chrisvoncsefalvay/vaers-outcomes huggingface dataset:
couldn't do her normal activities.; extreme fatigue; body aches; she was up all night; fever of 102 degrees; chills; extreme nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US069854_NC.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 29Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE number unknown; MANUFACTUERER UNKNOWN), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 29Apr2022, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 29Apr2022, outcome "recovering"; NAUSEA (non-serious) with onset 29Apr2022, outcome "recovering", described as "extreme nausea"; PYREXIA (non-serious) with onset 29Apr2022, outcome "recovering", described as "fever of 102 degrees"; SLEEP DISORDER (non-serious) with onset 29Apr2022, outcome "recovering", described as "she was up all night"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "recovering", described as "couldn't do her normal activities."; FATIGUE (non-serious), outcome "recovering", described as "extreme fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical course: Event: Patient reported she received the Pfizer booster on Friday 29Apr2022 and a fever of 102 degrees started that night along with chills, extreme nausea and body aches and she was up all night. Her symptoms lasted through Saturday and Saturday night and she also stated that she had extreme fatigue and couldn't do her normal activities.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Pain at injection site started day after injection and lasted about 3 days. Lymoh node swelling in left armpit noticed 2 days after injection. Swelling subsided several days later. Pain on inside of bicep near bone and at outter edge od ledt pectoral muscle started 4 days after injection and seemed to last about 5 days. Severe anxiety attacks started 5 days after injection. Today marks 5 days of this same anxiety attack. Dr started me on Lexapro and Atavan and melatonin. Body shakes still present and anxiety levels are super high.
Employee stated after 15 mins observation, that he experienced heart palpations for 2mins. This nurse then obtained employees vitals. BP - 126/80, P-80, O2-97. Employee was then observed by this nurse for 40 more mins. Employee stated @ 0902 he felt fine. Denies any prior anxiety/cardiac issuses when asked. Employee left observation @ 0905.
This spontaneous report was received from emergency medical technician and refers to a unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date between 13-OCT-2016 and 31-OCT-2016, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M015735, expiration date: 30-MAR-2018 and lot #M025870, expiration date: 24-MAY-2018) (dose, route and anatomical location were not reported) and properly stored sterile water diluent (manufacturer unknown) (route, anatomical location, lot# and expiration date were not reported). No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 90 minutes. There was no previous excursion reported. The call was because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012491:
Rash, joint soreness resulting in joint deformity, fever, swollen glands. Pt was prescribed various medications including antibiotics, methotrexate, prednisone, Naprosyn, folic acid and Tylenol.
Spike a fever of 103, chills, extreme fatigue, backache, headache, sweats
I developed a rash on my arms and chest that subsided after 25 minutes but returned the next day. It is now 4 days since injection and I still have the rash. I spoke with Dr who I will see on 2/12. I?m currently taking antihistamines but Dr wants me to discontinue 3 days before appointment.  Rash still present but only on pills 2 days.
Left thigh red, swollen, warm to touch. Started 24 hrs after vaccine administered. Treated with Duricef.
made her arm sore and made her tired for a few days; made her arm sore and made her tired for a few days; This is a spontaneous report from a contactable consumer, the Patient, from a Pfizer sponsored program. A 71-year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine, Lot number: EW0161(Then it says U682 or it says UU82 or 6682), Expiration date: Unknown), via an unspecified route on 22Apr2021 as a single dose for covid-19 immunization. Medical history included blood pressure, cholesterol medication and osteoporosis. The Alprazolam, Effexor, Cymbalta and Togranil all for Antidepressant, Celexa for pain (stool blockage, stool was sitting in colon, bad cramps while taking. take therapy for 2 to 3 months) and Xanax for Panic attack. The patient's concomitant medications were not reported. She had the first shot and it did not bother her. It made her arm sore and made her tired for a few days. The outcome of the event was unknown.   Follow-up attempts are needed; Additional information has been requested.
This is a spontaneous report from a contactable healthcare professional (physician assistant), via a Pfizer sale representative. A 16-year-old female patient of an unspecified ethnicity received the first dose of TRUMENBA, via an unspecified route of administration on 22Feb2018 at 0.5 ml, single for MENACTRA, intramuscular on 22Feb2018 at unknown dose and frequency for serogroup B meningococcal disease prevention. Medical history included ongoing Sulfa allergy, ongoing CIPRO allergy and had ongoing oral birth control (Taking Riboflavin). Concomitant medications included ongoing EPIPEN from 2014, and ongoing riboflavin for birth control. On 22Feb2018, the patient experienced palpitations. The patient also had a rash on her face and neck on unspecified date. On 25Feb2018, 3 days after receiving the doses, the patient went to the emergency department. She was not admitted to the hospital. The patient was treated with BENADRYL and Hydroxyzine and recovered completely the same day. The patient thinks the cause of her palpitations and rash was the meningococcal group b rlp2086 because it was her first dose and she had previously had a dose of the meningococcal vaccine a/c/y/w conj (dip tox). The reporter did not indicate causality for either vaccine. The patient was seen at the doctor's office on 27Feb2018 by the reporter and an additional physician assistant at the office. It was now flagged on the patient's chart to not give her a second dose of meningococcal group b rlp2086. The outcome of the events was recovered on 25Feb2018.
The first dose of SHINGRIX (3/20/18) patient experienced an intense adrenaline reaction where patient reports hairs standing up throughout body immediately. This reaction itched throughout whole body for 2-3 days. However, patient reports no hives/rash/difficultly breathing, only itching. Patients' itching was resolved on its own after 3 days.
body temperature rising; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (body temperature rising) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PYREXIA (body temperature rising). At the time of the report, PYREXIA (body temperature rising) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: rising (High) rising.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment medication. No relevant concomitant medications were reported.
The patient came back on 13Dec2021 and received another booster dose; Administration of lower dose than recommended; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Administration of lower dose than recommended) and EXTRA DOSE ADMINISTERED (The patient came back on 13Dec2021 and received another booster dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 103F21A, 032L20A, 011A21A and 058H21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included OMEPRAZOLE, URSODEOXYCHOLIC ACID (URSODIOL), VEDOLIZUMAB (ENTYVIO), METOPROLOL, MESALAZINE (MESALAMINE), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CETIRIZINE and AMLODIPINE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 06-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Administration of lower dose than recommended). On 13-Dec-2021, the patient experienced EXTRA DOSE ADMINISTERED (The patient came back on 13Dec2021 and received another booster dose). On 06-Dec-2021, ACCIDENTAL UNDERDOSE (Administration of lower dose than recommended) had resolved. On 13-Dec-2021, EXTRA DOSE ADMINISTERED (The patient came back on 13Dec2021 and received another booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The caller reported that an immunocompromised patient received the Booster dose (0.25ml) of the Moderna Covid-19 Vaccine, but should have received the third dose instead (0.5ml). The patient came back one week later and received another booster dose (0.25ml).  No Treatment medication was reported.
This spontaneous report as received from a registered nurse refers to a 5 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 08-SEP-2017, the patient was vaccinated with improperly stored PROQUAD lot # M036295, expiration date 13-FEB-2018, (strength, dose, dose number and route of administration were not provided) for prophylaxis. The vaccines were reconstituted with properly stored doses of sterile diluent (MERCK). The vaccines were exposed to temperature range of 6 degree Fahrenheit (F) to 14 degree F for 1 hour and 20 minutes. This report was because of a digital data logger. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008666: US-009507513-1709USA008861.
she got really sick with all three of the vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "she got really sick with all three of the vaccines"; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "she got really sick with all three of the vaccines". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "she got really sick with all three of the vaccines".  Additional information: Daughter was 44 and she got really sick with all three of the vaccines. Daughter never said that to her before. Thinks a lot of people just don't say anything and don't report it. Will talk to her daughter about calling and filing a report. Thought she was feeling better. Its wearing off. Doesn't know how the symptoms work through the system exactly. Starting to feel a little bit better. Doesn't know that she will make it to her appt Wednesday though. She can't shower to get out of house. She walks and rides a bike everyday. So this has really put her our. Doesn't get sick very often at all.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt received the covid vaccine dose #2 on 01/19/2021 at 08:00 AM Two hours later, she is reporting that she has a new onset of "itchy red rash from her chest spreading to her face." Denies angioedema, SOB but her throat starts to itchy and her voice is changing.  Denies any respiratory, cardiac, or neurological symptoms.
Patient got MMR and PCV 7 on 08/13/2003.  Started generalized rash few minutes after shots.  No other symptoms.
Right side of my neck and arm  excruciating pain for over a month see medical records at Hospital
Symptoms started about 30 hours after vaccine and lasted for about 21 hours. They started with a feverish feeling in my head (temperature was 98.0 degrees, but eyes and head felt the same as a fever). Extreme muscle aches started in the arm, moved to the armpit, and then I started feeling them all over?the kind of aches that rest doesn't relieve.  Took 400 mg ibuprofen and it helped a little.  At 2:30 pm the next day, they quite suddenly stopped and I felt normal again.
There is redness and it's still warm to the touch; There is redness and it's still warm to the touch; Swelling; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (reported as this past Monday) at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that there was redness and it's still warm to the touch; and a little swelling on an unspecified date. The patients stated that he/she gets allergy shots so this was not unusual for him/her and getting little reactions like that. The patient was not concerned because there weren't any other side effects to speak of and was wondering how long he/she should watch it like that. The patient clarified that it was red but not like 'in slender' (not clarified). According to the patient, he/she had redness before with injections so just wondered what would be the normal course of time. Outcome of the events was unknown.  No follow-up attempts are possible. Information regarding the batch number cannot be obtained.
Received 1st dose of Moderna COVID-19 vaccine on 12/30/2021 at 0830 am. Called on 01/04/2021 to report extreme chills/shaking, headache and muscle aches that started 12/31/20. Reports symptoms resolved in 24 hours.
Itching on arms shoulders back and head. No rash.  Blood pressue146/88, HR 84  pulse ox if 98%.  Patient is anxious about itchiness.  Benadryl 25 mg given refused to  take 50 mg.
Pneumovax administered right deltoid Apr 27 (site) soreness noted that evening- fever that night nausea 2 days with increased area right upper arm discomfort, pt noted April 29 erythema at immunization site, extending distally o/e right upper arm- irregular (poorly detoured borders) erythema, callor, tenderness, induration- 6 x 2cm area no axillary lymphad.
Received flu vaccine on 11/29.  Ten minutes later she experienced a seizure.  Later that evening she experience another seizure.  She does have a one year history of seizure disorder, treated with Trileptal and Neurontin.
warmth; was a hard lump; , her arm swelled up to almost baseball size; redness; pain at the injection site; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warmth), VACCINATION SITE MASS (was a hard lump), VACCINATION SITE SWELLING (, her arm swelled up to almost baseball size), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (pain at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warmth), VACCINATION SITE MASS (was a hard lump), VACCINATION SITE SWELLING (, her arm swelled up to almost baseball size), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (pain at the injection site). On 21-Jan-2021, VACCINATION SITE WARMTH (warmth), VACCINATION SITE MASS (was a hard lump), VACCINATION SITE SWELLING (, her arm swelled up to almost baseball size), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (pain at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
I experienced feverish chills for about the first half of the night. Now, I have pain in my lower back/abdomen, and I have a headache. I experienced the latter symptoms in the early hours of the following day.
Flu like symptoms including chills, body aches, fever, and fatigue for 4 days after vaccination shot
Fever, low back pain, tingling of arms & legs- starting 12 hours after injection, mildly responsive to OTC pain meds for 24 hours. Decreasing affects for additional 48 hours. Red splotches started appearing at sore injection site at 48 hrs & continuing to expand through present size of  4-1? splotches at current time of 90 hours after injection. Current pain level at injection site of 20% of pain at hour 12.
This spontaneous report as received from a consumer who was a company employee refers to her 13 month old daughter. On 30-JUL-2014 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot #, dose, strength and route unspecified). On 25-AUG-2014 the child developed a rash that was at first macular but quickly became vesicular. Some lesions were crusted on 25-AUG-2014. It was the fifth day a few new lesions have continued to appear on 29-AUG-2014. The patient had a low grade fever of 100.5 (unit unspecified) on the first day of illness (on 30-JUL-2014). Child also had some vomiting on unspecified date in August 2014, but otherwise appears well. The outcome of the vents was unknown. Additional information has been requested.
arm became itchy and started to swell;  continued all night; upper arm is all swollen  now,hot  and itchy.  The pharmacy did nothing wrong.  I never had this reaction before.
My arm at the injection site is extremely sore and painful. It is weak I can barely pick anything up. The muscle part of my arm is painful. The skin at the back of my head felt like it tighten up and stuck. My neck felt like it had a crook in it. I am still having pain in my arm. I still can barely pick anything up.
2nd dose before month 2; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 4y2p4, expiry date 31st January 2023) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 15th September 2021, the patient received the 2nd dose of Shingrix. On 15th September 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The registered nurse reported a patient received 2nd dose of shingrix less than the minimum recommended interval (before month 2), which led to shortening of vaccination schedule. The reporter confirmed that, the patient was not immunocompromised. The reporter consented to follow up.
Initial unsolicited report received from health care professional on 07-Sep-2018. This case is linked to cases 2018SA256129 and 2018SA255093 (same reporter). This case involves a four-years-old male patient who was vaccinated with a 0.5 ml dose of IPV (VERO) [IPOL] (Batch number : N1J45, expiration date : 05-Oot-2019, subcutaneously in right leg on 06-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation. It was a case of actual medication error due to incorrect product storage. It was also reported that vaccine was exposed to temperature of 49.8 degrees F. The excursion lasted approximately 4 hours. It was unknown if the patient experienced any adverse event or not. 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. Documents held by sender: none.
Diffuse ,red, splotchy rash started on left arm (vaccination arm) but not at the vaccination site. Slightly itchy.  Then it spread to right arm within 24 hours. Then splotches started anterior  neck.  No other symptoms.   About a week later , splotches still present all the same places and  now skin is peeling. Still red in color.     Have been using Benadryl and Benadryl cream,  moisturizer lotion.   I have pictures.  Still has skin condition at the time of this report
1-1 1/2 wks after getting vaccines pt. noted red raised bumps on skin in clusters. Itchy, intermittent on arms, legs, stomach and back. No fever. Continues to be a problem 4 mo after vaccines. Pt. thinks it is from varicella.
vomiting x1, finger swelling per Mom which resolved with 5 ml of benadryl
No additional AEs; a 4 year old male patient inadvertently received an extra dose of PEDVAX HIB on today 03/31/2023; This spontaneous report was received from a medical assistant (also office manager) referring to a 4 years old male patient. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On an unknown date, at 15 months old, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) one time dose for prophylaxis (strength, dose and route not reported, lot #W015927 and expiration date: 15-FEB-2025).  On 31-MAR-2023, the patient inadvertently received an extra dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (extra dose administered). He was caught up on all vaccines. No adverse event was reported.