chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I took the vaccine and still got shingles/suspected vaccination failure; shingles/ Still got shingles; severe pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 12-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient took the vaccine and still got the shingles. The patient mentioned severe pain for sure. The reporter denied to follow-up. 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.
Body aches, chills, and neck soreness. Lasted approximately. 15 hours.
pt seen in ER for lt sided chest pain & rt sided abd pain several hr p/lifting a heavy load;MI was considered & r/o;high BP was ID 170/108;liver enzymes were elevated;MD does not believe that vax was r/t subclinical case of hep B;
My chest muscle, nipple and rib under right arm are still sore/ chest muscle pain/ rib pain; Nipple sore; This case was reported by a physician and described the occurrence of musculoskeletal chest pain in a adult patient who received Herpes zoster (Shingrix) (batch number Y7JL5, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced musculoskeletal chest pain and nipple pain. On an unknown date, the outcome of the musculoskeletal chest pain and nipple pain were not recovered/not resolved.   It was unknown if the reporter considered the musculoskeletal chest pain and nipple pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient got vaccine 5 months before the reporting day and stated that his/her chest muscle, nipple and rib under right arm were still sore. The reporter asked whether this happened to others. The follow-up would not possible, as no contact details were available. The batch number for vaccine was reported as YZJL5, however as per sales data sheet it was updated as Y7JL5
mom states pt awoke @ 1AM on 24MAR94 w/pain in rt armpit accompanied by itching small lump noted @ area approx size of a quarter sl edematous area; mom also states rash around area; no fever;
Irritable bowel syndrome (IBS); really dizzy; the dose flares it up (IBS); his left sub-mandibular lymph node is tender and swollen; vomiting/ Still vomiting; chills; fever; body ache; constipation; flue like symptoms; diarrhea/ severe diarrhea; This spontaneous case was reported by a nurse and describes the occurrence of IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome (IBS)), CONSTIPATION (constipation), INFLUENZA (flue like symptoms), DIARRHOEA (diarrhea/ severe diarrhea) and DIZZINESS (really dizzy) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced CONSTIPATION (constipation), INFLUENZA (flue like symptoms), DIARRHOEA (diarrhea/ severe diarrhea), VOMITING (vomiting/ Still vomiting), CHILLS (chills), PYREXIA (fever) and MYALGIA (body ache). On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome (IBS)), DIZZINESS (really dizzy), IRRITABLE BOWEL SYNDROME (the dose flares it up (IBS)) and LYMPHADENOPATHY (his left sub-mandibular lymph node is tender and swollen). At the time of the report, IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome (IBS)), CONSTIPATION (constipation), INFLUENZA (flue like symptoms), DIZZINESS (really dizzy), IRRITABLE BOWEL SYNDROME (the dose flares it up (IBS)), LYMPHADENOPATHY (his left sub-mandibular lymph node is tender and swollen), CHILLS (chills), PYREXIA (fever) and MYALGIA (body ache) outcome was unknown and DIARRHOEA (diarrhea/ severe diarrhea) and VOMITING (vomiting/ Still vomiting) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test increased: increased Increased.     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.   This case was linked to US-MODERNATX, INC.-MOD-2021-142320 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Significant Live follow-up added On 20-May-2021: Significant follow-up appended; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-142320:
Fevers chills big lump under left arm small bump still present felt like something was going on with brain wasn't a headache. For like 3 days didnt feel like my self stomach was aching for a day
Right thigh red and swollen warm to touch, indurated, 12 cm w x 10 cm long. Walking but with difficulty.
generalized itching; itching at injection site; redness at injection site; swelling at injection site; hardness at injection site; flu like symptoms; discomfort at injection site; pain at injection site; This case was reported by a nurse via call center representative and described the occurrence of generalized pruritus in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received 2 to 3 years ago from the date of reporting).   On 26th February 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th February 2019, 1 days after receiving Shingrix, the patient experienced injection site discomfort, injection site pain and influenza-like symptoms. On an unknown date, the patient experienced generalized pruritus, injection site itching, injection site erythema, injection site swelling and injection site induration. On an unknown date, the outcome of the generalized pruritus, injection site itching, injection site discomfort, injection site pain, injection site erythema, injection site swelling, injection site induration and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the generalized pruritus, injection site itching, injection site discomfort, injection site pain, injection site erythema, injection site swelling, injection site induration and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The day after receiving the Shingrix, she developed flu like symptoms, and discomfort and pain at the injection site. Less than a year after receiving Shingrix, the patient also developed redness, swelling and hardness at the injection site. The patient stated that the redness looked like streaks. The patient also developed generalized itching, all over, but especially at the injection site. The reporter consented to follow up. In core outcome of the events generalized pruritus, injection site itching, injection site discomfort, injection site pain, injection site erythema, injection site swelling, injection site induration and influenza-like symptoms were recovered/resolved, however in source document the outcome of this events were reported as recovered/resolved with sequel.
Developed red, itchy rash to trunk, progressed to patches that coalesced on his arms, thighs and trunk. Starting day 9-10 after vaccine. No fever or other constitutional symptoms. Treated with oral NSAIDS.
Information has been received from a nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB, strength: 2.5mcg/0.5 ml (lot#, expiration date, route and dose were not reported). The nurse reported the patient only received a partial dose of RECOMBIVAX HB since there was leakage around the needle and a "drop" of RECOMBIVAX HB dose fell on the patient's leg. No adverse effects reported. No product quality complaint was involved. It was unknown if the patient sought medical attention. Additional information has been requested.
1/24, extremely painful, red & hot arm; had to ice/depress. 1/25, palpitations 4-5 x's day, muscle weakness. 1/26, palpitations 4 x's day, extr cold (burning) hands, muscle weakness, stiff neck. 1/27, upper arms shivering beneath skin 15sec
Had anaphylactic shock; This case was reported by a consumer via other manufacturer and described the occurrence of anaphylactic shock in a elderly female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced anaphylactic shock (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic shock was unknown.   It was unknown if the reporter considered the anaphylactic shock to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The reporter reported for herself. The age at vaccination was not reported. The patient had anaphylactic shock with the flu shot.
pt recv vax 8JAN99 1030AM & approx 4" down from shoulder bone;arm sore 8JAN99, more sore 9JAN99;9JAN99 PM fever;no temp taken, chills, sweating, loss of appetite, insomnia, had 3" diameter hard;warm area @ inj site;infect;
Pt recvd 3 Hep B vax given 26JUL89, 31AUG89, & 23JAN90; Following these titer was neg; Pt recvd a 4th dose of Engerix-B vax 10AUG90; Pt seroconverted p/4th dose titer=11;
PT WAS GIVEN PFIZER SHOT EXPIRED BY 2 DAYS.  NO ADVERSE EVENT BY THE TIME OF THIS REPORT.
Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The Concomitant medications were not reported.  The treatment information was not provided.  The action taken mRNA 1273 with the events was considered as not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: The follow-up document was received on 10-JUN-2021 and has no new information.
rash at the injection site; itches; size of a "small woman's hand"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site), PRURITUS (itches) and HAND DEFORMITY (size of a "small woman's hand") in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site), PRURITUS (itches) and HAND DEFORMITY (size of a "small woman's hand"). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE RASH (rash at the injection site), PRURITUS (itches) and HAND DEFORMITY (size of a "small woman's hand") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications were reported.  Treatment medications include took 2 Tylenol .
Late on day of vaccine was cold/chilled. Next day Fever rose to 103 degrees at 7pm, chills, nausea, diarrhea, tired, dull headache all day. Took Tylenol/Motrin, slept, fluids. Knew these were possible side effects so next 2 days I rested & did nothing.
felt achy almost like had the symptoms of the virus/the minute got in bed I started hurting all over, all over my body, ached all over; noticed the aching in my back and the front of my thighs; noticed the aching in my back and the front of my thighs; extremely tired; got up about 7 times during the night; muscle ache; My temperature is 99, last night it was 98; Congestion where in the morning I will have phlegm; Congestion where in the morning I will have phlegm; Dry cough; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date in Feb2021 as dose number unknown, single for COVID-19 immunization. Medical history included hearing aid user (hearing is not good). The patient's concomitant medications were not reported. The patient experienced dry cough on an unspecified date in 2021, felt achy almost like had the symptoms of the virus/the minute got in bed i started hurting all over, all over my body, ached all over, noticed the aching in my back and the front of my thighs, extremely tired, got up about 7 times during the night, muscle ache, my temperature is 99, last night it was 98 on 02Mar2021, congestion where in the morning i will have phlegm on an unspecified date in 2021. Patient's daughter is a nurse and she wanted patient to take it, otherwise patient wouldn't have. This morning it (temperature) was 99 even. It was reported that it was just a normal ache, not anything that would even single one come to patient's attention, but what patient want to know because of age can he/she ignore this and just wait and see how it goes. Outcome of event Dry cough was not resolved, felt achy almost like had the symptoms of the virus/the minute got in bed I started hurting all over, all over my body, ached all over, noticed the aching in my back and the front of my thighs, muscle ache and My temperature is 99, last night it was 98 were resolved on 03Mar2021. Outcome of extremely tired, got up about 7 times during the night and Congestion where in the morning I will have phlegm were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
24 hours after, 4/4/2021 at 10:45 am soreness at site on arm (expected and consistent with my 1st dose of the vaccine), however began experiencing full body pain at all joints- toes & fingers, elbows, especially knees. About 47 hours after 2nd dose, 9:45am on 4/5/2021, apparent marble/grape sized ball (swollen lymph node?) on left side where the base of the neck meets the left shoulder. By hour 50 swollen/ throbbing & visible redness at lymph node.
This spontaneous report was received from a physician. The physician reported that the appearance of VAQTA vial was similar looking to FLUZONE for ages three and up. He stated that the VAQTA comes with a purple plunger and so does FLUZONE. He also stated that the appearance of the RECOMBIVAX HB vial was similar looking to FLUZONE for under three years of age. He reported that the RECOMBIVAX HB comes with a yellow plunger and so does FLUZONE. The physician stated that a mistake can easily happen because of the similar appearances especially when you work in a busy pediatric office. He confirmed that a mistake did not occur. Additional information has been requested.
10-12 days after vaccination I started with intense itching all over the body, without evidence of rash. Since is something that had never happened, I wonder if it may be a an adverse reaction because I haven't changed my alimentary habits, nor soaps or detergents.
Information has been received from a health professional concerning a 10 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 27-Apr-2007, the patient was diagnosed with chickenpox. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of several from same source. Additional information is expected.
After I received my first dose within 5 minutes I lost feeling in both of my arms and my legs (similar feeling of when your arm falls "asleep"...it was a tingling feeling).    Then is started to go to my face a little bit.      10 minutes after my teeth started chattering and I started to get cold.  Followed by severe shaking which lasted a few hours.   Required me to go to the ER or evaluation.
administration of extra dose to a patient who has completed her 5 dose DTaP with no reported adverse event; Initial information received on 11-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient who was administration of extra dose of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] who has already completed her 5 dose DTaP with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Immunisation.   On 08-Jul-2022, the patient received 0.5 mL dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (formulation and strength not reported; lot: C5851AA, expiry date: 25-Mar-2023) via intramuscular route in the left deltoid for immunization  On 08-Jul-2022, the patient was administration of extra dose of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] who has already completed her 5 dose DTaP with no reported adverse event (extra dose administered) (latency: same day)  Action taken was not applicable.  Outcome: Unknown   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 guidelines. 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.
On 5/11/00, pt was given 3 shots; IPV, DTP, and HIB. Her problems started almost 2 days later. She was not the same little girl I know. She was very cranky and would cry for hours (non-stop) like she was in pain, then she started to get flu-like symptoms (runny nose and chest congestion) to where she couldn't breathe. I called the pediatrician and he told me she was fine and it was because the weather was changing. She was like that for a while. I called again and he told me I was getting upset over nothing and that she was ok, because she had no fever. So I took his word for it and I even told him I think she is having a reaction to the shots and he said no, it's the weather. That Friday night, I laid her down to sleep for the night and she never woke up. They told me it was SIDS and for some reason I just can't believe that. She was fine until they gave her them shots.
Within 24 hours of receiving this vaccine,  the area below and to the side of the injection site became very red and swollen and painful.  The dimensions of the red area are 6 inches by 3 inches.  I will continue to monitor this reaction and contact my doctor if  it does not go away within a week.
I was tired and had a headache.  I had body ache.  I went to the ER on the 19th of Sept.  On the 18th, tested positive for Covid-19.
Patient was administered vaccine by pharmacist; is unsure if dose was delivered. She says she heard a "popping" sound at the time of administration. She was upset that she might not have gotten the vaccine and is at risk.
I tested positive for the flu on 12/19/22, but negative for COVID-19. I had fatigue, body aches, chills, a fever of 102.6. I contacted my doctor and was prescribed TAMIFLU. I also took TYLENOL as needed. I am feeling better, but still dealing with some of these symptoms.
Arthralgia, see next section.  Narrative: Dose #1 Day #1 Vaccine in LEFT arm, per employee, within a few hours felt war, flushed. At home, felt warm, extremely weak, heart racing, temperature was 100 degrees, took two tylenol, Day #2 fatigue, could not get up, achy joints, didn't go to work, in bed all day, chills. Day#3 felt tired, joints did not ache as much as Day #2 and not as fatigued. felt better in afternoon, 10p felt more like self.
This spontaneous report as received from a medical assistant (also reported as healthcare worker) refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with MMR II, lot number for private vaccine stock J006994, expiration date 14-JUN-2015 (dose and route were not reported) that had a temperature excursion. Patients were vaccinated with improperly stored TD. No adverse effects were reported. The reporter was unable to provide any patient information or dates of vaccination. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative:  86 years old male with colon cancer with metastases 91 and an lesion lung cancer on the left side died of cancer on 8/30/2021. Pt had received covid vaccines on 1/14/21 & 2/13/21. Death is not related to vaccines.
Pt was administered vaccine by Rph on 6/01/15, on 6/3/15 pt returns to pharmacy with erythema and warmth around injection site.
rash in her leg; This is a spontaneous report from a non-contactable Consumer or other non-HCP (patient) communicated to Pfizer-sponsored program Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: unknown), via an unspecified route of administration on 19May2021, as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 24May2021, after 5 days, the patient developed a rash in her leg. The reporter reported that, after 5 days, she developed a rash in her leg. She called in because she rescheduled her second dose of the vaccine from June 11 to June 18 to allow the rash to heal. She wanted to know if that is okay and if the efficacy will be the same. Caller refused to provide her mailing address and phone number. Outcome of the event was unknown at the time of this report. Information on the lot/batch number has been requested.