chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bad cold; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cold in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On an unknown date, the patient received RSV vaccine and INFLUENZA VACCINE. On an unknown date, several days after receiving RSV vaccine, the patient experienced cold (Verbatim: Bad cold).  The outcome of the cold was not reported.   It was unknown if the reporter considered the cold to be related to RSV vaccine.     It was unknown if the company considered the cold to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 27-SEP-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received RSV vaccine and flu vaccine and few days after experienced bad cold. It was unknown if the reporter considered the cold to be related to Influenza vaccine. Follow-up would not possible as no contact details were available.
positive Covid-19 test; This spontaneous case was reported by a nurse and describes the occurrence of SARS-COV-2 TEST POSITIVE (positive Covid-19 test) 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 SARS-COV-2 TEST POSITIVE (positive Covid-19 test). At the time of the report, SARS-COV-2 TEST POSITIVE (positive Covid-19 test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.  Company Comment : This case concerns a patient of unknown age and gender with no medical history, who was tested positive for Covid 19 unknown days after receiving the mRNA-1273 Vaccine. The event was considered Non serious and is an AESI. The details of doses were not specified. The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report.   This case concerns a patient of unknown age and gender with no medical history, who was tested positive for Covid 19 unknown days after receiving the mRNA-1273 Vaccine. The event was considered Non serious and is an AESI. The details of doses were not specified. The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report.   Reporter did not allow further contact
Approx 10 hrs after injection- headache and nausea, 12 hrs severe chills/fever x4 hrs then sweating x2 hours. Resolved at 24 hrs
Hello, patient has a pretty big red mark on his left leg that is swollen under the skin and feverish.
Pt called the following day approximately 21 hours after the immunization was given. States that he is in a "full-on Hashimoto's attack." States he felt fine on the evening the vaccine was given and the following morning, however, around 11:00 he developed whole body muscle and joint pain and weakness. States he has a "brain fog." States he doesn't want anyone to touch him due to the pain. States all he wants to do is lay down. Denies fever/chills. NO localized soreness/swelling/redness. No headache. He wanted to report this so that people with Hashimoto's could be cautioned appropriately. RN discussed that he could be experiencing side effects to the vaccine as written on the VIS. Requested pt call the next day to discuss symptoms. Pt did not do this. RN called and tried to get ahold of pt and messages left to update clinic on status.
tachycardia to the point of sweating and fainting, paleness occurred, trouble catching breath, and the same time the tachycardia started I got very dizzy.  This lasted for about 30 minutes an hour and 15 minutes after I received the vaccine. I also had limited range of motion of the arm I got injected with for at least a week and it was sore even after the first week. Then I had a sharp pain that radiated from my shoulder to the top of my neck on the bony surface on the spine.  This pain started around 4 days after the vaccine and stayed for about a week.
Around 1 pm-itchy a lot but able to move arm, no fever, O/E 10 cm x 6 cm-swelling of muscle noted-circle rash-shape of bandage notice on 3/11/07
The expected adverse effects of fatigue and head pain began immediately, but that evening chest and left arm pain started. I thought it would end, but the chest pain and palpitations continued daily for the next 2 to 3 months. Afterwards, they would happen on occasion and still do to this date. In the first 2 to 3 months after receiving the vaccine, I would get so winded after walking from the train station or up stairs that I would have to stop. Many times throughout the day I had to stop what I was doing and not only rest but sleep. I was exhausted and felt overwhelming pressure around my heart and increased heart rate daily.
Pt received FLUZONE HD and PNEUMOVAX 23 in left arm. Patient stated that at night on 10/12/16 she started experiencing redness, swelling, and aching in her left arm. Patient stated that the affected area does not itch. Patient came to pharmacy on 10/14/16 to notify pharmacist of symptoms. Patient was directed to see her doctor regarding her symptoms, but declined.
Minor body ache; head ache; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Minor body ache), HEADACHE (head ache) and PYREXIA (Slight fever) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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 25-Jan-2021, the patient experienced PAIN (Minor body ache), HEADACHE (head ache) and PYREXIA (Slight fever). At the time of the report, PAIN (Minor body ache), HEADACHE (head ache) and PYREXIA (Slight fever) had resolved.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Pt says worst pain ever in her right arm from shoulder to fingertips.  Advise OTC pain relief. Pt received gabapentin 100mg taking 1-3 capsules at bedtime from doctor.
Body aches. Muscle pain. Headache. Fatigue. Nausea.
Information has been received from a physician concerning a 11 year old female with no pertinent medical history who on 12-SEP-2008 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (lot #660618/0572X).  There was no concomitant medication.  "Three months after administration of her first dose of GARDASIL", on 12-DEC-2008 the patient experienced weakness, sore throat, nausea, vomiting, diarrhea, paleness and abdominal pain.  "One month later", the patient's symptoms had not resolved and she was also experiencing chest pain, headaches, dizziness, swollen lymph nodes, chills and myalgia.  The patient had office visits.  "White blood cell differential count and white blood cell count" were normal.  "Four weeks ago", on approximately 12-DEC-2008, the patient was prescribed PRILOSEC.  At the time of the report, 09-JAN-2009, the patient had not recovered.  Follow-up information received on 12-JAN-2009 from the physician via medical records indicated that on 18-DEC-2008 the patient was taken to the physician's office for follow-up.  It was reported that the patient had a sore throat and abdominal pain which persisted one month.  The patient vomited for four times on 08-DEC-2008 (previously reported as 12-DEC-2008) and had a diarrhea "last week".  There was no blood.  The patient was treated with omeprazole, 2-3 times daily for 3 weeks.  At the time of the follow-up visit, the patient's abdominal pain worsened and she also had chest pain with deep breath, cough, headaches which happened "every day for one week" and cough.  Lab tests performed on 18-DEC-2008 included: giardia antigen was negative, stool culture revealed no salmonella, shigella or campylobacter SP. isolated, white blood cell count and white blood cell differential count were normal, Epstein-Barr viral capsid antigen immunoglobulin M antibody was negative, EBV capsid antigen immunoglobulin G antibody and nuclear antigen immunoglobulin G antibody were positive.  It was reported that the patient's mother was suspecting that her daughter's "recent medical troubles may be a side effect of GARDASIL".  Per mother, the patient also experienced "generally feeling unwell" and bad stomach ache.  The reporter considered the patient's adverse events to be disabling.  Additional information has been requested.  All available medical records will be provided upon request.  2/2/09 MR received from PCP from 9/12/08 to 12/18/08. Seen for 12 yr WCC 9/12/08 with normal exam.  ? DUB for 2 prolonged periods with recent menarche. Acne. Vax given.   OV 12/18/08 for c/o sore throat, diarrhea, chest pain, R sided neck pain, migraines, cough and abd pain x 1 month. 4 episodes of vomiting 12/5/08. PE (+) for epigastric, RLQ and LLQ discomfort. Assessment:  H/A.  Abd pain.  Hyperemesis. ? GER.  ? (unreadable) ? AGE.  Sent for labs.  Letter from parent  1/4/09 ? suspect HPV vax in symptomology as above in addition to nausea, dizziness, swollen glands, tiredness, weakness, chills, feeling unwell, aching muscles and bad stomach aches.
Dose #1 given 1/25/2021 Moderna lot # 004M20A Pt was i the ED 2/21/2023- due to fall, weakness, COVID +, made comfort care and died 2/22/2023 at hospital.
7 days p/vax pt devel rash;red papules 3 on face; 1 on lt arm 2 on rt arm & 1 on leg;no known exposure to varicella;
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact doses, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 03-NOV-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot number reported as L07560, expiration date: June 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
12 hours after shot, 102 degrees F fever, chills, weakness, stayed in bed all next day  The following day, I had severe pain in right scapular, feels like someone stuck a knife in me. Pain continued for 21 days, currently being treated for shingles.  Physician said I have rash on my back scapular. Pain radiates from scapular to underarm and back. Experiencing tingling sensation in lower arm and thumb, index and middle fingers.  Very painful.
w/in 24hr of vax pt exp hearing related sx in both ears;voices are heard @ two distinct pitches @ the same time-a nl pitch & a very low pitch;marked hearing loss;inability to recognize familiar voices;singing voices sound off key;
1/08/21 Strong chills at approximately 10PM night of vaccination 1/09/21 Bad headache upon waking the next morning (around 8AM) that lasted for approximately 1.5 hours 1/11/21 Mild redness, itching, and swelling on fingers. Did not realize this was due to vaccine initially. Swelling has gone down but mild symptoms persist as of today 1/22/21. Just went to the dermatologist where he suspected a reaction to the vaccine as symptoms appear consistent with "COVID toes". I have never had a reaction to a vaccine before or any allergic reactions
third full dose and not being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (third full dose and not being immunocompromised) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 9399) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Cartia 240 for Atrial fibrillation, SIMVASTATIN for Cholesterol, LEVOTHYROXINE for Hypothyroidism, APIXABAN (ELIQUIS) for an unknown indication.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (third full dose and not being immunocompromised). On 29-Oct-2021, ACCIDENTAL OVERDOSE (third full dose and not being immunocompromised) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that Lot number 9399.. (patient couldn't read the last two numbers) and patient was not immunocompromised and the pharmacist said that she gave a full dose for the third shot, and that this is the recommended dosage for older patients. No treatment medications were reported.    This case was linked to MOD-2021-369334 (Patient Link).
Patient complained of fatigue, but woke up the following morning and experienced very tight chest pains that lasted about 20 minutes but then went away. She did say her blood pressure was lower than her normal, and advised she check again to see if it re-regulated.
This child was "fussy all day", "felt hot", legs were sore, (no temp taken until 8 PM). At 8 PM, temp of 100, gave Tylenol, injection sites were "hard and hot" at 8 PM. At 10 PM, his temp was 103, he was taken to the hospital. At Midnight, his temp was 104.6 at the hospital, they gave him Motrin, 10 minutes later he had a seizure. He was hospitalized. 60 day follow up on 11/04/2003: "Vaccine recipient did recover from adverse event."
Tenderness, edema, fever s/p vaccination with TDAP. Lt upper arm. Swelling generalized. Erythema and warmth extended 2" diameter around injection site and extended medially down to middle of upper arm.
I got my period again only after 12 days. I?m usually 28+ days regular.
Patient reported that the night of receiving the shot, she experience severe "night sweats" along with a slight hand tremor.  She did not record her temperature. These symptoms mostly resolved by the morning after taking ibuprofen and persisted to a lower degree until full resolution 3 days later.
Dose administered in am 1/22/20.  That evening client reports muscle pain in upper left arm.  Applied rubbing alcohol to upper left arm.  In am 1/23 patient could not move left arm due to pain.1/24 Arm pain was improving, could move arm and sleep without disturbance.   1 am on 1/25 client awakened with itching and hives around neck and left upper arm.  At 4am, awakened with right sided facial swelling and itching and hives on left arm increased. No exposure to any irritants or medication.  Client did not take any medications to treat symptoms.  Reports mild dizziness while in waiting area immediately after receiving dose-resolved.  Denies oral itching., respiratory concerns, nausea, diarrhea, cough.   On 1/26 Injection site is pink, slightly swollen in a 1cm x 1cm region.  Client reports left upper arm, right cheek and right neck itch.  No hives visible.  Upper cheeks and lower periorbital area appear slightly swollen.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 66-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 23-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805422 was crossed linked to original case 201804863 due to same reporter.
I had a combination COVID-19 and flu vaccination at 8 pm on Friday. At 2 pm on Saturday, I had a stroke.
Get the flu shot / Prior to getting the flu/ Suspected Vaccination failure; flu; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 58-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) powder for injection for product used for unknown indication and mepolizumab autoinjector device administration system for product used for unknown indication.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season, Nucala 300 mg cyclically and mepolizumab autoinjector device. In November 2019, less than a year after receiving Influenza vaccine Quadrivalent 2019-2020 season and not applicable after starting Nucala and mepolizumab autoinjector device, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent 2019-2020 season. It was unknown if the reporter considered the influenza to be related to Nucala and mepolizumab autoinjector device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient received Nucala in February or March 2019, 300 miligram monthly injected at an infusion center and experienced flu in November 2019. The reporter stated that, the patient did get the Flu shot the stronger one for older patients, prior to getting the flu, which led to Vacciantion failure and influenza. The reporter consented to follow up. This case was considered as a suspected vaccination failure case as the time to onset and the lab test confirmation for influenza were unknown.
Had fever chills headache body aches on 3/31/21. Felt fine on 4/1/2021. Had a headache no problem. Got in shower. While in shower could not breathe. Got out took Pulse Ox. It was 88 and their was a rash at vaccine site. Was told to monitor pulse ox and use rescue inhaler as it was all I had to use. If got worse go to hospital.  It stayed under 90 till around noon. It went up to 94. By evening it was back up to 98.
pt recvd vax; fine rash started on chest & spread to stomach, buttocks;
died; This is a spontaneous report from a non-contactable consumer, this consumer report same events for 5 patients, this is the 3 of five report.   A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient died on an unspecified date.  It was not reported if an autopsy was performed. Reporter said they tried to say nurse didn't die, but she had an obituary so she clearly did die so that's just one, reporter had seen 4 self.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101524663 same reporter/product/event, different patient; Reported Cause(s) of Death: died
Terrible illness; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced malaise (serious criteria other: as per reporter). On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The case was reported by patient's daughter/ son. The age at vaccination was not reported. It was reported that the patient did get a flu shot  again for the 3rd year the patient got deathly ill. The patient's family told him din't get another flu shot.  The patient did not get any more flu shots and he never did get the flu again. This is 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR157706:same reporter US-GLAXOSMITHKLINE-US2020AMR165253:same reporter US-GLAXOSMITHKLINE-US2020AMR165254:same reporter
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies were not reported. On 18-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received form the same source. Additional information has been requested.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  It was reported that, the vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Patient was administered a dose of the monovalent COVID-19 vaccine after they were no longer authorized. Patient was contacted and specified she did not have any symptoms.