chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme left shoulder/arm pain that was prolonged and traveled down left arm. Initially thought it was normal reaction to vaccine but it persisted several weeks after injection which prompted doctor visit 10/21/19 for evaluation. No arm injuries prior to event.
This case was reported by a consumer and described the occurrence of neuromuscular symptoms in a 36-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 15 October 2012 at 11:30 the subject received a dose of FLUARIX (unknown route, left arm). On 15 October 2012, 6 to 8 hours after vaccination with FLUARIX, the subject experienced sore arm (injection site). That night, hours after vaccination, the subject experienced shivering, but denied a fever. The subject reported that "the soreness progressed over the next 3 days." On 18 October 2012, 3 days after vaccination, the subject experienced body pain, numbness in the hand, and arm pain. The subject reported "body pain all over his body and severe pain in his arms and numbness in his hands." On 20 October 2012, reported as the Saturday following vaccination, the subject was seen in the emergency room but "was not admitted". The subject completed an Magnetic Resonance Imaging test and other laboratory tests. Within a month after vaccination, "the recent lab work showed elevated liver enzymes and high creatine phosphokinase." At the time of reporting, results from the MRI were not known. Follow up from the consumer indicated that he had been diagnosed with "neuromuscular bad reaction to the vaccination [neuromuscular symptoms]." This case was assessed as medically serious by GSK. At the time of this reporting, the adverse experience of sore arm (injection site) and shivering was resolved after 24 hours. The body pain was reported as improved. The adverse experiences of numbness in hands and severe pain up arms were reported as unresolved. The outcomes for the neuromuscular symptoms, elevated liver enzymes and high creatine phosphokinase were unknown.
Chills - from 3am to 5:30am today  My left arm is very tender / painful - on the spot where I got the shot. Also felt some swelling of nods under a my armpit.  Tired/ body aching
Immediately after receiving vaccine, patient eyes began to roll. He then started having jerking movements and body stiffness. Patient was lowered to floor. BP 120/90 P64, SpO2 98% on room air. Patient A&O x3 after approx. 1 min. Cool compresses applied to face/head along with fan. BP 130/99, P81, SpO2 99% room air. Patient sat upright. Denies any further complaints and states, "This always happens when I see needles and get a shot." Additional monitoring in recovery. Patient ambulated from facility with mother. No s/sx of distress noted.
Complained of prustic papular rash day after vaccination to 2 different sites and immunization.  Patient with history skin sensitivity, eczemia reacts similar to other products in hygiene lotions.
Vaccine recipient reported symptoms of tingling in the tips of index and middle finger on left hand at the time of COVID-19 administration. Symptoms resolved 15 mins later and vaccine recipient continued on with their day with no further issues.
pt seen by nurse 5JUN96 w/local rxn @ site of inj (redness & minimal puffiness), no fever & no pain then seen by MD 7JUN96 11:05 w/hx of hives like rash on arms, chest, abd & legs since evening of 6JUN96;had URI sx runny noise & congestion;
Information has been received from healthcare worker concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients received unspecified improperly stored doses (Oka/Merck) VARIVAX (strength, frequency and route unknown, Lot# L026406 and Exp. date 15-JUL-2017). The vaccines were expose tot 9F for 3 hours. This was the first excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
04/11/06 at 10:35 Hep B, vac given at 11am employee called C/O Tongue swelling, advised to come straight to ER arrived at 11:21 c/o tongue very sensitive and feels weak all over. Itchy, VS 96.9, 84P, 18R, 118/88 BP, 98% POX RA, no stridor or distress. Scattered inspiratory wheeze. No swelling of tongue or oral mucosa. Decreased Itching with Benadryl. Treated with Benadryl 50 mg PO, Claritin 10 mg PO.
1 month after receiving the vaccine, I experienced shingles flare on the inner wrist of my left arm.  It resolved after taking a course of medication.  August 9th, my right eye was inflamed and severely painful and went to the eye doctor who diagnosed a shingle flare.
lightheadedness, nausea, lethargic & dizziness; pain in the back of neck, elevated BP; was seen in ER: 17DEC93 No response to f/u request;
Bilateral pulmonary emboli; A spontaneous report  was received from a physician concerning an 80-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) experienced shortness of breath and oxygen level low.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received her first of two planned doses of mRNA-1273 (LOT: unknown) on 05-Feb-2021.  On 05-Mar-2021, approximately 1 day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 048A21A) intramuscularly for prophylaxis of COVID-19 infection.    On 06-Mar-2021, the patient developed shortness of breath and her oxygen level was low.  On 09-Mar-2021, she was diagnosed with bilateral pulmonary embolisms. No hospitalization was required. The reporter stated that the patient had no history of blood clots.    Treatment for the event included apixaban.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
pt recv vax & pt began sneezing c/o throat tightness & need to spit up;given epi & improved over next 10min;
Tinnitus high frequency in background constant; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 02Apr2021 at 18:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid, low platelets and liver fibrosis. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA) and cetirizine hydrochloride (ZYRTEC); all for unknown indications from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took dicloxacillin (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. On 06Apr2021 at 05:00, the patient experienced tinnitus high frequency in background which was constant. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus high frequency in background which was constant was not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 04-MAR-2013, the patient was vaccinated with ZOSTAVAX, .65 ml, subcutaneous (lot number and expiry date not provided). On 28-MAR-2013, 25 days after onset of therapy the patient experienced small rash on her chest. The pharmacist assistant there are no vesicles on the rash, but it is raised and the patient assistant "it burns when it scratch it". The outcome of small rash on her chest and "it burns when I scratch it" was unknown. The reporter did not assess the relationship of small rash on her chest and "it burns when I scratch it" to ZOSTAVAX. Additional information has been requested.
got a subconjunctival hemorrhage in right eye and blood pressure has been between 140-150/92-97 since 3/2/21
Chills all night first night, fever next day at 101.7, vomiting , arm swelling like bumblebee stings, hard red knot stayed for 4-5 days, extreme fatigue
3" by 3 1/2" reddened swollen area on right leg where DTaP was given. Warm to touch. Lasted 2-3 days, no c/o pain. Did not take to physician.
Received Tdap 3-26-08.  (A documented Td was given 7-22-02, but patient did not disclose.  8/07 Td given because it wasn't documented).  Reports that 45 minutes after injection developed rash on neck, chest, abdomen, small area of upper arms anterior to axillae that was itchy.  Had mild respiratory wheezing.  After using an inhaler and 2 doses of Benadryl taken at different times, felt relief.  Also had a headache.  Today small amount diffuse like red rash remains on left neck.
Pt recv vax on 10/14/97; on same day pt exp local rxn from shoulder to wrist; vax given SC rather than IM
Headaches daily; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old, male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: unknown) at an unspecified dose via unspecified route of administration on left arm on 08MAR2021 (at the age of 26-year-old at vaccination) as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: unknown) on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history included allergy to penicillin (Pcn). Concomitant medication was not provided. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 09MAR2021, the patient experienced headaches daily. No treatment was received for the adverse event. The clinical outcome for the event headaches daily was reported as recovered with lasting effects at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
fever, vomiting  no swelling, soreness @ inject site; possible gastroenteritis;
Patient developed fever, chills, and tachycardia within hours of the dose. She presented to the ER and was admitted to the ICU for presumed sepsis (h/o immunosuppression plus known immunodeficiency) and was started on brand spectrum antibiotics but no infection was found. She remained febrile to about 40C for approximately 18 hours and then defervesced. She was tired and weak with new headache thought to be due to underlying myasthenia gravis so she was transferred to near ICU for bipap overnight. She became confused, started vomiting, and complained of neck stiffness and headache worsening overnight. A head CT performed the following AM was completely normal and LP revealed an opening pressure of 55cmH2O. Protein of 22, glucose of 50, 4wbc, 10rbc, meningoencephalitis panel was negative including crypto antigen. Cultures were also negative.  Patient's symptoms resolved completely with removal of CSF via LP. 8 hours later, she again developed worsening headache, nausea/cvomiting, and confusion. A repeat LP revealed OP of 55cmH20 again and more fluid was removed with same result of complete resolution of symptoms. An MRI/MRV was done and venous sinus thrombosis was ruled out. In fact there were no abnormalities shown at all. Patient had recurrence of symptoms again about 8-10 hours after the LP and a lumbar drain was placed. Over the last 2 days, her drain as been putting out less and less CSF and she has felt well and is without symptoms. During this time, CBC and CMP remained normal. She will undergo plex today as she is due for this to treat her MG. We hope it will also reduce the vaccine reaction. Of note, patient regularly receives IVIG and got her most recent dose about 2 weeks prior to vaccination.
Patient was due for IPV and DTap so she was given Kinrix. Staff unaware at time that kinrix should not be given past the age of six. Patient didn't report any adverse reactions.
Employee reports he received flu shot and had an immediate anaphylactic reaction with shortness of breath, lightheadedness. Rapid response was contacted and administered epinephrine. Employee was transported to urgent care and received BENADRYL and IV SOLU-MEDROL. Employee was observed and discharged.
L55XW45 Left arm (tricep) area red, swollen, warm to touch. Pt stated it was tender in area. Pt did not apply ice to area or take any anti-inflammatory at onset of reaction.
Pt recvd vax 2SEP92 & 5 minutes following vax pt exp syncopal episode; complexion became grey & fainted for a few seconds; BP remained nl; however could not stay on feet; recovered w/in 15 minutes;
Gardasil 9 and Adacel administered on 7/31/23. Presented to ED on 8/3/23 with pruritic rash on abdomen, chest, arms, and back that started previous day. Patient was administered epinephrine, prednisone, and cetirizine. Follow an observation period, patient reported improvement with less pruritic rash.
Headaches (mild), increase in fasting glucose 30% from 124 to 155 or more, fatigue, weight gain 5lbs or more, edema of the feet and hands (mild).
Patient was vaccinated in left deltoid muscle with prevnar vaccine and afluria.  Prevnar had to be done twice  since pt moved arm (flinched) with 1st prevnar and full dose wasnt injected. therefore another dose was given 1 inch apart.  patients arm hurt 2 days later and continued for more than a week. On 09-09-19 RPH told patient to go to urgent care. Dr referred patient to neurologist since there were no physical findings. we are now awaiting the patient contacting us after she sees neurologist
Unimmunized patient who was begun on "catch up" series has developed alopecia.  Family feels immunizations are the cause.
The vial used was initially stored in the refrigerator on 30-Jun-2022 and administered on 04-Aug-2022; No adverse event; vaccine was administered after 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was administered after 30 day use by date), PRODUCT STORAGE ERROR (The vial used was initially stored in the refrigerator on 30-Jun-2022 and administered on 04-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     It was unknown if patient had any allergies. It was unknown if patient had event diagnosed with COVID-19. Acute and chronic illnesses at the time of vaccination was unknown.  Previously administered products included for Product used for unknown indication: (Other vaccine given within 1 month prior to Moderna COVID-19 vaccine), DTaP (Other vaccine given within 1 month prior to Moderna COVID-19 vaccine), pneumococcal vaccine (Other vaccine given within 1 month prior to Moderna COVID-19 vaccine) and Hep B (Other vaccine given within 1 month prior to Moderna COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with DTaP, Hep B, and pneumococcal vaccine.    On 04-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was administered after 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial used was initially stored in the refrigerator on 30-Jun-2022 and administered on 04-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine was administered after 30 day use by date), PRODUCT STORAGE ERROR (The vial used was initially stored in the refrigerator on 30-Jun-2022 and administered on 04-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (vaccine was administered after 30 day use by date) and PRODUCT STORAGE ERROR (The vial used was initially stored in the refrigerator on 30-Jun-2022 and administered on 04-Aug-2022).    It was unknown if patient was under any concomitant or regular medication.   Number of doses/vials: 1 dose/1 vial.  The injection was administered in the thigh.  The vial did not undergo any temperature excursions.  It was reported that HCP did not know if patient experienced any symptoms after the vaccine was administered.  It was reported that HCP did not know if any treatment was given.
belly tenderness; nausea; constipation; belly pain; This is a spontaneous report received from a contactable consumer. A 9-year-old female patient received BTN162b2 (PFIZER-BIONTECH COVID-19 VACCINE) 10 ug, as dose number unknown, single on 04Nov2021 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that starting on 06Nov2021 she reported belly tenderness, nausea, constipation, and belly pain. Emergency room ruled out appendicitis. Seems better the day of the present report 08Nov2021 and she will return to school the day after this report (09Nov2021). Event took place after use of product. The outcome of the event was resolving.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
For the three days right after the vaccination, had a fever and extreme fatigue.  Two weeks after this vaccination, developed lymphadenopathy and then on 1/11/22 developed a significant rash over her trunk and back that is in a Christmas tree pattern along with severe itching.    Itching and rash have not subsided, lymphadenopathy has lessened.
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Weakness-Severe, Additional Details: Patient experienced swelling, chills, waekness, tiredness night of injection. Body symptoms lasted for 4 days, swelling is still current. Rph reccomended benadryl and lidocaine topical to help patient, and recommended follow up with md for if needed
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX. Previously experienced adverse reactions included injection site swelling, injection site erythema, injection site rash and discomfort (see case US2018GSK011692). Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received in January 2018). Concomitant products included ADVIL and BENADRYL. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was recovered/resolved. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The reporter was the husband of the patient. The age at vaccination was not reported. The reporter declined to answer any follow-up questions during the call. The reporter wanted to relay information to GSK about what the healthcare professional directed in order to be shared with other future consumers. The patient received second dose in the SHINGRIX series a couple of weeks before the date of reporting. Her healthcare professional told her to take an over the counter BENADRYL about 30 minutes to 1 hour prior to having the 2nd dose in the series. Then after having the 2nd dose of the series, her physician told her to take another BENADRYL 2 to 3 hours afterwards and then, if needed to take another in 4 hours. Also, the patient was instructed to take two 2 over the counter ADVIL along with the BENADRYL 2 to 3 hours after having had the 2nd dose of SHINGRIX. The patient followed the physician's instructions and had only a minor reaction for a couple of days after the 2nd dose in the series. The reporter declined to address any questions or to be further contacted, so there was no further related information beyond what was documented. The reporter declined to provide his specific mailing address beyond zip code or his phone number. The reporter said his wife had already contacted GSK to report her reactions after the 1st dose in the series.
On 05/07/2022 I developed body aches and a bit of a cough. The next day it was worse. I did a COVID-19 at home test that was negative. I did another at home test on 05/09/2022 and it was positive so I called my doctor and they prescribed me Paxlovid. I have been taking that ever since. I am still fatigued but my cough is better and the body aches are better. I was able to sleep last night without coughing. I also have a bit of sore ness in the right side of my chest. It was worse at the beginning but it getting better. I also have a bad taste in my mouth from the medication.
Starting December 22nd, 2021 i have had hives all over my body, head to toe. It started with being itching on my head but has been tracking all over my body since then, including my eyes.  The hives are itchy had leave my body with red blotches and raised edges of skin.
a horrible local reaction with swelling and redness on the arm; a horrible local reaction with swelling and redness on the arm; it had gotten worse everyday for at least 3 days; This spontaneous report has been received from a pharmacist via a company representative referring to a 62 years old female patient. No information on patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided.  On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot #, expiration date, dose and route of administration were not provided) for prophylaxis.   On an unspecified date, she experienced a horrible local reaction with swelling and redness on the arm and it had gotten worse (disease progression) every day for at least 3 days. The outcome of all the events was not recovered. It was unknown if treatment was given or lab diagnostics/studies were performed for the events.  The causality between varicella virus vaccine live (Oka/Merck) (VARIVAX) and all the events was not provided.