chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Under arm sore and puffy; Under arm sore and puffy; swollen lymph nodes; This is a spontaneous report from a contactable consumer (Patient). A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 11Mar2021 18:45 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation.  Medical history included hypertension, shellfish allergy. The patient's concomitant medications were not reported.  On 16Mar2021, patient experienced under arm sore and puffy, swollen lymph nodes. Outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected
This spontaneous report was received from a nurse concerning an unspecified number of patients of unknown age and gender. Pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients received an unspecified dose of (Oka/Merck) VARIVAX (Lot # L024256; expiration date: 01-JUL-2017) (route not reported), which was improperly stored. Concomitant therapies were not provided. No adverse effects were reported. This is one of two reports from the same source (MARRS # 1602USA001373). Additional information has been requested.
Initial information received on 07-Sep-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case is linked with 2018SA256110, 2018SA256129 (same reporter). This case involves a 10 years old female patient who received vaccine IPOL while it was stored at temperature of 49.8 degrees Fahrenheit. The excursion lasted approximately 4 hours. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR VACCINE for Immunization; VARICELLA VACCINE (LIVE) for Immunization; and HEPATITIS A VACCINE for Immunization. On 01-Aug-2018, the patient received a once 0.5 ml dose of suspect IPV (VERO) lot N1J45 expiry date 05-Oct-2019 via subcutaneous route in the left arm. It was a case of actual medication error due to incorrect product storage. It was not reported any adverse event was occurred or not. 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.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 10:01 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age reported as 28.14  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
but she tested positive for COVID-19; but she tested positive for COVID-19/ COVID symptoms/fever; This is a spontaneous report from a contactable nurse (patient) and a nurse. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at left arm, at single dose for covid-19 immunization. Medical history was none. There were no concomitant medications. The patient was supposed to receive the second dose of the vaccine on 25Jan2021. She tested positive for COVID on 17Jan2021. Also reported that she tested positive for COVID-19 on 19Jan2021, she did have some COVID symptoms, she was better now, she treated them by she kept herself at home. She said a fever was all she had, for two days, she drank a lot of water. She spoke to her supervisor who told her she could delay her second dose up to 40 days after the first dose. She would like to know if this is true. She also needed advice because she didn't know what to do since she already got the first vaccine dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event tested positive for COVID-19 based on the known safety profile. However the short duration of 5 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
first dose of Shingrix on September 30th, 2020 / second dose on Nov 3th, 2020 / given less than 2 months apart (34 days apart); This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 3rd November 2020, the patient received the 2nd dose of Shingrix. On 3rd November 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The sister called for her brother. Age at vaccination was not reported. The patient had first dose of Shingrix on 30th September 2020. The patient received the second dose less than 2 months apart (34 days apart) from 1st dose which led to shortening of vaccination schedule. The reporter did not consent to follow-up. This case is linked to the case US2021090119, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021090119:Possible same reporter and patient
BlurredVision, Myalgia, Arthralgia, blindness when vehicle lights shine in eyes at night, generalized body inflammation Narrative:
Patient's left arm where  got the shot, from shoulder down to my wrist it was very itchy; Patient's left arm where  got the shot, from shoulder down to wrist it was very red; Chills; fever; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Patient's left arm where  got the shot, from shoulder down to my wrist it was very itchy), VACCINATION SITE ERYTHEMA (Patient's left arm where  got the shot, from shoulder down to wrist it was very red), CHILLS (Chills) and PYREXIA (fever) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Patient thought patient had Covid some time back, after going to this big party. Patient felt so sick. It had to have been Covid. But this was in 2020, before patient got any shots.") in 2020. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1) in February 2021, Moderna COVID-19 Vaccine (Dose 2) in March 2021 and Moderna COVID-19 Vaccine (3rd dose/1st booster) in October 2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    In September 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced VACCINATION SITE PRURITUS (Patient's left arm where  got the shot, from shoulder down to my wrist it was very itchy), VACCINATION SITE ERYTHEMA (Patient's left arm where  got the shot, from shoulder down to wrist it was very red), CHILLS (Chills) and PYREXIA (fever). At the time of the report, VACCINATION SITE PRURITUS (Patient's left arm where  got the shot, from shoulder down to my wrist it was very itchy), VACCINATION SITE ERYTHEMA (Patient's left arm where  got the shot, from shoulder down to wrist it was very red), CHILLS (Chills) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-320123 (Patient Link).
Initial unsolicited report received from a nurse on 23 May 2018. This case involve a child (age and gender not reported) who received only Dtap/IPV portion of PENTACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date. It was a case of Inappropriate reconstitution technique. No adverse event was reported. 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. Documents held by sender: none.
Received a 3rd dose in error; sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 453LA, expiry date 18th February 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter stated that, the patient received a 3rd dose of Shingrix in error, which led to extra dose administered.   Follow-up information received from pharmacist on 17th November 2020 : The patient's demographics were updated. On 30rd March 2018, the patient received 1st dose of Shingrix and on 20th September 2018, patient received 2nd dose of shingrix. Order sent to pharmacy for vaccine administration by MD office. The patient reported pharmacy for vaccine stating it was his 1st dose. Access was temporarily unavailable and pharmacy did not check patient's chart for previous vaccination. Pharmacy records were in an old pharmacy system not easily visible or retrieved. Then vaccine was administered to patient. During documentation process it was discovered that the patient had previously received 2 doses of vaccine in 2018. On 29th October 2020, the patient received 0.5ml of 3rd dose of Shingrix, intramuscularly. On an unknown date, less than a month after receiving vaccine, the patient experienced pain in arm for 3 days. It was unknown if the reporter considered the pain in arm to be related to Shingrix The VAERS details were updated. The patient and provider was notified about medication error and patient reported no harm.
I had a reaction within 24 hours after receiving the vaccine. I was in bed for a week with fever, chills, vomiting and diarrhea. In 11/2022, I got sick with the RSV virus and later I was diagnosed with pneumonia.
Chills, shaking, teeth chattering started around 10:00 pm. Could not get warm, despite several layers of clothing and blankets. Lasted several hours.  Happened again about 3:00 pm on May 7. Uncontrollable shaking and chills. Wore winter parka in the house, along with blanket, trying to get warm. Lasted about 2 hours.  Today have a raised, swollen red lump on arm at site of injection.
Fever; Myalgia; Not feeling very sick/sick; Needed someone to help her to the commode and take care of her; sick; . This case was reported by a physician and described the occurrence of fever in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number JC55P, expiry date unknown) for prophylaxis.   On 18th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fever, myalgia, feeling unwell, walking difficulty and sickness. On an unknown date, the outcome of the fever, myalgia, feeling unwell, walking difficulty and sickness were recovered/resolved.   It was unknown if the reporter considered the fever, myalgia, feeling unwell, walking difficulty and sickness to be related to Shingrix.  Additional details were reported as follows: The reported batch number GC55P for Shingrix did not exist and was updated to JC55P as per the sales database. The the patient did not had immediate reactions but later told the doctor that she had experienced fever, myalgia and not feeling very sick for 3 days after the vaccine was administered.  She was so sick that she needed someone to help her to the commode and take care of her. Consented to follow up.
2day p/vax pt both legs became numb from the knee down. uncontrollable internal shaking/trembling from hips down. hot flash, weakness in upper limbs, nervous/trembling sensation throughout body.
Bell's palsy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's palsy) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's palsy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication information provided. No relevant treatment medication information provided. Company Comment : Reportedly the patient developed Bell's palsy after vaccination. In the setting of a likely temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded. Additional information has been requested.   This case was linked to MOD-2021-288145 (Patient Link).; Sender's Comments: Reportedly the patient developed Bell's palsy after vaccination. In the setting of a likely temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded. Additional information has been requested.
Pt had asthma attack after receiving vaccine - was treated w/ albuterol neb soln.
Stomach pain; reddness at injection site; swelling at injection site; Soreness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of stomach pain in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number BP57E, expiry date 7th December 2021) for prophylaxis.   On 9th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced stomach pain, injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the stomach pain, injection site erythema, injection site swelling and injection site pain were unknown.   It was unknown if the reporter considered the stomach pain, injection site erythema, injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: At the time of this report the patient was experiencing severe stomach pain. The reporter consented to follow up.
p/vax pt devel fever, rash, diarrhea, fussiness, tenderness & pustule;
L arm paresthesias, nausea, syncopal episode 30-40 minutes after injection
Irregular and heavy period started within 12-14 hours of receiving the first shot of my Moderna vaccine and lasted 6 days. This was in the middle of my cycle, and I am otherwise 100% regular (27 day cycles with a 5 day period once a month).
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 27-year-old female.  Neither medical history nor concomitant medications were reported.  On 23-Feb-2009, the patient received expired FLUMIST vaccine.  The vaccine had an expiration date of 11-Jan-2009.  As of 18-Mar-2009, there was no adverse events associated with this medication errors;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.  Follow-up information was received on 12-May-2009:  Product Complaint Investigation results.
time course) and treatment, if any:    Headache, Myalgia,  tired, sore left arm,   Narrative:
Patient stated after the vaccine she had a fever and was nauseous but all resolved after 24 hours. She woke up today with chest pain/ tightness and stated it is painful to breathe. She was advised to go to the ER.
This spontaneous report as received from a physician refers to a 23 year old female patient. The physician reported that on 13-JUN-2013 the patient was vaccinated with the first dose of GARDASIL (lot # H020692, expiration date 15-AUG-2015). On 13-JUN-2013, the patient experienced significant migraines that lasted two days (until 15-JUN-2013) after receiving her first dose in the series of GARDASIL. The physician reported that the patient's migraines were disabling and she could not leave the house for two days. The patient went to the physician's office on 14-AUG-2013 to receive her second dose in the series of GARDASIL, however it was reported that the physician discontinued therapy with GARDASIL and the second dose was not administered, because the patient experienced significant migraines after receiving the first dose. At the time of the report, the outcome of significant migraines was reported as recovered/resolved. GARDASIL was not reintroduced. The physician considered significant migraines to be disabling. Additional information has been requested.
This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender (who is a healthcare worker). On 31-JUL-2017, the patient was vaccinated with M-M-R II, lot # reported as "N034856" and expiration date 27-JUL-2017 for prophylaxis. Other suspect therapies included sterile diluent (MRK). On 31-JUL-2017, after administration to a patient, the patient accidentally exposed to the product via skin contact. The nurse reported that the patient felt a small drop of the vaccine on her face. The nurse reported that the healthcare worker did not feel any vaccine get into her eyes, but flushed them with saline as a precaution. No adverse event reported.
SWELLING AND PAIN AT INJECTIONS SITE WHICH STARTED WITH IN 24 HRS.  SITE IS STILL SWOLLEN, 7 X 6 CM, 48 HRS AFTER VACCINE ADMINISTRATION.
PENTACEL vaccine mixed incorrectly. HIB was mixed with saline diluent. PENTACEL will need to be given again.
The injection site pain that hurt all day; It is really really hot from like my shoulder almost to my elbow; I was running a fever; Tiredness; Headache; I have muscle pain; Joint pain so bad; Chills; Nauseous; Pain in arm; I can't eat; I couldn't get out of my bed; This is a spontaneous report received from a contactable consumer(patient).   A 48-years-old female patient received bnt162b2 (BNT162B2) dose 1, via an unspecified route of administration on 21Aug2021 (Batch/Lot Number: FC3182; Expiration Date: 31Oct2021) as single dose  for covid-19 immunisation  .  Medical history included coagulopathy,  breast cancer , covid-19 on Nov2020. Concomitant medications included boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN) taken for menopause, start and stop date were not reported.  The patient experienced  injection site pain that hurt all day  (non-serious) on Aug2021 with outcome of unknown , it is really really hot from like my shoulder almost to my elbow (non-serious) on Aug2021 with outcome of unknown , I was running a fever  (non-serious) on Aug2021 with outcome of unknown , tiredness  (non-serious) on Aug2021 with outcome of unknown , headache (non-serious) on Aug2021 with outcome of unknown , i have muscle pain  (non-serious) on Aug2021 with outcome of unknown , joint pain so bad (non-serious) on Aug2021 with outcome of unknown , chills (non-serious) on Aug2021 with outcome of unknown , nauseous  (non-serious) on Aug2021 with outcome of unknown , pain in arm  (non-serious) on Aug2021 with outcome of unknown , i can't eat  (non-serious) on Aug2021 with outcome of unknown , i couldn't get out of my bed  (non-serious) on Aug2021 with outcome of unknown.  The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive   on Nov2020  .   Follow-up attempts are completed. No further information is expected.
About a minute after the injection patient rolled his eyes up and fainted, woke him up after 30 seconds and stayed with him until emergency crew came and took him to hospital. according to emergency crew his Blood Pressure was very low.