chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 15 year old white female student who on 09-APR-2008 at 10 am was vaccinated in the right deltoid with the second dose of GARDASIL (Lot # 659964/1978U).  Concomitant therapy included TRINESSA.  The patient's mother called office indicating that on 11-APR-2008 the patient experienced generalized itching, site not reddened and no rash.  The patient recovered on 14-APR-2008.  No product quality complaint was involved.  Additional information has been requested. This is a follow-up to report (s) previously submitted on 5/14/2008- Initial and followup information has been received from a nurse concerning a 15 year old female student who was vaccinated with the first dose of GARDASIL on 07-JAN-2008.  On 09-APR-2008 at 10 am the patient was vaccinated in the right deltoid with the second dose of GARDASIL (Lot # 659960/1987U).  Concomitant therapy included TRINESSA.  The patient's mother called office indicating that on 11-APR-2008 the patient experienced generalised itching, site not reddened, looks fine, and no rash.  The patient was given ZYRTEC and had some relief. The office recommended BENADRYL and to go in the ER if the reaction worsens. The office called to check on 14-APR-2009 with no response from the patient. The patient recovered on 14-APR-2008.    Additional information has been requested.
I received my first dose but was then told that it may have been improperly stored.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (I received my first dose but was then told that it may have been improperly stored.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (I received my first dose but was then told that it may have been improperly stored.). At the time of the report, PRODUCT STORAGE ERROR (I received my first dose but was then told that it may have been improperly stored.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient was informed after receiving the first dose that the clinic was suspended for improper storage and that the patient could have 2 more shots.Patient enquired if patient should have one more or 2 more doses. AE Submitted  No treatment medication was reported. No concomitant medication was provided.
Day after initial shot my arm became sore, red, hot, swollen and hard.  This was in addition to other side effects.  This subsided after 4-5 days. On day 9 after injection my arm became red, and hot again at the injection site.  It was not as inflamed as the initial injection reaction, however very noticeable.  On day 10 I woke at night with vertigo as well.  I was able to fall back asleep after about an hour, and when I woke the next morning the vertigo has subsided. My arm had redness on and off for about 5 more days, seeming to get worse after my shower.  The redness has now subsided completely, however it looks as though I have a minor "bruise" under my skin at the injection site.
Hot flash, flushed skin, "feels dizzy" BP 160/106 PM Cold pack and cold water given.  6:20 PM BP 171/100 P 82.  Reviewed with MD.  Lying down feet elevated.  6:44PM 140/90.  6:50 PM 130/84.  Pt up and ambulating with no issues.
Stomach pains, fever, chills, bloody diarrhea. Was seen in ER and given IV fluids.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were unknown. On 21-OCT-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K008884, expiration date 20-SEP-2015,, dose: 0.65 ml) subcutaneously (expired product administered). Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
injection site red and swollen (30mm induration), fever (101.5 F)a day after vaccination, short of breath on third day;  Augmentin 875 1 PO BID x 7 days; Albuterol inhaler
Pt presented with complaints of midsternal chest pain, SOB. He was found to have elevated troponins >700 at peak along with some shortness of breath.  He was given fluids and NSAID.
Large hive appeared approximately 12 hours after injection. Hive measures approximately 5 centimeters in diameter, circular. Lightly inflamed, slight itching, warm to the touch, light pain when touched. Pain has decreased since onset. Pain was moderate at first appearance and for approximately 6 hours after (from about 6:30 am to 12:30 pm). Took two Advil and pain lessened. Size of hive and itching has remained the same.
p/vax pt exp a case of chickenpox of breakthrough varicella w/more than 50 lesions all over body;pt was reported to have no fever & not much malaise;pt sought unspecified medical attention;
Patient reports hives/itching all over top half of body 1 hour after flu vaccine administered. Treated w/BENADRYL 50mg - resolved hives. Reappeared 24 hours later - retreated w/BENADRYL 50mg resolved.
2nd booster dose; 2nd booster dose; chills; injection site redness; lymph nodes under arm sore; Fatigue; Inappropriate dose of Vaccine administered; 2nd booster dose; This is a spontaneous report from a contactable consumer or other non-health care professional reported for patient. A patient of unspecified age and gender received forth dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), dose 4 via an unspecified route of administration, unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 4 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administered at unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single, second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administered at unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 2, single, third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administered at unspecified anatomical location administered at unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 3, single for COVID-19 immunization. On an unspecified date, the patient experienced 2nd booster dose, chills, injection site redness, lymph nodes under arm sore, fatigue. Event took place after use of product. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
3-29 thru 4-1 extensive Diarrhea  Extensive sleeping Exacerbation of Hepatic encephalopathy; confused, unable to form sentences or speak; unable to make sense if speaking
Body aches, chills, fever, headache at 1300 3/5. Had R shoulder pain after receiving.  In evening on 3/6 symptoms of fever chills, Headache , body ache resolved. Sunday 3/08 shoulder pain resolved when she woke up.
Facial swelling and shortness of breath, sleepy. Pt referred to ER. Pt received vaccine previously.
Pt.'s mother states that after receiving the 1st dose of Phizer 06/23/2021, started experiencing symptoms 06/23/2021 evening of itchiness and hives lasting 24hrs. Treated with Benadryl. No noted Primary visit. Symptoms have subsided.
At 4am, the night after receiving the vaccine, I woke up with dizziness and nausea. This continued throughout the entire next day. By Saturday evening I had a fever of 101 degrees, a severe headache and severe nausea, muscle and joint pain. I was in bed that entire day and evening and was unable to go about my normal activities. By Sunday morning, most of the symptoms were gone except a mild headache and fatigue.
3 cm induration/redness and mild edema in anterior/lateral left thigh. does not want to bear weight on left leg.  cranky, fever, decreased appetite since night of vaccination date. Temp 102.9F tympanic
Mother signed form and sent back via email to nurse with permission to give 2nd Menactra and 1st Men B. Pt came in the room acting normal not anxious. Nurse gave MCV4 to pts R deltoid with no issues. Nurse was giving Men B and while she was giving it pt went pale and his head went down to his chest and body went limp. After about 5 seconds pt's arms and hands came in towards his body and became stiff. after another 5 seconds pt's arms went out towards his sides and remained stiff and body was tight and his head went back. After another 5 seconds pt's body came out of the stiffness and into a normal state. Pt started to respond to nurses. He remained pale and clammy. It was about a total of 20 seconds pt was in the state of seizure like activity. Nurse called Mother and stated to her what happened and that at this time pt was back in his normal state but just pale. Nurse stated to mother that nurses are with pt but nurse would like pt to be seen by a doctor. Mother said she will be on her way. The last time pt got vaccines he was pale, dizzy, and lightheaded. Nurse got ice and water for pt. Pt remained pale and clammy for about 5 minutes. Pt regained color and stated he felt "normal" or as he did before the shots just a "little clammy" still. Pt drank about two cups of water and remained sitting in chair until parents came. Nurses explained to parents what happened and gave list of what was given to pt and in what arm. Nurse explained that this will be reported to CDC and that she can refuse the next vaccination. Parents took pt from the room and were taking him straight to the ER to be seen. Nurse stated to call the office if they had any further discussion.
Pain in left arm; Pain in neck and head/face on left side; Pain in neck and head/face; Left side has pain and a little throbbing.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: ER8734) via an unspecified route of administration in the left arm on 30Mar2021 at 17:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included cervical vertebra injury (yes, I am also experiencing some nerve issues due to damage in cervical vertebrae). The patient had no allergies to medications, food or other products. Concomitant medications included heme iron (MANUFACTURER UNKNOWN), lorazepam (ATIVAN), TYLENOL (MANUFACTURER UNKNOWN) and spiranolactone (MANUFACTURER UNKNOWN); all from on an unknown date for unspecified indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 30Mar2021 at 18:00, the patient experienced pain in left arm, also on left side of neck and head or face, pain and a little throbbing on left side but not on right side. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in arm, pain in neck and face, pain and throbbing left side were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Red bumpy rash on tops of both feet, oozing.like hives Arm shot site sore 4 days + Made my chronic Lymphedema worse! New site of red skin and lymphedema on left knee
VACCINE WAS OUT FROM SATURDAY AND IT WAS ADMINISTERED ON MONDAY; VACCINE ADMINISTERED AT EXPIRATION TEMPERATURE; This spontaneous report received from a health care professional concerned a 47 year old female. 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: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 09:19 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced vaccine was out from saturday and it was administered on monday. On 03-MAY-2021, the subject experienced vaccine administered at expiration temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was out from saturday and it was administered on monday and vaccine administered at expiration temperature was not reported. This report was non-serious. This case, from the same reporter is linked to 20210503927.
Not feeling good after the booster; Kind of achy after the booster; kind of  tired after the booster; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling good after the booster), PAIN (Kind of achy after the booster) and FATIGUE (kind of  tired after the booster) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced FEELING ABNORMAL (Not feeling good after the booster), PAIN (Kind of achy after the booster) and FATIGUE (kind of  tired after the booster). At the time of the report, FEELING ABNORMAL (Not feeling good after the booster), PAIN (Kind of achy after the booster) and FATIGUE (kind of  tired after the booster) outcome was unknown.            No concomitant medications was reported. No treatment drug details was reported.
Information has been received from a physician concerning a 77 year old female patient with VICODIN, LYRICA and AMBIEN allergies, diabetes mellitus, hypertension and obesity, who on 05-OCT-2007 (also reported as 07-OCT-2007) was vaccinated with a dose of ZOSTAVAX in the left arm. On 07-DEC-2008 the patient experienced a zoster rash on the left side of her abdominal wall. Physician reported that the patient went to the ER for treatment either Sunday or Monday and was seen for a follow up visit in the office either Monday or Tuesday. Physician reported that the patient was treated with LYRICA and VALTREX. The patient was slow to recovered. The patient sought unspecified medical attention. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. Follow up information received on 16-DEC-2008 stated that the patient was slow to recover. The patient had a 10 on a pain scale. There were no other symptoms. There was no history or exposure to chickenpox or herpes zoster. Follow up information received on 06-JAN-2009 stated that the patient developed zoster and TIO dermatome on the left side; the patient was treated with LYRICA and VALTREX. At the time of this report the patient was recovering. Zoster at TIO dermatome on the left side were considered to be disabling. Additional information is not expected.
Five days after the vaccine, started having tingling/pins and needles in both lower legs and feet.  Seven days after the vaccine, started also having tingling/pins and needles in lower left arm and hand and a bit in left shoulder.  So far the symptoms are continuing and it is day nine since I was vaccinated.
Parent described large area of redness/edema.  Left deltoid area extending above the shoulder and into neck region.  Took child to ED on 05/15/2003 where Dr diagnosed cellulitis and placed child on Trimox for same.  Mother stated she could not get child to take any Tylenol or Advil after vaccination as advised.
FACIAL SWELLING. EYES SWELLED SHUT. TOOK DIPHENHYDRAMINE ORALLY AT 09:30PM ON 12/30/20. WENT TO SLEEP SHORTLY AFTER TAKING DIPHENHYDRAMINE AND FACIAL SWELLING WAS RESOLVED UPON AWAKENING THE FOLLOWING DAY. RESIDENT STATES SHE TESTED POSITIVE FOR COVID-19 ON 11/10/20
Patient was admitted to the hospital on 9/13  for both chest pain and abdominal discomfort.  Called paramedics after a sharp pain was felt in her epigastric region and profuse sweating occurred.
Moderna COVID 19 Vaccine EUA: 15 mins after administration, I felt dizzy and cold, last for an hour then resolved. 14 hours after administration I had fever,  chills, headache and sever body aches
Hives all over body dissipated after 7 days. Patient followed up with primary care provider.
Swelling and erythema and warmth over left deltoid with onset more than 24 hours after immunizations (less than 36 hours), covering area about 10cm X 4cm, oval. No nidus or fluctuance. Non-tender, non-pruritic, FROM of arm, no pain, no fever and no other symptoms. Rx'd Benadryl and ibuprofen and cool compresses. Return to ER prn any worsening or pain.
Pt called stating that after receiving Hep-B vaccine #3 on 2/1/02 and arriving home, she noticed left eye swelling and a rash on left wrist. She did not seek medical treatment. At the time of call, on 2/4/02, she was with swelling and advised to follow-up with PMD.
2-17/24-07 injection site pain; hip, knee, ankle pain; exhaustion. 2-25/3-3-07 ringing in ears; hot flashes; red spots on body; exhaustion; headache; increased blood pressure. The only symptoms left are body spots; ear ringing as of 12-4-07.
This case was reported by a nurse via call center representative and described the occurrence of nausea in a 19-year-old female patient who received BEXSERO. Previously administered products included BEXSERO (1st dose received in December 2016) and BEXSERO (2nd dose received in February 2017). Concomitant products included biotin, vitamin d and Probiotic. On 31st January 2018, the patient received BEXSERO. On 31st January 2018, unknown after receiving BEXSERO, the patient experienced extra dose administered. On 1st February 2018, the patient experienced nausea, general body pain, feeling unwell, light headedness, feelings of weakness, gagging, stomach discomfort, defecation urgency and absent bowel movement. On an unknown date, the outcome of the nausea, general body pain, feeling unwell, gagging and stomach discomfort were not recovered/not resolved and the outcome of the light headedness, feelings of weakness, defecation urgency, absent bowel movement and extra dose administered were unknown. It was unknown if the reporter considered the nausea, general body pain, feeling unwell, light headedness, feelings of weakness, gagging, stomach discomfort, defecation urgency and absent bowel movement to be related to BEXSERO. Additional details were provided as follows: This case was reported by the registered nurse who is the mother of the patient. The age at vaccination was not reported. The patient received the BEXSERO vaccine at her college health clinic after receiving an email from the school about mandatory vaccinations before being admitted into classes. The patient received BEXSERO even though she had already previously received her first dose of BEXSERO in December 2016 and then the second dose in the BEXSERO series in February 2017, which led to extra to extra dose administered. On 1st February 2018, 1 day after BEXSERO, the patient experienced nausea, extreme body aches, feeling unwell, light headedness, gagging, feelings of weakness, stomach feels like it is in knots with the feeling of needing to have a bowel movement but being unable to have a bowel movement. The reporter thinks her daughter's stomach may be cramping based on her described symptoms. The patient keeps gagging but had not been able to vomit. The patient currently feels really weak and lightheaded. The reporter gave permission to be contacted by agency.
I experienced about 3 weeks of profound exhaustion. First three days were also accompanied by nausea that affected my ability to eat regularly. Sleeping upwards of 10-12 hrs when I normally average 7 I couldn't even stand to shower and my legs were heavy.  Profound fatigue and exhaustion. I spoke to my psychiatrists who told me just to rest and couldn't offer much more beyond that. By January 26-27-28th it started to slowly resolve on it's own.  I could not walk within 10 mins I was fatigued. I was too tired to safely drive to Dr. I did a phone visit with Dr.  I am 50% better but I am still exhausted, sluggish , brain fog.  Nausea did get better. The fatigue is not nearly as bad.  I was just advised to sleep more.
Fainting, dizziness, weakness, fast heart rate, nausea, diarrhea
pt recv vax & devel a inj site rxn;this is 1 of 6 pt from this facility to devel an inj site rxn p/vax;
Tightness arm/ shoulder to ear like a swelling then got a metallic taste in mouth / gland felt swollen to about voice box area and had some dizziness for about 1  1/2 hours that just felt some tiredness rest of day.  stated about 40 minn after vaccine.    pt has not ever had any other vaccine in her life this was the first.    other item she had a reaction to was Bactrim that had some facial swelling and inflamed eye.  pt is not on meds to know
Seriousness criteria other medically significant (OMIC). Initial report received on 11/7/06 from a health care professional. A 59 year old female pt, with no concurrent illnesses, and a past medical history of hypertension, metabolic syndrome, and increased cholesterol, had received a first dose, right deltoid, IM injection of Adacel, lot number C2556AA, on 8/17/06. Forty three days post immunization, the pt developed severe bilateral face pain and right facial paralysis that included the eyelid. The pt did not complain of any visual impairment. At an unspecified amount of time later, the pt was evaluated by a neurologist. A Lyme antibody test was neg, and the pt was treated with Prednisone and Acyclovir. At the time of this report, the pain in the left face had resolved, but the right facial paralysis was continuing.
Death Cardiac arrest Hyperkalemia NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) ESRD needing dialysis (CMS/HCC)
On 12/15 patient started having fatigue, fever and anterior neck pain which continued for 2 weeks. Pain radiated to the ear and jaw.At the same time the neck became swollen with a palpable nodule on the LT thyroid. This progressed to right sided neck pain. Patient also intermittently experienced elevated temp at night to 100-100.5. Symptoms improved with Tylenol and Ibuprofen. This continues to be an ongoing issue
On 12/19/00, the pt experienced progressive worsening fever, erythema, right arm pain, edema and induration. The pt was diagnosed by a physician with cellulitis. She was treated with oral Cephalexin for 7 days and two courses of IV Cephalexin as an outpatient in her physicians office. The pt's symptoms completely resolved by 12/29/00. Upon internal review the pt's experience was considered an other "important medical event". Additional information is not expected.