chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; vomiting; dirreha; muscle weakness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 52-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 3rd November 2019, the patient received the 2nd dose of Shingles vaccine. In November 2019, less than a week after receiving Shingles vaccine, the patient experienced fever, vomiting, diarrhea and muscle weakness. On an unknown date, the outcome of the fever, vomiting, diarrhea and muscle weakness were unknown.   It was unknown if the reporter considered the fever, vomiting, diarrhea and muscle weakness to be related to Shingles vaccine.  Additional details were received as follows: The patient had the second dose of shingles vaccine and experienced fever, vomiting and diarrhea , muscle weakness. The patient asked whether the events were normal.
Pt states that her arm was sore the day of the vaccination. She went to the ED later that day. The soreness subsided and when she went to the MD yesterday, the soreness was discussed and noted but this was not the reason for her MD visit. Today she states the soreness has returned. This was reported to MD.
burning sensation all over/her skin felt like it was on fire; burning sensation all over/her skin felt like it was on fire; breaking out in hives; This is a spontaneous report from a contactable consumer, the patient's mother. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8735, second dose) solution for injection intramuscular in the right arm on 03May2021 (at the age of 18-years-old) as a single dose for COVID-19 vaccination. There was no relevant medical history. There were no concomitant medications. Historical vaccine included BNT162B2 (first dose, Lot ER8731) for COVID-19 vaccination on 11Apr2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06May2021, the patient was breaking out in hives. On 09May2021, the patient had burning sensation all over/her skin felt like it was on fire. The patient was taken to the doctor (office visit). By Sunday (09May2021), the patient was completely covered and went to the ER (emergency room) where she was treated with IV diphenhydramine (BENADRYL) and steroids. The patient was not admitted to the hospital. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
1JUL95 temp & didn't take bottle well also had diarrhea; 2JUL95 small pinpoint raised red dots spread over entire body; pt taken to MD 3JUL95 mom states no test done but looked @ child stated probably rxn to MMR
Initial report received from a healthcare professional on 04 October 2013. A 71 year old female patient received FLUZONE HD (lot # unknown, expiration date unknown) on 03-Oct-2013. After vaccination on 03-Oct-2013, the patient experienced wide spread body aches and chills. The patient did not recover from the events. Documents held by sender: none
Nursing; This spontaneous case was reported by a physician and describes the occurrence of EXPOSURE VIA BREAST MILK (Nursing) in a  infant of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the mother received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the infant was diagnosed with EXPOSURE VIA BREAST MILK (Nursing). At the time of the report, EXPOSURE VIA BREAST MILK (Nursing) outcome was unknown.        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.   This case was linked to MOD-2021-013188 (Parent-Child Link).   See case MOD-2021-013188 for details regarding the Parent case.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
collapse; respiratory distress; hypotension; tongue swelling; throat tightness; blood pressure abnormality; chest pain; increased swelling; skin changes; This is a spontaneous report from a non-contactable other hcp.    A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration on an unspecified date) at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. During her 15 minute waiting period after the injection, the patient began to experience throat tightness. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, chest pain, collapse, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. Treatment included: antihistamines. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A contributory role of vaccine BNT162B2 to the reported events cannot be excluded based on the plausible temporal relationship and product safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ehics Committees, and Investigators, as appropriate.
Syncope. Patient had not eaten since 12pm so blood sugar plus high ambient temperature could've been factors. Patient las seated for 30mins and allowed to recover. She was offered drinks and snacks. It was suggested emergency services should be called, but guardian refused. Patient felt better in a couple of minutes and was able to leave and walk on her own.
Nausea/vomiting became unresponsive went into cardiopulmonary arrest and died - was unable to be resuscitated by emergency department staff.
Patient had body rash above torso and was breaking out in sweats and chills on 10/22. Patient said she felt a minor cold 2 days after vaccination. A couple of days later had a rash which she saw a Dr. and they prescribed a steroid. On 10/22, went to hospital for treatment for fever, rash, body aches.
Pain and soreness in the arm of the injection, Fever, Chills, Fatigue, Headache
Left arm warm swelling, red from shoulder to 1 inch above elbow. Seen by doctor. Cool compresses, Tylenol. Return if not better.
This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 02-JUL-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of information were not reported) (lot # J005010 and expiry date: 23-OCT-2015) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA.  This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Hospitalized for optic neuritis bilateral 09/11/06. Symptoms started 09/08/06 Hep A and Tdap given 8/21/06, sibling seen in clinic. Patient not yet seen here, No other information available. 01/09/07-records received and reviewed for DOS 9/11-9/13/2006 DC DX: Optic neuritis Presented with chief complaint eye pain and blurry vision on right. Two days prior to presentation reports having pain in the right eye, specifically with movement. Following day blurry vision from same eye. Next morning examined by optometrist felt findings concerning for optic neuritis.  PE: WNL afebrile, Cranial Nerve II on morning following admission decreased visual acuity on right of 20/25, she reports that this had been improved over night following first dose of steroids. Funduscopic examination revealed bilateral disk edema with blurring of the disk margins most prominent on right and mildly involving nasal aspect on the left.   Initiated RX with Solu-Medrol IV.
Disruption of stable INR. Patient previously stable on warfarin 3.5mg daily. INR began to run low on 4-29-21 necessitating a dose increase on 5-14-21 to 4mg daily. Patient had an episode of slurred speech during this time he was low. No other cause of low INR could be identified after much investigation.
fever of 102 was reported as worsened; fever of 101- 102 , 102.6 now; feeling like the flu; This is a spontaneous report from a contactable consumer. This consumer reported for an 80-year-old male patient (reporter's husband) patient received first dose of BNT162B2 (Solution for injection, lot number: EL9262, Expiration date; unknown), via an unspecified route of administration in left arm on 08Feb2021 11:15AM at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had temperature (fever), of 102 was reported as worsened. and feeling like the flu worsened on 08Feb2021 at 08:00PM or 09:00PM. Patient temperature 102.6 higher than 07Feb2021. Patient taken vaccination facility in mall. Mentions patient got the two-tear shingle shot in Sep2020 and had fever for that and didn't feel well. They had no product or information to provide NDC, lot or expiration date for the shingles vaccine. Mentioned he does have an appointment with his primary care doctor today at 4:15 PM. He was scheduled to received the second dose on 04Mar2021. The outcome of event was not recovered.  No follow up attempts are possible. No further information is expected.
Patient was given Pfizer Covid 19 dose in error, the patient had requested Tdap(Boostrix), and had previously received 2 doses of Moderna Covid  vaccine.  The Tdap was then given in the other(left) arm so the patient would know which vaccine was involved if any reaction occurred.  The patient reports no ill effects so far on the next day.
I had really bad chills and  fever I lost my taste and smell and  started feeling extremely  fatigued. I could not get out of bed. I went got 2 covid test, I got a rapid and a send off both came back negative. I stayed in bed for a week.
Day of 11/23/2021 Patient come to get MODERNA vaccine (covid-19) during the event when nurse administered the vaccine patient tell him who is at the clinic at the time of the second dose of 03/31/2021 noticed a bruised in the area. Maybe two weeks later (do not exactly remember) had another bruise on muscle and today after the vaccination had another small bruise on left arm. I took notes and recommended to go to the doctor, I asked and still has not gone after 8 months.
Information has been received from a health professional concerning a 5 year old Hispanic male, with no known allergies, who on 06-JUN-2001 was vaccinated with a first dose in the right deltoid of Varivax (Lot# 635453/0756K). There was no illness at the time of vaccination. Subsequently, the patient experienced mild case of breakthrough chickenpox. It was reported that the patient had recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a health professional indicated that on 03-MAY-2006 the patient experienced lesions on his body that were diagnosed as varicella. It was reported that the patient recovered on 12-MAY-2006. Additional information is not expected. Two of the patient's brothers experienced chickenpox following vaccination with Varivax (WAES# 0605USA00678 and 0605USA00813).
2" circular swelling noted, left side of neck pink in color and warm to touch. No mobility issues.
This case was reported by a nurse via sales rep and described the occurrence of feeling unwell in a 60-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling unwell and shoulder pain. On an unknown date, the outcome of the feeling unwell and shoulder pain were recovered/resolved. It was unknown if the reporter considered the feeling unwell and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 59 or 60 years old. The patient felt crappy and could not get out of bed for 2 days and had sore shoulder for 2 days. The reporter did not agree to be followed up.
CHILLS; 101 DEGREE FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered for prophylactic vaccination.  On 08-NOV-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 10-NOV-2021, the patient experienced chills. On 10-NOV-2021, the patient experienced 101 degree fever. Laboratory data included: Body temperature (NR: not provided) 101 degree fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and 101 degree fever was not reported. This report was non-serious.
Tongue swelling, hoarseness, red rash on face, arms, chest, face swelling, lips swelling, tight throat. Treated at ER with epi, Benadryl, steroids, Pepcid.  Symptoms returned gradually over the next 24 hours.  Second visit to ER 6:00pm next day, same symptoms, however, tongue swelling not present.  Treated with Benadryl, steroids, and Pepcid.
faint feeling; left arm was painful between shoulder and elbow; loose stools during the day/had to use the commode many times; weak; chills all night long; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (faint feeling), DIARRHOEA (loose stools during the day/had to use the commode many times), ASTHENIA (weak), CHILLS (chills all night long) and PAIN IN EXTREMITY (left arm was painful between shoulder and elbow) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 20-Apr-2021, the patient experienced DIARRHOEA (loose stools during the day/had to use the commode many times), ASTHENIA (weak) and CHILLS (chills all night long). On an unknown date, the patient experienced DIZZINESS (faint feeling) and PAIN IN EXTREMITY (left arm was painful between shoulder and elbow). At the time of the report, DIZZINESS (faint feeling), DIARRHOEA (loose stools during the day/had to use the commode many times), ASTHENIA (weak), CHILLS (chills all night long) and PAIN IN EXTREMITY (left arm was painful between shoulder and elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Soreness at site of injection at L Delt 1 hr p admins of vaccine 11/7/07.
pt recvd vax & exp pain & stiffness in the rt arm; The vax still has pain, but it is not as bad as it was initially;
PATIENT WAS ADMINISTERED 0.25 ML OF THE MODERNA BIVALENT 50 MCG/0.5 ML INSTEAD OF THE FULL 0.5 ML DOSE. THIS WAS DISCOVERED THE NEXT CLINIC DAY ON 4/21/23. PATIENT WAS ADMINISTERED A FULL 0.5 ML DOSE ON 4/24/23 PER CDC GUIDELINES FOR PATIENTS WHO WERE UNDERDOSED.
This spontaneous report as received from a registered nurse refers to her 73 years old husband. The patient was vaccinated with 1 time ZOSTAVAX subcutaneously on 01-AUG-2012. Lot# was unspecified. On 07-OCT-2012, the patient had itchy rash on the right side of his back after receiving a dose of ZOSTAVAX. On 08-OCT-2012 the reporter stated that the patient had redness the size of a quarter. On 09-OCT-2012, the patient had a blister with redness the size of a dime. On 10-OCT-2012, it was the same size but was now appeared to be crusted over, and it had no liquid in it. The patient did not seek medical attention and was recovering. Additional information has been requested.
Date of Last Typhoid shot 19Mar2014. Gave the Patient another Typhoid Shot on 10Jun2014 instead of the Yellow Fever Vaccine he was supposed to recieve.  Patient was notified of event, and recieved the Yellow Fever vaccination.
Pt. started to experience a severe vasovagal reaction and had the following symptoms: Nausea, lightheaded, vomiting, tingling, and numbness. Pt. had not eaten in a couple of days. Pt. vomited approximately 5 times. Vitals were taken at 1601 and were the following: BP - 146/96, HR - 106,  RR - 19, and Temp. - 96.9 F. Pt. cleaned up and given small sips of water. Advised her to eat small amounts of food prior to next dose.  Second set of vitals  were taken at 1619 and were the following: BP - 142/96, HR - 100, RR - 18, Temp. - 96.8 F. Pt. stated she was feeling better and was released to go home at 1628.
tingling and intense itching to the right forearm and back of right hand, with some blistering on the back of the right hand but no blistering on the arm. to date, 08/18/2021, I am still continuing to suffer with the tingling, burning, and itching of the forearm.
Parent reports 8AM 6/2/05 onset of fine red rash per translator. Seen in clinic 6/2/05 at 3:30PM fine red rash over entire body. Child alert, active, no resp distress, Rx. Benadryl 1/2 tsp q 60. 6/3/05 status of rash and redness, seen ER diagnosed. Dx post viral syndrome, no out of country contacts.
Arm felt sore; Redness 2x3 inches size; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm felt sore) and INJECTION SITE ERYTHEMA (Redness 2x3 inches size) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness 2x3 inches size). On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm felt sore). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CIPROFLOXACIN HYDROCHLORIDE (CIPROFLO [CIPROFLOXACIN HYDROCHLORIDE]) for Adverse event, at a dose of 250 mg twice a day. On 02-Feb-2021, PAIN IN EXTREMITY (Arm felt sore) and INJECTION SITE ERYTHEMA (Redness 2x3 inches size) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   Received treatment including ice at vaccination site. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm felt sore) and INJECTION SITE ERYTHEMA (Redness 2x3 inches size) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness 2x3 inches size). On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm felt sore). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CIPROFLOXACIN HYDROCHLORIDE (CIPROFLO [CIPROFLOXACIN HYDROCHLORIDE]) for Adverse event, at a dose of 250 mg twice a day. On 02-Feb-2021, PAIN IN EXTREMITY (Arm felt sore) and INJECTION SITE ERYTHEMA (Redness 2x3 inches size) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   Received treatment including ice at vaccination site.