination with FLUZONE, the subject experienced sweating profusely, peculiar body odour and lesions nos. The subject's mother first thought that the issue was due to abrasions from the subject's cleats. The subject was diagnosed with scleroderma morphea in 2007, but her mother noticed the lesions before this time. The subject received FLUZONE on 04 September 2007, went to practice and started sweating profusely and developed an unusual body odor that lasted three months. She also broke out in additional scleroderma morphea lesions. At the time of reporting, the scleroderma morphea was unresolved, unusual body odor was resolved, sweating profusely and scleroderma morphea lesions were unspecified.
cheek feels bruised and is very swollen and hurts to touch; cheek feels bruised and is very swollen and hurts to touch; cheek feels bruised and is very swollen and hurts to touch; oozing rash on my chest that burns; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1, via unspecified route of administration, administered on the left arm on 08Mar2021 (Batch/Lot Number: not reported) as 1st dose, single dose for COVID-19 immunization. The patient's medical history included allergies on peaches and apples and patient had filler in both cheeks and lips. The patient's concomitant medication was not reported. On 10Mar2021, the patient reported that her left cheek felt bruised, very swollen and hurt to touch. The patient had filler in both cheeks and lips and only one cheek was swollen. The patient also reported that she had oozing rash on chest that burns. Treatment received was unknown. The outcome of the events was not recovered.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
pt recvd vax & 29SEP92 exp nausea, dizziness & extreme fatigue for 8 days; pt did not receive treatment;
Information has been received on 11-JUN-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-APR-2008, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician as recommended for routine adult health maintenance and for the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus ZOSTAVAX is intended to prevent. During July 2016, the patient was treated in a clinic for a blistering vesicular eruption, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Fatigue, joint pain, swelling in right wrist fingers as of November 2000 also in right foot.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-JUN-2015, the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route not provided) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster.  On or about 31-MAY-2016, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. On or about 28-JUN-2016, at the medical center the patient was  treated for ongoing and worsening symptoms, at which time he was diagnosed with post-herpetic neuralgia, a chronic condition of nerve damage and pain secondary to shingles outbreaks. The patient was prescribed gabapentin (NEURONTIN) for management of his painful conditions.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.  Additional information has been requested.
Pt awoke on morning of 13JUL91, had no use of lt arm & leg, mouth was druped to the rt side; No fever brought to ER;
11:55 hives found @ site of VARICELLA injection. 11:58 BENADRYL given. Pt. itched until 12:30. Hives improving. No eye symptoms.
PARASTHESIA IN LEFT ARM - ARM THAT INJECTION WAS ADMINISTERED IN - LASTING LESS THAN 1 MINUTE WITH SPONTANIOUS RESOLUTION - PT IS AN MD
Started on 8/11/21. Severe Constipation, Nausea, Abdominal pain and Fatigue.  Rx: Antinausea meds.
Information has been received from a nurse practitioner concerning a 5 year old male patient who on 11-MAY-2009 was vaccinated with a second dose of MMR II (lot # 663519/1771X ) 0.5ml, subcutaneously. Concomitant therapy also given on 11-MAY-2009, included tuberculin purified protein derivative (manufacturer unknown), DAPTACEL and POLIOVAX (manufacturer unknown). After he got the three other shots and before he got MMR II "seemed fine and was standing" On 11-MAY-2009 right after given MMR II "his head leaned over to the side like he had passed out". The nurse grabbed him and he started having "seizure like movements". Oxygen was administered as an intervention to prevent serious criteria. The office called 911, and he was transported to the emergency room but was not admitted. He was still having "seizure like movements" when he was taken from the office. There was no information whether or not the seizure like movements stopped and then restarted before he was taken from the office or if they lasted from when they first started until he was taken from the office. Unspecified date the patient recovered. Electroencephalography (EEG) and blood work were performed, results not reported. Follow up information has been received via telephone call from a nurse who indicated the physician had set the patient up with a neurologist to rule out a seizure disorder. The patient had no problems after receiving the first dose of MMR II. Follow up information has received from a health professional concerning a 5 year old male patient with no pertinent medical history and no known drug allergies, who on 11-MAY-2009 was vaccinated with the second dose of MMR II (lot # 663519/1771X ) in the right deltoid, a fifth dose of DAPTACEL (Lot# C3139AA) in the left deltoid and a fourth dose of POLIOVAX (Lot# B0009) in the left deltoid at 2:30 pm. On 11-MAY-2009 after given the last dose of MMR II the patient started shaking, his eyes rolled back, the he started seizuring. The patient required a visit to emergency room/doctor visit. On 11-MAY-2009 the patient recovered. Upon internal review seizure was determined to be an other important medical event. No further information is available.
Extremem muscle weakness, especially in legs, unable to stand, low grade fever, disoriented, confused, no appetite. Had to have 2 people help me up off the floor.
Case number PHEH2016US023412 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 51 year old patient whose gender was not specified. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 01 Dec 2015. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.