chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure; I've had it 2xs; painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient had shingles, before got the vaccine) and pain.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The reporter stated that he/she had shingles twice, Once before the vaccine and 14 years late r the patient had 2 vaccine shots and still experienced shingles. The patient stated that it was very, very painful both times. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Started getting super sick with respiratory issues and ear issues went to dr starting February when it got where I could breathe then every month following was at the doctor's then blood work showing I developed RA.
Information has been received from a 72 year old female consumer reporting on herself with drug reactions to many pills who 10 years ago (in January 2002), was vaccinated with a dose of PNEUMOVAX 23 (lot number, dose and route not reported) and six months ago (on approximately 24-JUL-2011), was vaccinated with another dose of PNEUMOVAX 23 (lot number, dose and route not reported). Secondary suspect therapy included a dose of diphtheria toxoid/tetanus toxoid (manufacturer unspecified) (lot number, dose and route not reported) administered on the same date (on approximately 24-JUL-2011). Concomitant medication included many unnamed medications. The consumer reported that in 2009 she had breast cancer treated with lumpectomy and radiation. The consumer reported that she had 4 weeks of radiation treatment for breast cancer, she took ABILIFY tablets and experienced a red forehead, red legs and feet, felt like stomach was punched, was unable to drink fluids, vomiting, pulse elevated, blood pressure low and partial kidney failure. She was admitted to the hospital overnight and received intravenous fluids. The ABILIFY was discontinued. The consumer then resumed radiation for a total of 7 weeks. She was unable to tolerate anastrozole used for breast cancer, which caused her to feel "horrible and not feeling well". The consumer reported that 6 months ago (on approximately 24-JUL-2011), after receiving PNEUMOVAX 23 and diphtheria toxoid/tetanus toxoid (manufacturer unspecified) she experienced red arm in the arm that received PNEUMOVAX 23. She also developed a fever and chills. She was seen by a dermatologist and had a biopsy of her arm. The consumer stated that the biopsy showed it was probably a drug reaction. The outcome of red forehead, red legs and feet, felt like stomach was punched, was unable to drink fluids, vomiting, pulse elevated, blood pressure low, partial kidney failure and "horrible and not feeling well" was unknown. At the time of the report the outcome for breast cancer was unknown and the patient had recovered from red arm, fever and chills. No further information is available.
Fever to 102.2, lethargy, then  day 3 rash, emesis X 2, to ER, virus vs symptoms to vaccine,
Fever greater than 103 during night after shots, went to MD. MD reported fever down when at office but probably was shot related.
In between both shots, my Mirena IUD failed, I was two weeks pregnant at the time of my second dose, unknown to me at the time. I had slightly dislodged my IUD, but I'd been having sex prior to this without pregnancy. Medication Abortion Failed, with Misoprostol & Mifiprestone. Ended up needing emergency surgery for a rupturing fallopian tube.
Rash covering anterior chest, bilateral upper arms, flank, trunk, ankles, and thighs. Warm to touch and extremely pruritic
Patient had a rash and swelling in the arm.; Patient had a rash and swelling in the arm.; This is spontaneous report from a contactable Pharmacist. A contactable Pharmacist reported for 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration on unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 Immunisation. Patient medical history and concomitant medication were not reported. Caller mentioned he has a patient who had the COVID-19 Vaccine but is unsure if it would be the Pfizer or Moderna COVID-19 Vaccine. Caller reported that, 3 days after getting the vaccine, Patient had a rash and swelling in the arm on unspecified date. Caller seeking guidance on the management of this side effect; mentioned Benadryl as a treatment option. Patient received treatment with Benadryl.The Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient was revaccinated in 03/19/21 and has since received dose 2 on 04/09/21.
01/25/22 I tested positive for Covid. My symptoms included sore throat, runny nose, headache, achiness in upper arms, muscle aches for a couple of hours, and possibly a fever. I did wake up in the middle of the night all sweaty like I had broken a fever. My biggest issue was the head congestion and it was awful. Symptoms lasted about 7 days. I went ahead and self isolated for 10 days so I didn't spread it. I was also exhausted for 4-5 days. Major symptom was my head and I couldn't tell if it was the coronavirus or allergies because of the cedar pollen.
Narrative: COVID infection following COVID vaccine series 03/03, Pfizer, dose #1 03/24, Pfizer, dose #2 07/24 pt cc: cough, fatigue, rhinorrhea, sore throat exposure: unknown 08/05 COVID swab, result: detected 08/12 SARS-COV-2 LINEAGE result: pending 08/12 SARS-COV-2 clade result: pending
Broke out in a rash, "Like a heat rash" on forehead, inner aspect of elbows, lower back and on calf of legs. Hospital states rash on legs is more "patchy" in nature.
Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Bell's Palsy-Medium, Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: Headache-Mild
Spotty, red, raised rash over torso x 1 1/2 days.
About 3-6 hours after vaccination I started having a real bad headache and neckache. Muscle aches and joint pain. My symptoms lasted about 1 day, after seeing the doctor my symptoms almost immediately disappeared.
Narrative:  73 year old male admitted on July 18 2022 with fever, nausea, emesis, and requiring 2-3L oxygen.. He had received Moderna vaccine x 4 on December 28 2020, January 26 2021, October 29 2021, June 7 2022. He was treated with remdesivir 200 mg x 1 then 100 mg IV daily x 3 days and dexamethasone 6 mg daily x 3 days.. He symptomatically improved and w as transferred out of acute care unit on 7/27.
developed peripheral neuropathy/ full blown peripheral neuropathy; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6201) via an unspecified route of administration, administered on the left arm on 11Mar2021 09:45 at a single dose for COVID-19 immunisation. The patient's medical history included peripheral neuropathy. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 18Feb2021 for COVID-19 immunization (Lot number: EN6198, at 10:45 AM at the Left arm). On 14Mar2021 the patient developed peripheral neuropathy. Symptoms started a few days after second vaccine. She had had some issues prior that may or may not have started after second vaccine, but they were intermittent. She had full blown peripheral neuropathy since second vaccine. Therapeutic measures were taken as a result of the event which included medication (unspecified). The event resulted to a doctor or other healthcare professional office/clinic visit. Patient was not pregnant. The facility where the vaccine was administered was in a Public Health Clinic facility. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event was not recovered.
Extreme sore throat to the point where I could barely swallow. It started out with allergy symptoms, dry cough and a little bit of itchy eyes and stuffy head on the 13th. On the 15th I tested positive and my throat was so sore I could barely swallow. Within 20 hours I got Paxlovid and by the 17th the severity of the soreness started decreasing. I positive for 22 days. Seven days after Paxlovid I tested negative. Two days after I tested positive with increased symptoms. I was prescribed Acyclovir and a round of antibiotics. I started a second round of Paxlovid on the Aug 2 nd, and tested negative on Aug 6th.
Cellulitis of (L) upper extremity -start KEFLEX, cool compresses.
Swollen gland in left side of neck; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 17Apr2021 at 14:00 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included insulin lispro (HUMALOG), insulin degludec (TRESIBA), metformin (MANUFACTURER UNKNOWN), semaglutide (OZEMPIC) and Statin (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 27Mar2021 at 14:00 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. On 19Apr2021 at 00:00, the patient experienced swollen gland in left side of neck. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen gland in left side of neck was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Arm was sore after first dose; Doses administered > 1 month apart; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore after first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses administered > 1 month apart) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses administered > 1 month apart). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore after first dose). On 18-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses administered > 1 month apart) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore after first dose) had resolved.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow-up TCR contains no new information. The patient did not have any adverse event or effect to report. On 24-Jun-2021: Significant Follow-up added - added information for event after 1st vaccine, updated medical history
Ringing in the ears; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of TINNITUS (Ringing in the ears) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 immunisation.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced TINNITUS (Ringing in the ears). At the time of the report, TINNITUS (Ringing in the ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant or treatment medications were reported. The patient was seen by the ENT and was advised to proceed with the second dose.
patient experienced pain that has lasted for at least two weeks.  reports going to see her dr. and had what she claimed is a diagnosis of cellulitis.
FULL COVID SYMPTOMS INCLUDING: SHORTNESS OF BREATH, CHEST & SINUS CONGESTION, COUGHING, FEVER, BODY ACHES & FATIGUE; PARTIAL NUMBNESS TO RIGHT SIDE OF FACE, DIARRHEA X 2 DAYS, NAUSEA W/ VOMITING X 3,
Patient fell from chair to floor hitting head and sustaining small laceration above left eye.  He also experienced mild seizure activity that lasted approx 10 seconds. Patient quickly regained consciousness and was assisted to triage area. BP 140/86, HR 82, O2 sat 97%RA. EMT came and assessed client and cleared him to leave. Client ambulated out of facility without difficulty
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was vaccinated by at a physician's office by a nurse with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles, or severe herpes zoster. On or about 25-JAN-2016, the patient was treated by a physician for the onset of a painful rash, which was diagnosed as herpes zoster, or shingles. The patient was prescribed acyclovir and gabapentin for management of her painful symptoms. On or about 04-FEB-2016, subsequent treatment for a follow up on her shingles diagnosis and was prescribed prednisone and continued on gabapentin for management of her painful symptoms. On or about 22-MAR-2016, she had ongoing treatment for her painful blistery strain of shingles. On about 27-JUL-2016, she sought subsequent treatment to follow up on her post-herpetic neuralgia and was prescribed gabapentin for management of her painful symptoms. On or about 27-SEP-2016, she had ongoing treatment for her post-herpetic neuralgia and was prescribed capsaicin topical cream with continued gabapentin. As a direct and proximate result of ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
I started Paxlovid on 5/3. By 5/6 I had no symptoms. My rapid antigen test was barely detectable as positive. I finished my Paxlovid on 5/7. On the next 4 days, I tested every day with a rapid antigen and it was still appearing barely positive. 4 days after my last dose 5/11, I had sever fatigue, brain fog, muscle aches, chills, and was bed ridden. I got slightly better, two days later, but was then bed ridden again for 2 more days on the 14th and 15th. My rapid antigen test at that point was strongly positive and has stayed that way through today 5/19. On Monday the 16th, I was feeling better but still had fatigue, brain fog, cough, and congestion. On the 17th I was bed ridden again with all the same symptoms as well as muscle aches. Today, I'm still experiencing some brain fog and fatigue but was able to take a short walk with my wife.
w/in 24 hrs of vax pt devel generalized pruritus & mild erythema w/o hives;
KIDNEY STONES; COLITIS ULCERATIVE AGGRAVATED; COLITIS; This spontaneous report received from a patient concerned a 42 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, frequency 1 total, administered on 04-JUN-2021 for covid-19 vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, the patient experienced kidney stones, colitis ulcerative aggravated, and colitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from colitis ulcerative aggravated, had not recovered from colitis, and the outcome of kidney stones was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210947670-COVID-19 VACCINE AD26.COV2.S-Kidney stones, colitis ulcerative aggravated. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
No adverse event.  Incorrect Moderna Covid19 vaccine strength administered.  Reported to, NP.  Directed to inform family and have client return to vaccinate with correct Moderna Covid19 vaccine.  Called and spoke with, mom, at to explain incident and apologized.  Mom agreed to bring in child on May 24, 2023 at 3:45 pm appointment to vaccinate with correct Moderna bivalent Covid19 vaccine.
Vaccine-GARDASIL - admin. - 6/9/08 - pt called on 7/7/08 - stating L arm where shot given wnt. to hurt.  Advised to take ibuprofen 600 mg TID- heat like compress & recheck if not better.  Pt called 7/14/08 cont pain.  Appt 7/18/08 pain resolved.  Exam neg.
The day after I got booster vaccine I woke with a temperature of 100.9 and climbed to 102. Right knee swollen to three times it's size, all joints achy , headache ,  hot and cold..
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter (Other HCP). The reporter is the patient. A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm, as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High bp" (unspecified if ongoing), notes: Other medical history: High bp; "thyroid" (unspecified if ongoing), notes: Other medical history: thyroid; "osteopenia" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; LEVOTHYROXINE; LIOTHYRONINE; IRBESARTAN; VITAMIN E [TOCOPHEROL]; VITAMIN B12 [CYANOCOBALAMIN]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19".  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19.  Therapeutic measures were taken as a result of drug ineffective, covid-19 includes Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
4/24 -6/11/21: Approximately weekly episodes of fatigue, fever, lethargy lasting 1-2 days. 6/12 - 6/13/21: Symptom listed above plus shortness of breath, mild chest discomfort. 6/14 - 6/15/: Symptoms above plus heart arrhythmia 6/16 - 6/18/21: Hospitalized for pulmonary embolisms (both lungs). Treated with heparin IV, then subcutaneous lovenox. 6/18/21 - Discharged and prescribed Eliquis 5mg twice daily.
Dose 1: Arm soreness, Dizziness, Fatigue starting 20 minutes after dose and lasting 2 days. Dose 2: More severe soreness, swelling at biceps and progressing to forearm Lasting from 2 days post to 7 days post. Chills, aches muscles and joints (flu-like) no fever, for 1 day, day after shot. ****Dizziness, balance unsteadiness, brain fog starting 2 days post to present (1 month) Standing only.  This last one is worrisome. Doesn't really show signs of improvement.
After I got the second dose of the vaccine I got super tired, dizzy and nauseous. It was two days after my shot and I was trying to work out. I had to lay down in the middle of my work out. I am a triathlete, and I am normally in good shape. The next morning, I could not get out of bed because I was dizzy. It lasted for two more days and I mostly slept. I had two more episode of dizziness. The first time was about nine weeks after the vaccine. I woke up with the same dizzy feeling and I slept for the whole day. I felt a little better the next day. The last time it happened was early in September. I was very dizzy with nausea and the next day I was even more dizzy. It lasted for two days and my Covid-19 test was negative. I was given a lot of blood work and all the results were normal. My doctor does not know why it has been happening.
patient was given pfizer vaccine that was stored in the freezer past temperature excursion allowed. Patient's gaurdian and patient has NO complaints or adverse events.
Bad headache that over the counter medicine doesn't help. Tried Ibuprofen, Excedrin Migraine, Comtrex Nighttime, Dayquil and Nasal Decongestant. Severity of headache somewhat eased after wrapping head with microwaveable heating pad. Pain in both forehead and back of head/neck. Husband had vaccination same day/time and is also experiecing SAME symptoms and feeling tired.