chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A sore arm; Patient received the second dose of the vaccine 13 days after the first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (A sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine 13 days after the first dose) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine 13 days after the first dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (A sore arm). On 24-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine 13 days after the first dose) had resolved. At the time of the report, PAIN IN EXTREMITY (A sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information reported. No treatment medication information reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Route of the suspect medication was added and event- a sore arm was added
This case was reported by a pharmacist via call center representative and described the occurrence of muscle weakness upper limb in a 54-year-old female patient who received SHINGRIX (batch number ER5ZB, expiry date 6th September 2021) for prophylaxis. On 26th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced muscle weakness upper limb, injected limb mobility decreased and tendonitis. On an unknown date, the outcome of the muscle weakness upper limb and injected limb mobility decreased were unknown and the outcome of the tendonitis was not recovered/not resolved. It was unknown if the reporter considered the muscle weakness upper limb, injected limb mobility decreased and tendonitis to be related to SHINGRIX. Additional details were reported as follows: The patient was vaccinated on left arm. The pharmacist did not provide patient's initials when asked. The reported batch number ER5ZK did not exist and was updated to ER5ZB as per sales datasheet.
Box 17 - Shingrix   Pain at injection site, severe body aches, fever (101), sore throat, diarrhea, nausea, black circles under eyes (may be due to lack of sleep), unsteady (also could be due to lack of sleep). No medical attention sought.   Box 22- HepA/B
Red/ itchy area on site of injection 7 days after injection. This was not present within the first days. It has gone down but it?s still red and at times itchy.
Rash. Tiny papules around eyelid, other parts of face. Resolving.
Pt received the H1N1 shot at 5:15 pm 20 minutes later pt experienced hives on bilateral forearms, without respiratory distress. BENADRYL 50mg/1mL given. Pt tolerated well.
Patient is experiencing rash as a long-term reacting after given COVID vaccine. Rash comes randomly, appears as raised rash/scratches/blotches. Started about 10 days after receiving vaccine and persists for 3 months.
No adverse events occurred; however, when speaking to the mother it was stated that she was immunocompromised.  After giving the patient the dose and speaking with the mother, it was discovered that the patient was not immunocompromised.
Narrative:  first dose received 01/07/2021 second dose received 02/05/2021 patient tested positive on 09/25/2021
Rash 4 hours after shot raised itchy rash itches from toes to nose. SX persist taking Benadryl. Had called ER, looking for recommendation for Med. Recommended to go to walk in clinic for evaluation. 5/8/00 PC F/L didn't see only called made to walk in clinic doctor at the Clinic and was told that it is a allergic reaction to the vaccine. Rash is getting better only took Benadryl.
Client states her eyes swelled shut, her hands became swollen and she had noisy breathing(maybe wheezing) all started 2 days after vaccine and the symptoms didn't resolve until 8 days after they started.  She did not obtain medical care.  She doesn't speak English and didn't know she should've gone to the ER.  Plans to now schedule to see her doctor to find out if she should get a different covid vaccine as she had a reaction to Moderna.
Severe shaking and convulsions. This was not the chills. I could not stand up straight from shaking and had to put in a mouth guard to keep my teeth from chipping. Lasted 1-2 hours.
Facial rash, redness, swelling, itching.  Started day after vaccination, treated by MD three days after vaccination.
Severe blinking and eye spasms leading to being diagnosed with BEB (Benign Essential Blepharospasm.  Diagnosed in October 2021.  Began botox injections on November 6, 2021 due to inability to keep eyes open.
5:00 PM C/O ITCHING TO  LEFT UPPER EXTREMITY AND TORSO,  SCANT RAISED PAPULES TO LEFT FOREARM AND WRIST 5:15 VS B/P 132/76,P 93,RR 20 BENEDRYL 25MG PO GIVEN FOR ITCHING. MONITORED IN MEDICAL OFFICE.5:45 PM CONTINUE TO C/O ITCHING WITH INCREASED IRRITATION SPREADING T/O TORSO, DR NOTIFIED, RECEIVED ORDERS TO REPEAT BENEDRYL AND GIVE UP 100MG PO PRN, GAVE 25MG MORE AT THIS TIME, CONTINUE TO MONITOR IN MEDICAL OFFICE. 6:20PM VS B/P 108/82, P 82, RR20  PATIENT STATES TO HAVE DECREASED IRRITATION AND LESS ITCHING AT THIS TIME, NOTABLE FOR DECREASED RAISED RASH TO LEFT FOREARM AND WRIST AREAS.
Right upper arm injection site became swollen, painful, red and hot.  Treated with injection of antibiotics and a prescription for two antibiotics for 10 days.  No fever.  Injection site improved within 12 hours and continued to improve daily until gone.
Experienced moderate headaches everyday for 7 days following first series of vaccine. (NDC el9263) On day 7, woke up in the middle of the night with intense nausea and headache. First thought to have food poisoning because husband who received the same vaccine also had similar symptoms. Both vomited multiple times and experienced severe headaches. After second series of vaccine (NDC en 6201), experienced headaches everyday again which required in taking multiple doses of ibuprofen. On day 7, woke up in the middle of the night with intense headache. Developed intense nausea, headache, neck pain, stiffness, light sensitivity, watery eyes, congestion and could not continue to work. Took multiple doses of advil and had to take off work. No vomiting occurred. Did not see a physician but consulted a coworker/neurologist friend who thought I fit the description of aseptic meningitis. No lumbar puncture or laboratory evaluation was done. Rechallenge was positive.
day one after vaccine sore lymph nodes under arms, sore arm at injection site, sweats, headache, tired,  day 2 after vaccine abdominal pain and leg spasms twitching in legs these systems have continued until this report date.
2/9/21- after vaccination injection about an hour site was sore, warmth  to touch and R arm was  heavy.  Took Tylenol 500mg 1 tab @11pm due to 4/10 pain headache ,was relieved the next day. Sore on the R arm last about 3 days. 2/16/21-@1:40pm started to feel an itchy bump pea size on the R arm , applied hydrocortisone cream. By 11pm site was red and hives looking . Measured 2.5x2 inches, continues to be itchy and warm and slightly sore. 2/17- redness measures 3.5x3 inches. 2/18- redness and warmth on the surrounding area were slightly fading but still Continue to be itchy(did not apply hydrocortisone cream since the 17th) 2/19-resolved. 2/28/21- felt pea size lump on my R armpit, was  sore but after 3 days it disappeared.
Patient received 5 doses of the Janssen Vaccine instead of one dose. This was an administration error. A follow up was conducted with the patient who had no side effects or long term effects.
?Moderna COVID?19 Vaccine EUA approximately 4-1/2 X 3 inch swollen, hot, red, itchy achy local reaction at site of shot
suspected vaccination failure; currently have the shingles; pain is terrible; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingrix doses in 2018. At the time of reporting, the patient was having shingles and stated that pain was terrible. The patient stated he or she could not imagine what shingles would have been if the patient had not been vaccinated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Systemic: Body Aches Generalized-Medium, Systemic: Dizziness/Lightheadedness-Medium, Systemic: Exhaustion/Lethargy-Medium, Systemic: Hypertension-Severe, Systemic: Tachycardia-Medium.
Patient has a history of Hodgkins Lymphoma with radiation to mediastinum/chest (2012) and high risk for breast cancer. Found to have asymptomatic left axillary lymphadenopathy on screening mammogram and subsequent US.
Vaccination error, person under the age of 18. No adverse events reported by mother or patient.
Red splotchy rash all over the front torso, most noticeable on breast area, stretching up to neck and down to belly. Hot to the touch but no itching or irritation. I also experienced this symptom, to a lesser degree, after dose 2 of Moderna but did not report it at the time.
Very achy body.  Chills.  extreme fatigue.  Head aches .  Couldn't stay awake  felt too bad.  tired all day and forced to Slept at least 3 hours in the afternoons.  This went on for a good week.
have shingles and vaccine\ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles and Shingles vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Within several hours, post vax Anthrax #2, pt developed bilateral testicular pain. Several days later, he noted onset of diffuse myalgias. Testicular pain and myalgias persist, 1 year later. Actually received Anthrax dose #3, but no further doses since. Diagnosis of Prostatitis by UA, initially and treated.
Pinky rash upper breast; Itchy rash upper breast; Tenderness in right arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Pinky rash upper breast), RASH PRURITIC (Itchy rash upper breast) and VACCINATION SITE PAIN (Tenderness in right arm of injection) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038k20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer, Hypertension, Diabetes and Alcohol allergy (Allergy: alcohol when drinking).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Pinky rash upper breast), RASH PRURITIC (Itchy rash upper breast) and VACCINATION SITE PAIN (Tenderness in right arm of injection). At the time of the report, RASH ERYTHEMATOUS (Pinky rash upper breast), RASH PRURITIC (Itchy rash upper breast) and VACCINATION SITE PAIN (Tenderness in right arm of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient uses unspecified medication for breast  cancer survivor, blood pressure, diabetes as concomitant medications.
Pt was administered erroneous doses of Hep A, MMR, and Varicella - no treatment needed.
fever; headache; loss of taste; This is a spontaneous report from a contactable consumer (patient). A 27-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever, headache, loss of taste. Patient wanted to know are there any medications he can take. The outcomes of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
UrticariaPruritus pain, soreness, itchiness, swelling Narrative:  day 4 - noted soreness to arm; day 8 - noted itchiness and swelling to injection site; no further symptoms after
Patient had vasovagal reaction that required nurse to lay on floor and elevate feet. Patient's head slumped and nurse immediately noticed and placed in lying position with feet elevated. patient regained awareness and was A&Ox3, but required O2. patient was monitored and left under own power with out assistance. Patient given ER precautions and states understanding.
Diaphoritic, vomiting, pale, ?, lethergic, Better in 6 hrs.  No site irritation.
Symptoms and event are per parents reports.  Per Father's report: Dad reviewed with me that after leaving office, they stopped for ice cream, no symptoms noted. Dad not sure if symptoms or rash had started upon arrival to their home or after.  After arriving, per Dad, patient said she was itchy, a hive was found and then hives began to increase. Dad was not aware of tongue/lip throat tingling or any other symptoms, denies SOB/cough/vomiting and denied lip/mouth/throat swelling and complaints from child. Mother took over at some point, he said he would need to check with her. In the a.m. of Friday, child still had itching and rash at injection site. Per mother's report, sent via email to me, this is her email:  (I would like to note that this is indicative of possibly anaphylactic reaction, therefore could have been a life threatening event.) Patient had a reaction to her varicella vaccine last night within 20 minutes of leaving the office. She had severe hives, and some swelling and tingling in her mouth/throat/ears/nose. We gave her several doses of Benadryl over the next several hours and she was able to fall asleep around midnight. She is better this morning, still itchy, and has redness and swelling at the injection site that are more severe than she's had in the past. She is also complaining of a headache, such as she had with the last Varicella vaccine. As these reactions are going from mild to worse over the last months, especially with MMR and Varicella, we are going to make a report to VAERS and you will want to document the symptoms on her record. As the MMR and Varicella are complete, I'm not sure there is anything else we need to do and no follow up visit seems necessary unless you disagree. I just wanted to let you know.
Henoch-Schonlein purpura;pt devel rash & taken to ER 16MAR97;18MAR97 dx rash & swelling  of joints-HSP;pt exp pain in lt knee, dec walking,h/a;pain neck,pt irritable & screaming;dx vasculitis poss HSP r/o meningitis;BP began to fall;
Hep A given first. HPV 9 given second. Client fainted immediately after administration. Fainting spell lasted approx 5-10 seconds. Cool, wet towel placed on client's forehead. Client laid down. Drank water. Observed for 5 minutes in clinic. Client left talking/walking with father.
Pt developed flu-like symptoms, muscle ache, and joint pain. Eventual paralysis requiring hospitalization. Treated with prednisone and fosomak. Still experiencing pain and soreness, especially in chest, thighs, arms, and back.60 day follow-up dated 01/29/00 states the pts symptoms are ongoing. Per doc 195954,patient still has symptoms and he is taking medications with prednisone otherwise would not be able to function.
Within 30 minutes of injection experienced left shoulder/arm pain, minor numbness in jaw/face.  Over the next week experienced a dramatic increase in left-sided upper body muscle pain, facial paresthesias, and sudden new anxiety/adrenaline dumps. Panic attack on May 5 resulted in hospital ER visit. Symptoms progressively worse and bad for May-June-July before easing somewhat. Included muscle spasms in arms, legs, and torso, twitching, paresthesias (tingling, numbness, vibrating) especially in hands and feet, constant anxiety, chest tightness, GI discomfort and abdominal pain, insomnia, jaw/neck/lip numbness and tingling, tooth pain, groin pain, lower back pain, neck and shoulder pain, mostly in left side. Between August and November symptoms gradually got better with relapses and spikes in symptom recurrence every 1-2 weeks including sudden onset left-sided chest pain. Symptoms worsening through December 2021 and February 2022 with new relapses, including chest/shoulder/arm pain (left side), neck/throat tightness, anxiety spikes, tingling in fingers. Lower right back pain/tension has persisted since the vaccine.
thumb keeps twitching; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (thumb keeps twitching) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced MUSCLE TWITCHING (thumb keeps twitching). At the time of the report, MUSCLE TWITCHING (thumb keeps twitching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported
Atopic dermatitis, rash - desonide .05% cream BID x 3-5 days.
Information has been received from a physician concerning his 4 yr old daughter who was vaccinated at 12 months of age with a dose of varicella virus vaccine live. Subsequently, the pt developed a very mild case of chickenpox. One pox on her chest became infected and she was treated with oral antibiotics. No other complications were noted. Additional information has been requested.
PATIENT WOKE FROM A NAP AROUND 4:30PM AND FELT VERY HOT PER MOM. MOM GAVE HER A DOSE OF ACETAMINOPHEN AND WAS HOLDING HER ON THE COUCH WHEN PATIENT STARTED SEIZING. MOM CALLED EMS AND WAS TAKEN TO ER FOR EVALUATION.;
Pfizer / BioNTech: Dose Number: 3; Paxlovid: COVID 19 Treatment; Pfizer / BioNTech: Dose Number: 3; Paxlovid: COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovering" and all described as "Pfizer / BioNTech: Dose Number: 3; Paxlovid: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Positive, notes: Rebound symptoms and positive home test starting on 08Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Paxlovid included as a treatment drug.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 1st March 2019, the patient received the 1st dose of SHINGRIX. On 1st March 2019, less than a day after receiving SHINGRIX, the patient experienced fever, general body pain, headache, sleeplessness, pain in arm, ear pain and influenza-like symptoms. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the fever, general body pain, headache, sleeplessness, pain in arm, ear pain and influenza-like symptoms were recovering/resolving. It was unknown if the reporter considered the fever, general body pain, headache, sleeplessness, pain in arm, ear pain and influenza-like symptoms to be related to SHRINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient reported by evening he was experiencing the following symptoms, fever, body aches, headaches, unable to sleep, sore left arm, sore left ear. The patient was taking Aleve for pain management. The patient reported some improvements in these symptoms since day of vaccination. The patient said on the day of reporting, he felt like getting over the flu. The reporter gave consent to follow up.
Dizziness; A spontaneous report was received from a consumer who was also a 93-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced dizziness.   The patient's current condition included acid reflux. Products known to have been used by the patient, within two weeks prior to the event, included losartan not specific.  On 18 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route for prophylaxis of COVID-19 infection.  On an unspecified date patient started to experience dizziness.   No treatment was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event was not reported.