chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 63 year old adult male of an unspecified ethnicity. Initial information was processed along with the additional information received on 24-AUG-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: severe back pain, short term memory loss, and allergy. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, and expiry: UNKNOWN) dose was not reported, 1 total, administered to left arm on 13-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 62 years old. Concomitant medications included alprazolam, and sertraline.  The patient received additional non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 035C21A , expiry: UNKNOWN) dose was not reported, administered on 01-DEC-2021 to left arm for covid-19 prophylaxis. The patient was treated with Paxlovid for the treatment of covid-19 infection with the start date of 01-AUG-2022 and end date of 05-AUG-2022. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. On 14-AUG-2022, on the day of reporting, the patient woke up fatigued, no energy, and felt like he had a cold and retested positive after 2 prior negative tests, coded as confirmed covid-19 infection (Dose number in series 2) which led to confirmed clinical vaccination failure (Dose number in series 1). On 14-AUG-2022, Laboratory data included: COVID-19 virus test Positive. Laboratory data (dates unspecified) included: COVID-19 virus test Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable, elasomeran (Moderna Covid-19 Vaccine) was not applicable and with paxlovid was drug discontinued. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0:20220848508-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccine failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Fever; nausea; body aches; sore throat; cough; headache; This is a spontaneous report from a contactable nurse (reported for herself). A 23-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 142), intramuscular on 07Jan2021 at single dose at right arm for COVID-19 immunization. Medical history included known allergies: Penicillin, diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility type Vaccine was Doctor's office/urgent care. The patient experienced Fever, nausea, body aches, sore throat, cough, headache on 09Jan2021. No treatment received for the adverse events. The events were non-serious per the reporter. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.
The patient had an adverse reaction after the flu shot was given. She felt warm and was having difficulty breathing. She was administered an Epipen and monitored. The pharmacist called 911 as a precaution.
Onset of Hyperthyroidism - positive for Graves disease. Previous normal bloodwork (several years wroth).
Really tired; A little bit of temperature; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (Really tired) and PYREXIA (A little bit of temperature) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Really tired) and PYREXIA (A little bit of temperature). At the time of the report, FATIGUE (Really tired) and PYREXIA (A little bit of temperature) 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.   Concomitant medication were not provided. Treatment information was not provided.
This spontaneous prospective pregnancy report as received from a nurse refers to a 16 year old female patient. No information about medical history, concurrent conditions was reported. On 28-AUG-2014 the patient was vaccinated with GARDASIL (lot # K005083, expiry date 04-NOV-2016 (also reported as 05-NOV-2016) dose# 1 in the series, dose, unit and route not reported)). No concomitant medications were reported. The patient was pregnant at the time of administration with an estimated date of last menstrual period (LMP) of 10-MAY-2014 and an estimated date of conception of 24-MAY-2014 (both dates calculated from the estimated due date (EDD) of 15-FEB-2015 that was reported). Initial exposure to GARDASIL was at 15 week(s). No adverse effects reported. The pregnancy outcome was unknown. There was no product quality complaint. Additional information has been requested.
10 hour mini-stroke paralysis of left side, followed by 8 hours of hallucinations.  I waited it out since my cell phone was out of reach.
Awakened at 3:00 AM with elevated temperature - 104.1 - nausea, vomiting, muscle aches and pains, headache - overall feeling like a severe case of the flu - Seen in Urgent Care around 11:00 morning of 1/6/21 where the Urgent Care Provider gave me a Dx of COVID-19.  Performed a COVID-19 test and sent me home with Tylenol/Ibuprofen, Zofran, increase liquids and rest  -  Symptoms stayed for 5 days Vaccine #2 - same type of symptoms lasting for 3 days -  Booster -same type of symptoms - less in severity lasting 2 days
Fever 101 (normal temp less than 97) , chills, headache, slight nausea. Hard swollen 2" x 4" hot area around injection site.
Patient reports that on day 1 her arm was difficult to move within 4 hours of injection. Had severe pain in her arm and was unable to get comfortable. Notes that she had mild numb sensation in a few of her fingertips but relieved by moving them. She took NSAID for patin and went to bed in the afternoon. Woke later in the evening with fever 100.2 and had fitfull night sleep due to arm pain. No headaches and fever did not last. Day 2-4 she was progressively more able to move her arm and the soreness began to lessen. Still having some dull pain with movement on day of report to pharmacy.
Patient felt nauseous tried to walk to bathroom fainted multiple times - (2-3) transported to hospital - fully recovered - frighten of needles.
Breakthrough case admission after 3 vaccines Moderna 2/25/21 Lot# 010A21A;  Moderna 3/25/21 Lot# 047A21A;   Moderna 11/19/21 Lot# 013F21A
5.5 cm x 5.5 cm erythematous annular area on back of left arm, warm to touch, minimally tender. Outline drawn around area. Pt to take BENADRYL and use cold compress if needed.
2hr p/vax pt began screaming, not eating/drinking;t99.1, swelling rt thigh (mild)-redness around immun site;
autoimmune disease; This case was reported by a consumer via interactive digital media and described the occurrence of autoimmune disorder in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced autoimmune disorder (serious criteria GSK medically significant). On an unknown date, the outcome of the autoimmune disorder was not recovered/not resolved.   It was unknown if the reporter considered the autoimmune disorder to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received autoimmune disorder in high school. After receiving Meningococcal B vaccine, the patient had autoimmune disorder. The patient never had another vaccine of any kind in 22 years.
Low-grade fever, body aches, chills and injection site soreness - symptoms began 8-10 hours after vaccine was administered and lasted for about 18 hours
Diagnosed with Covid after Vax  , started with extreme headache , body aches and now coughing. Lots of inflammation in nose/sinus. minor chest pains, shortness of breath. hallucination, slight feverish . No taste or smell.( Confusion and loss of direction)
Complained of petechial bruises. Saw doctor on 8/9/00, 2 days, post vax, with bruises on legs, sores in mouth, blood on lips in the AM for 2 days. No recent illness or tick or insect bites. Swelling 1+ at inguinal nodes and 2+ at axillary nodes; bruises and petechia. Treated with Prelone. On 8/22/00, phone call from mom. She wants to stop sibling from receiving IZ's based on what happened with this son and advised her to speak with the doctor about the advantages and disadvantages and she said she would consider this and call back.
The reports concerns a 11 year old male presented with 24 pruritic papular, vesicular and crusted skin lesions typical of varicella, macrocytic anemia, jaundice and sclera icterus. Family history was positive for hereditary spherocytosis (HS). Labs: Hemoglobin 9.7 g/dl, MCV 92FL, Reticulocytes 7.7%, Haptoglobin <8 mg/dl, Bilirubin (total/direct) 4.3/0.0 mg/dl, Lactate Dehydrogenase 957 IU/L. No spherocytes on peripheral blood smear. Day 3: Hb 11.1 g/dl and Reticulocytes 13%. Four weeks after presentation Hb 12.5g/dl, MCV 86 FL, Reticulocytes 2.0% and total bilirubin 1.4 mg/dL. OCT (Direct Coomb's Test) was negative. Varicella IgG was 3.5 (positive) and IgM was <0.9(negative). Osmotic fragility testing confirmed HS. In BTV skin involvement may not progress beyond the papule stage and production of acute phase anti-varicella IgG and IgM (and so hemolysis) may be short lived and so not detected. Our patient's skin lesions were most helpful in making the diagnosis. Hemolysis was likely mediated by anti I/anti P IgM antibodies and hence the negative OCT with polyspecific Coomb's reagent (IgG and C3d) at room temperature in our patient. It is possible that in patients with HS hemolysis is induced by alteration of splenic function induced by the varicella infection. Conclusion: Though now very rare the hematological complications of varicella infection continue into th post varicella vaccination era. Through this report we hope to encourage early recognition of these problems. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
she had a reaction 2 hours later; numbness in her tongue; her face was swollen for 3 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she had a reaction 2 hours later), HYPOAESTHESIA ORAL (numbness in her tongue) and SWELLING FACE (her face was swollen for 3 hours) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION COMPLICATION (she had a reaction 2 hours later), HYPOAESTHESIA ORAL (numbness in her tongue) and SWELLING FACE (her face was swollen for 3 hours). At the time of the report, VACCINATION COMPLICATION (she had a reaction 2 hours later), HYPOAESTHESIA ORAL (numbness in her tongue) and SWELLING FACE (her face was swollen for 3 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.
Dizziness, headache, neck stiffness started day of immunization and has increased in severity since then. Also reporting sweating, heavy for 10 min about 3 x day.
accelerated heart rate (up to 120 bpm); This is a spontaneous report from a contactable  consumer.  A 74-years-old male patient  received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), lot number= EL9262, via an unspecified route of administration, in left arm, on 20Jan2021 at 15:00 (at the age of 74 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  Medical history included heart failure, chronic kidney disease, bronchiectasis, heart attack 3 years previous. Concomitant meditations were received (not specified) within 2 weeks of the vaccination. On 20Jan2021, the patient experienced accelerated heart rate (up to 120 bpm) lasting 10 hours, starting approx 2-3 hours after injection. The patient was not hospitalized for the event nor received treatment. The clinical outcome of the event was recovered. Since the vaccination, the patient has not been tested for COVID-19.
The infant had immediate pallor (less than 3 minutes), decreased muscle tone and listless, no loss of consciousness. No treatment, gradual improvement over 10-15 minutes.
8 patients received the expired tenivac with no reported adverse event; Initial information received from on 14-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who received the expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No preservative Adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Jun-2023, the patient received an expired dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No preservative Adult Suspension for injection (lot U7092AA, Expiry date: 24-Jun-2023, with unknown strength and dose) via unknown route in unknown administration site as prophylactic vaccination with no reported adverse event (expired product administered) (Latency: same day).  It was reported "Caller clarified that a total of 8 patients received the expired Tenivac, but she does not have any patient information at this time."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
2 days post vaccine.  Limited motion of left arm with vomiting, headache, fever & chills.  Left arm muscle spasms & twitching.  No visual difference in size of arms.  No redness or heat to site.  Complaints of arm pit soreness.  To see care at urgent care.  Client put on Zithromax, Medrol pack & Motrin.
Patient received a COVID vaccination for her second dose on 3/3/21 at 1538.  She had informed the staff of the clinic that she did have a local reaction following her first dose (9days later) that she saw her PCP for. This was just treated with Zyrtec and no further intervention.  At 25 minutes following her second dose PA noticed that the patient appeared flushed.  He checked with the patient and she said she was ok.  A few minutes later noticed the patient was even more flushed.  At that time went and evaluated the patient - her BP was elevated 150/94 HR of 112 ad Pulse ox of 96%.  The patient reported feeling different than how she felt after her previous injection.  Clinic team offered for patient to be transferred to ER for further evaluation if she would like which the patient accepted.  She was transferred to ER via wheelchair in less than 5 minutes in stable condition with mild nausea.  She was cared for in ER by Dr.  Patient reported feeling tired and 'heavy' in the ER.  Dr evaluation found a generally healthy patient with a non-toxic appearance  Lungs were clear and no obvious signs of swelling or other signs of an immediate allergic reaction.  Patient was given oral diphenhydramine and observed until she felt comfortable going home.  Discharged from ER at 1733
About 8 hours after getting the shot, I felt tired, then got chills. A couple of hours later, I had diarrhea and nausea with vomiting. This lasted for about 1 hour or so. I became dehydrated and also had a headache. This morning, I seem to be fine - just exhaustion and some headache.
arm pain for about 24 hours on her right arm; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jun2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter would like to know the possible side effects of taking the Pfizer´s COVID-19 vaccine, and how long would the side effects last after receiving the second dose of the vaccine. She already received both doses of the Pfizer's COVID-19 vaccine and developed several side effects, she received the first dose on 23Jun2021, and she developed arm pain for about 24 hours on her right arm. The outcome of the event was unknown.
Initial unsolicited report received from a consumer on 11 November 2015. This case involves a 43-year-old female patient who was vaccinated with a first dose of FLUZONE (batch number: UH910AA, expiration date: 30 June 2014, dose was not reported) intramuscularly in left arm on 14 February 2014. The patient's medical history and concomitant medication were not reported. On an unspecified day in March 2014, two-three weeks following the vaccination, the patient experienced athlete foot type proplem and fissures developed in both feet. The patient felt that athlete foot type proplem was caused by her laundry detergent. Patient was evaluated and treated symptomaticly by her physician and dermatologist. The patient required ER or doctor visit. Laboratory investigation includes, patch testing positive for acrolates, methyl 2 hydroxyacrylate and stated negative or positive for thimerosal. On an unspecified date, the patient received OTC preparations, symptomatic treatment and UV light treatments and steroids as a corrective treatment. As of August 2014, the patient was not recovered from events as the symptoms remained and the patient had to stop working. List of documents held by sender: none.
Pronounced lower back pain and left leg pain, commencing second day after vaccination. Experienced both in milder form at the same interval after first vaccination.
12/20/2005 developed low grade fever 99.6 OE multiple lesions, too numerous to count, all over body (macular, papular and vesicular). Treated with Valacyclovir. Pt did not present with any respiratory symptoms. Completely scabbed over by day 8.
Received the COVID vaccine on 12/22/2020 - approximately 4 hours later started with body aches, took NSAID and went to bed, woke up with loss of taste and smell and other COVID symptoms
This spontaneous report was received from a 53 years old female consumer referring on herself. On 02-JUL-2013, she was vaccinated with the first dose of ZOSTAVAX, subcutaneous in the left arm. On 02-JUL-2013, the consumer stated that when the vaccine was administered a clear liquid dripped on her arm. She stated that the pharmacy advised her it was plasma. She states the pharmacy offered to re-administer the vaccine to be sure she was protected. She also stated that on her left arm, at the injection site, she has redness, pain, itching, and swelling, which started on 03-JUL-2013. No treatment was given for the events. The outcome of clear liquid dripped on her arm and the injection site, she had redness, pain, itching, and swelling was unknown. She sought medical attention. Attention information is not expected.
I received the PNEUMOVAX 23 vaccine yesterday and had an allergic reaction to it. I experienced extreme itchiness of skin, especially the bottoms of my feet. My arm and armpit are extremely sore. I cannot lift my arm without pain and I cannot sleep on that side. An approximate six inch area surrounding the injection site is red and hot to the touch.
got sick as a dog; Initial information received on 12-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non- healthcare professional (hcp).  This case involves a 77-year-old and unknown gender patient who got sick as a dog after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose, route: unknown) (lot number and expiry date: not reported) in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date, the patient developed a non-serious event of got sick as a dog (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, Never Again, I'm 77 going on 78. It is unknown if the patient experienced any additional symptoms/events. Since this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was unknown.  It was not reported if the patient received a corrective treatment for the event (got sick as a dog).  At time of reporting, the outcome was Unknown for the event got sick as a dog.
Left arm swollen and red to elbow. PHN had pt's mom to take to MD. MD told mom to give Benadryl and cool compresses to area and that it was a reaction to whooping coughing per grandfather.