chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe itching of both hands and feet; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (severe itching of both hands and feet) in an 84-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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PRURITUS (severe itching of both hands and feet). At the time of the report, PRURITUS (severe itching of both hands and feet) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Tdap was given today and then I saw that she had this vaccine in 2007 (9/18/07).
Raised welt at injection site on the first injection, then the second injection had the same welt plus torso hives described as extremely itchy.
I have taken Moderna booster 3rd dose and the seasonal flu shot on the same date and time on two different arms at a pharmacy.   I am relatively healthy individual and never in the life had allergies or issues with any medication.   After a week or so upon the Moderna booster shot, I have been noticing a medium to severe itchiness all around the body - head to toes, including the palms. I also have hives.   Hives and itching temporarily stops when I take over the counter antihistamines, but again itching would get worsen within days after stopping to take antihistamines. It is little over a month now. Not a very severe or a life threatening condition.   Initially I thought itching was related to my international travel, but I returned back to US and still the itching not stopped.
After about 5 min of receiving his second Pfizer vaccine, pt suddenly developed generalized raise erythematous rash on arms legs, back . Hx: In anticipation  onset of anaphylaxis, after appearance of rash on lt arm, pt put on stretcher , undressed immediately, and generalized rash noted. none pruritic. v/s and sat NORMAL. airway NORMAL. lungs clear. given pt's very concerning rash but lack of indication of impending anaphylaxis, given 50mg po benadryl. rescue called for trans and observation in ER where given 30mg prednisone po  and monitored. was observed in ER and discharged after 2 hrs observation. 24 hrs later, pt continues to do well.  Dx : acute allergic reaction to pfizer vaccine.
DTAP- injection given on 1/10/11. Lt deltoid swollen, erythematous & tender.
Sore Arm after first vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in deltoid left, administration date 31Mar2021 (Lot number: EN6207) at the age of 62 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine (Adverse Event:  Local Reaction; Redness at injection site., Vaccine/Brand Name:  Flu Vaccine/No Brand Name, RA, Lot Number, or Expiration date known by caller.), administration date: 16Oct2020, when the patient was 61 years old, reaction(s): "Local Reaction; Redness at injection site.".  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "recovered" (01Apr2021), described as "Sore Arm after first vaccine".  Additional information: The events did not require a visit to emergency room and physician office. The patient had no prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
patient is only 16 and received the shot. age recommendation is 18. tried calling patient multiple times but no answer. left voicemail explaining to call back
Patient received second COVID-19 vaccine dose (Pfizer) on 4/19/21, only had fatigue that day. The following day, patient woke up with nasal congestion, headache, body aches, left arm soreness at the injection site. She had chills that night. Yesterday, +fatigue, body aches, chills, and nasal congestion worsened. Today, patient noticed nasal mucus was yellow this morning. All other symptoms have resolved today except for nasal congestion and body aches (though body aches have significantly improved). Patient took ibuprofen and phenylephrine for these symptoms. I believe the nasal congestion may be from a separate viral infection, but the other symptoms are possibly more related to adverse events of the vaccination.
Noticed extreme inner ear itching prior to going to bed. Almost like there was an insect kind of itching. When I reclined to go to bed, I noticed difficulty breathing nasopharyngeal swelling and immediately got up and drank some water and realized my throat felt tight.  I instructed my spouse to wake me in 2 hours to make sure I was ok and I slept elevated with pillows. 4:00am with same throat tightness and chest heaviness and tightness. Took Albuterol inhaler at 6:00am and again at 8:00am, felt much better.
I felt like i had the flu; This case was reported by a consumer and described the occurrence of influenza like illness in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza like illness. On an unknown date, the outcome of the influenza like illness was unknown.   It was unknown if the reporter considered the influenza like illness to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported but the patient could be 74 or 75  years old. The patient reported that how the shingrix would still be as effective if it had been a year since her first injection and had not received the second dose at the reporting date. The patient was willing to receive the 2nd dose of Shingrix. A year ago, the patient experienced all of the side effects felt like had the flu after receiving 1st dose of Shingrix. The patient would have conversation to one of Shingrix product specialist. They did like for us to gather a little bit of information.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 06-NOV-2012 at 03:22, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
After dose 5 of the Moderna vaccination I experienced severe fever my spouse tested me in November for Covid 19 and I tested positive.
Couldn't move her neck. She kept going to the ER and they labeled it as inflammation. She went again and she was running a temp and her blood pressure was very high. Her blood work should she had an infection in her spine and would need to have surgery. She had the spine surgery. After being home for a week lymph nodes had swollen up in her neck. She had to go back to the hospital where she had to undergo another surgery. She was then referred to an internal medicine dr. Aug 16th she left to go to overseas she had a slip and fall and fractured her tailbone. Which after all the surgeries caused her balance to be off.
15-year-old  received a Moderna booster shot; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year-old  received a Moderna booster shot) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year-old  received a Moderna booster shot). On 28-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year-old  received a Moderna booster shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Severe cough shortness of breath fevers congestion high blood pressure nausea vomiting severe fatigue increased insomnia increased anxiety
breathing very hard; could not even go to sleep; arm was also hurting; It was very sore that night; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (breathing very hard), INSOMNIA (could not even go to sleep), PAIN IN EXTREMITY (arm was also hurting) and PAIN (It was very sore that night) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced DYSPNOEA (breathing very hard), INSOMNIA (could not even go to sleep), PAIN IN EXTREMITY (arm was also hurting) and PAIN (It was very sore that night). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, DYSPNOEA (breathing very hard), INSOMNIA (could not even go to sleep), PAIN IN EXTREMITY (arm was also hurting) and PAIN (It was very sore that night) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, Heart rate: increased (High) Increased. On an unknown date, Heart rate: high (High) High (Rapid heart beat during day time).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Patient felt heart beating was very fast and breathing very hard. It lasted for a while and patient could not even go to sleep. The next night was better. Previous day, patient had rapid heartbeat during the day. Patient never had any trouble with rapid heartbeat or breathing. It was very sore that night (same day of first vaccination), and for a couple of days it continued.
Student complained with chest pains 2 hours after receiving FLUMIST at school based flu clinic.
Experienced sore arm, drowsiness, headache, hot/cold flashes, nausea day after first shot. Lasted for two days. All symptoms went away BUT returned on 04/29/2021 - 6 days after the shot Drowsiness, headache, hot/cold flashes, nausea and vomiting, achy joints. Lasted for four days. More severe than previous reaction.  Went to bed for two days, Nyquil, Advil
Vaccine administered on 6/10/15 around 4 PM. Approximately 3 hours later began experiencing polyuria, fever and headache. Reports urinating 8-10 times large volume. Awakened this AM feeing fine.No urine output yet today.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 (Lot number: FL3198) at the age of 49 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Relapsing Remitting Multiple Sclerosis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Droperidol, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0171, Location of injection: Arm Left), administration date: 30Apr2021, when the patient was 48 years old, for COVID-19 immunization, reaction(s): "I developed Tinnitus after the first two doses"; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Left), administration date: 08Apr2021, when the patient was 48 years old, for Covid-19 Immunization, reaction(s): "I developed Tinnitus after the first two doses". The following information was reported: TINNITUS (disability), CONDITION AGGRAVATED (disability), outcome "not recovered" and all described as "The tinnitus worsened after the 3rd dose". The event "the tinnitus worsened after the 3rd dose" and "the tinnitus worsened after the 3rd dose" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus, condition aggravated (course of high dose steroids).
Night of vaccine I felt prickly all over, like pins. By Tues 2/23, day after injection, I had a shingles rash forming under my right arm. Confirmed shingles Wed 2/24 AM @ urgent care. On 7 day dose of Valtrex 3xs/day.
I have been feeling fatigue for the 1st 10 days with wierd soreness feeling in the heart I picked up the cold on 1/03/2022 got tested for covid on the 7th results was negative. On the 24th I noticed that I was getting tired after 5 hours of work or normal activities with a little bit of shortness of breath I went to the clinic on Feb 15th, then gave me a inhaler and on the 18th they check my ekg which was fine and blood pressure was normal also a blood work was done it was OK and on the 24th had a xray of my chest they said it was good I quite my job on January 28th because I was being told that I was lacking on my job due to performance I'm still stuck with 5 hour only able to do normal activities I really believed that the booster shot started all this I am not normal
Had PNEUMOVAX here on Wed, developed redness and pain around site, with fevers to 103, not feeling well, and leg swelling up, itching and redness spreading, so went to ER on Thursday, given IV steroid and put on BENADRYL. The site area developed bruising, but now is much improved. He wouldn't walk for a day or two, and now still walking on tiptoes, but fevers and redness are gone. Has always gotten fevers with vaccines, so initially mother wasn't too concerned, never reacted like this. Did not get any hives or redness other than the injection site area, but it spread down leg.
Patient received COVID vaccine Pfizer 2 dose series on 3/2/21 and 3/25/21. On 8/10/21, patient was found down at home and admitted for COVID infection/pneumonia. Patient was also found to have probable superimposed bacterial aspiration pneumonia and acute respiratory failure with hypoxia. As of today (8/14/21), patient is still admitted in the med/surg unit.
patient was given a dose of Menactra that had expired, no AE; Initial information received on 07-Aug-2020 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 11-year-old female patient who was inadvertently vaccinated with an expired 0.5 mL first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]  (lot U6219BA and expiry date: 16-Jun-2020) via an unknown route at an unknown administration site for prophylactic vaccination on 24-Jul-2020.  The patient's medical history, past medical treatment, past vaccination and family history medication were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Immunisation.  It was an actual medication error case due to expired vaccine used.  At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Itchy lump at the vaccination site; Itchy lump at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Itchy lump at the vaccination site) and VACCINATION SITE PRURITUS (Itchy lump at the vaccination site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Itchy lump at the vaccination site) and VACCINATION SITE PRURITUS (Itchy lump at the vaccination site). At the time of the report, VACCINATION SITE MASS (Itchy lump at the vaccination site) and VACCINATION SITE PRURITUS (Itchy lump at the vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.
pushed me into a very bad low Saturday night; having problem sleeping all day; kind of like flu like symptoms was even worse; heart was racing over 145 beats per minute now wasn't doing anything; Rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (COMIRNATY), administration date 11Mar2022 (Lot number: FK9895) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DEPRESSED MOOD (non-serious) with onset 12Mar2022, outcome "unknown", described as "pushed me into a very bad low Saturday night"; SOMNOLENCE (non-serious) with onset 12Mar2022, outcome "unknown", described as "having problem sleeping all day"; INFLUENZA LIKE ILLNESS (non-serious) with onset 12Mar2022, outcome "unknown", described as "kind of like flu like symptoms was even worse"; HEART RATE INCREASED (non-serious) with onset 12Mar2022, outcome "unknown", described as "heart was racing over 145 beats per minute now wasn't doing anything"; RASH (non-serious) with onset 12Mar2022, outcome "unknown", described as "Rash". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of depressed mood, somnolence, influenza like illness, heart rate increased, rash.  Additional Information: I am calling to report some side effects from Pfizer vaccine, my first shot. I, pushed me into a very bad low Saturday night, got it on Friday the 11th. I was having problem sleeping all day Saturday I was into a low, kind of like flu like symptoms was even worse, my heart was racing over 145 beats per minute now wasn't doing anything. Lasted about a day, now I have a rash. Consumer stated, I do not take any other medication, Young and healthy. Prior vaccination was reported as none.  No follow-up attempts are possible. No further information is expected.
little headache or fuzziness in her head; little headache or fuzziness in her head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administration date 10Feb2021 (Lot number: E19262) at the age of 85 years 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: HEADACHE (non-serious), FEELING ABNORMAL (non-serious) all with onset Feb2021, outcome "unknown" and all described as "little headache or fuzziness in her head".  Additional information: Other Products, Patient History and Investigation Assessment were Not Provided. The patient says that right after the first one, she just had a little headache or fuzziness in her head, not a headache, right after. The patient Weight was 97-98lbs.  No follow-up attempts are possible. No further information is expected.
pt recv vax & 5 days post vax pt exp a rash w/hives all over body;7 days post vax pt exp hot & cold flashes;all sx resolved;
Chills; Fever; Body ache; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 10:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date and the patient did not have any other relevant medical history. The patient had no allergies to medications, food, or other products. The patient did not receive any medication within 2 weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 14:00, within several hours of vaccine dose, the patient experienced chills, fever and body ache, which lasted for one day and the patient was feeling better. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills, fever and body ache were resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
High fever (over 101), chills, body aches, headache, fatigue Stayed home & slept, took Tylenol Symptoms lasted about 24 hrs & were completely gone when I woke up the second day after I had received the vaccine
Small - dime-sized - raised welt at injection site.  Area is warm to touch and mildly itchy.  Only other side effect was arm soreness for 3 days after injection.
Initial unsolicited report received from a pharmacist on 25-Aug-2017. This case involves 71 year old female patient who was vaccinated with a first dose (also reported as previous dose 0) of ADACEL batch number- U5654AA, expiry date - 27-APR-2019 in right deltoid and PNEUMOVAX left deltoid (Dose, route were not reported for both the vaccines) on 21-Aug-2017. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) not provided. Illness at the time of vaccination was none. Any other vaccinations within four weeks of vaccinations were also not reported. On 25-Aug-2017, four day following the vaccination, the patient had redness and swelling on her left arm that was larger than 2 inches with itching. It was reported that during the discussion it was noticed that the PNEUMOVAX was given on the Left arm and the ADACEL on the Right the pt confirmed it is her left arm that she is having the reaction will call Merck to report the VAERS but, advised patient that will also complete the report since it was mostly complete. Also advised her prior to this discovery that the pt should be advised to see her primary provider for evaluation. Patient required emergency room (ER)/ doctor visit. Laboratory investigations and corrective treatment were none. Patient was not recovered from the event. List of documents held by sender: none.
t104 for 2 days; trouble swallowing, awake all noc crying; went to MD had a viral injection;