chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shoulder ache, second shot, and it was even worse; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (The patient got over acute shingles about a year ago after losing 2 months out of his/her life). Previously administered products included Shingles vaccine with an associated reaction of arthralgia (Received 1st dose on an unknown date, for tolerance of 1st dose, refer case US2022AMR127330). Concurrent medical conditions included pruritus (the patient had some minor itching at times).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced shoulder pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the shoulder pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:US2022AMR127330   Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient still had some minor itching at times. The patient stated that, all the vaccinations he/she had for overseas travel, etc.  The patient experienced shoulder pain again after 2nd dose.  The patient stated that he/she waited 6 months for the second shot of shingles vaccine and it was even worse. The patient stated that, still far better than getting shingles. Additional Supportive Information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR127330:1st dose
AE: patient passed out post vaccine administration, however; the patient did not hit head on the hard surface or become unresponsive.
This literature report has been received from the authors of a published article. This report refers to a female infant who presented with classic Kawasaki disease (KD) shortly after receiving her routine 4 month vaccination series. The present patient was first admitted with fever, edema and erythematous-purplish rash of the extremities, 1 week after receiving PEDIARIX, Haemophilus influenza type B (Hib) (manufacturer unknown) (dose, lot# and route unknown for prophylaxis), PREVNAR 13, and ROTARIX at age 2 months. At that presentation, she had poor perfusion, elevated leukocytes, platelets, and lactate, and underwent conventional infant rule-out sepsis management. Cerebrospinal fluid panel, urinalysis, and all cultures were normal/negative; the patient quickly improved with supportive care, was suspected to have viral sepsis, and was discharged after 2 days. The patient remained well through her routine 4 months well child visit. Twelve hours after receiving vaccines (again, PEDIARIX, PREVNAR 13, and ROTARIX at that visit, she developed a fever. This persisted until presentation on day of illness (DOI) 4, at which time she had a temperature of 39.4 degree Celsius, hemoccult positive diarrhea, and an erythematous macular rash on her torso. By DOI 7 she had dry, cracked lips, intermittent non-purulent conjunctivitis, and edematous feet with red soles. KD was suspected based on standard criteria: laboratory data were notable for C-reactive protein 97.1 mg/L, hemoglobin 10.2 g/dL, and albumin 2.8 g/dL; viral respiratory screen, urine and blood cultures were negative; echocardiogram and abdominal ultrasound were normal. With ongoing flares of body rash and feet swelling, and refractory more than 39 degree Celsius fever, she was given intravenous (i.v.) immunoglobulin (IVIG) and aspirin on DOI 9. She defervesced during the IVIG infusion, the swelling resolved the next day, and besides a fading reticular rash, she was at her clinical baseline at discharge on DOI 11. Subsequently, she received all expected 6 months vaccines except ROTARIX, and received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and Varicella vaccines (manufacturer unknown) at 12 months - all with no issues - and had remained otherwise well through 15 months of age. The reporter considered the event to be related to the suspect therapies. Upon internal review, the event of Kawasaki disease was determined to be medically significant.
Redness, swelling around injection site - left anterior thigh, size 14 x 15 cm.  Not raised. Site tender to touch.
Pt. reported feeling dizziness 5 min. after getting vaccinated.  Vital signs taken: BP 145/91, HR 84, O2Sat 99%, R 16.  Pt. also reported getting anxious when he sees vaccines.  At 10:19am pt. stated "Dizziness is going away and I feel better."  At 10:28am pt. went home.
Patient reported headache 3 days after receiving 2nd dose; felt tired; Patient started experiencing shaking, chills, aching, sore body and pain same day at night after; Patient started experiencing chills same day at night after receiving 2nd dose; Patient started experiencing shaking same day at night after receiving 2nd dose; Patient started experiencing aching/ sore body/ pain same day at night after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Patient started experiencing shaking same day at night after receiving 2nd dose), PAIN (Patient started experiencing aching/ sore body/ pain same day at night after receiving 2nd dose), HEADACHE (Patient reported headache 3 days after receiving 2nd dose), CHILLS (Patient started experiencing chills same day at night after receiving 2nd dose) and FATIGUE (felt tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 03-Mar-2021, the patient experienced TREMOR (Patient started experiencing shaking same day at night after receiving 2nd dose), PAIN (Patient started experiencing aching/ sore body/ pain same day at night after receiving 2nd dose), CHILLS (Patient started experiencing chills same day at night after receiving 2nd dose) and MYALGIA (Patient started experiencing shaking, chills, aching, sore body and pain same day at night after). On 04-Mar-2021, the patient experienced FATIGUE (felt tired). On 06-Mar-2021, the patient experienced HEADACHE (Patient reported headache 3 days after receiving 2nd dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, TREMOR (Patient started experiencing shaking same day at night after receiving 2nd dose), PAIN (Patient started experiencing aching/ sore body/ pain same day at night after receiving 2nd dose), HEADACHE (Patient reported headache 3 days after receiving 2nd dose), CHILLS (Patient started experiencing chills same day at night after receiving 2nd dose), FATIGUE (felt tired) and MYALGIA (Patient started experiencing shaking, chills, aching, sore body and pain same day at night after) outcome was unknown.            Concomitant medication : Thyroid medication
Information has been received from a physician via a company representative refers to a 12 year old female patient with possibly depression. The patient was not pregnant. The patient received dose 1 of GARDASIL in approximately SEP-2012 (reported as sometime in the fall of 2012). It was unspecified when dose 2 was administered. Dose 3 was administered in MAY-2013. All the three doses were 0.5ml, intramuscular without lot# provided. Initially, the patient developed a prolonged case of mononucleosis which began in JAN-2013. She then developed presyncope and orthostatic hypotension. She had been seen at a medical centers and a clinic. The patient was treated with midodrine, hydration and salt tablets. She was not hospitalized. The patient also developed chronic headaches and had been prescribed TOPAMAX, NEURONTIN and LAMICTAL to treat the headaches. The patient was diagnosed with Postural Orthostatic Tachycardia Syndrome (POTS) and dysautonomia. The physician said there was no significant disability and presently the patient was able to play basketball. The physician also reported that the patient's mother searched on the internet and read that there were 6 cases of dysautonomia reported in the "Journal". Physician had no further information about these cases. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Sore left arm after her booster dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore left arm after her booster dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore left arm after her booster dose). At the time of the report, MYALGIA (Sore left arm after her booster dose) outcome was unknown.            No concomitant and treatment medications were provided. The patient had a sore left arm after her booster dose. Patient reports no other adverse reactions.   This case was linked to MOD-2022-448733 (Patient Link).
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Additional Details: Patient passed out after administration of second vaccine. EMS was called and patient passed out and had a mild seizure while EMS was checking his vitals.
Body aches, numbness & tingling at injection site. Pain 8/10. Was given prescription for pain at ER.
Swelling to Left mid forearm to area just above elbow; redness and warm to touch. Client received flu and Pneumovax on 11/15/06. Visit to physician made for treatment of symptoms and received oral antibiotics-per client report.
Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 21-months old male patient who received 2 doses (0.25ml) of FLUZONE QUADRIVALENT (Batch number: UT6315UA, expiration date: 30-JUN-2019) via intramuscular in the right thigh on 03-DEC-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PENTACEL and Hepatitis (unclear type) for Immunisation. It was actual medication error due to extra dose administered. It was reported that the patient had no side effects. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
rash around pt waist, chills, headache. pt. came to the pharmacy to report these side effects Wednesday 02/17/2010 at about 7 PM.  She reported that the rash was almost gone but she still had the chills
Initial and follow-up information has been received from the Merck Pregnancy Registry via a licensed practical nurse concerning a 20 year old female with a history of social alcohol use in the first and second week until pregnancy confirmed who on 18-JUL-2007 was vaccinated intramuscularly with a first dose of GARDASIL.  Concomitant therapy included SKELAXIN five times total for a muscle relaxant and ADVIL 200 mg (frequency not reported).  Subsequently the patient was five months pregnant and did not realize it.  The patient was a Gravida 1, Para 0.  The patient's last menstrual period was in early February 2007 and the date of conception was on 14-FEB-2007.  At 25 weeks gestation the patient visited the physician for her 1st obstetric appointment.  On 23-JUL-2007 an ultrasound was performed to confirm pregnancy revealing a 25 week gestation.  On 30-JUL-2007 another ultrasound was performed that revealed an intra-uterine pregnancy at 25 4/7 weeks gestation and confirmed male fetus.  On 06-NOV-2007, at thirty nine and five days from the LMP the patient delivered a normal male infant.  Labor and delivery were uncomplicated.  The apgar scores were 9 and 9.  At the time of the report the patient had recovered.  Follow up information was received on 28-MAR-2008 from the physician's office.  The mother called the physician's office on 07-JAN-2008 at 1:43 pm and reported that the infant was 2 months old and had a stuffy nose, sneezing and watery eyes.  The infant also had a slight temperature of 100 degrees on 06-JAN-2008.  On 7-JAN-2008 at 1:55 pm it was noted to observe the infant and do DIMETAPP and ADVIL/MOTRIN.  Additional information is not expected.
The day after receiving the vaccine, my left shoulder, upper back (between shoulder and neck) began to hurt. I thought it was from the intramuscular injection, so I didn't think anything of it. But, the pain continued for a month (today). I cannot lift my arm above 90 degrees to the ground without pain, and it disrupts my sleep, since I feel pain when I move my arm at night. It is one month today, since I received the vaccine, and the pain is still the same intensity as when it started.
Fainted. Was on exam table so allowed to lay back onto exam table as became pale. Regained consciousness within 15 seconds. Cool cloth to head. After 15 minutes sat up drank juice. Sat for 15 minutes no other issues. PC to mother 5-16-14 & client doing well only soreness at injection sites.
After injection, immediate burning down to hand. Developed extreme lethargy, nausea, rash, fever (25 hours post injection), right sided weakness, right sided pins and needles (from cheek to leg)
6/22/06 Fever, redness and swelling at all injection sites (AM). 6/22/06 evening went to ER - fever, large, red, swollen both thighs. 6/23/06 Hives extending to arms, trunk, leg and fever persists.
We've administered expired Moderna Covid-19 vaccine to several patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
On 2/9/2008, subject developed sore throat and swollen cervical lymph nodes bilaterally, fevers to 99-100 F. MD was seen on 2/11/2008, lymph node to one side was 4 cm, the other side swollen but less than 4 cm.  Strep test was negative. MD diagnosed as viral pharynitis but was placed on/ completed antibiotic course as precaution. No rash or other symptoms reported by father.
unexpected loss of consciousness, uncertain if syncope or seizure, but diagnosed as new onset seizure disorder by the end of the hospitalization work up
Pt vaccinated with Td developed severe unilateral headache rt arm pain and numbness.
About 11 hours after the vaccine (in addition to red, hot, swelling at site, which happened with the first vaccine as well), I experienced a headache, spine ache, chills, tired - felt like I had the flu.  In addition, this morning, the 27th, my breast nipples are a purplish color (which I found very odd.)  After 36 hours, the flu like symptoms have dissipated, other than fatigue.
Dizzy, achy, flu like symptoms, horrible head ache, sweats & chills, just couldn't get out of bed, heavy ness in chest.  these symptoms lasted 3 days
Pain in left shoulder since 10/13/06 (date of vaccine administration). Seems to be getting  increasingly worse.
IPOL being administered post excursion with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received  via Nurse on 04-Oct-2022. Agency number: 01306722  This case involves a 14-year-old female patient to whom IPV (VERO) [IPOL] being administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA412359 and 2022SA412040.  Concomitant medications included Hepatitis B Vaccine for Immunization.  On 23-Sep-2022, the patient received 2nd dose of suspect IPOL vaccine being administered post excursion at dose 0.5ml once (lot: U1C571M, expiry date: 17-Jun-2023) via intramuscular route in the left deltoid for immunization with no reported adverse event (poor quality product administered) at same day latency.  Action taken: Not applicable.  At time of reporting, the outcome was not recovered.    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 the 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.
Site of shot very painful after 2 hours.  Then upper arm became red and hot within 2 hours.  Next 24 hours the upper arm from the injection site and up became very red and hot...then spread to my upper back on the left...and then spread across my upper back entirely.  Still there after 48 hours.
Mother states she noticed pt holding his throat and became concerned/increased anxiety. Pt states no complaints and says mother is "too protective" LS clear, negative outward s/s of reaction. Pt states dry throat since MUCINEX. Observation only.
Flu like symptoms for 1-2 days, and extreme swelling, redness, and hot for about a 2 inch radius around injection site. Treated with ice packs. Swelling has reduced but even 5 days later is red and slightly swollen.
sore on in the injection site; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient).  A 49-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the right arm on 26Dec2020 08:30 AM at a single dose as COVID vaccine. Medical history included seasonal allergy and high blood pressure. Concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient previously had known allergies to amlodipine. The patient experienced sore on in the injection site on an unspecified date. Treatment was not received for the event. She has no COVID prior to vaccination. She did not have COVID tested post vaccination. The outcome of the event was recovering.   Information about lot/batch number has been requested.
was fine at first then a little after 2 hours I started all of a sudden to get  very light headed and dizzy....face felt very funny....swollen face and nausea along with slight fever and headache.
painful legs; trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (painful legs) and DYSPNOEA (trouble breathing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (painful legs) and DYSPNOEA (trouble breathing). At the time of the report, PAIN IN EXTREMITY (painful legs) and DYSPNOEA (trouble breathing) outcome was unknown.            No concomitant medications or treatment details were reported.  Patient received the second dose on 14-Apr-2021 with Lot Number-044A21A.
improperly stored dose of Varivax was administered to a patient; no adverse effect; This spontaneous report was received from a pharmacist referred to a patient of unknown age and gender.  Patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) via subcutaneous route for prophylaxis (dose unknown, lot # R030614 and expiry date 23-OCT-2020) (product storage error). The temperature at which the vaccine stored was 39.5 degree F for a time frame of 46 hours (digital data logger report). There were no previous temperature excursions. The patients did not experience any adverse effects. No product quality complaint was present.
Moderate joint pain with feelings of "arthritis" and tingling as if my arms were asleep. The joint pain was in my neck, arms and hands. 25 days later, my left arm is still tingling.
awoke morning p/vax w/temp elevated to clinic @ noon; temp 105.5; MD alo noted reddness of throat & ears; recvd DPh, APAP & Iv ATB; pt has no problem @ present;
This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's current condition, pertinent medical history and concomitant therapy were not reported. On 21-DEC-2021 the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # T027936 and expiration date 18-AUG-2022) for prophylaxis (product storage error). The temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA)(M-M-R II) was 27.4C for 53 Hours and 30 Minutes. There is no previous temperature excursion.
Patient recieved 2nd dose of Moderna at 10:00am and was instructed to remain seated for 15 minutes in waiting room before leaving.  About 1-2 minutes afterward, patient fell out of chair, hitting the left side of her forehead.  Patient was conscious when approached.  She was asked if she was okay and if she needed emergency services.  Patient declined.  Patient was encouraged to lay down if she was still experiencing lightheadedness, but returned to sitting in chair.  Patient requested a ginger ale and one was obtained with her.  Pharmcist remained with patient while this was being obtained.  Patient called in the person who had brought her to appointment.  Once friend had arrived, patient was encouraged to continue waiting another 10 minutes.  At the end of patient 10 minutes patient got up to leave, but was again asked if she wanted emergency services called to examine her.  Patient again declined and departed.