chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient inadvertently received an extra dose of Shingrix.; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a male patient 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 extra dose administered (Verbatim: patient inadvertently received an extra dose of Shingrix.).The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 07-SEP-2023 The reporter reported that his patient inadvertently received an extra dose of Shingrix, which led to extra dose administered. The reporter did not provide complete information.  No additional details outside of those provided in this report. The reporter consented to follow up.
False positive covid test after covid vaccine on 12/29/20. Tested positive on 1/11/2021 and tested negative on 1/13 and 1/15/2021 Narrative:
temperature excursion was 47.5F; total time of excursion was 1 day and 13 hours with no reported adverse event; Initial information received on 28-Feb-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a patient with unknown demographics who had temperature excursion was 47.5f; total time of excursion was 1 day and 13 hours with no reported adverse event while receiving vaccines IPV (VERO) [IPOL], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and HIB (PRP/T) VACCINE [ACT-HIB] and while treated with TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient started taking TUBERSOL (TUBERCULIN TEST) Solution for injection dosage unknown (lot - C5762CA) for Product used for unknown indication for immunization.  On an unknown date, the patient received a  dose of suspect HIB (PRP/T) VACCINE with unknown dose lot 9977H via unknown route in unknown administration site for immunization.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE with unknown dose lot C5923AA for immunization.  On an unknown date, the patient received a  dose of suspect IPV (VERO) with unknown dose lot U1A601M via unknown route in unknown administration site for immunization.  On an unknown date the patient had temperature excursion was 47.5f; total time of excursion was 1 day and 13 hours with no reported adverse event (product storage error) (unknown latency) following the administration of HIB (PRP/T) VACCINE, (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and (unknown latency) following the administration of IPV (VERO).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (temperature excursion was 47.5F; total time of excursion was 1 day and 13 hours with no reported adverse event).  At time of reporting, the outcome was Unknown for the event temperature excursion was 47.5f; total time of excursion was 1 day and 13 hours with no reported adverse event.  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.
Pt recv vax on 9/30/98; 5 min post vax pt exp buckling knees & slumping over, pt hit counter when falling, pt had red splotching on front neck/ LA/ rt arm x 20 min
Swelling fr top of leg to ankle lasting less than 48hrs; Onset was w/in 24 hrs of inject; No hx of allergies, 4th DTP shot; Is allergic to Penicillin; poss anaphylactic rxn;
Spotty red itchy rash on arms and trunk and neck. More than 100 bumps
About 28 hours after receiving the injection, my smartwatch alerted me that I had an abnormal heart rate. Through the next hour, my heart rate increased to 105 bpm. My resting baseline is 60 bpm (I'm a self-proclaimed health nut and monitor my heart rate, nutrients, etc daily.). My heart rate was elevated for several hours while I was resting and it kept me from falling asleep. My face felt like it was burning but there was no rash. At times my face felt like it was not attached to my body. My nose swelled shut but I did not have difficulty breathing through my mouth. My entire body felt hot inside but I was having chills and sweating. Even covering myself in a thin bedsheet was uncomfortably hot. I have had an intense headache since my heart rate elevated until now, and my face continues to feel tingly as well as my arms and hands at times. The best I can describe it is like the time I took amoxicillin and found out I was allergic. The only difference was I got a rash all over my body with the amoxicillin.
Low BP and Above normal temp; above normal temp; This is a spontaneous report received from a contactable consumer (patient). This 62-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0151) via an unspecified route of administration on 11Apr2021 (at the age of 62-years-old) as a single dose in the left arm for COVID-19 immunizations. Medical history included pollen allergies, high blood pressure (BP), low iron, low vitamin D, and allergies to sulfa, penicillin, and nickel. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient took unspecified concomitant medications. The patient previously received dose 1 of BNT162B2 (lot number EP6955) on 21Mar2021 as a single dose in the left arm for COVID-19 immunization. On 13Apr2021 at 16:00 the patient experienced low blood pressure and above normal temperature. The patient visited a doctor or other healthcare professional office/clinic as a result of the events. The patient reported treatment was  check blood pressure and temperature twice daily. The outcomes of low blood pressure and above normal temperature were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced headache. On AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea and chills was not reported. This report was non-serious.
Tingling in arms and hands around 10:30pm on the day of receiving the flu vaccine around 3:45pm. I felt numb in that area while having intercourse with my husband that night it was very odd completely unusual. I woke up this morning 12/23/22 while body sore and developed a headache by 11am. Food does not taste right. By this evening my body feels weird right tupper arm hurts very much I feel weak and light headed and nauseous.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium
Patient came to a covid clinic stated it was his 1st Pfizer vaccine.  Told several staff it was his first Pfizer vaccine.  When vaccine information was entered into regulatory authority it noted he had received 2 modernas, 2 pfizers and this additional pfizer
Swelling at injection site, redness with extreme temperature, redness spread to whole upper arm by 8:00 PM. On 3/11/16 Dr. diagnosed a bacterial infection and prescribed Clindamycin.
c/o "trouble swallowing last night (5/7/03) and burning sensation in throat, "swelling lymph glands" and c/o stomach and back cramps".  Unsure if symptoms related to Td injection or cat bite.  Also, left arm at injection site sore.
Severe pain/ache in upper arm/elbow at time of vaccination and dissipating after the vaccination
diagnosed with shingles; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Last Wednesday (17Mar2021), patient was diagnosed with shingles and is still suffering from the side effects. She asked her doctor if it is okay to take the second vaccine and they said it was okay, but she is calling to see if it is okay. The outcome of the event was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained
8 days after the Covid 19 Moderna Vaccine #1 was received, I started having adverse symptoms:  left side of mouth was numb, face got numb and then left eye would not close completely. After Emergency Room visit, I was given a Cat Scan and MRI and the neurologist  diagnosed  my condition as  Bells Palsy.
Post vax, pt's arm hurt for a day, and it was very, very bruised.
Patient received vaccine 9/14, tested positive for COVID 2 days later on 9/16. Patient admitted for dyspnea, fever, chills, is still undergoing inpatient treatment.
received first dose of bnt162b2/by the 3rd (03Jan2021), he was diagnosed as covid positive; received first dose of bnt162b2/by the 3rd (03Jan2021), he was diagnosed as covid positive; patient lost his sense of smell and taste; patient lost his sense of smell and taste; This is a spontaneous report from a contactable nurse (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on 17Dec2020 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient reported he needs advice on the second dose of the vaccine. Patient stated he is an ER nurse and received the first dose of the vaccine on 17Dec2020. On 31Dec2020, patient lost his sense of smell and taste and by the 3rd (03Jan2021), he was diagnosed as covid positive. The patient underwent lab tests and procedures which included Covid test: positive on 03Jan2021. The patient is asking how safe it is to get the second dose now and if there's a time period that he should wait so that he can get the second dose. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.  Further information like diagnostic detection of virus genetic material or virus protein antigen needed for meaningful medical assessment.
Nurse incorrectly administered Fluzone High Dose to patient. Nurse overrode alerts in our system about patient age in order to give. Nurse was new to the area and unfamiliar with pulling from system. Nurse had come from another area with an system so supervisor was not aware that she needed additional training. Nurse stated she felt rushed because provider was ready to see patient and pulled rather than asking another nurse for help.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden for prophylaxis. The patient's past medical history included influenza and meningitis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), viral meningitis (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure, viral meningitis and influenza were unknown. It was unknown if the reporter considered the vaccination failure, viral meningitis and influenza to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were received as follows: The patient had meningitis in the past, causes the patient zero thought because none of the vaccine could stop meningitis. The patient had flu without the vaccine. The patient was sick for few days at home. After vaccination with Influenza vaccine, the patient was ended up with viral meningitis. Flu vaccine didn't even stop it. Influenza vaccine may not prevent the flu but it would make flu easier to get over. This case was considered as suspected vaccination failure case since time to onset was unknown at the time reporting. Flu with Influenza vaccine ended up in hospital for a few days.
Low grade fever (99.8) - resolved after 30 hours, nausea with 2 episodes of vomiting 3/21/18 at 2:00 and 4:00 am. Malaise, GI distress, Right Deltoid pain, hot to touch, mild edema; and Right axilla, shoulder and neck pain - resolving at present.
Fever; Chills; headache; This is a spontaneous report from a contactable consumer (patient's parent). A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Left arm on 18Mar2021 09:00 as dose 1, single for COVID-19 immunisation. Medical history included history of 2 times of pneumonia after bronchitis from an unknown date.There were no concomitant medications. Patient had no known allergies. Prior vaccination, patient was diagnosed with COVID and did not receive any other vaccines within four week. On 19Mar2021,after 16 hours of injection, at 01:00, the patient experienced fever, chills and headache. No treatment was received in response to the events. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Flu injection was given in my left arm. Since the injection on my arm is still hurting deep in area. I am have difficulty raising my arm and using my left arm. Also pain in the arm with decreased range of motion. Came over in Feb 2019. Staff member was unable to find the form. Informed me to come back.
I got the shots and I still. Have them/Suspected vaccination failure; Still have them; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 14-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shots and still had them. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Fever ~100.2 (24 hours), headache (72 hours), chills (48 hours), body aches (72 hours).
Telephone call reported client had reaction to PN vaccine left deltoid region that affected it. Arm and side of body. Redness, rash and pain. Client seen DR 11/15/2005.
Ventricular tachycardia. Atenolol stopped. Cavedilol started.
3cm x 3cm area of redness and swelling left upper arm. Treatment with cold compresses and Motrin.
A seizure occurred for about a minute 12 hours after a minute. Patient also experienced nausea and vomiting after the seizure.   Patient was taken to the ER.
pt recv vax & devel an inj site rxn characterized by a 10-40cm area of redness & pain;pt recovered;this is 1 of 111 pt from this facility to devel an inj site rxn p/flu vax lot# 4978296;
Pt recv vax on 10/14/97; on 10/15/97 pt exp fever (103F), vomiting, red/warm/sore vax site, right side flushed face
I got my period the next day i received the Pfizer vaccine. It came 5 days earlier than scheduled.
Chills, lethargy, sore arm at int. site muscle stiffness. Felt better this a.m. 8/24/2021. Improving
30 yo M with fever, myalgias, fatigue and flu-like symptoms 2 days after receiving Tdap vaccination. T is 101.2. He has headache and "feels really sick". He has no meningeal signs on exam and no localized neurologic symptoms, or findings to suggest Guillain Barre syndrome. No evidence of anaphylaxis. There is no evidence of cellulitis on exam and the injection site looks remarkable. He does have muscle tenderness and pain with movement. This seems to be more in the muscle rather than in the joint. Symptoms seem most consistent with systemic reaction to the Tdap vaccination. Advised close follow-up, or return to the clinic if he is not continually improving over the next 24-48 hours. RN also met with him in the exam room and emphasized the follow up care, IE drinking plenty of fluids, taking TYLENOL alternating with ibuprofen. Pt. instructed to get into the shower if temp is greater than 101. Pt. instructed to call clinic if temp is greater than 101.4.
Soreness in arm, inability to lift above head; Soreness in arm, inability to lift above head; fatigue; minor nausea; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318 and expiration date unknown), via an unspecified route of administration on the right arm on 27Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included COVID-19; prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included Vitamin D NOS and Multi-Vitamin. The patient previously took injectable Iodine and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced soreness in arm - inability to lift above head, fatigue and minor nausea on 27Jan2021 at 13:00 (01:00 PM). No treatment was administered for the events. Since the vaccination, the patient has not been tested for COVID-19. The events were resolving.
Got shot 1/5/17 came in pharmacy 1/7/17 arm is red at injection site, warm to touch, raised bumpy and she has numbness going down her arm into her fingers-hand feels tight.
13 hours after injection the left side of face went numb as well as partial tongue and left inner check  It lasted 3 hours   11 hours after injection chills, fever, nauseous , sweats, and bone aches . Lasted 30 hours   48 hours after injection baseball size lump under right arm pit- swollen lympnode still there 2 days since it appeared  48 hours after injection blood circulation in hands and feet are not what they usually are they are blotchy and red and extreme sensitivity to cold -still ongoing
Other complications following immunization, not elsewhere classified, initial encounter on 2021-01-05.
My son received his MMR shot at 1 year old and shortly after, began showing autistic behavior. He was completely normal before this. Sat up at 4 1/2 months, walked at 9 months and started talking at 10 or 11 months. After he received this IZ, this started to disappear. He is now autistic and I know he would not be without the MMR vaccine. The presence of mercury, aluminum and formaldyhide are in this vaccine. They are at toxic levels. Please take this off the market and make other kids safe from this happening again. Every symptom for mercury poisoning is a symptom for autism. I am utterly shocked that this relationship has been overlooked for so long. He now has food intolerances, allergies and digestive problems, visual disturbances, sensory problems and the list is endless. No formal diagnosis to be made until child's 3rd birthday, now in speech, physical and occupational therapies, went through psychological testing.
Vaccine was given at 11:30am...about 3pm I developed body aches, including headache and chills...I took Ibuprophin and within an hour the symptoms went away. On 11-10-2007 I noticed redness at the site,and slight soreness.
35 Y/O FEMALE PT  CAME TO ER WITH C/O ABD PAIN  X 1 DAY  LAST NIGHT SEVERAL VOMITING EPISODES
Information has been received from a pharmacy student concerning a patient who on 13-AUG-2007 was vaccinated with 0.65 ml of ZOSTAVAX (Oka/Merck).  On 01-OCT-2007 the patient was administered a second dose, 0.65 ml, of ZOSTAVAX (Oka/Merck).  The reporter indicated that the patient received two separate doses, 0.65ml, of ZOSTAVAX (Oka/Merck) and it was believed that the patient failed to seroconvert.  The patient was not experiencing any known symptoms.  There was no product quality complaint.  Additional information has been requested.
not feeling good; dizzy; in bed; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (not feeling good), DIZZINESS (dizzy) and FATIGUE (in bed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced ILLNESS (not feeling good), DIZZINESS (dizzy) and FATIGUE (in bed). At the time of the report, ILLNESS (not feeling good), DIZZINESS (dizzy) and FATIGUE (in bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.