chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The arm in which she received the vaccination was extremely sore through the night.; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration in the left arm on 22Mar2021 at 11:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as no. The patient did not have a history of allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had experienced extremely sore arm in which she received the vaccination through the night on 22Mar2021 at 13:00. It was further reported that the pain subsided in the next day. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported event. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab) on 23Mar2021 and the result found to be negative. The clinical outcome of the event the arm in which she received the vaccination was extremely sore through the night was resolved on 23Mar2021. No follow up attempts are needed. No further information is expected.
Excruciating pain at injection site, inability to move arm.  Flu-like symptoms for about 8 hours: shivering, sweating, muscle aches.
This is a spontaneous report from a contactable other HCP (Pharmacy Intern) calling on behalf of the pharmacist reported same events for 2 patients. This is Report 2 of 2 for the wife, a 65-year-old female patient. A 65-year-old female patient received PREVNAR 13 (Lot # S43277, Expiry Date Sep2018, NDC # 0005197102) intramuscular at 0.5mL, single at left arm on 11Dec2017 for immunization, given at Pharmacy/Drug Store under standing orders. No medical history to report. Patient's Medical History (including any illness at time of vaccination): None. Concomitant vaccination included ZOSTAVAX (Merck, Lot # N020945, Expiry date 26Oct2018) subcutaneous at right arm on 11Dec2017 for immunization. The patient's left arm has been swollen for a week primarily at the injection site on an unspecified date with outcome not recovered. Reporter seriousness for left arm swollen was reported as medically significant. Reporter stated the 2 patients received the vaccines around the same time and their reactions were pretty severe. The reporter considered the event was related to the study medication PREVNAR 13. Sender's Comments: A causal association between administration of PREVNAR 13 and the onset of "swollen for a week primarily at the injection site" cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product. Linked Report(s): US-PFIZER INC-2017546967 same reporter/drug/event, different patient.
No known adverse event occurred, however, recipient received Moderna as their second dose after receiving Pfizer as their initial dose 9/19/22.
pt recvd vax 12SEP94 & 14SEP94 pt exp 3 episodes of eye rolling, shaking of body, & unresponsiveness, lasting 1 1/2-2mins, low grade fever 100.8;
pt recv vax 26MAR99 and devel gastroenteritis on 29MAR9;tx as outpatient w/resolution;no daycare exposure or antecedent family illness;sibling devel gastroenteritis;
09/24/22 presents to ED for "weakness". PMHx of " hypertension, CKD III, MGUS, mitral valve prolapse, non-inducible SVT (per EP study 11/12/19), sick sinus syndrome status post dual chamber pacemaker placement in 2017"
Subject in pneumococcal vaccine trial, with severe COPD was hospitalized for pneumonia. Vaccination took place on 1/7/08. According to physician relationship is 'None'.
Two days after receiving vaccine, patient developed acute swelling and tenderness in right lower extremity and diffuse whole body urticaria.
patient presented with approximately 3 inch long by 2 inch wide red area where vaccine was administered on back of right arm. Skin was warm to the touch. Patient did not complain of any other symptoms.
Mother called and reported red swollen area on are where shot was given about the size of a quarter ((L) upper arm delt).
12 year old received the Flubok vaccine, no AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 12 years old patient who was vaccinated with a dose of  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QSAA2009 and expiration date:30-Jun-2021) via unknown route in unknown administration site as prophylactic vaccination on an unspecified date (PT: product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration (same day latency).  No adverse event reported at the time of reporting.  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 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.
I need to know,I had the COVID 20days ago, if it's okay I have the second dose.; This is a spontaneous report received from a non-contactable consumer (patient) from a Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that on a IVR call, the patient wanted to know that, he had the COVID 20 days ago and whether it was okay, if the patient have the second dose. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient reports that her hands and feet went numb for a good week after SHINGRIX starting the next day. All symptoms started the next day. She felt foggy and couldn't remember things. Her arm got red and felt hot and this lasted for 5 days. Patient states area beneath where shot was given is hard. She couldn't sleep and had horrible nightmares for two weeks. She didn't feel good for two weeks.
Sore throat, fatigue. This began 2 days after the injection; I woke up with the sore throat.
Itching; pretty big rash on her arm (arm of the injection); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and RASH (pretty big rash on her arm (arm of the injection)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D9A21A O 09A21A (patient not sure)) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PRURITUS (Itching) and RASH (pretty big rash on her arm (arm of the injection)). At the time of the report, PRURITUS (Itching) and RASH (pretty big rash on her arm (arm of the injection)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment for the event included diphenhydramine. Treatment Benadryl
NRBCs came back abnormal / It is a low count but it should be a cero; This spontaneous case was reported by a consumer and describes the occurrence of RED BLOOD CELL COUNT ABNORMAL (NRBCs came back abnormal / It is a low count but it should be a cero) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 026L20A and 026120A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RED BLOOD CELL COUNT ABNORMAL (NRBCs came back abnormal / It is a low count but it should be a cero). At the time of the report, RED BLOOD CELL COUNT ABNORMAL (NRBCs came back abnormal / It is a low count but it should be a cero) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Nucleated red cells: abnormal (abnormal) NRBCs came back abnormal.         No concomitant medication were provided. No treatment details were provided.  Event onset date for RED BLOOD CELL COUNT ABNORMAL will be in JAN 2022.
fully vaccinated with moderna 1st dose on 01/15/21 and the 2nd on 02/02/2021 at hospital  covid related death
Narrative: Patient reported headache and light headedness following administration of Pfizer covid vaccine. Patient reported recurrence of this following second dose of Pfizer covid vaccine. Patient was monitored without additional intervention and was able to depart.
allergic to shingles vaccine ingredients; This case was reported by a consumer via interactive digital media and described the occurrence of allergy to vaccine 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 allergy to vaccine. On an unknown date, the outcome of the allergy to vaccine was unknown.   It was unknown if the reporter considered the allergy to vaccine to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age vaccination was not reported. The patient reported that he/she was allergic to ingredients in shingles vaccine.
Pt developed joint pain, burning aches, heart palpitations, light-headedness, mild stiff neck and chills which started the night after 1st shot and continued. Comes on, in early spring 2000 and 2001 and continued throughout the summer. Had 2 more shots of Lymerix since the 1st one.
Fever, Chills, Headache, Severe Muscle Ache, Sore Throat, Cold Sweats, Hallucinations for 8 days.
Patient complained of severe itching at injection site. Itching gradually subsided. No other signs of allergic reaction observed.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age. Since 25-JUL-2014, the patients were vaccinated with VAQTA (lot#, expiration date, route, frequency and dose were unknown) which had been improperly stored. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
On the morning of day 8, after 5 days of  since the initial injection side effect( sore arm), my skin around the injection  site started to itch intensely. The area became hard and swollen. By the end of the day, my entire left arm was sore. This morning, day 9,  awoke to a large red rash around the injection site, a more swollen arm with pain. Throughout the day, the pain started to radiate throughout both shoulders and into both wrists and hands.
This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), ASTHENIA (a little weakness) and VACCINATION SITE PAIN (Sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The patient's past medical history included Sinus infection in April 2021. On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (Sinus infection), ASTHENIA (a little weakness) and VACCINATION SITE PAIN (Sore arm). At the time of the report, SINUSITIS (Sinus infection), ASTHENIA (a little weakness) and VACCINATION SITE PAIN (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient reported that she started taking antibiotic since 7-8 days as she has a sinus infection. The antibiotic didn't help so she visited ENT twice. Patient has a lot of allergies. The current sinus infection started about 2 weeks ago. No concomitant medications were reported.
Swelling of entire thigh with redness and refusal to bear weight on leg due to pain within 4-5 hours of injection. Parent started BENADRYL and MOTRIN immediately, swelling improved but was still present when seen in clinic on 11/2/17 at 1430. Patient was able to bear weight. Parent reporting similar reaction to flu injection last year that required ER visit.
I always react to any vaccinations, so my arm always gets really sore for quite a few days. I don't remember exactly, but I remember I was feeling kind of crummy the next day. Headachy, flu type symptoms, but that went away after one or two days. It wasn't until about the beginning of May but I started getting these tremendous headaches and thought it might be from high blood pressure and went to the urgent care (6/10/22). They told my blood pressure was 185 and told me to see my primary care physician. I wasn't able to get in. I went to the ER on 6/12/22 My blood pressure was almost up to 190. They gave me a lisinopril. I saw a nurse practitioner that following Monday, 6/13/22. Went back the following weekend to the ER because it was around 200. The following day I saw a doctor at my normal facility and he said he would play around with my medications, but nothing helped. Then finally I saw my allergist on 7/7/22, who I have regular appts with, she is more familiar with my health history and said that it was possible that my liver was overloaded. She was able to add some supplements that allowed me to feel more normal, but I'm still feeling headaches on my left side. N-acetyl cysteine, magnesium, hawthorne extract, and another one that I have since stopped taking. I feel more comfortable with my allergists. Along with those supplements I am also taking lisinopril 6.5 mg.
6 DAYS OF SINTOMES MUSCULAR PAIN,FEVER , SWELLING ON SHOULDER,LIMITED IN MOVIEMENT ON THE ARM  AFTER THE FOUTH DAY SINTOMES ARE MILD, SWELLING WENT DOWN.
pt woke up crying about 3 hrs p/vax recvd; when picked up became unconcious for about 5 minutes; no temp breathing normally; taken to ER; dx rxn to pertussis;
Night wakening, fussiness, constant crying, poor appetite, vomiting, skin rash (head, face, neck, ears, behind ears, abdomen, back, legs, arms, feet), low grade fever, wt loss.
severe diarrhea(5 times just today); soreness; sweats; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), HYPERHIDROSIS (sweats) and DIARRHOEA (severe diarrhea(5 times just today)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0474A21) for COVID-19 vaccination.     Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 25-Mar-2021, the patient experienced PAIN (soreness) and HYPERHIDROSIS (sweats). On 27-Mar-2021, the patient experienced DIARRHOEA (severe diarrhea(5 times just today)). At the time of the report, PAIN (soreness), HYPERHIDROSIS (sweats) and DIARRHOEA (severe diarrhea(5 times just today)) outcome was unknown.            patient had  been drinking a lot of fluids. patient treatment details was unknown or not provided.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16-year-old male patient received BNT162b2 (BNT162B2), on 21May2021 as dose 1, single (Lot number: EW0177) intramuscular, on 18Jun2021 as dose 2, single (Lot number: EW0177) and on 15Jan2022 as dose 3 (booster), single (Lot number: FL3209) at the age of 16 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jul2022, outcome "recovering" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jul2022) Positive, notes: covid test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected
Information has been received from a registered nurse concerning a 23 year old female patient with drug hypersensitivity who a month ago was vaccinated with GARDASIL intramuscularly, lot # 661764/0650X.  The patient reported to the nurse that she developed a lump at the injection site where the HPV vaccine was given.  At the time of reporting, the patient had not recovered.  Additional information has been requested.  This is one of several reports received from the same source.
On the 9th day (03/28/2021) since the day of receiving the first injection (03/20/2021) I woke up with an itchiness and firmness in the shoulder area of the injection site. Previously, I had no reactions to the shot whatsoever, other than a "bruising" pain the next day following the injection, which healed immediately. By the end of the day, I had a large 6" red rash on the injection site shoulder, that was swollen, firm, hot to the touch and slightly itchy. Reading online that this was a side-effect noted in the Moderna trials, I elected to observe it and not get medical attention for it. I purchased Diphenhydramine HCI 25 mg antihistamine tablets and took two each night, starting on the 29th and through the duration of the rash. The swelling had gone down by the next morning and was completely gone by end of day. I continued to have a rash, firmness, hotness on the area, and a slight itch until 04/02/2021, 6 days later. At this point, the firmness and hotness subsided, but I continued to have a fading rash until 04/04/2021. I experienced no other side-effects or illness. I will be getting my second shot, but in my right arm instead.
Information has been received from a pharmacist concerning an 11 year old female patient with allergic reaction to GENTAMYCIN and no pertinent medical history who on 30-MAR-2009 and 28-AUG-2009 was vaccinated IM with the first dose (lot# 661952/1129X) and second dose (lot# 662724/0313Y) of GARDASIL. On 19-JAN-2010, the patient was vaccinated with the third dose of GARADSIL (lot # 662304/1023Y) IM. The patient had been experiencing headache, nausea and vomiting after receiving each dose of GARDASIL. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Lightheaded initially. Felt a little nauseous and tired  Then went home and experienced vertigo when I turned my head or bent forward. Still having vertigo off and on since vaccine. I have had vertigo before but usually never lasts this long or has felt quite like this.
Real sick; Couldn't really move; Fatigue; Headache; Sore feet and hands and body aches; Pain in the arm; Swelling and pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), PERIPHERAL SWELLING (Swelling and pain in the arm), ILLNESS (Real sick), DECREASED ACTIVITY (Couldn't really move) and MYALGIA (Sore feet and hands and body aches) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was Reported.     On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm), PERIPHERAL SWELLING (Swelling and pain in the arm), MYALGIA (Sore feet and hands and body aches) and HEADACHE (Headache). On 20-May-2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced ILLNESS (Real sick) and DECREASED ACTIVITY (Couldn't really move). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (pain in the arm), PERIPHERAL SWELLING (Swelling and pain in the arm), ILLNESS (Real sick), MYALGIA (Sore feet and hands and body aches), FATIGUE (Fatigue) and HEADACHE (Headache) was resolving and DECREASED ACTIVITY (Couldn't really move) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Med Info Agent: No concomitant medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-154410 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: FUP TCR included additional events and updated outcome of the events.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-154410:Patient's wife
Warmth, tenderness, erythema 10cm around Flu injection site with 2-3 hrs of injection.
9-27-07 patient came in with reaction to 2nd Varicella; Slight tenderness at site with slight erythema, slight edema, afebrile, with approx 10in radius. Treatment; Benadryl and Ice packs. do apply ice pack directly to skin and RTC or call with any problems. 9-27-07 When Pt's mom came back into clinic to check immunization site. Pt's mom now stated that she was not sure if Pt. had had the chicken pox disease or not. Pt's mom led me to believe that Pt. had some chickenpox bumps a few years ago.
This case was reported by a physician via sales rep and described the occurrence of joint pain in a 69-year-old female patient who received Shingrix for prophylaxis. On 31st July 2018, the patient received the 2nd dose of Shingrix. On 1st August 2018, 1 days after receiving Shingrix, the patient experienced joint pain, fever, muscle pain and nausea. In August 2018, the patient experienced rash. On an unknown date, the outcome of the joint pain, fever, muscle pain, nausea and rash were unknown. It was unknown if the reporter considered the joint pain, fever, muscle pain, nausea and rash to be related to Shingrix. Additional information was received as follows: The patient has had persistent adverse reactions with onset 24 hours post the dose of Shingrix including joint paint, fever, muscle ache and nausea. The patient also developed a persistent skin rash which started 2 weeks post the dose of Shingrix. The reporter agreed to follow up from GlaxoSmithKline.
Local reaction, red, swollen, hurts, no temp. Shots on Tuesday, reaction gone on Friday.  Did not see doctor.  Used cold compress at sight.