chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 6 minutes after receiving vaccine, patient experiencing left arm was feeling heavy.  Patient felt like the arm was feeling "weak".  May have had some tingling in the fingers.  Initial BP 137/72  HR 95  O2=97%.  Heaviness in the arm dissipating after 20 minutes.  At 25 minutes, patient starting feeling a dull pain in forearm ascending to the left side of the neck with some intensity, but subsiding to a very dull pain.  Tingling in the fingers subsided, but very mild at 30 minutes.  At 5:35pm, BP 147/75  HR 91 O2=98%.  At 5:45pm patient reports some mild tingling in fingers.  Pain in the neck area and arms feel more like a stiffness than pain.  Patient released from clinic at 5:50pm.
This spontaneous report was received from a physician via company representative refers to a 60 year old female patient. On an unknown date, the patient was vaccinated with ZOSTAVAX on dose, 0.65 ml, subcutaneous. On an unknown date, the patient experienced shingles. The outcome of the event was reported as improved, but it was not specified whether the patient was still recovering or has recovered fully. The reporter did not provide the causality between the event and the suspect drug. No further AE information has been provided. Additional information has been requested.
Caller stated having the COVID-19 Primary Series Vaccination with Pfizer and 1 Pfizer booster. She had COVID-19 at the end of Jul; Caller stated having the COVID-19 Primary Series Vaccination with Pfizer and 1 Pfizer booster. She had COVID-19 at the end of Jul; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovered" (2022) and all described as "Caller stated having the COVID-19 Primary Series Vaccination with Pfizer and 1 Pfizer booster. She had COVID-19 at the end of Jul". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: She had COVID-19 at the end of Jul2022 during one week and then tested negative again; (Jul2022) Positive, notes: She had COVID-19 at the end of Jul2022 during one week and then tested negative again. The patient stated she had the COVID-19 Primary Series Vaccination with Pfizer and 1 Pfizer booster. She had COVID-19 at the end of Jul2022 during one week and then tested negative again. She  had her second booster dated for 03Sep2022 and wanted to know if she should wait for the Omicron specific vaccine to be available. The reporter mentioned her need to know about the specific booster to get was regarding a travel. She and her husband had programmed for Oct (as reported). The patient also wanted to know if she should get COVID-19 antibody testing to know if she was protected, since her HCP told her she could get the regular Pfizer COVID-19 booster. The patient wanted to know if she should get the "normal" Pfizer COVID-19 Vaccine booster or wait for the Omicron specific vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt recvd 1st hep B vax 17APR90 & exp pain @ inject site that burned down to elbow & lasted 2-4 hours.
My son has Cystic Fibrosis. He was diagnosed at the age of 15 months old. Has been seeing doctors in the Pulmonary Clinic. He does see other doctors as well. He is currently caught up on all his vaccinations. On October 7, 2013, Dr's office gave patient his first GARDASIL shot. He got the shot in his right (Delt) shoulder area. After the shot he did have arm soreness and redness over the next few days. I called the Drs office and they said that was normal. Over the next few weeks the soreness was still there, then on October 28, 2013 his right arm was locked and he could not move it up over his shoulder. Some of his symptoms were the soreness, popping of the shoulder, and him not able to have full range of motion. Then I just called Dr. Went to see him on November 1, 2013 and he had a x-ray done. Then on November 8, 2013 we had a MRI done, and then on November 12, 2013 we went back to Dr, and patient's test results. Dr said he has no shoulder, it is bone on bone. Not saying the shot cause it but, all of patient's doctors that I spoke to seemed concerned as am I. It even happened again on the 2nd shot of GARDASIL. Patient's second shot of GARDASIL was given on December 19, 2013 at Dr office. His second shot was given on his left (Delt) shoulder area. Then exactly 3 weeks after his shot was given, on January 9, 2014, he started getting the same symptoms. His shoulder was popping but was still able to use it. I called Dr office and they wanted to see him. On January 16, 2014 went back to see Dr and he did another x-ray and it showed exactly was the other x-ray showed on his other shoulder. So this is why I'am so concerned and reporting these to you. Not sure if the shots caused these but it seems so coincidental that it happened again. The timing between when he got each shot and when he had problems, then saw the doctors are 3-4 weeks. All the doctors that I spoke to about this agreed that this all seemed so coincidental and I should report these to the FDA. After talking with Dr office, I am no going to give the 3rd GARDASIL shot patient.
Severe fatigue, grogginess, prickly sensation on skin (but no fever); inabi;ity to focus; no appetite.  Slept for probably 20 of 24 hours.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 18:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 41 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EL9267), on 09Mar2021 as dose 2, single (Lot number: EN6205), on 28Sep2021 as dose 3 (booster), single (Lot number: EW0181) and on 06Jun2022 as dose 4 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type I Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "SVT" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing). Concomitant medication(s) included: NOVOLOG, start date: 01Oct2001; NORTRIPTYLINE, start date: 01Jul2015; LIPITOR, start date: 01Jan2018, stop date: 04Jan2023; PROTONIX [OMEPRAZOLE], start date: 01Feb2007; ASPRIN, start date: 01Jul2010; TOPROL XL, start date: 28Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received Paxlovid from 05Jan2023 to 10Jan2023.
Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild
Symptoms began later in the same day the vaccine was received. Fever was between 100-102 for about 48 hours from symptom onset, and had significant joint pain in all joints, but especially knees. Major fatigue but unable to sleep because of intensity and discomfort of symptoms. Outbreak of new aphthous ulcers in mouth. Contacted physician to ask if I could take acetaminophen or ibuprofen to lower fever and get relief from joint pain - was advised both were safe to use. Took acetaminophen. Major symptoms resolved after 48 hours, but some general fatigue, loss of appetite, and night sweats continued for approximately 1 week post-vaccine.
Bloody nose that would not stop/ her bloody nose episodes have been occurring on and off; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPISTAXIS (Bloody nose that would not stop/ her bloody nose episodes have been occurring on and off) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028921A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced EPISTAXIS (Bloody nose that would not stop/ her bloody nose episodes have been occurring on and off) (seriousness criterion hospitalization). The patient was hospitalized on 03-Apr-2021 due to EPISTAXIS. At the time of the report, EPISTAXIS (Bloody nose that would not stop/ her bloody nose episodes have been occurring on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment included saline, humidifier and other treatments, not specified. Very limited information regarding the event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information has been requested.
Reporting a vaccine administration error: unauthorized age group. Vaccinated while not yet 18 years of age. No adverse event.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received SHINGRIX. Concomitant products included CALTRATE, Fish Oil + Vitamin E, Vitamin C and Multivitamin. On 8th May 2018, the patient received SHINGRIX. On 8th May 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling and contusion. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site erythema and injection site swelling were unchanged and the outcome of the contusion was unknown. The reporter considered the injection site pain to be related to SHINGRIX. It was unknown if the reporter considered the injection site erythema, injection site swelling and contusion to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she received the SHINGRIX vaccine 10:00 a.m on left arm and it hurt during injection which surprised her because she usually had a high tolerance for pain and the pharmacist put a Band Aid on the site and she took the Band Aid off and there was a two inch red circle all around and the area was swollen. She claimed that the area was painful and felt like a bruise when touched but she had no pain if she does not touch the area. She noticed the swelling and redness after approximately eight hours after the injection. Staff failed to obtain the pharmacy information because of an IT issue during the phone call.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EW0161), in left arm, as dose 2, single (Lot number: EW0171), in left arm and as dose 3 (booster), single (Lot number: 33030BD), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "obesity" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "iron deficiency" (unspecified if ongoing); "acute asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "recovered" (2022) and all described as "Treatment of COVID-19". The patient received paxlovid on 06Jul202 for treatment of COVID.The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.
no adverse event; received an unknown number of doses of GARDASIL-9 following a temperature excursion; Information has been received from a medical assistant regarding an unknown number of patients of unknown age and gender. The patients' medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On unknown date, the patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, for prophylaxis, lot number R029515 with expiration date in 08-JUL-2021 (strength, route of administration, strength and anatomical location were not reported).  The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was stored at a lowest temperature range below 36 degrees Fahrenheit (°F)/ 2°F (34.3F)  (multiple excursions) for the time frame of 13 days, 21 hours and 45 minutes. It was unknown if any previous temperature excursion had occurred and the digital data logger was involved.  No adverse effects were reported in any patients.  This case is non-valid due to lack of patient identifiers.  As of 12-JUN-2020, the medical assistant provided the patient's identifiers for the patients that received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) that underwent a temperature excursion.  The patient was a 11-years-old female patient, that received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 10-DEC-2019.  This case is one of 4 cases received from the same reporter.; Sender's Comments:  US-009507513-2006USA005345: US-009507513-2006USA005344: US-009507513-2006USA005346:
Patient experienced redness and warmth at and immediately around the injection site starting 02/27/2018. Patient presented to pharmacist on 02/28/2018 with redness and warmth that started at the injection site and extended distally to approximately 2-3 inches from the elbow in a 2-3 inch wide band. Patient was counseled to take cetirizine 10mg and follow up with PCP if reaction worsens or does not improve.
In the end of December she developed right wrist pain and some mild swelling, then pain in both arms from elbows to hands, and then it started in the back on her thighs in hips bilaterally and her right ankle.   She still has the headache that is unchanged x 1 month, but the other symptoms were new, and she had never had them before.  She still has it and it is 1/6/21.
The vaccine triggered a large increase in my lymphedema starting at the end of day 3.  My entire body (under my arms, my sides, my upper and low legs) filled with fluid and I have needed repeated drainages from my lymphedema therapist to deal with this.  It is now a month later and I am still dealing with this problem.   This is absolutely caused by the vaccine as I have not had issues like this before except during the pandemic shutdown when I could not receive treatment for several months.   There was no warming about in increase in lymphedema symptoms publicized about the bivalent vaccine so I did not have a chance to discuss this with my medical providers.  My providers are now concerned about me receiving another booster.   I already had dysautonomia before getting covid, and now have long covid and the vaccines were very important to me, but I am afraid to get another one.
prolonged irritability w/high pitch cry, wide eyed fright like stare x 4-5 hrs beginning 3-4 hrs p/vax; irritability & clinginess lasted 72 hrs;
Client received Tdap and MCV and approximately one minute later stood up and then sat back down. Client rolled his eyes back and went limp. Client was layed down flat on the ground.  Client would shrug shoulders in response to questions. Client drank water. Supervisor notified and evaluated client. BP was 78/52.  Mom states he passes out all the time and has not consumed food or liquid this day. Client repositioned and BP 98/52.  Legs elevated and lollipop given.  11:00  bp 106/66 laying down.  Client assisted to sitting position. Zero complaints of vertigo noted. BP sitting at 11:05 110/72. Client left the building with family member at 11:05 ambulating independently.
blood clots; Their period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting; Their period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting; nausea; vomiting; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. The reporter reported similar events for 2 patients. This is one of the 2 reports. A female patient in her 20s received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The reporter stated issues about the vaccine were being suppressed such as issue with bell's palsy and mentioned that she according to the nurse where her mother was currently admitted; they saw a 50-60% of hospitalization among vaccinated people. The reporter also knew 3 young women in their 20s that have been vaccinated as well. The one was hemorrhaging in the hospital while the two had blood clots on an unspecified date. Their period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting. There was also one woman suspected to be pregnant has a miscarriage. Outcome of events was unknown.  The lot number for bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101202717 same reporter, drug and event, different patients
On the first day after taking the shot: couldn't walk well; very dizzy; loss of balance; blurry vision; couldn't focus; difficulty riding my bike. I went to the doctor and I was recommended to see a neurologist. I gradually got better over time. I still have soreness in my ribs and I can walk somewhat normally. I feel like I have 90% recovered.
This spontaneous report was received from a nurse and refers to a 4 month old female patient. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On 05-FEB-2018, the patient was vaccinated with an expired dose of ROTATEQ orally, lot # M011832; expiry date 25-JAN-2018 (dose was not reported). No adverse effects were reported. The vaccine did not undergo a temperature excursion.
High fever - lethargic - 103.2 - approx. 12 hrs after vaccines (PREVNAR & FLUZONE) vomited x1 - gave ADVIL - fever decreased to 100.2.
C/o extreme fatigue, aching all over, severe h/a & low grade temp beginning 24 hrs p/receiving vax; pt reported to PMD 23JAN93; 27JAN pt exp severe arthritic-like pain in hips & other joints that caused difficulty walking; dx serum sickness
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications details were provided. No Treatment Medications details were provided.   This case was linked to MOD-2021-395985 (Patient Link).
Axillary swelling with pain and erythema starting the evening of the day of injection and continuing through to next day when seen in office. reaction (R) axillary region.
This is a spontaneous report from a contactable consumer or other non-healthcare professional. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Since the vaccination, the patient has been tested for COVID-19. It was reported that patient who had caught Covid after vaccination on an unspecified date also reported that several others they knew had also tested positive after vaccination (believe 2 others). It is unknown whether the vaccine they had received is the Pfizer vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Child had redness, edema, heat, and blistering of the skin to right thigh, redness, edema, and heat to the left thigh. Did not report fever, disfigurement or disability.
After I received the vaccine about 1 1/2 hours later I started experiencing a metallic taste in my mouth. I am also experiencing no appetite.  Throughout the night I had to force myself to eat. I'm still experiencing no appetite and this is very unusual. The metallic taste is still present, but it is getting better
Extreme allergy, itching all over body, as if it were a stab inside the skin. which has not let me sleep for two weeks, pressure has dropped, dizziness and tiredness. I have use BENADRYL GEL 0.5% alcohol base for the itching. The itching has gone down.
red, swollen, and itch; soreness in her arm; red, swollen, and itchy; red, swollen, and itch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (red, swollen, and itch), VACCINATION SITE PAIN (soreness in her arm), VACCINATION SITE ERYTHEMA (red, swollen, and itchy) and VACCINATION SITE SWELLING (red, swollen, and itch) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (red, swollen, and itch), VACCINATION SITE PAIN (soreness in her arm), VACCINATION SITE ERYTHEMA (red, swollen, and itchy) and VACCINATION SITE SWELLING (red, swollen, and itch). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (red, swollen, and itch), VACCINATION SITE PAIN (soreness in her arm), VACCINATION SITE ERYTHEMA (red, swollen, and itchy) and VACCINATION SITE SWELLING (red, swollen, and itch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment details included that the patient took Tylenol for pain.
Blood in stool. First noted by pt's mother the morning of 8/13/11.
Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, sore throat, drainage, and fatigue. pain and swelling at the injection site. Narrative:  Other Relevant History:
Severe shoulder pain between 20-36 hours post injection.  Taste of metal in mouth intermittent x 2 days.  Moderate lethargy/fatigue intermittent days 2-7 post injection