chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 18 months old patient who received a dose of 0.5 ml QUADRACEL (frequency once) lot number: UT6259KA, expiration date: 30-Jun-2019 via intramuscular route in right arm on 28-Sep-2018. The patient's medical history was not reported. Concomitant medications included FLUZONE QUADRIVALENT for Immunisation; PREVNAR 13 for Immunisation; and HEPATITIS A VACCINE for Immunisation. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that the patient did not experience any 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 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. List of documents held by sender: none.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed approximately 20 papular vesicular varicella rash, located on her trunk neck and right ear. She also experienced low grade fever.
little shaky; drowsiness; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (little shaky), SOMNOLENCE (drowsiness), FATIGUE (fatigue) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 036A21A) for COVID-19 vaccination.     Concomitant products included CLONIDINE, LOSARTAN, AMLODIPINE, INSULIN DETEMIR (LEVEMIR) and INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (little shaky), SOMNOLENCE (drowsiness), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, TREMOR (little shaky), SOMNOLENCE (drowsiness), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.            Treatment information was not provided.
Skin Rash 3 hours after vaccines given Seen in emergency room was given Benadryl Per ED Note No Rash was actually noted. Due to moms description of hives patient received Mom describes Rash as facial hives. No documentation Per ED NOTE
Swollen lymph node in left underarm; Body ache; nausea; lethargy; chills; joint pain; tiredness; headache; This is a spontaneous report from a contactable consumer (Patient). A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Apr2021 14:00 (Batch/Lot Number: Unknown) at the age of 31-years-old as single dose for covid-19 immunisation. Medical history included the patient diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were None, the patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen lymph node in left underarm, body ache, lethargy, chills, joint pain, tiredness, headache, nausea on 20Apr2021 05:00. No treatment received for the events. Since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Had three shots, still got shingles/Suspected vaccination failure; Shingles; Had three shots; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 10-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received three doses of Shingles vaccine. The reporter stated that after received three doses of Shingles vaccine patient experienced with Shingles. Follow-up would not possible as no contact details were available. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The patient received 3rd dose of Shingles vaccine, which led to extra dose administrated.
pt indicated 3 hours after receiving the shot her harm got sore and started to swell.  She indicated that in 2 day after her both arms were swelling and very painful and she ended up going to ER.
CLIENT COMPLAINT OF TACHYCARDIA, DIZZINES,NAUSEA,DIAPHORETIC, ASESSED BY MD ALL S/S ARE NEW, BP INCREASED ELEVATED HR WITH PALPATATIONS, SENT TO ER VIA EMT.
Itching that started all over body a few days after injection, spontaneous rashes that start a week after injection
Swelling (size of a large grape), inflammation, soreness of the Supraclavicular lymph nodes on the left side of neck.
Itchy all over body, puffy feeling eyes. Started on 1/23/21 and still occurring as of 1/25/21. Encouraged to call his provider.
Pt did not have any reaction, however expired vaccine was administered. Moderna Vial was punctured on 9/13/21 a little after 1:13 PM. Dose was given  a little after 5:15 PM on 9/14/21
Red and blotchy skin along with dizziness and tachycardia that resolved in 30 minutes.  Patient was monitored and given something to drink.
vomiting; pain at injection site; headache/throbbing; migraine; This is a spontaneous report received from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in left upper arm on 17Apr2021 at 52 years old at 08:52 (Lot Number: EW0161; Expiration Date: Jul2021) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were none. There was no history of all previous immunization with the Pfizer vaccine considered as suspect, no vaccine was administered within 4 weeks Prior Vaccinations, no events followed prior to vaccination. Patient got connected with you after doing a report for her side effects from the Pfizer Covid 19 vaccine. She was concerned about the second round, if this was considered a severe reaction or normal. She had little pain at injection site and headache at first on 17Apr2021 that turned into a 36 hours migraine with vomiting. Migraine started from 17Apr2021 and Vomiting started from 18Apr2021. Caller stated she had a reaction and was just curious if this was still considered one of the more normal side effects. Caller stated she experienced a migraine that lasted almost 36 hours with vomiting. Caller stated she was a little hesitant to receive the second dose. Caller stated she received the vaccine Saturday 17Apr2021 in the morning and she developed a headache the throughout day and it was throbbing. Caller stated she still had a little bit of a headache when she woke up on Monday but it was much better and reduced down to a mild head-ache. Caller stated she definitely had this all night Saturday, then all day Sunday and most of the night, and then the severity was much less Monday morning where it was manageable. Caller stated the migraine stopped later on Monday (19Apr2021). About treatment, patient stated just before she vomited she took an Advil so she did not know if it was in her system long enough. Caller stated and so later on since she was not sure she took two Advils the equivalent of like an Ibuprofen it was generic. There was no Relevant Tests. The patient had recovered from headache and migraine on 19Apr2021, and recovered from Vomiting on 18Apr2021. Outcome of pain at injection site was unknown. Serious criteria was non-serious.  No follow-up attempts are needed. No further information is expected.
Covid arm- rash at site of injection a couple days after it was given. Itchy, hot to touch, swollen.
Worsening of arthritis pain in affected joints. Pain in joints not already identified as arthritis involved.  Much higher level of pain than before receiving vaccine.
After the 3rd vaccine was given on 8/13/2009 patient complained of not feeling well. Is extremely fatigued. Then in March of 2010 she started having episodes of extreme all over body pain so bad we took her to the ER twice.  An MRI in April 2010 showed nothing. Patient then started a neck tic in June 2010. August 15, 2010 @ 2:30am patient started having seizure like episodes and weak legs to the point she can't walk very far and needs a wheel chair. She was diagnosed with Tourettes, dystonia, fibromyalgia and RSD. June 16 2013 patient had to undergo deep brain stimulation but she still suffers with bad dystonia and chronic pain and still uses a wheelchair.
Pt had flu shot 9-17-13 AM came home from school with diffuse rash facial edema. Temp to 102. Pt given BENADRYL and DECADRON IM.
SOON AFTER VACCINATION PATIENT EXPERIENCED CHILLS, SYNCOPE AND BRADYCARDIA. EMS ON SITE. PATIENT TRANSPORTED TO ER.
Hard lump & red rash right below injection site.  Rash About the size  of a grapefruit- a little Itchy. Hot. Benedryl helped itchiness along with hydrocortisone.
There were no vaccines left at the facility; Did not feel well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well) and PRODUCT AVAILABILITY ISSUE (There were no vaccines left at the facility) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced MALAISE (Did not feel well). On 17-Feb-2021, the patient experienced PRODUCT AVAILABILITY ISSUE (There were no vaccines left at the facility). On 22-Jan-2021, MALAISE (Did not feel well) had not resolved. On 17-Feb-2021, PRODUCT AVAILABILITY ISSUE (There were no vaccines left at the facility) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to event was not provided
on 12/16/2020 my arm was red from the injection like everyone else but my symptoms began the next day on 12/17/2020 I was in the shower in the morning it was noticeably sore and the following day the 18th it was quite a bit bigger and red, I could still move my arm. I was overly tired and very sluggish  I went to the Dr on the 18th and they gave me a prescription for keflex and prednisode
HEPATITIS B: 5/13/2014, 10/14/2005, 9/17/2004, 7/12/2004; HEPATITIS B: 5/13/2014, 10/14/2005, 9/17/2004, 7/12/2004; HEPATITIS B: 5/13/2014, 10/14/2005, 9/17/2004, 7/12/2004; This spontaneous report has been received from a physician, via medical records from a case in litigation for ZOSTAVAX (2204USA001772), referring to a 4-month-old female patient (pt). Information about the pt's concomitant medication, current condition and historical condition was unknown.     The pt was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, strength, batch/lot#, route, and expiration date were unknown) for prophylaxis on 12-JUL-2004, 17-SEP-2004, 14-OCT-2005 and 13-MAY-2014 (inappropriate schedule of product administration, extra dose administered). The outcome of the events was unknown.; Sender's Comments:  US-009507513-2204USA001772:
The area of injection site was swollen and I had severe pain for at least 5 days, which still lingers. I had a fever which lasted for about 5 days and was severely exhausted with muscle pains. I also developed a dry cough and chills. I have been out of work since
diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and NAUSEA (Nausea) 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 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced DIARRHOEA (diarrhea) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (diarrhea) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.   This case was linked to MOD-2021-237221, MOD-2021-237221 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow up received on 25-jun-2021, confirms initial is of 1st dose and it describes patient received the 2nd dose; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Developed a buboe in Injection site armpit. 12/01/2021:  After receiving vaccine on 12/01/2021 at ~8:45am, arm swelling occurred about 2-3 hours later at injection site and soreness/very sore around upper arm (this was similar to first two injections).    12/02/2021:  Upon waking up next morning, noticed bruise at injection site (no bruising after first 2 shots) with a series of small red dots in a circle around the injection site.   Also had very swollen lymph nodes in the armpit of injection site arm.  So swollen, could feel a buboe somewhere between size of golf ball and baseball.  Buboe was very distinct.  Chose to leave area alone and did not keep checking for rest of day. 12/03/2021:  Buboe was still present, but did not seem as firm or well-defined.  Each day thereafter, buboe continued to become less defined and to recede.  By 3rd day from shot, felt more just like swollen lymph nodes; no distinct buboe felt.  Probably took almost a full 2 weeks for swollen nodes to completely go away.  Regarding the bruise, it may have developed the day of injection, not sure.  Didn't bother to remove bandage or visually check the injection site until the next morning (12/02).  Note:  Shot 1 received April 2021.  Shot 2 May 2021.  This 3rd shot was the booster (all were Moderna).
This spontaneous report as received from a pharmacist refers to her 56 years old mother with penicillin allergy, neomycin allergy, pork allergy, hypercholesterolemia and hypertension. The patient was vaccinated with a dose ZOSTAVAX on 24-SEP-2012. No other co-suspects were reported. Concomitant medications included: DIOVAN. On 25-SEP-2012, the patient experienced increased blood pressure, red, raised area at the injection site and headache within 24 hours of administration of ZOSTAVAX on 24-SEP-2012. The injection site reaction was resolved and the hypertension was controlled by adjustment the dosage of the patient's DIOVAN. The patient continued to have headache as well as dull, persistent pain on one side of her face, extending into the hairline. This had been diagnosed as a shingles-like pain by the patient's unspecified physician. There were no lesions. No further information was provided. The outcome of increased blood pressure, shingles-like pain, headache and red, raised area at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
patient apparently did not want flu shot and she was under impression that she got booster moderna.  3 months after the shot when she was informed that she was given flu shot on 3/07/22 she claimed that she was having allergic reaction to flu shot but didn't mention what reaction she had. she never returned to pharmacy after her shot to report adverse reaction and she didn't seek  any treatment or hospitalization for the vaccine. her dr was also contacted to confirm she was given flu shot on that day and didn't have any reaction.
Within 1 week of Covid-19 vaccine, blood sugar was 600-700; Within 1 week of Covid-19 vaccine, a1C was double digit; This is a spontaneous report received from a contactable reporter(s) (Physician).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes. The patient's concomitant medications were not reported. The following information was reported: HYPERGLYCAEMIA (non-serious), outcome "unknown", described as "Within 1 week of Covid-19 vaccine, blood sugar was 600-700"; GLYCOSYLATED HAEMOGLOBIN INCREASED (non-serious), outcome "unknown", described as "Within 1 week of Covid-19 vaccine, a1C was double digit". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Context: The report is cross referenced to report ID: # Caller is a physician calling in regards to the Pfizer Covid-19 vaccine. While reporting on another patient, caller reported that there was another case involving a patient that received the Covid-19 vaccine that the caller was a consultant on. Caller reported that he did not know if the patient received the Pfizer Covid-19 vaccine or not. Caller reported that the patient to begin with had diabetes and the patient's A1C was 6.  Caller reported that within 1 week of getting the Covid-19 vaccine, the patient came to the hospital and had a blood sugar of 600 to 700.  Caller reported that the patient's A1C was also in the double digits. Caller declined to complete report.  Caller reported that he did not know if the patient received the Pfizer Covid-19 vaccine or another vaccine. Caller reported that he was just consulted in the ICU to treat the patient and didn't know any further information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had called to schedule a COVID vaccination at our clinic, on 04/19/21 when asked if  this would be her first Covid Vaccination shot, patient stated yes, she hasn't had the shot before. Patient was scheduled for a 1st shot Covid prime that day and was instructed to come 15 minutes early to receive education on vaccination. Patient arrived and completed the CDC Prevaccination Checklist for COVID-19 Vaccines.  Patient had stated NO- to question 2( Have you ever received a dose of COVID-19 vaccine ). This nurse makes it a routine to go over the questionnaire  with patients, to address and thing they might not understand. This nurse did ask patient again if she had had any vaccinations, and the patient stated no. Patient was given the Moderna vaccination at visit and scheduled a booster shot ( second Covid on May 17th on her Covid Immunization card. When going to update patients  Immunization record on the state site, it was discovered that patient had received one dose of  the Covid Pfizer shot on 02/03/21 at another Clinic. This means the patient didn't notify this nurse prior and had stated verbally and on written questionnaire that they had never received the Covid vaccine prior to 04/19/21.
severe headaches; nauseous for 24 hours a day basically; throwing up periodically; now worse and worse and worse/progressively getting worse; I'm exhausted, no energy whatsoever; I'm exhausted, no energy whatsoever; I've lost about thirty pounds in the last month; This is a spontaneous report from a non-contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 26Feb2021 as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for COVID-19 Immunization and the patient had no reaction on exposure to vaccine. The patient reported, she had been progressively getting worse. Had been to the doctor and they aren't sure what's going on with it. She has experienced severe headaches, nauseous for 24 hours a day basically, throwing up periodically and now worse and worse and worse, exhausted, no energy whatsoever, lost about thirty pounds in the last month. She had various tests and they haven't been able to figure it out. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
From correspondence received on 11/08/01, it was reported that a 43 year old femalepatient receiveda Fluzone SV '01-'02 vaccination administered IM in her left deltoid to 11/07/01.reportedly that same day the patient developed larangitis, shortness of breath and soreness in the back of her neck. the patient has not been evaluated by a physician. Past mediucal history - asthma, Medications-allegra and Previcid.