chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; chills; muscle pain; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 17Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: unknown), administration date: 27Mar2021, for covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset Apr2021, outcome "unknown", described as "nausea"; CHILLS (non-serious) with onset Apr2021, outcome "unknown", described as "chills"; MYALGIA (non-serious) with onset Apr2021, outcome "unknown", described as "muscle pain".  Additional information: Caller was calling on behalf of his wife who got and finished the 2 doses of the vaccine yesterday 17Apr2021. They were aware of the side effects, and he stated that she had this like nausea, chills, and muscle pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a pharmacist referring to a 70 year old female patient who was enrolled in a market research (titled as ZOSTAVAX HCP Competitive message testing). The patient's medical history and concurrent condition were not reported. On an unknown date of 2008, the patient was vaccinated with one single of ZOSTAVAX, subcutaneous (dose, strength, dose number and lot# were not reported). Information regarding concomitant medication was not reported. On an unspecified date of 2008 the patient experienced swelling at injection site. The outcome of the event was reported as recovered on an unknown date of 2008. The reporter considered the event to be non-serious and related to ZOSTAVAX. Additional information is not expected as the reporter refused to be contacted.
This non-valid spontaneous report as received from nurse refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. From 08-NOV-2017 to 14-NOV-2017, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # N017686, expiration date: 02-FEB-2020, dose, schedule, route of administration were not reported) and PEDVAXHIB (lot # N012120, expiration date:01/30/2020, dose, schedule, route of administration were not reported) both for prophylaxis. Reporter stated that on unknown date, the vaccines were stored between 9 degrees Celsius to 25 degrees Celsius for 5 minutes. There were no previous temperature excursions. The digital data logger was involved. The patients did not experienced any adverse events. Product quality complaint was not involved.
Information has been received from a certified medical assistant concerning a 15 year old female, who on 28-Dec-2006 was vaccinated IM with a 0.5 ml dose of Zostavax vaccine (lot#654603/1405F) instead of Gardasil vaccine (yeast). It was reported that this was a case of staff error, not product confusion. The administering medical assistant said that she thought the Gardasil vaccine (yeast) was stored frozen and she just grabbed the vaccine, which was Zostavax vaccine (lot#654603/1405F), from the freezer and gave that to the patient. No symptoms were noted. Unspecified medical attention was sought. There was no product complaint involved. No further information was provided. Additional information has been requested.
given Hiberix reconstituted with sterile water; given Hiberix reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 594CF, expiry date 13th July 2022) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. A nurse reported that, it was possible that, the patient was given Hiberix that might have been incorrectly reconstituted with sterile water instead of saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Healthcare professional did not have specific patient information or dates administered at the time of report.  The healthcare professional stated that, the specific lot was administered over a range of a couple of months.  The reporter consented to follow up. This was 1 of 9 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022022662:Same reporter US-GLAXOSMITHKLINE-US2022AMR024234:Same reporter US-GLAXOSMITHKLINE-US2022AMR024236:Same reporter US-GLAXOSMITHKLINE-US2022AMR024237:Same reporter US-GLAXOSMITHKLINE-US2022AMR024238:Same reporter US-GLAXOSMITHKLINE-US2022AMR024239:Same reporter US-GLAXOSMITHKLINE-US2022AMR024240:Same reporter US-GLAXOSMITHKLINE-US2022AMR024241:Same reporter
Within 25 minutes of the injection in my left arm, my lips, tongue, gums, skin around eyes, and forehead were very itchy. No swelling occurred. Symptoms subsided within an hour. This did not occur with the first or second doses of the Pfizer vaccine (taken in March/April 2021). Nor did this reaction occur with the 2021 flu vaccine or tetanus vaccine (both were given in September 2021).
Patient received a BOOSTRIX 12/5/14. Had received an ADACEL 10/12/2010.
Injection site redness; Injection site  welt; Injection site hot to touch; Injection site raised; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 17-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number Z7275, expiry date 31st August 2021) for prophylaxis.   Concurrent medical conditions included eosinophilic esophagitis and celiac disease.   On 16th September 2020, the patient received Fluarix Quadrivalent 2020-2021 season. On 18th September 2020, 2 days after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced injection site erythema, injection site wheal, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site wheal, injection site warmth and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site wheal, injection site warmth and injection site swelling to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were as follows: After receiving dose of Fluarix Quadrivalent 2020-2021 season, the patient experienced injection site reactions redness, a welt, hot to touch and raised. The reporter was the patient's mother. The patient received the vaccine on Wednesday and on Friday the injection site reactions presented and progressed. The reporter consented to follow up.
Blurriness in left eye, rapid increase in eye pressure,  damaged optic nerves,  diagnosed with glaucoma,        all occurred within six months of the vaccines.
Extreme joint pain. Chills with violent shivering, constant runny nose. Trouble with balance.  The previous 4 vaccines I received (2 Moderna original, 1 Moderna booster and 1 Pfizer booster) presented absolutely no problem for me.
She got her vaccine, had injection site pain starting at 12:30 AM. Her wrist hurt alot but was not concerned about that. She woke up at 12:30 with right leg cramping like a Charley horse from her hip to her foot and could not release it. It was very, very tight and in a spasm. That lasted many hours. She went back to bed, and when she woke up again around 5:30 or 6:00 her leg was still somewhat cramped, but her calves were completely twitching and tiny muscle spasms, and she would say hundreds to thousands of them going off all the time, tiny muscle spasms. Since then she has been left with this problem in her calves specifically, but also all over her entire body including her cheeks, thighs, stomach, buttocks all day every day. It seems to lessen at times, but comes back, worse at rest and did not have any issues like this before the vaccine. It is mainly generalized in her calves. She has seen a doctor and her doctor did not give her anything to treat the condition.  She has just been dealing with it on her own pretty much.
When vaccination was being entered into database, it was noticed that the child had just received an H1N1 vaccination onn 12/14/2009.
developed a bump on his left clavicle between his shoulder and neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A male patient received BNT162b2 (COMIRNATY), on 05Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "aorta vein was cut ", start date: 2002 (unspecified if ongoing), notes: had to be repaired and patched with Teflon. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (First booster dose, unknown manufacturer), for COVID-19 Immunization. The following information was reported: BONE DISORDER (non-serious), outcome "unknown", described as "developed a bump on his left clavicle between his shoulder and neck".  Additional information: Seriousness was reported as No. Caller in regards to the Pfizer BIONTECH COVID 19 vaccine. Reports he got his 4th shot last Friday the 5th 05AUG2022 and has developed a bump on his left clavicle between his shoulder and neck. Caller states he got the shot in his left arm. He concerned because he has history back in 2002 in a accident his aorta vein was cut and had to be repaired and patched with teflon, concerned about the bump and seeking information. Is there any information about the bump, has this been reported before?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1 month after recv vax pt devel cough, congestion, elevation of wbc & lymphocyte counts & intolerance to feeding.  pt has been afebrile.
This case was reported by a nurse and described a 59 year old male patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  On an unspecified date in 2002 or 2003, the patient received the third dose of Engerix-B.  Approximately 6 to 12 weeks later a hepatitis B surface antibody titer was negative.  The nurse stated that, "All injections were given intramuscularly in the deltoid muscle with a 1 inch needle.  The nurse considered the event to be probably related to vaccination with Engerix-B.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old female patient who received SHINGRIX for prophylaxis. On 4th February 2019, the patient received the 2nd dose of SHINGRIX. On 5th February 2019, 1 days after receiving SHINGRIX, the patient experienced fever. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The patient got her 2nd shot of the SHINGRIX, a day before the date of reporting. In the morning of the date of reporting, the patient woke up with a fever of 102-degree F. The reporter wanted to know if that was normal and that 102-degree F was not a bit high. The reporter was provided with the link for the package insert or prescribing information (PI) for the product. The reporter saw that fever was one of the side effects and was just wondering if 102-degree F was pretty high. The reporter did give the patient some TYLENOL, in the morning. The reporter asked should the patient go to see the physician and the reporter was referred to health care provider as primary resource for the patient care. The reporter would check with health care provider and would read the PI information also.
Initial report received from a local newspaper via Novartis employee on 14 Jun 2010: This child patient was vaccinated with influenza virus vaccine (manufacturer unknown) on an unknown date. After vaccination, the patient presented with mild respiratory episode and got infected with H1N1 virus. A pediatrician commented that the patient was not hospitalized due to the events. The time interval between respiratory distress and vaccination was reported as less than 15 days. However, no therapy and event onset dates were specified. The child was healthy and at home at the time of this report. Two cases of same events were reported in the newspaper (see companion case PHHY2010AR39547).
At about 09:20 am, client complained of  feeling lightheaded and dizzy but stated "I'm ok". Several minutes later client continued to feel lightheaded and dizzy. Did not know if it was "anxiety". Vital signs were take and water given. Monitored until symptoms were resolved.
Muscle aches advancing to extreme muscle and joint pain; migraine headache; chills and fever (2.5 degrees above my normal); fatigue; injection site swelling and redness, mild nausea lasting about 24 hours.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient fainted while sitting in chair after immunization. Recovered within 1 minute.
As soon as injection was given, he began to have seizure like activity as reported by RN that administered the injection. He urinated on himself. Seizure like activity lasted an estimated 2-3 min. then he was awake alert and oriented.
Patient screened for first dose of Pfizer vaccine. He checked no history of allergies or reactions to medications or vaccines. In the initial screening he informed me he had a phobia of needles but this is usually with blood draws. He reported he should be fine with vaccinations. I inquired on previous reactions and he denied any allergic reaction just that he does not like them. I asked him how I can help give the vaccine. We had him look away and to think of a different situation. I asked him if he would like to know when I am administering or just use distraction. He chose to be informed when he would feel a slight poke. Vaccine was administered with no issues.  Within the minute following the vaccine patient started to feel dizzy. Hung his head a bit but was responsive. I requested staff assistance to help the situation including RN to prevent any episodes of syncope.  We provided water which he was able to drink. He was still seated and we suggested putting head between legs. This was not comfortable for him so we moved him to the floor. About 3-4 min in he began to sweat a bit more and appeared Pale. We obtained a BP and pulse. BP was 112/60 and pulse around 60.  When he felt hot, sweaty and appeared pale we all decided to call EMS to be cautious. He maintained BP, no SOB, did not lose conscious. EMS evaluated him, med list provided and vitals. He was on medications for anxiety.  They released him after about 30min and reported a panic attack and not related to the vaccine.  Patient walked out of the clinic with his partner and was stable. He is requesting 2nd dose of the vaccine. I informed him nurse would review and would have a plan for future injection.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 03-APR-2015, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 01-MAR-2016, the patient was treated at a medical center for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
cancer; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer was recovered/resolved.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A patient received the 1st dose of Shingrix about a year ago and was later diagnosed with cancer. She was cancer -free now and would like to get the 2nd dose. The pharmacist did not have any of the patient demographic information at the time of report.
Regular Migraine Headache B/P 150/110, HR 60, O2Sat 95% Pt. left at 9:10am stat that he was feeling better, refused second B/P saying that , "It's okay."
Information has been received from a healthcare worker concerning a male patient who sometime between 26-OCT-2007 and 03-DEC-2007, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 658555/0964U). Subsequently, within 24 hours of receiving the vaccine, the patient experienced localized reaction around the injection site, pain and swelling. The patient also experienced flu-like symptoms of fever and abdominal pain for 72 hours. Blood work was done but results were not reported. The patient was seen in the office for unspecified medical attention. Subsequently, on an unspecified date, the patient recovered. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2021 at 14:00 as dose 1, single (Lot number: EL3249), in right arm, on 04Feb2021 at 14:00 as dose 2, single (Lot number: EL3302), in right arm, on 05Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FF2590), in right arm and on 27Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FM0173) at the age of 64 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LIPITOR oral, start date: 02Mar2015, stop date: 06Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with oral, Paxlovid from 06Aug2022 to 11Aug2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
Pt with report of swollen lymph node around left clavicle within 24 hours of vaccines.  Painful, unable to move arm, visible lump
I had progressive dyspnea beginning 4-6 months after first vaccine.    My nightly 2 mile walk became more difficult and I could barely manage one mile.  Symptoms progressed until I was found to have an oxygen saturation of 83% during a stress test in July of 2022.  Diagnosed with CTEPH, with a large saddle embolus.  I am very thin - 6 ft tall, 160 pounds -- no source for embolus ever found.   I was on oxygen and sent to hospital for pulmonary endarterectomy of my segmental and subsegmental pulmonary vessels -- hypothermic cardiac arrest and open-heart surgery.   Doing much better now, off oxygen and improving hemodynamics.   All tests show normal clotting function;  I'm now on coumadin for life.
Placed in the fridge on 11-Jan-2022 and administered on 16-Feb-2022; patient was administered expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Placed in the fridge on 11-Jan-2022 and administered on 16-Feb-2022) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 034A21A and 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered expired moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Placed in the fridge on 11-Jan-2022 and administered on 16-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Placed in the fridge on 11-Jan-2022 and administered on 16-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  The reporter stated that they initially called on 12-May-2022 and reported a total of 18 patients received expired doses after the 30 days Use by Date. On 17-May-2022, the reporter reported after doing further research, that the actual total number of patients that received expired doses after the 30 days use by date was 82 patients total and not 18 patients. The date the vial initially stored in the refrigerator was 11-Jan-2022 which meant that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA. Reportedly, the vial didn't undergo any temperature excursions. On 16-Feb-2022, patient took first booster.   The patient had not reported adverse reaction to the reporter's knowledge.  No treatment information was provided.
Headache Nausea  Body aches  All started 8 hours after dose and persisting 18 hours later
CHILLS; FEVER; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 at 10:00 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested.  On 06-MAR-2021, the patient experienced chills and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and fever was not reported. This report was non-serious.
Hot Ness in face,  swollen glands under arms, my arm is killing me like no strength still,  I honestly think it's causing me to feel like I'm heating up in my face