chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My arm felt almost paralyzed from the pain within hours of the shot. I couldn't concentrate and it was hard to watch tv. I could not move my arm since to do so was extremely painful. Woke up disoriented and dizzy in the middle of the night. Went back to sleep but upon waking at 4:30 am in addition to the arm pain, I was nauseous and felt like I had the stomach flu. I couldn't think straight and my mind was fuzzy. I felt woozy. I arose and drank some coke to ease my nausea and to endeavor to feel less light headed. Went back to bed. I wasn't sleeping but rather was doubled up with a general flu like condition. At about 5:30 am since I was so chilled, I took my temperature. It was a 100.6 enough to give me discomfort with hot and cold chills. My whole body ached and every joint was achy. At this time, I took 1-650 mg Acetaminophen. At 6:00 my fever had gone down to 99.9. Still nauseous and not able to eat. At 8:30 my fever had gone up to 100.3. At 10:15 I was experiencing chills again but this time my fever was only 99.8. I stayed in bed, flat out like I had a flu bug. at 12:17, my temperature was up to 101.5 and at this time I took a 2nd a second Acetaminophen of the same dose. I sipped some ginger ale. I remained in bed all afternoon. At 7:00 pm, my fever was 101.4. At 8:00 pm I took another Acetaminophen of the same dose. at 8:30 I was able to eat something. Throughout the whole day my arm was painful and I was unable to lay on it. Moving it hurt. While painful it was not the same paralyzing pain I experienced the day before. I went to bed at 8:45 pm as I was exhausted and very weak. The next day upon rising, I was very tired, nausea was gone but I felt like I was weakened from being sick. As the day progressed, I got stronger. My arm was sore but more normal. Another day after that, I was symptom free.
A primary care physician reported that a patient (age, gender, race and ethnicity not provided) who "was just not responding to Engerix" a year ago received HEPLISAV-B (Hepatitis B vaccine) for Hepatitis B immunization and the patient responded after just one dose of HEPLISAV-B. Medical history was reported as immunocompromised. The patient was reported to have tried different vaccines previously 3 times without success; it was not very clear whether it was 3 doses or 3 series, but with different vaccines, likely 3 series. No relevant concomitant medications were reported. On an unspecified date, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) through an unknown route and site. On an unspecified date, after having been vaccinated with HEPLISAV-B, the patient was reported to have responded after just one dose of HEPLISAV-B. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Inj given 6/18/07. 6/19/07, at school pt noted large hot, red lump on back of right arm. Saw MD, gave Benadryl cream and ice. Resolved completely in 1 week.
Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional by phone. This case involves a 46 years old male patient who was vaccinated with 0.5 ml dose of DAPTACEL (Batch number: C5190AA and expiry date: 11-Apr-2019) via intramuscular route in the right deltoid on 11-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included a dose of FLUZONE QUADRIVALENT. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if any adverse event occurred or not following the vaccination. 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. Documents held by the sender: none.
Swelling of arm, tender pain in arm lasting 4 days, was given Cipro.
pt recvd vax 9MAR94 approx 4PM; 1045AM 10MAR pt exp flashing a/eyes, unable to see, flushed, hot, shakey & h/a; seen by MD nothing noted on exam @ 1PM same day feeling washed out; c/o weakness in arm & achy;
Herpes Zoster- Information has been received from a physician's office concerning a 19 month old female patient who on 21 Oct 1998 was vaccianted with varicella virus vaccine live.  On approximately 19 May 2000 the patient devloped shingles that consisted of a rash on the right side of the body.  There was no reported fever.  The patient had a recent exposure to chickenpox.   The patient sought unspecified medical attention and was treated with calemine (+) camphor (+) pramoxine hydrochloride (Aveno), cetiririne dihydrochloride (zyrtec), and mupirocin (Bactroban).  Additional information has been requested.
Clammy, sweating and rash to BUE and chest. Patient will be seeing PCP for treatment.
An adult pt rec'd immun & one wk later, now has some localized swelling.
Patient received the Covid-19 vaccine. She reports symptoms of sudden onset itching throughout entire body 5 minutes post-injection along with sudden onset severe headache.  Vaccine injection time 1715, symptom onset at 1720.   Vitals: @1720: BP 148/94, HR 79, O2 98  @1725: BP 148/83, HR 80, O2 99 (PO benadryl 50mg given at this time) @1730: BP147/80, HR 70, O2 96 @1735: BP 148/82, HR 71, O2 99 @1745: 149/92, HR 74, O2 98 @1755: BP 148/71, HR 73, O2 97 @1805: patient ambulated to restroom.  Patient stated that "symptoms aren't improving at all after benadryl -- I think I should go to the emergency room.  Wait until I get back from the bathroom to call 911." @1814: Patient returned from restroom, 911 called @1820: EMS arrived, care handed off to EMS @1825: EMS transported patient to ER
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. Medical histories and concurrent conditions were not reported. The reporting pharmacist stated that an some improperly stored doses of ZOSTAVAX lot # K009810, expiration date: 10-OCT-2015 were administered (route of administration was unknown) to an unspecified number of patients on 01-JAN-2015 and 14-JAN-2015. No concomitant medication was reported, neither was any adverse event. Additional information has been requested.
Information has been received from a physician concerning a 6-7 year old male who, at 12 months of age, in approximately 1999, was vaccinated with a subcutaneous 0.5 ml dose of varicella virus vaccine live. It was reported that the patient developed break through chickenpox with over 200 lesions. It was noted that the patient may have had lesions in his mouth. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
This non-serious initial spontaneous case, was received from other health professional (Nurse) on 18-Oct-2017, concerns a patient of unspecified age and gender. This was 7th out of 31 reports. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 04-Oct-2017, this employee was given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected.
vesicular rash scattered on trunk & extremities (feels fine, no fever) began 26OCT97;seen in office today 27OCT97;to remain out of school x 1wk & take usual precautions to prevent spread;
pain in the lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 62-year-old female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PULMONARY PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "pain in the lungs". Additional information: The patient experienced a sharp pain in the lungs which lasted about 3mins and then it went away. Her doctor office did not think it was from the vaccine. Caller wanted to know would the cold like symptoms can last more than 1 to 2 days. Caller stated a friend of hers got the Pfizer covid vaccine and experienced cold like symptoms. They lasted one day and was gone the next day. cold symptoms like chills, aches and pain, feeling sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient returned two to three days after the vaccination to the pharmacy.  Pharmacist on duty at the time was uncertain if rash was due to shot and suggested patient go to his physician.  Physician called pharamcy on 11/25/14 and stated rash was setermined to be vaccine related and called in a Medrol Dose for treatment.
fever 100.1 chills, malaise, headache nauses,diarrhea
not been sleeping; shortnessof breath; tired; Dose 2: Appetite is gone; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EW0169), via an unspecified route of administration, administered in Arm Left on 28Apr2021 11:00 AM (at the age of 54-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient had the first dose on 07Apr2021 in her left arm, lot: EW0158 for Covid-19 immunization and experienced Shortness of breath, awful cough, decreased appetite and tired. No prior Vaccinations (within 4 weeks). The patient's concomitant medications were not reported. On 28Apr2021 dose 2: appetite is gone, shortness of breath, tired. On an unspecified date, not been sleeping. She had her first dose of the Covid-19 Vaccine on 07Apr2021 and her second dose yesterday 28Apr2021. The patient happened to be tired on 28Apr2021. After the 15 min of second dose patient experienced shortness of breath and felt like she was gasping for air, due to this she was she laying down. Her appetite was gone and she has an issue breathing. The patient underwent lab tests and procedures which included chest x-ray: negative, computerised tomogram: negative on an unspecified date, electrocardiogram: normal, fibrin d dimer: normal, full blood count: normal, ultrasound scan: negative, the patient got negative for Covid. The outcome of shortness of breath was recovering, the outcome of dose 2: appetite is gone, was not recovered. The outcome of not been sleeping and tired was unknown.   PSCC Communication: Caller provides multiple times for second dose administration, clarifies second dose was given at 11:15 AM. Referred caller to her physician for medical advice.Caller disconnected while on hold. Medical Information agent states she will call them back with the number provided.  No follow-up attempts are needed. No further information is expected.
COVID19 Positive after fully vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID19 Positive after fully vaccinated) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (COVID19 Positive after fully vaccinated). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID19 Positive after fully vaccinated) outcome was unknown.            Concomitant medications were not reported by the reporter Treatment drugs were not reported by the reporter
About December 1, 2022, I experienced cold symptoms that included coughing, sneezing, and a sore throat. The next morning, I tested myself for COVID-19. The result was negative. The symptoms persisted for 9 more days. During that time, I took a second COVID-19 test. It was also negative. On the 9th day, I called my doctor as I was not getting any better. I went to an appointment the next morning. I was given a Flu test and tested positive for Influenza A. They told me I was too far into the symptoms for medication. I was told to continue taking over the counter medications. My symptoms persisted for about another three weeks. By the end of the year, I felt like I had finally recovered. I don't think my symptoms were related to the vaccine.
Swelling at injection spot hasn't gone down; swelling and pain in left armpit began 03/08 and hasn't gone away
3 hrs after dose of FLUMIST c/o hives & itching on lower extremities. Gave ZYRTEC-resolved 1 hour after dose.
Initial report received from Healthcare professional on 01 Dec 2009: This patient was vaccinated with FLUVIRIN H1N1 on 24 Nov 2009. On 27 Nov 2009 the patient developed vesicles on left forearm along the C6 dermatome. First vesicles appeared 3 days after vaccination. Vesicles spread around the deltoid. The reporter states that patient now had herpetic lesion around the palmer surface between the thumb and forefinger. Vesicles were clustered. Lesion appeared to look like shingles. The outcomes of events were not reported.
This case was reported by a pharmacist via call center representative and described the occurrence of oral thrush in a 56-year-old female patient who received SHINGRIX. Concurrent medical conditions included breast cancer. Concomitant products included letrozole. On 19th February 2018, the patient received SHINGRIX. On 20th February 2018, 1 days after receiving SHINGRIX, the patient experienced oral thrush. On an unknown date, the outcome of the oral thrush was not recovered/not resolved. It was unknown if the reporter considered the oral thrush to be related to SHINGRIX. Additional details were provided as follows: The health care professional called to report that the patient who received the SHINGRIX vaccine developed oral thrush the following morning. The health care professional did not have vaccine lot number or expiry date and no date of birth of the patient was reported.
pt recv vax & 4JUL98 10 days later pt devel petechial hemorrhages in mouth, arms, trunk;went to ER & was adm to hosp;platelet count as low as 1000 dx idiopathic thrombocytopathy;
low grade fever 10 days p/vax & 2 days p/fever, a morbilliform red rash of 3mm-6mm papules appeared;both the fever & rash subsided several days later & pt was back to usual state of good health
presented with cough x2 weeks; admit with Covid (no PNA) and CHF to THHVH; tx with Vit C, Vit D, zinc, no supplemental O2 needed;
While sitting in observation area (10 minutes after booster dose), patient felt nauseated/lightheaded and had a headache. Patient placed in recliner with lower extremities elevated.  Vital signs monitored for 30 minutes. BP slightly elevated but returned to normal. Pulse Ox: 100-98%. Patient felt fine when she left.
4/20/21 sore upper left arm and chills - all day 4/21/21 sore upper left arm, chills, vomiting beginning at 1 a.m. and continuing until 11:15 a.m. began taking Ondansetron 4mg, diarrhea began at 7:15 a.m. and continued all day 4/22/21 some chills, diarrhea continued until 1:45 a.m. 4/23/21
@1:48pm, patient is sitting in the chair, alert and verbally responsive with his mom next to him. patient received MGC/HPV/FLU VACCINE . Right after receiving the vaccines, patient stated " i feel light headed". LN assessed the patient, put the head of the chair  down , patient laying down with legs elevated. CODE BLUE was page overhead. Multiple staff came to help assessed the patient . Patient remains alert and verbally responsive but still feeling light headed . @1:50pm, vs 156/102, pulse 75, rr 20, 02 sat 97% ra.  @1:51 vs, 144/95, pulse 64, rr 20 02 sat 97% ra. Patient remains alert and verbally responsive.  @1:54pm, vs 144/95, pulse 78, rr 20 , 02 sat 100% ra. Patient stated " i feel better". Patient is now sitting in the chair, upright position. Staff still monitoring the patient.   @2pm, patient stated, i feel better and i am ready to go. Advised patient to report to his PCC about what happened today after receiving vaccines. Per mother, she already spoke with the doctor and reported .  Patient left the clinic with his mother.
Headache swelling with red streaking that developed 1/12 Narrative:  very anxious as developed headache, redness swelling and streaking at injection site on 1/12 used tylenol and benadryl and it improved by 1/14
The evening of the shot, I went to bed and shortly there after, before falling asleep, I experienced severe body spasms. They originated in the lower back. My upper body shook every time and occasionally my legs also. Currently taking 100mg of Gabapentin 4xs daily, It helps, but spasms continue till today. It occurs mostly at night while laying down, occassionally while sitting.
screaming inconsolably for 4-5hr post vax w/DTAP, Hep B;
she was hospitalized after the first vaccine; 2 bags of IV medication for being dehydrated; diarrhea; headache; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (she was hospitalized after the first vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE and CETIRIZINE HYDROCHLORIDE (CETRIZINE) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DIARRHOEA (diarrhea), HEADACHE (headache) and VOMITING (vomiting). On an unknown date, the patient experienced HOSPITALISATION (she was hospitalized after the first vaccine) (seriousness criterion hospitalization prolonged) and DEHYDRATION (2 bags of IV medication for being dehydrated). On 22-Jan-2021, DIARRHOEA (diarrhea), HEADACHE (headache) and VOMITING (vomiting) had resolved. At the time of the report, HOSPITALISATION (she was hospitalized after the first vaccine) and DEHYDRATION (2 bags of IV medication for being dehydrated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, COVID-19: negative tested negative..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Nausea medication, 2 bags of IV medication for being dehydrated.  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.   This case was linked to MOD-2021-085893 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Additional information received; 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.
CG states that about 11 hrs after she received her vaccine, she developed left arm pain on 12/30. On 1/1/21 she went to the UC. She was dx with Neuritis and was prescribed Gabapentin.
Prior to receiving any COVID-19 vaccination, I had no health issues. I had extensive blood testing done in late 2016 and only had a B-12 deficiency. I received both my vaccine doses by the middle of July 2021. I went for a routine checkup in October 2021 and discovered that my TSH levels had changed, but at that time it was nothing to worry about. However, following my 3rd shot (booster) in February 2022, I began developing symptoms I did not realize were related (hair loss, fatigue, sudden weight gain, feeling depressed, constipation, dry skin, etc.), and by the end of April I started experiencing what felt like having something stuck in my throat. At the start of May, it began feeling like my throat was closing so I went to the doctor as soon as I could get an appointment. After some troubleshooting and new bloodwork testing, it was discovered that my TSH were off the chart. I was diagnosed with hypothyroidism and prescribed Levothyroxine to bring my TSH back to normal. I am still in the beginning stages of finding the right dose.
This spontaneous report as received from a Licensed Practical Nurse refers to a 9 week old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 26-JUN-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020, for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293.
Stuffy nose, runny nose and fever/chill for several days.  Follow-up - Patient's name updated.
wednesday evening sever chills, t102, swelling of site of vax;(swelling about double sauce dish size);swelling into lymph nodes & breast area;seen by MD given med;