chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got shingles after the shot/Suspected vaccination failure; Got shingles after the shot for shingles event; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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 Information: GSK Receipt Date: 23-Feb-2023 Reporter's Comments: The case was received from the consumer via interactive digital media. The reporter reported that the patient (reporter's father in law) got them after the jab, never had them before. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding primary schedule, time to onset for event and laboratory confirmation of shingles were not provided. The follow-up could not be possible as no contact details were available.
Within the first 24 hour after second dose I began having severe joint paint, unable to uncurl my hands and joints. I had a bad fever and my heart rate for the entire 24 hours was over 100, up to 160 bpm. The symptoms that have continued after the vaccine have been headaches and elevated heart rate. It got better between 2nd and 3rd dose but after booster it began to get worse again with heart rate spikes, even when I am just sitting on the couch.
12/26/2020 EE states that she started having some upper respiratory congestion with no other symptoms. She states that she traveled to out of town on 12/23/2020 and again on 12/24/2020. On 12/31/2020, EE states that she started coughing up yellow mucus with a little blood with no other symptoms. She has never tested positive for Covid and hasn?t had any exposure that she is aware of.
Lymphadenopathy; Throat started to swell; Throat irritation; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PHARYNGEAL SWELLING (Throat started to swell), THROAT IRRITATION (Throat irritation), PAIN IN EXTREMITY (Sore arm) and LYMPHADENOPATHY (Lymphadenopathy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Hypersensitivity reaction. Concurrent medical conditions included Allergy to antibiotic (Shortness of breath, elevated blood pressure, and rash.), Allergy to antibiotic (Flagyl caused rash and flushing.), Allergy to antibiotic (Bixin rash and shortness of breath.), Allergy to antibiotic (Levaquin), Drug allergy (Codeine caused hallucinations), Drug allergy (Percocet) and Drug allergy (Demerol). Concomitant products included ATORVASTATIN for Cholesterol, ASA for Heart failure, TELMISARTAN and SPIRONOLACTONE for Hypertension, VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 09-Mar-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PHARYNGEAL SWELLING (Throat started to swell), THROAT IRRITATION (Throat irritation) and PAIN IN EXTREMITY (Sore arm). On 11-Mar-2021, the patient experienced LYMPHADENOPATHY (Lymphadenopathy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) 09-Mar-2021 for Throat irritation, at a dose of 1 dosage form. On 09-Mar-2021, PHARYNGEAL SWELLING (Throat started to swell) and THROAT IRRITATION (Throat irritation) had resolved. On 11-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 15-Mar-2021, LYMPHADENOPATHY (Lymphadenopathy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Heart rate: 136 (Inconclusive) Patient heart rate (HR) went up to 136 Bpm at 11:41 AM., 109 (Inconclusive) Patient heart rate (HR) 109 Bpm at 11:45 AM., 102 (Inconclusive) Patient heart rate (HR) 102 Bpm at 11:53 AM., 109 (Inconclusive) Patient heart rate (HR) 109 Bpm at 12:13 PM. and 74 (Inconclusive) Patient heart rate (HR) 74 Bpm after taking Benadryl at 12:29 PM..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow up report included information regarding medical history, allergies, concomitant medication,  symptoms details, and outcome.
Information has been received from a physician concerning a 16 weeks female patient who within the last several months was orally vaccinated with the second dose of ROTATEQ (Lot # and expiration not reported). It was reported that on an unspecified date, 24 hours after receiving the second dose of ROTATEQ the patient experienced severe diarrhea. The patient sought unspecified medical attention. It was reported that the patient would not receive the third dose ROTATEQ. At the time of reporting the outcome of the patient was unknown. This is one of several reports from the same source. Additional information has been requested.
diaphoretic; diarrhea; nausea; headache; oral temperature of 100.7; body aches; in the morning woke up with chills; This is a spontaneous report from a contactable other hcp.  A 30-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), intramuscular arm left single dose on 06Jan2021 14:00 for covid-19 immunisation. Medical history included sleep apnoea syndrome, chronic sinusitis. Concomitant medication included colesevelam. No other vaccine was received in four weeks.  The patient experienced in the morning woke up with chills on 07Jan2021 03:15, oral temperature of 100.7 on 07Jan2021 05:00, body aches on 07Jan2021 05:00, nausea on 07Jan2021 05:40, headache on 07Jan2021 05:40. On 07Jan2021 06:25 all described symptoms getting worse in severity. On 07Jan2021 06:35 patient took acetaminophen at recommended dose. Patient then had diarrhea on 07Jan2021 06:40. On 07Jan2021 07:00 all described symptoms were improving. On 07Jan2021 17:00 patient was diaphoretic with an oral temperature of 99.4 and only symptoms left were body aches. The patient underwent lab tests and procedures which included body temperature: 100.7 (05:00) and 99.4 (17:00) both on 07Jan2021. The events recovered in Jan2021; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020519940 same patient/drug, different event separated with time
This spontaneous report was received from a registered nurse and refers to a 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N001489 with expiry date 12-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Administered dose past the manufacture expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered dose past the manufacture expiry date) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered dose past the manufacture expiry date). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered dose past the manufacture expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.  The vial had not undergo any temperature excursions.
mom states had to take pt to ER 22JUL96 because lips were swollen & covered w/yellow film;ER told mom pt was having allergic rxn to something & gave med;pt seen in clinic 24JUL96 lips still sl swollen & covered w/yellow exudate;pt better;
Information has been received from a physician, concerning a 14 year old female patient, who on 02-MAR-2007 was vaccinated with the first dose of Gardasil. There was no concomitant medication. Subsequently the patient experienced a generalized, non-pruritic, maculopapular rash (date not specified). At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
(L) shoulder swelling - MCV4 vs TDAO. Swelling = (14/16 cm) T and R + ice pack on swelled area. BENADRYL 125/5 sig 2 tsp po q 8 hours #200 cc.
Pt received FLUVIRIN ON 11/2/08 and then developed redness/ swelling at injection site later that day (1cm round) ((L) upper arm). Pt started treatment today.
Headache, exhaustion, nausea, diarrhea, rash at site.
Onset one month after administered final dose of vaccine. Originally, swelling on the underside of both big toes.  In the past few months, my swelling has increased and I am now experiencing intense burning pain, neuropathy and swelling in my hands (palms) and feet (underside only).  It is episodic, with the most intense and debilitating symptoms lasting a few days, then decreasing slowly, only to start again a few days later. My hands are contracting and I'm experiencing deep joint pain in my hands and feet.  No diagnosis, still engaging specialists to diagnose this baffling condition.
24 hrs after vaccine tiny rash itchy on chest and following along ribs on abdomen lasting 48 hours. 72 hrs after vaccine leg cramps in calf of right leg only at night woke me up from sleep and lasted 2 nights.
Rash on torso 15 days after 1st vaccine. 20 days after 1st vaccine diagnosed with Shingles.
several pt from this facility devel inj site rxn p/vax;the reporter was unable to specify the number of pt who exp this event;addtl reports will be generated when identifying info is provided;
Patient is an 8 year old male who presented to the emergency department on 11/18/2021 with complaints of shortness of breath and chest pain after playing basketball for two hours. Patient received the Pfizer 5-11 year old vaccine on 11/17/2021. Troponin was mildly elevated, suggesting myocardial injury. The ESR and CRP were normal. The ECG was normal but had periods of sinus arrhythmia with elevated heart rate up to 115 BPM.
Patient would present himself off & on with anger outbursts, mood swings & getting in his "zone" which was like he couldn't process what I said until a few seconds afterward. His preschool called twice & had me pick him up.
Acid reflux; stomach upset; This case was reported by a consumer via interactive digital media and described the occurrence of esophageal acid reflux in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10th October 2022, the patient received Shingles vaccine. On 11th October 2022, 1 days after receiving Shingles vaccine, the patient experienced esophageal acid reflux and upset stomach. On an unknown date, the outcome of the esophageal acid reflux and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the esophageal acid reflux and upset stomach to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the shingle vaccine on Monday.  Tuesday morning he/she woke up with acid reflux and had been having it since. The patient had never had this before.  The reporter wanted to know if this could be a side effect of vaccine. The patient saw where stomach upset was a symptom but did not mention reflux. Additional Supportive Information: The follow up would not possible, as no contact details were available.
Information has been received from a nurse concerning unspecified number of patients of unknown age and gender. The patients' concurrent condition, concomitant medications and medical history were not provided. On an unknown dates, the patients were administered improperly stored doses of ROTATEQ (lot # L008054, expiration date 30-NOV-2016; lot # M002252, expiration date 28-FEB-2017) (strength, dose, frequency and route were not reported). It was reported that the vaccines were exposed to a temperature of excursion 14.3 Celsius degree for 10 hours and 42 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Received 2nd dose covid vaccine around noon 4/1/21 and was standing in kitchen some hours later and suddenly felt weak. Eased self to floor. States "I was unable to move." Missed lunch date on Sunday, 4/4/21 and was found on his kitchen floor laying on R side. Arrived via EMS 16:30 weak, incontinent of urine with large, fluid-filled  blistering R upper arm, sloughing of skin R ribcage, R axillary, and medial aspect R arm. Stage 2 and 3 pressure ulcers to R shoulder, hip, knee, ankle.  Blanchable erythema on his back. Dry oral membranes, lips, tongue. Extreme weakness/pain. AOx4.
I got my second Pfizer jab in June 2021. I immediately developed strong hiccups 20 minutes after that, and it lasted for a few hours. Two weeks later, I got the so-called silent reflux (LPR), which is similar to GERD. The ENT doctor prescribed Pepcid which cured the symptoms in 3 weeks. However, I started to experience constipation and then began to alternate between constipation and diarrhea. For the past one and half years, I have been experiencing chronic IBS-like symptoms such as abdominal pain, gas, bloating and diarrhea. The gut become very sensitive since then. My GI doctor recommended me to take probiotics, which solved 70-80% symptoms since I took that. However, there is still something there and I just do not understand why all of this happened
Swollen lymph node underarm left side same side as vaccine. Mildly painful for about 10 days.
Extremely high blood pressure. By the time I got to the hospital it was 218/185. I was in hospital for 5 days. Was discharged on 04/12/2022.
Urticarial swelling 1 inch diameter 24 hours later.  Swelling 4 inches in diameter with central tenderness 48 hours after immunization, pruritic - no fever or systemic illness.
flu vax administered lt deltoid 3:55 26OCT95; 4:20 pale, diaphoretic, weak nauseated; BP 80/64, AP 48; given DPH;4:25 skin warm, not as diaphoretic; 4:30 cheek pink, no diaphoresis, able to amublate without assistance, nausea gone;BP 88/64
Severe pain at injection shot.. and then also had bilat PE and clots in leg. Difficulty using arm 9 months later.
pt recvd vax & exp arm ache; swelling made hard lump at inject site; pain in the arm from deltoid muscle to the elbow; soreness to touch; redness below inject site;
Day 1 *Shot rec'd at 1:10pm *10-15 minutes later tip of tongue started tingling & started sweating - told provider I was either having a reaction to shot or anxiety attack (felt quick drop in blood pressure, profuse sweating & thirst, felt faint) - provider offered water & a fan & asked me to wait another 5-10 minutes under observation to see if it passed * Intense reaction diminished by 2:30, but tongue & fingers and toes remained tingling * Headache & body aches started almost immediately after injection, but didn't increase until about 6:30p * Around 6:30p, went to bed with sudden spike in fever, chills, body aches (joints, back, neck), intense headache * Fever spiked between 99-104 & intense side effects through the next 6-7 hours (usually run about 97.4 on current thermometer)  * Vomited twice * Two ibuprofen slightly relieved discomfort & pain and fever didn't spike as high after 10p   Day 2 * Improvement - Side effects more in-line with what I'd expected - slight fever spiking throughout the day, headache, muscle aches, arm pain, fatigue, lack of appetite  Day 3 * Improvement from day 2 - no fever, lessening headache & muscle ache, increased arm pain
I had my vaccination on 09/15/2022. On 10/09/2022 I had sinus congestions stuffy nose conjunctivitis in left eye. I had a low-grade temperature. I tested COVID-19 Positive at home. I spoke with my doctor on 10/10/2022.  The doctor office prescribed Mucinex Tylenol and eye drops. It was not a bacterial conjunctivitis. My O2 levels never dropped below 97. On 10/22/2022 I tested negative. I am still experiencing some congestion and told to keep with the Mucinex.
pain started in lt shoulder-radiating to elbow & lt fingers 1 wk p/MMR; was seen in office; referred to MD orthopedist; MD referred to neurologist;
Information has been received from a licensed practical nurse concerning an 18 year old female with an allergy to penicillin and no medical history, who in June 2007, was vaccinated intramuscularly with a first dose of Gardasil and a second dose in July 2007. There was no concomitant medication. The patient had become pregnant sometime between the two doses. Her last menstrual period was 11-JUL-2007 and her estimated delivery date was 16-APR-2008. On approximately 08-AUG-2007 the patient had a miscarriage. No laboratory diagnostic studies were performed. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. Upon internal review spontaneous abortion was considered an other important medical event. Additional information has been requested.
Patient had bright yellow diarrhea in the morning, followed by diarrhea with blood in the late afternoon/early evening.  She called the pharmacy to ask if this was of concern.  Pharmacist advised her to seek medical attention tonight at the ER or a walk-in clinic.
Information has been received from a physician concerning a 3 year old patient who on approximately 03/19/01 was vaccinated with Hepatitis A vaccine inactivated. On approximately 03/20/01, the patient developed a fine (slight bumps) non-pruritic rash above and below the site of the injection. The rash appeared within 36 hours post injection and "now" lasted into day four post injection. The reporting physician did not feel that this was a hypersensitivity reaction to the vaccine, but she thought it was most likely a contact dermatitis to the alcohol swab. As of 03/23/01, the patient had no other symptoms. The patient sought unspecified medical attention. No further information is available.
Patient said 24 hrs after vaccine administration she came down with chills, low temp, skin hurt to touch all over and fatigue. As of approximately 130 pm Sun. 9-22-13 feels better, just tired.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a consumer via (other manufacturer- Abbvie ) concerned a 57 year old adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, once total administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose and frequency were not reported from an unspecified date to 2021 for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On 2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative, and COVID-19 virus test positive (NR: not provided) positive.  On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: VO 20210531141-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Red slightly raised area at injection site 4x6cm. Onset 24 hours after vaccine. No pain, no fever.
No additional AE/PQC; improperly stored PROQUAD that was inadvertently administered to a patient; This spontaneous report was received from a nurse and refers to a unspecified age and gender patient whose medical history, concurrent conditions, and concomitant therapies were not reported.  On 15-JUN-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin, rHA) (PROQUAD) subcutaneous injection, administered for prophylaxis at a dose of 0.5 milliliters (ml) (lot number: W023867, which was determined to be valid with expiration date: 24-JAN-2024; strength, anatomical injection site, and route of administration were not provided) (product storage error).  No additional adverse events (AE) were reported (no adverse event).
approximately 24 hrs after shot in left arm, IM, Left armpit swelling, assume lymph nodes. Slightly painful. Pain went from a 4 out of 10 to a 2 in 24 hrs, to 0 after 48 hours. Armpit is still swollen now. Visually obvious but no pain.
Information has been received from a physician concerning a 17 year old female with a history of asthma and drug hypersensitivity to Keflex who on 13-NOV-2007, originally reported as 20-Nov-2007, was intramuscularly vaccinated with Gardasil (lot # 657737/0522U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 14-Nov-2007, originally reported as 21-NOV-2007, the patient experienced dizziness, nausea, vomiting and tenderness at injection site.  Subsequently, the patient recovered from dizziness, nausea, vomiting and tenderness at injection site on 14-Nov-2007, originally reported as 22-Nov-2007.  No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of flushing in a adult female patient who received Zoster vaccine for prophylaxis. On 13th December 2018, the patient received the 1st dose of Zoster vaccine. On 13th December 2018, immediately after receiving Zoster vaccine, the patient experienced flushing. In December 2018, the patient experienced pain in arm. On 13th December 2018, the outcome of the flushing was recovered/resolved. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the flushing and pain in arm to be related to Zoster vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine on left arm. The patient requested to know if it would be better to get the 2nd dose of vaccine at the time of reporting or wait for 4 more months. The patient experienced arm soreness and flushing. The patient planned to receive the 2nd dose of SHINGRIX.