chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash at the injection site). At the time of the report, VACCINATION SITE RASH (Rash at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment medications were unknown.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 26-MAY-2021 contains non-significant information.
Left sternal heaviness radiating to left neck; severe malaise; intermittent dyspnea; diminished exercise reserve; lasted one week +/-; better with NSAIA;  In retrospect, a similar event happened with 4th dose, but only 3-4 days duration
states had rigors from 1100pm to 4 am.  states temp am 12/31/20 was 102.3 with body aches, fatigue and joints hurt.  0830 took tylenol and advil, temp at 1047 is 100.2 and still has body ached, fatigue and joint pain.  manager directed her to contact health.  I (health) directed her to ED for evaluation.
Sudden onset of shortness of breath while vacuuming that worsened over the course of the next several hours. ER visit and hospitalization for elevated cardiac markers, transferred to tertiary facility for further care. Diagnosed with Takotsubo syndrome (apical ballooning). Intermittent episodes of chest pain and shortness of breath for several months following. Did seem to recover until recent visit with recurrent symptoms of shortness of breath and swelling in the legs.
Woke up with intense vomiting and nausea. Vomiting continued for 6-8 hours, any liquid intake was swiftly vomited. Pepto and Tylenol helped by late afternoon.  Symptoms gone by next day but recovery took days Food poisoning ruled out,
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: pt came in and showed rph her arm. advised to use benadryl and seek out medical assisatnce if it continues or worsen. advised to seek er or EMS in case of anaphylaxix and explained what anaphylaxis is. pt understood
Large swollen red area at site of injection that appeared 14 days post injection. Has almost completely diminished since appearing on 1/22/21
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. The pharmacist reported that, on 20-FEB-2015, the patient was vaccinated with ZOSTAVAX, lot # K020801, expiration date: 31-JAN-2016 (dose and route of administration were not provided). No concomitant medication was reported. On an unspecified date in February 2015, the patient experienced injection site reaction described as localized blisters at injection site only. The patient sought medical attention by calling pharmacy. The outcome of the event was unknown. The relatedness between the event and the vaccination with ZOSTAVAX was not provided. Additional information has been requested.
April 7th 6pm - April 8th 10am: nausea and fever (reached 103.5°), did not go down with acetaminophen and lowered slightly with ibuprofen April 7th - April 11th: sore arm
body convulsions; torn muscle; subsequent muscle spasms; This is a spontaneous report from a contactable consumer (patient)  A patient of unspecified age and gender received COVID-19 VACCINE  MANUFACTURER UNKNOWN via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced body convulsions (hospitalization) on an unspecified date with outcome of unknown , torn (hospitalization) on an unspecified date with outcome of unknown , subsequent muscle spasms (hospitalization) on an unspecified date with outcome of not recovered.  The clinical course was reported as follows:When I received my Pfizer J&J COVID-19 vaccination in April, I had extremely severe reactions that included full body convulsions, which resulted in a torn muscle and subsequent muscle spasms that eventually led to my hospitalization. I'm still having muscle spasms from the injury due to the convulsions caused by the vaccine.  The lot number for the vaccine, [COVID-19 VACCINE], was not provided and will be requested during follow up.
Severe dizziness; Felt disconnected from my body; Nausea; Tongue was numb; Loosing my voice; Aching headache; Very sharp sudden pain on both sides of my temple behind my eyes, my temples on my face on my head and behind my eyes; Victimized stomach, vomiting; Very sharp sudden pain on both sides of my temple behind my eyes, my temples on my face on my head and behind my eyes; Victimized stomach, vomiting; I felt very weak and like a brain clot like I had a hard time focusing; I felt very weak and like a brain clot like I had a hard time focusing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old patient received bnt162b2 (BNT162B2), administration date 18Jun2021 (Lot number: EW0177) at the age of 66 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: DIZZINESS (non-serious) with onset 18Jun2021, outcome "unknown", described as "Severe dizziness"; FEELING ABNORMAL (non-serious) with onset 18Jun2021, outcome "unknown", described as "Felt disconnected from my body"; NAUSEA (non-serious) with onset 18Jun2021, outcome "unknown", described as "Nausea"; HYPOAESTHESIA ORAL (non-serious) with onset 18Jun2021, outcome "unknown", described as "Tongue was numb"; APHONIA (non-serious) with onset 18Jun2021, outcome "unknown", described as "Loosing my voice"; HEADACHE (non-serious) with onset 18Jun2021, outcome "unknown", described as "Aching headache"; FACIAL PAIN (non-serious), EYE PAIN (non-serious) all with onset 18Jun2021, outcome "unknown" and all described as "Very sharp sudden pain on both sides of my temple behind my eyes, my temples on my face on my head and behind my eyes"; ABDOMINAL PAIN UPPER (non-serious), VOMITING (non-serious) all with onset 18Jun2021, outcome "unknown" and all described as "Victimized stomach, vomiting"; ASTHENIA (non-serious), DISTURBANCE IN ATTENTION (non-serious) all with onset 18Jun2021, outcome "unknown" and all described as "I felt very weak and like a brain clot like I had a hard time focusing".  Additional information: Patient reported that three hours later, patient had severe dizziness, aching headache, and felt disconnected from body. And then came very sharp sudden pain on both sides of temple behind eyes, temples on face on head and behind eyes and tongue was numb. Then came like nausea, victimized stomach, vomiting and was loosing voice. Patient felt very weak and like a brain clot like had a hard time focusing. Also reported the pain going behind eyes.  Information on Lot/Batch number was available. Additional information has been requested.
while giving the Modern injection the patient moved right when the needle went into her arm. The liquid came down her arm and on her shirt. I discussed with her and we gave another injection in her right arm
Vaccine expired when given, expired 11/5/21 and was given 11/5/21
Arm is still swollen; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had it 6 times).   In July 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced swelling arm. Shingles vaccine was discontinued. On an unknown date, the outcome of the swelling arm was not recovered/not resolved.   The reporter considered the swelling arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter was a consumer who stated that they had it 6 times and got the 1st dose of vaccination 6 week ago. The reporter had stated that their arm is still swollen and they had a bad reaction to it and stated that if they should not to get the second one. Additional supportive information: Follow-up would not possible, as no contact, details were available.
After administration of VARICELLA and flu vaccine patient developed a slight cough and skin reaction with hives. Pulse Ox remained 98-99 % with resp. of 40 and pulse of 100-120. No wheezing was present and Benadryl was administered and patient transported to ER by 911.
bad sore throat; felt unwell; tired; groggy; This is a spontaneous report from a contactable other health care professional (patient). A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0198, Expiration date: Unknown), via an unspecified route of administration, administered in left shoulder on 30Jun2021 10:53 (at the age of 79-year-old) as single dose for COVID-19 immunisation at Pharmacy/Drug Store. Medical history included diabetes, blockages in her leg (Just found out she has blockages in her leg and has to go see a vascular surgeon), thyroid, blood pressure, glaucoma and cholesterol; all from an unknown date. Patient did not have relevant family medical history. The patient previously took flu shot (FLU VACCINE VII) on an unknown date for immunization and experienced needle stick and soreness in the arm. Concomitant medication(s) included insulin human (NOVOLIN R) from an unknown date and ongoing taken for diabetes mellitus (Has been taking for 2 years); insulin aspart (NOVOLOG) from an unknown date and ongoing taken for diabetes mellitus (Has been taking over 2 years); levothyroxine (MANUFACTURER UNKNOWN) from an unknown date and ongoing taken for thyroid (Has been taking at least a year); valsartan (MANUFACTURER UNKNOWN) from an unknown date and ongoing taken for hypertension (Has been taking at least a year); chlorthalidone (MANUFACTURER UNKNOWN) from an unknown date and ongoing taken for blood pressure; ezetimibe (MANUFACTURER UNKNOWN) from an unknown date and ongoing taken for cholesterol (Has been taking for probably 3 months) and brimonidine tartrate, timolol maleate (COMBIGAN) from an unknown date and ongoing taken for glaucoma. Additional vaccines were not administered on same date of the Pfizer suspect. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Jul2021, the patient experienced bad sore throat, felt unwell, tired and groggy. The patient underwent lab tests and procedures which included blood pressure measurement: suddenly 248/117 and ultrasound scan: some blockages; both on an unspecified date. Patient was received treatment for event felt unwell. It was reported that, On 30Jun2021, she had her first shot. It gave her a really bad sore throat. She just felt really tired and had to go to bed. She felt really unwell. She is getting the second shot 21Jul2021. She wanted to know whether the second one going to be worse than the first one. She noticed really bad sore throat in the next morning. She gargled salt water and mouth wash the second day, then it subsided, somewhat. She took Tylenol for that unwell feeling. Started the same time as the sore throat. It was not instantaneous or anything. By the second day, it was actually not lingering. She was going to a vascular surgeon on 19Jul2021. Does not know if this is pertinent or not. Patient was not visited to emergency room and physician office. The clinical outcome of event bad sore throat was resolving and outcome of other events was unknown.
patient received first dose of Moderna vaccine on 5/12/21. Bagan experiencing palpitations and tachycardia shortly after. Reports experiencing palpitations and tachycardia daily which wakes her from her sleep. Also reports diarrhea and hyper vivid dreams, the diarrhea has since subsided however. She has had 2 syncopal episodes since the vaccination.
Pt. had fall resulting in hip fracture o 1/30 at LTC facility, transported via ambulance to hosp, admitted, had hip sx, rec'vd vaccine doses on 1/4 and 2/7, tested (+) for COVID on 2/8; possible hospital acquired COVID infection, family reports runny nose seemed to be only sxs.
Chills, low grade fever, run down, fatigue, headache, joint aches, muscle aches, nausea, mental fog
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow-up information from the registered nurse who provided patients details. This report refers to a 10 week old infant patient. On 16-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB lot# J016188, expiration date 02-OCT-2016, (dose and route were not reported) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
nasal discharge; weakness/no energy; fatigue; deep breath; upper respiratory cold; feeling bad; coughing; Initial information received on 31-Oct-2022 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 45 years old female patient who experienced deep breath, upper respiratory cold, feeling bad, nasal discharge, weakness/no energy, fatigue and coughing after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Oct-2022, the patient received 0.7ml once (1X)  dose of suspect influenza quadrival A-B high dose HV vaccine (formulation, dose, lot number and expiry date not reported) via unknown route in the left arm for immunization.  On 25-OCT-2022 the next day the patient started feeling bad (feeling abnormal), upper respiratory cold (upper respiratory tract infection) and coughing (cough)  (latency; 1 day) She stated that the HCP's at Urgent Care did not really determine why she was feeling like this or any treatments at a time. She states that she did not get a chest xray that day, but is going back today to get one. On an unknown date the patient states that her symptoms were having a lot of nasal discharge (rhinorrhoea), weakness (asthenia), fatigue, having to deep breath to avoid pneumonia (hyperventilation) (unknown latency) and feeling it in the base of her lungs. The symptoms are continuing and have not improved.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events
recent blood work shows no immunity; This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a female patient who received Hepatitis A vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis A vaccine and Hepatitis B vaccine. On an unknown date, 7 years after receiving Hepatitis A vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The age at vaccination was not reported. In 2013, the reporter received Hepatitis B and A series as separate shots.  She completed the series for both shots.Brand name of hepatitis A and B shots unknown.  The reporter reported recent blood work shows no immunity to Hepatitis A or B and her gastroenterologist recommends re vaccination with Twinrix. The reporter did not consent to follow up.
Case number PHEH2014US003837 is an initial spontaneous report received from a nurse on 21 Feb 2014: This report refers to a 10-year-old patient of unknown gender who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) on an undetermined date. The vaccine was reported to be from the 2013/2014 season. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 21 Feb 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as Adult product administered to child.
See attached hospital records myositis; received flu shot (seasonal) 10 days prior to symptoms.   11/9/09:  Hospital records received for dates of service 10/8/09 to 10/10/09.  Dx:Upper extremity weakness, improving, most likely secondary to myositis.  Mild rhabdolysis secondary to viral myositis.  Assessment:  Developed fever, myalgia, lethargy, persistent muscle pain in both upper and lower extremities with persistent weakness of the upper extremities.  UE strength 2/5, decreased DTR's in UE's.  Forearm soreness on grip exercises.  Slight paresthesias of the tips of the fingers.  Improved UE weakness on DC.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 79-year-old female patient who received Shingles vaccine for prophylaxis. The patient's past medical history included keratosis. Previously administered products included Shingles vaccine (1st dose, refer case US2018145443). In July 2018, the patient received the 2nd dose of Shingles vaccine. In July 2018, 1 day after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the patient experienced injection site pain, general body pain, injection site erythema and rash. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the fever, injection site pain, general body pain, injection site erythema and rash were recovered/resolved. It was unknown if the reporter considered the fever, injection site pain, general body pain, injection site erythema and rash to be related to Shingles vaccine. Additional details were provided as follows: The 2nd dose was administered sometime in the 2nd week of July. The next day after that dose, she had a fever of 100.4 that lasted 2 days. She also had redness and soreness at the injection and general aches that lasted 3 to 4 days. A rash also presented around the same time. The rash presented in the folds of her skin under her breast area, in the groan area, armpits and lower part of her right leg. She also had a prior condition of benign keratosis with spots all over her body. Those spots became very red especially on her back and abdomen areas. She said that she might have had all the same symptoms (with the exception of the fever) after the 1st dose but they were much less severe after dose 1.
A 24 year old female with a history of environmental allergies, received the 4th dose of Anthrax vaccine on 09/25/2001.  There were no other vaccines given on this date and the patient had no illness at the time of the vaccination.  This patient had a previous reaction of injection site inflammation to AVA at the 3rd dose.  The only concomitant medication reported at the time of the event was birth control pills.
Lymph nodes in my left breast (given in  left arm ) were triggered after the first vaccine, and then nodes in all parts of my body acted up after second vaccine, except I had no more nodes triggered in either breast about two weeks from the first shot. Nodes are still flaring up, but no additional meds were require as I do take a Tylenol author. In the A.M. and P.M.
doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 05-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   On 05 NOV 2021, vial was initially stored in the refrigerator. No temperature excursions was noted and patient did not experience any adverse event.   Treatment medications were not reported.
Pain in vaccinated arm; raised red welts running across arm and toward armpit; headache, woozy feeling and tiredness; feeling of fever, but no fever.
This spontaneous report as received from a nurse via field representative refers to a 25 years old female patient. Patient was not pregnant. No demographic information provided for patient. Pertinent medical history was reported as none. On 26-MAR-2014, the patient was vaccinated with GARDASIL injection, Lot # 5009243, expiry date 23-APR-2016, dose 3, dose (unknown), route of administration (unknown), for human papillomavirus. Concomitant therapies included NUVARING and ACYCLOVIR. On 26-MAR-2014, the patient developed pain at the injection site, lump at the injection site and redness at injection site. On 20-APR-2014, the patient called the doctor's office to report the lump at the injection site had gotten bigger, and changed appearance. The nurse described the lump as the size of a penny. Patient sought medical attention due to office visit. No lab diagnostics studies were performed. No treatment was given for adverse events. Action taken with respect GARDASIL was not applicable. No Product quality complaint was involved. The outcome of events was not resolved. Causality was not provided. No further adverse event information provided. Additional information has been requested.
The day after receiving the vaccine, the patient was reaching for something and felt a pain in her shoulder. She called me on 12/19/19 to report that she was unable to move her arm and was wearing it in a sling. I advised her to contact her doctor.
Patient sent a message complaining of swelling in her, swelling hot to touch, red rash on her arm, headache, extreme fatigue and sleepiness, and nausea and vomiting.