chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles / Suspected vaccination failure; Shingles; Acute pain associated with shingles, pain persists; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Shingles / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and acute pain (Verbatim: Acute pain associated with shingles, pain persists). The outcome of the vaccination failure was unknown and the outcome of the shingles and acute pain were resolved.   It was unknown if the reporter considered the vaccination failure, shingles and acute pain to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles and acute pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-APR-2023 The physician reported that in the past, some of his patients after receiving one dose of Shingrix experienced the acute pain associated with the shingles. He mentioned that with some of these patients the pain persists and was not transient and lasted as long as a patient with a Shingles experience. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case is linked with US2023AMR052430, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR052430:Same reporter
Child fainted shortly after receiving vaccines. We were able to revive him but he was pale and lethargic. We called an ambulance.
8/1/13 4cmx3cm red raised, warm at injection site. 8/2/13 8cm x 4.5cm red raised, warm at injection site, with white ring or halo around. Very itchy.
This spontaneous report as received from a physician assistant refers to an unspecified patient of unknown age and gender. No medical history and concurrent conditions were reported. The patient was vaccinated with GARDASIL injection on 15-MAR-2013 and 01-JUL-2013 (lot number, dose, frequency, route not reported). No concomitant medications were reported. The patient was in office on 30-JUL-2015 to receive the third dose. No adverse events were experienced. The outcome of inappropriate schedule of drug administration was unknown. No product quality complaint (PQC) was filed. Additional information has been requested.
pt says about 6 days later her left arm felt like it pins and needles in it the day after taking the vax that felt like paresthesia . On 5/4/2021 she went to the ER.  She had multiple test and everything came back negative and everything was ruled out.  She was prescribed steroids.    On 5/8/2021 the numbness and tingling started on all 10 of her toes and right finger tips and she still has a numb arm.  She will FU w/ her PCP on 5/10/2021 via tele visit.
Developed severe itching the hands; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier: NUS2021US198285 (Novartis).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Developed severe itching the hands".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2022, the patient received the 1st dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. The patient had received his first dose of Shingrix a day before reporting.  He stated that he experienced a sore arm after his dose which had not resolved till the time of reporting. The reporter did not consent to follow-up. Reporter did not wish to provide an address or date of birth.
MOUTH WATERING; MIGRAINE; SOMNOLENCE; FLUSHED FACE; CHILLS; EXTREME TIREDNESS/ FATIGUE; NAUSEA; LOW GRADE FEVER; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25/MAY/2021) dose was not reported, administered on 07-MAR-2021 09:30 for prophylactic vaccination.  The patient vaccinated at right arm. Concomitant medications included magnesium glycinate.  On 07-MAR-2021, the subject experienced somnolence. On 07-MAR-2021, the subject experienced flushed face. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced extreme tiredness/ fatigue. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced low grade fever. On 07-MAR-2021, the subject experienced injection site pain. On 09-MAR-2021, the subject experienced migraine. On 11-MAR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative, and Rapid influenza diagnostic test (NR: not provided) Negative. On an unspecified date, the subject experienced mouth watering. Treatment medications (dates unspecified) included: metoclopramide, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushed face, and chills on 08-MAR-2021, and low grade fever, and injection site pain, and had not recovered from migraine, nausea, somnolence, extreme tiredness/ fatigue, and mouth watering. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non-serious.
Fatigue, chills, fever, nausea, aching bones, headache, shivering, irritability.
Patient has had pain in her left arm since receiving the flu shot on 9/26/17. She states that her left arm has begun to have weakness in addition to the pain, with an increased intensity in the last several days. She also reported that her fingers are sometimes numb, tingly, and swollen (compared to her other hand). Prescriber has been contacted and will follow up with patient.
A swollen lymph node under collar bone on 3/27/21, 2 days after having the 2nd shot on 3/25/21. Now (4/3/21) it's been a week, the enlarged lymph node is still there and painful.
This spontaneous report as received from a nurse refers to an 18 year old male patient. The patient's concurrent conditions included vitamin D deficiency and Depression. On 07-NOV-2014 the patient had titers drawn which revealed negativity for immunity against measles. There was no documented evidence of receiving M-M-R II, subcutaneously (Lot number J006136, expiry date 24-APR-2015) (dosing regimen and frequency unknown). Concomitant therapies included vitamin D (unspecified) (Manufacturer unknown) and LEXAPRO. On 29-JUL-2015, the patient had repeat titers drawn which also resulted in negative immunity against measles (antibody test negative). There was no lab diagnostic studies performed. There was no treatment provided for the event. The action taken with the therapy with M-M-R II was unknown. The outcome of antibody test negative was reported as not recovered. The relatedness of the events to the therapy with M-M-R II was unknown. There was no product quality issue reported. Additional information has been requested.
No additional AE reported; Administration following an excursion event; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 24-AUG-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella, and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin) (PROQUAD) lot #T031825 was confirmed to be valid, expiration date 16-MAR-2022, for prophylaxis (dose, route, and site of administration were not reported). The administered dose was exposed to the temperature of -10.7 degrees Celsius for 192 hours. No additional adverse event was provided.
No additional adverse effects reported.; then inadvertently received a second dose on 18-AUG-2020.; This spontaneous report was received from a nurse, referring to 7-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 16-JUL-2020, the patient was vaccinated with one dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) injection (dosage, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number and expiration date were not reported), as prophylaxis.   On 18-AUG-2020, the patient inadvertently received a second dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) injection (lot number S021457 which has been verified to be valid, expiration date reported and validated as 03-MAR-2022) (dosage, vaccination scheme, frequency, route of administration and anatomical site of injection were not reported), as prophylaxis (inappropriate schedule of product administration). No additional adverse effects were reported in the patient.
Information has been received from a registered nurse concerning a 23-week-old patient who on 04-DEC-2007 received a first dose of Rotateq. No adverse symptoms. A product quality complaint was not involved. Additional information has been requested.
Vaccinator inadvertently took a vial from stock with a BUD (10 weeks refrigerated) of 5/29/2023. The vials had not yet been quarantined or disposed of.  Patient has had no known adverse effects. Report is simply due to the use of stock that had passed the BUD by 2 days. Department of Health Services has been contacted for guidance, and we are waiting for a response.
Migraine (lasted 3 days), nausea (lasted 2 days), vomiting (lasted one day), severe diarrhea (lasted 3 days), uncontrolled involuntary tremors/convulsions (lasted about 45 minutes), severe muscle aches (lasted 3 days), severe fatigue (lasted 3 days), abdominal pain (lasted 2 days). No medical treatment was sought.
headache; pain in her arm; joint pain; This is a spontaneous report from a contactable consumer (patient).A 51-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Mar2021 as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. On 13Mar2021, the patient experienced pain in her arm, on 14Mar2021, the patient had headache and on unknown date in Mar2021, patient had joint pain. It was reported that she got the first dose of the Pfizer covid on 13Mar2021 ( Saturday) and since that day she started having pain in her arm. Next day the arm pain was worse, and she had headache. Monday and Tuesday she had joint pain and she wonders how long this symptom will last since she was not like that before the vaccine. She mentions that she was a very active woman that does exercise every day. All that was left was the joint pain. The outcome of headache was unknown, and patient had not yet recovered from other events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Visual disturbances; Balance issues; Headaches; Extreme pain at the spinal area; Pain in their lower back; Sciatica pain; Numbness to the left leg and foot; Extreme pain; Extreme pain that kept them from sleeping; This case was reported by a consumer via call center representative and described the occurrence of pain in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number A5X5B, expiry date 7th March 2021) and (batch number ZJ4P2, expiry date 7th March 2021) for prophylaxis.   Concurrent medical conditions included stroke (Stroke from bacteria in the brain), cystitis interstitial and lyme disease (History of Chronic Lyme disease).   On 16th March 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On 16th March 2020, less than a day after receiving Shingrix, the patient experienced pain and sleeplessness. On an unknown date, the patient experienced visual disturbance, balance disorder, headache, pain in spine, low back pain, sciatica and numbness in leg. Shingrix was discontinued. On an unknown date, the outcome of the pain, visual disturbance, balance disorder and headache were not recovered/not resolved and the outcome of the sleeplessness, pain in spine, low back pain, sciatica and numbness in leg were unknown.   It was unknown if the reporter considered the pain, sleeplessness, visual disturbance, balance disorder, headache, pain in spine, low back pain, sciatica and numbness in leg to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose in Shingrix, and that night had extreme pain that kept the patient from sleeping. The reported batch number 2J4P2, however changed to ZJ4P2. The patient had experienced visual disturbances, balance issues, headaches and extreme pain at the spinal area.  The patient went to emergency room to be treated for the extreme pain in their lower back (sciatica pain with numbness to the left leg and foot).  The patient was unsure if this reaction was due to their Chronic Lime history or from the vaccine and the patient health care professional does not know how to treat the symptoms that have not been resolved.  Due to these complications the patient will not be getting their 2nd dose. The patient had been contacted Centers for Disease Control and Food and Drug Administration along with their health care professional to make them aware of her reaction.  The patient's health care professional does not know how to treat her condition due to history of lyme.  The reporter consent to follow up.
redness, warmth approx 3" diameter @ inj site w/ c/o mild itching, 24hr p/vax;
Information has been received from a registered nurse concerning an approximately 70 year old female who on an unspecified date was vaccinated with a dose of Zostavax. Subsequently the patient developed a disseminated rash all over her body. The patient did contact the physician regarding her reaction. There was no product quality complaint involved. No further information was provided. This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a nurse concerning an 84-year-old healthy female who on 30-Apr-2007 was vaccinated subcutaneously with a first dose of ZOSTAVAX (Merck) (lot# 652936/0981F). On 05-Apr-2007, at 1:45 pm, the patient developed a rash starting on her abdomen and BENADRYL and hydrocortisone cream were recommended. On 04-Apr-2007, the patient developed pruritic hives all over her trunk, buttocks, upper extremities and in the hair. She did not have any pain or respiratory symptoms. She was prescribed prednisone 20 milligrams BID for 2 days, 20 milligrams for 3 days and 10 milligrams for 4 days, and to continue with the BENADRYL. No laboratory or diagnostic test were ordered. It is reported that the patient recovered on 10-Apr-2007. There was no product quality complaint involved. No more information is expected. This is one of several reports from the same source.
pt started crying/screaming 2  1/2 hr p/vax left clinic 430PM;had screaming fits until 2AM then slept rest of noc;
Sore arm at injection site Fatigue Headache Mild nausea Pain &  swelling at the subclavicular lymph node location (Not Doctor diagnosed, SELF diagnosed)
Headache, itchy lumpy vaccine site, swollen lymph nodes in throat, fatigue
R arm allergic reaction, R arm cellulitis within 24 hours of receiving inj.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2011, the patient's healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2014, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EL9266), on 24Mar2021 as dose 2, single (Lot number: ER8733) and on 27Sep2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "OA" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "CA Prostate (no sign of recurrence)" (unspecified if ongoing), notes: CA Prostate (no sign of recurrence). Concomitant medication(s) included: METFORMIN; LANTUS; PRINIVIL; HCTZ; NAPROXEN; JANUVIA; GLIMEPIRIDE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient treated with Covid 19- treatment (Brand: Pfizer) from 24Jul2022 to 04Aug2022. Clinical course: Known allergies: none known. Other medication in 2weeks: Yes. Patient had rebound infection (2 positive tests after a negative test).  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and vaccination failure, Covid 19 cannot be completely excluded.
Headache, Fever, SORE ARM AT INJECTION SITE. CHILLS AT NIGHT. RESOLVED IN 3-4 DAYS Narrative:
2nd MMR given 8/26/04 left leg, 2 days later noted area 5"x4" red/warm c/o itching. Treated with Allegra 30mg BID x 3d, Motrin x 3d.
Adverse reaction from the COVID-19 vaccine; Headache; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Adverse reaction from the COVID-19 vaccine) and HEADACHE (Headache) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Adverse reaction from the COVID-19 vaccine) and HEADACHE (Headache). At the time of the report, IMMUNISATION REACTION (Adverse reaction from the COVID-19 vaccine) outcome was unknown and HEADACHE (Headache) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication information was reported.  Patient was not clinical trial participant.  She had a question on the new Moderna Covid-19 vaccine. Patient experienced an adverse reaction from the COVID-19 vaccine.  The event of headache lasted for 7 weeks.  No treatment information was reported.
This spontaneous report was received from a nurse referring to 5 unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of ZOSTAVAX for prophylaxis, lot # L046899 with expiration date of 23-FEB-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (DILUENT MRK) (dose, route, lot# and expiration date were not reported).   No adverse effects reported. It was stated that the vaccines underwent a temperature excursion of 6 ËF to 14 ËF (degrees Fahrenheit) for 155 days. No previous temperature excursion was performed. The call was not because of a "data logger". No further information was provided. There was no Product Quality Complaint (PQC) involved in this case. Additional information has been requested.; Sender's Comments: US-009507513-1705USA014053: US-009507513-1705USA013888:
PAtient was electively admitted secondary to complaints of severe low back pain and leg pain, underwent decompression and laminectomy and osteotomy for reduction of a spondylolisthesis at L4-L5. He has had immediate relief of his low back pain and leg pain. Hospital admission within 6 weeks of receiving the COVID vaccine.
The patient developed a rash consisting of ~5 red macules (2-3 mm diameter) on each shoulder lasting 4-5 days.  On 3/30/03 @ 9am, another fine, flat, red rash appeared on the patient's upper right chest and disappeared by 9pm that evening.  Neither rash progressed to a papule stage.  The patient experienced minor night sweats at this time, but no other symptoms were observed.  A physician was consulted on 4/1/03 regarding the apperance of the macules, but by that time the rash was fading and required no  further evaluation.   Prior to the appearance of the rashes, the patient also experienced fever (100 degrees F), chills, fatigue, and minor muscle aches--beginning on the morning of 3/27/03 and lasting approximately 24 hours.