chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3/12/2021- Friday morning a new onset right sided limp was noticed by helathcare provider preceptor for graduate studies. He recommended to take the day off from student preceptorship. Departed straight to healthcare facility who's known to me for ongoing care and management with conservative treatment of my childhood scoliosis. Doctor performed Piriformis Trigger point treatment. Therapy improved gait.  3/13/2021 Saturday- Worked at hospital, performed usual duties. Experienced mild discomfort over right hip, but able to walk.  3/14/2021 Sunday- Woke up for work at 4am with extreme lower back pain and weakness. Took Ty..
Asthma cleared up/eyes cleared up/right hand started to gain more strength after vaccine.; Asthma has gotten worse and he has been getting more asthma attacks lately; His eyes also are a little more blurry and foggy; Laryngitis; Cramps in his legs and hands; Doesn't have fluid in his lungs but does have shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Asthma cleared up/eyes cleared up/right hand started to gain more strength after vaccine.), ASTHMA (Asthma has gotten worse and he has been getting more asthma attacks lately), VISION BLURRED (His eyes also are a little more blurry and foggy), LARYNGITIS (Laryngitis) and MUSCLE SPASMS (Cramps in his legs and hands) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included VITAMINS NOS for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Asthma cleared up/eyes cleared up/right hand started to gain more strength after vaccine.), ASTHMA (Asthma has gotten worse and he has been getting more asthma attacks lately), VISION BLURRED (His eyes also are a little more blurry and foggy), LARYNGITIS (Laryngitis), MUSCLE SPASMS (Cramps in his legs and hands) and DYSPNOEA (Doesn't have fluid in his lungs but does have shortness of breath). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Asthma cleared up/eyes cleared up/right hand started to gain more strength after vaccine.) had resolved, ASTHMA (Asthma has gotten worse and he has been getting more asthma attacks lately), LARYNGITIS (Laryngitis) and DYSPNOEA (Doesn't have fluid in his lungs but does have shortness of breath) outcome was unknown and VISION BLURRED (His eyes also are a little more blurry and foggy) and MUSCLE SPASMS (Cramps in his legs and hands) was resolving.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Systemic: Nausea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Sore arm-Mild.
the day after the vaccine was administered I had symptoms of: pain in my sides and lowerback, and I had hives on my arms, stomach, wrists, shoulders. the hives came and went and showed up in these places off and on from Saturday January 30th until monday February 1st. I took tylenol on saturday and I applied alcohol to the hives because they itched.   The pain in my sides and lower back was very bad.
Parasthesia on both sides, upper and lower extremities. Weakness, and fatigue, now right side slight face numbness.
Case number PHEH2012US014605 is an initial spontaneous report received from a health care professional on 19 Jul 2012: This report refers to a patient of unknown age group and gender. This patient was given only the CYW-135 liquid component of MENVEO vaccine (batch number: unknown) intramuscularly on 19 Jul 2012. No other adverse reaction was reported following this administration error.
BREAKTHROUGH COVID INFECTION. PATIENT TESTED POSITIVE ON 11/05/2021. PATIENT FULLY VACCINATED ON 02/13/2021. PATIENT RECEIVED MONOCLONAL ANTIBODY INFUSION ON 11/09/2021
underwent a temperature excursion and was then administered to a patient; This spontaneous report has been received from a clinic administrator was received from physician and refers to a 3-year-old patient.  The patient's medical history, the patient's concurrent conditions, concomitant therapies, and drugs reactions or allergies were not reported.  On 21-JAN-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter, lot #U022732, expiration date: 20-JUL-2023, administered as prophylaxis (formulation, strength, and route of administration were not provided).  There was no adverse effect. The stored temperature was 12 degrees Fahrenheit (F) the time frame was 9 hours and 38 minutes. There was previous temperature excursion (9.7 degree Fahrenheit for 2 hours and 41 minutes; 10.8 degree Fahrenheit for 2 hours and 45 minutes; 10.6 degree Fahrenheit for 4 hours and 16 minutes; 11.1 degree Fahrenheit for 3 hours and 14 minutes; 10.9 degree Fahrenheit for 4 hours and 43 minutes; 10.8 degree Fahrenheit for 2 hours and 17 minutes; 18.3 degree Fahrenheit for 2 hours and 36 minutes; 18.7 degree Fahrenheit for 3 hours and 4 minutes; 12.4 degree Fahrenheit for 9 hours and 43 minutes; 17.4 degree Fahrenheit for 24 hours and 00 minutes; 19.9 degree Fahrenheit for 10 hours and 57 minutes. (product storage error).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA006001:
pt recv vax & appeared to have fainted p/vax;pt appeared to be having a sz-body rigid, arms in spasm, eyes rolling up in head, incontinent of urine;pt had no response to verbal commands;became responsive in about 45sec of nurse entering the
Narrative: COVID infection following completion of COVID vaccine series 03/19/21 COVID vaccine dose (J&J) 07/22/21 Presented with c/o dry cough, mild sob, fatigue, headaches, brain fogginess, generalize weakness, myalgia and diarrhea for 1 wk, sent to ED to r/o COVID; COVID test positive; seen in non-agency ED, with CXR showing bilateral pneumonia, prescribed Zithromax 250 mg tab, decadron 6 mg q day x 5 days, Doxycycline 100 mg 1 cap q 12h x 10 days 07/23/21 Pt reports fatigue, coughing, and denies any worsening SOB 07/24/21 Pt reports "lungs hurt," wet cough, thick white phlegm, diarrhea x 5 days-2 to 3 times per day; slightly improved fatigue, but still feeling sluggish, taste and smell returning, improving myalgia, dyspnea on exertion 07/27/21 Pt calls telecare to report shortness of breath with activity, shallow breathing, cough with clear secretions, fatigue, diarrhea, no appetite (states hasn't eaten in 6 days), weak, and shaking. Denies pain., recommended to go to ED; admitted to non-agency hospital due to low O2 sat; 08/02/21 Pt remains hospitalized
fever, unable to get up, incontinence, achy, drowsy, un able to eat.
Exactly 48 hours after injection, I became lightheaded, had to immediately sit down. Lightheadedness lasted all day.  This could have been life threatening should I have been driving or walking on stairs. That night I had a full-head debilitating migraine. Haven't had a migraine in 20 years prior to this. I continued to be lightheaded the following day, but no migraine. I did not seek medical care, since symptoms abated by 4/9. I am extremely reluctant to take the second dose of the vaccine, and would welcome your input on this.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Patient is still experiencing severe pain on injection site area. "COVID ARM" symptoms.
stayed in bed; Fever; Myalgia; This case was reported by a physician via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of myalgia (received 1st dose on unknown date and experienced fever  ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, myalgia and bedridden. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever and myalgia were recovered/resolved and the outcome of the bedridden was unknown.   It was unknown if the reporter considered the fever, myalgia and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever, myalgia for about 2 days and stayed in bed. This case has been linked with case US2019AMR204541, reported by the same reporter.
nausea; stomach pain; fatigue; headache; shivering; sore arm where she received the injection; This case was reported by a consumer and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chronic obstructive pulmonary disease (included difficulty breathing with other symptoms) and difficulty breathing. Concomitant products included VIRAL VACCINES (COVID VACCINE (NOS)) and VIRAL VACCINES (COVID VACCINE (NOS)).   On 17th August 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th August 2021, immediately after receiving Shingrix, the patient experienced injection site pain. On 20th August 2021, the patient experienced nausea, stomach pain, fatigue, headache and shivering. The patient was treated with maalox (nos) (Maalox) and acetylsalicylic acid (Aspirin). On 17th August 2021, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the nausea, stomach pain, fatigue, headache and shivering were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, nausea, stomach pain, fatigue, headache and shivering to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received her first dose of Shingrix and right away she had a sore arm where she had received the injection, soreness went away on the same day. As patient had COPD (chronic obstructive pulmonary disease) and included difficulty breathing with other symptoms, but her level of difficulty breathing was unchanged by the Shingrix vaccine. 3 days after receiving Shingrix, the patient experienced nausea, stomach pain, fatigue, headache and shivering.  The doctor recommended an aspirin, prescribed a compound called Maalox Cocktail and recommended a heat pad for abdominal pain.  That did help but nausea, stomach pain, fatigue, headache, and shivering are all unresolved, she had all of those symptoms till the time of reporting. The reporter consented to follow up.
Bivalent Pfizer vaccine given inadvertently as their first covid vaccine. Patient had no reactions and tolerated well.
patient had itchiness, redness, swelling, and pain to site where vaccine was given. Patient was given Medrol 4mg tablets and Methylprednisolone 125/2ml on 8/21/2019.
the pain of the vaccine was better than after the first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 16Jan2021 (Batch/Lot Number: EK9231) as dose 1, single for covid-19 immunization (at the age of 32-years-old). The patient medical history was not reported. There were no concomitant medications.The patient previously took multivitamin [vitamins nos] and MiraLax (patient stated that she has not taken any medication, even things she used to take those but she has not taken any of those in a while). It was reported that patient received first dose of vaccine and on an unspecified date in 2021 patient experienced the pain and she stated that the pain of the vaccine after second dose which she took on 05Feb2021 was better than after the first dose. Patient stated that she got the product because she was an essential worker, and everyone else at her work had gotten the shot and they were all acting like it was such a great thing. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021183644 similar report from same reporter
This spontaneous report as received from a pharmacist refers to a 70 year old female patient. The patient's drug reactions/allergies included penicillin. The patient's concomitant medication and pertinent medical history was reported as none. The pharmacist reported that, on 21-SEP-2015, the patient at the age of 70 years (confirmed date of birth 18-MAY-1945), received first dose of GARDASIL 9 (lot# and strength unspecified) 0.5 ml via intramuscular route and then on 01-FEB-2016, received second dose of GARDASIL 9 confirmed lot# L019297 with expiration date 18-AUG-2017, 0.5 ml via intramuscular route as it was recommended by a physician. The pharmacist reported that approximately on an unknown date in February 2016, an unspecified time after receiving the 2nd dose of GARDASIL 9 the patient developed "redness and swelling at the injection site". The patient sought medical attention by seeing an unspecified physician. There was no treatment given for the events. Lab diagnostics studies were not performed. The outcome of the events was reported as not recovered. Product quality complaint was not involved. No further information was provided. The reporter did not provide the causality between the events and the suspect therapy GARDASIL 9. Additional information has been requested.
Patient called into office on 12/20/17 and reported that she had been paralyzed from the flu shot we gave her, and stated she went to the hospital for 2 weeks.
4/20/2021   Patient was observed post Covid-19 immunization for 30 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  dizziness.   Assessment : Time of assessment 1620 Alert and oriented and Anxious.   Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN. Jiuce given, VS at 1620- BP- 137 98, P- 11, O2- 99%, recheck of VS at 1634, BP- 145/94, P- 97, O2- 100%       Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 45 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.      Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/20/2021  3:37 PM
5 min after I left I felt my face getting numb; she feels likes it getting worse, sometimes feels fine and then it will feel tight again; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (5 min after I left I felt my face getting numb) and REDUCED FACIAL EXPRESSION (she feels likes it getting worse, sometimes feels fine and then it will feel tight again) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No medical information history was reported.  Concomitant products included VITAMINS NOS, CALCIUM and IRON for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced HYPOAESTHESIA (5 min after I left I felt my face getting numb) and REDUCED FACIAL EXPRESSION (she feels likes it getting worse, sometimes feels fine and then it will feel tight again). At the time of the report, HYPOAESTHESIA (5 min after I left I felt my face getting numb) and REDUCED FACIAL EXPRESSION (she feels likes it getting worse, sometimes feels fine and then it will feel tight again) 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.   Patient concomitant medications included birth control pills.   Patient reported that pretty much whole left side of the face, upper lip, jaw, nose, eye and ear got numb. She was able to talk, eat and function for most of the part. She had not taken anything for the treatment of the numbness.
It's been about 2 1/2 years since first dose, second dose August 8, 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received two and half year before the reporting date in left arm).   On 8th August 2022, the patient received the 2nd dose of Shingrix. On 8th August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's Comments: The patient received Shingrix in his left arm. The patient gave his consent to follow up with the pharmacy. Additional Supportive Information: The patient received 2nd dose delayed than the recommended vaccination schedule, which led to lengthening of the vaccination schedule.
They have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Coivid-19 vaccine; They have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine; This is a spontaneous report from contactable Nurse.  This Nurse reported similar events for 6 patients. This report is for 5th of 6 patient.   A 64-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 28Mar2021 (Lot Number: ER8734; Expiration Date: 31Jul2021) at the age of 64-year-old as dose number unknown, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine.  The patient underwent lab tests and procedures which included COVID-19 Virus test: positive on unknown date.  The outcome of events was unknown. As of 19Aug2021, product Quality complaint Group provided conclusion:  The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8734 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8734, fill lot EP8686, and the formulated drug product lot EP8573. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101058200 same product and event, different patients
11/14/2019 employee developed a warm and reddened area on vaccine site given.  11/14/2019 developed a  0.5x0.5 diameter blister that popped  11/15/2019
Started having intense tingles and soreness across my entire body, this progressed to feeling cold chills, and ultimately intense shaking around 10:30 pm. I went home and started to get a headache, felt nauseous, and reached a fever of 103 at one point. By 11:30pm.  Took 2 500 mg Tylenol around 11.  Took a 200 mg Advil around 1:00 am. Took a look warm shower and did a sponge bath to try and lower the fever.   Woke up around 5 am and took two more 500mg Tylenol. Woke up at 10am temperature had returned to 97.7.   Feel fatigued but I?m ok.
Information has been received from a medical assistant referring to an unspecified number of patients with unknown ages and genders. On unknown dates the patients were vaccinated with improperly stored VAQTA (route, lot# and dose were unknown). No symptoms reported. It was not specified if the patients sought for medical attention. This is one of several reports received from the same reporter. Additional information is not expected as the medical assistant did not want to be contacted.
pt recv vax 12/97& 3/98 mom noticed pt devel chickenpox lesions. when evaluated at m.d. ofc 1 day later, pt presented w/an ear ache, cough & approx 40 chickenpox lesions.
Intertrochanteric fracture of right hip - Patient was admitted for pain control and physical therapy.  Pain was able to be managed with oral Norco.  Patient worked with physical therapy and was able to resume ambulation with a walker and with assistance.  Discharged to home. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Chills, headache, low-grade fever (100 degrees), sore rash on injection arm.
hives (left arm, neck, upper legs, chest), itchiness, "feeling hot all over"
Mild headache in the back of the head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Mild headache in the back of the head) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 02AL20A and 091F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, SERTRALINE, CLONAZEPAM, COLECALCIFEROL (VITAMIN D3) and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced HEADACHE (Mild headache in the back of the head). The patient was treated with PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (Mild headache in the back of the head) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-367550, MOD-2021-367552, MOD-2021-367092 (Patient Link).
This case was reported by a physician and described the occurrence of left arm pain in a 47-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. On 12 September 2006, the subject received an unspecified dose of Engerix-B (intramuscular, left arm). On 14 September 2006, two days after vaccination with Engerix-B, the subject experienced pain, numbness and tingling in the left arm. No other information was available at the time of reporting. At the time of reporting the events were unresolved. The physician considered the events were possibly related to vaccination with Engerix-B.
8 y.o. male presented to clinic 2 days after varicella administration with erythematous, edematous left tricep area with small pock mark at injection site.  Patient afebrile with no other symptoms.  Patient & mother were counseled r.e. expected adverse reactions to varicella vaccine; also, cold compresses & ibuprofen PRN were recommended.