chrisvoncsefalvay/vaers-outcomes huggingface dataset:
THERE ARE A GOOD NUMBER OF VACCINATED PEOPLE WHO DID WIND UP IN THE HOSPITAL; This spontaneous report received from a consumer via a social media via a company representative concerned multiple patients of unspecified age, sex, race and ethnicity. No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported and have been requested. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, multiple patients experienced hospitalization for an unspecified number of days after taking vaccination. The reporter asked that why was it so hard to understand that there are a good number of vaccinated people who do wind up in the hospital. The reporter knew two of them, one of whom almost did not make it. The reporter mentioned that if knew two, how many are there? The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for the multiple patients with there are a good number of vaccinated people who did wind up in the hospital was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-  20211141181 covid-19 vaccine ad26.cov2.s- Good number of vaccinated people who did wind up in the hospital. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient came to the clinic on the 17 of August and got two shots, TDaP, and MENVEO. Shots was given on left deltoid. Pt came back on the 21 of August with a moderate reaction. The pt skin turned green and red. Pt said that he went to the ER and came back on 21 of August to follow up.
9/21/99: Immediate hives on face and trunk w/i 5 mins of administration of vax. Called dr office and child was taken to his office; hives had started to fade by the time the child left the clinic.
Dose 1 was taken on 28-Jan-2021 and Dose 2 was taken on 21-Feb-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was taken on 28-Jan-2021 and Dose 2 was taken on 21-Feb-2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for COVID-19 vaccination.     The patient previously had received a COVID-19 Vaccine.  The patient's past medical history included Kidney stones. Concurrent medical conditions included Blood pressure high and Drug allergy (unknown drug). Concomitant products included LOSARTAN for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was taken on 28-Jan-2021 and Dose 2 was taken on 21-Feb-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was taken on 28-Jan-2021 and Dose 2 was taken on 21-Feb-2021) outcome was unknown.            No concomitant medication information provided.  Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No treatment information provided.   This case was linked to MOD-2022-582729 (Patient Link).
Injection site reaction- redness, itching pain, swelling in about a 1 1/2 inch round area around site on Rt ARM will apply hydrocortisone.
Hives, facial edema, coughing. Pulse Ox 94%, BP 103/62. Pt. given BENADRYL in office and observed for 1 hour. Facial edema, cough, hives improved. Pulse Ox 98%, BP 92/58.
Nauseous; Vomiting; Severe headache; Fever; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 2nd dose of Shingrix. On 19th September 2019, less than a day after receiving Shingrix, the patient experienced nausea, vomiting, headache and fever. On an unknown date, the outcome of the nausea, vomiting and fever were resolved with sequelae and the outcome of the headache was recovering/resolving.   It was unknown if the reporter considered the nausea, vomiting, headache and fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. At 11:00 AM, the patient received a dose of Shingrix. During the day the patient started to feel nauseous. By night time she was vomiting and had a severe headache and a fever.   At the time of report, the patient was in bed due to the headache. The reporter consented to follow up.
C/o-swelling and warmth from left deltoid to elbow. Temp 99.9
Information has been received from a legal firm regarding a case in litigation concerning a male child who was exposed to thimerosal beginning in or about 1/93 up through and including 8/98 and every time he received a multi-dose vaccine. It is alleged that as a result of the vaccines containing thimerosal, the pt sustained severe and permanent personal injuries, including being dx'd with severe autism and other neurological disorders. It is also alleged that the pt sustained further neurological insult from other vaccines, including MMRII which does not contain thimerosal but caused further neurological insult and exacerbated the neurological disorders from the prior thimerosal exposure. Upon internal review, autism, neurological disorders, exacerbation of neurological disorders and permanent personal injuries were considered to be "Other Important Medical Events". Additional information has been requested.  Reported on 03/26/2003: "Information has been received from a physician concerning a male patient with a cerebral infarction, a spinal cord disease (unspecified) and a history of a pneumonia and hernia operation who on 07/26/2002 was vaccinated with a 0.5mL dose of pneumococcal vaccine 23 polyvalent.  Secondary suspect therapy included carbamazepine 400mg (therapy dates not specified).  On 07/27/2002, the patient developed Guillain Barre syndrome and Miller Fisher syndrome.  In early August 2002, the patient developed a gait inability and was hospitalized.  On 08/06/2002, gamma globulin therapy was started.  The patient also developed nystagmus (onset date not specified).  On 08/09/2002, the patient recovered from the Guillain Barre Synderome, Miller Fisher syndrome and nystagmus.  The reporting physician felt that the Guillain Barre syndrome, Miller fisher syndrome and nystagmus were not related to pneumococcal vaccine 23 polyvalent vaccine, but strongly suspected that carbamazepine therapy had causality with the events.  Other business partner's numbers include NU0122.  Additional information is not expected.
sharp/pinching pain left sternum intermittently after vaccine 1 every 5-10 seconds over 5 minutes  ceased by the time patient escorted to obs. vitals checked patient sitting at side of strretcher   instrcuted if pinching/pain returns  persiss  seek further eval to ER or treatment facility   escorted to exit with  without difficulty at 1215  vs 1155 bp 151/87 hr 74 rr 18 o2 100  1205 bp 152/90 hr 70 rr 18 o2 99
Firm raised red lump at injection site. Rash developed over the next 2 weeks as a cluster of bumps with surrounding redness.  At 1 month after shot, there is still a remaining scar.
Patient with sudden onset of heart racing and flush skin.  It lasted 3-5 minutes.  BP 122/84, P-76, R 18.  Patient denies any SOB or difficulty breathing.  He states, "I think it anxiety."  Advised patient to remain in facility an additional 15 minutes after symptoms subsided.
The first time I had the vaccine in August I don't recall any side effects other than a slight soreness in my arm at the injection site.  However, this time I got quite ill to the point I stayed in bed from about 3 hours after the shot till about 36 hours later.  I felt weak, achy and had a low grade fever 99.7.  I had no energy - all I could do was sleep. I had the shot on Wednesday at 3:00, and started feeling ill about 3 hours later.  I recovered or felt like myself on Jan 1st.  The only effect as of today is the sore arm if touched.
Subject started with Anthrax vaccine Jan-Feb 2000 and has several shots since (latest being 8/16/03). By Oct03, subject had developed six nodules on his body, including his back.
Pfizer-BioNTech COVID-19 Vaccine EUA  NEW diagnosis and  onset of Type II Diabetes Mellitus,  symptoms started approximately 10-14 days after 2nd vaccination. Ongoing problem, started on Metformin.
We have a record that shows patient had VARIVAX in 2002. Came to our office 3 days w/a rash & dx with Ch Pox.
At around midnight of 6/19/2021 I started having contractions about 7 minutes apart and I was only 30 weeks and 5 days pregnant. After several hours of this I called the advice line of my OB and I went to the hospital per their advice. I was able to drive myself to the hospital and arrived around 7AM and they put me on a magnesium drip and gave me a steroid to help the baby's lungs to develop in the event that they were unable to stop the labor. They did a test on me for the hormone you release when in labor and it came back negative so they kept me on the magnesium drip and then another steroid 24hrs later. The hospital released me on 6/20/21 around noon, my contractions were still coming sporadically and mild and by 10PM that night they returned to about 7 minutes apart and they started speeding up around 11PM. I went to the hospital around 6AM on 6/21/21 and they checked me I was 5CM dilated and was 90% effaced and I was bleeding, the baby was in distress and not responding well. The DRs did an emergency C-section and she was delivered at 7:13AM on 6/21/21, she was fine, she was 6 weeks and one day and was 5 LBS 2ounces. But I guess that is about it. It was not my baby genetically, I was a surrogate and the pregnancy was IVF, so during all that process the parents were contacted and flew down. My DR when I asked her, she did not know why it happened. My son was born full term and I was induced for his pregnancy, he was born 2/1/2019. This child was estimated to be due 8/1/2021.
The dose was administered after the BUD date. Moderna did a lot test and showed that the dose received was safe and effective.
This spontaneous report as received from a registered pharmacist refers to a male patient of unknown age with no drug reactions or allergies. On 05-NOV-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J006887 exp 04-MAR-2015) intramuscularly. There was no concomitant medication. The pharmacist reported that on 05-NOV-2014, the patient experienced warmth in his whole right arm and it was very firm and hard as a rock. The patient experienced discomfort, soreness and redness in the entire right arm. The patient received treatment for the adverse events. At the time of the report, the patient was recovering. Additional information is not expected. There is no contact information.
fever; Vaccination site swelling; Vaccination site Pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site Pain) 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 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site Pain). On an unknown date, the patient experienced PYREXIA (fever) and VACCINATION SITE SWELLING (Vaccination site swelling). On 27-Mar-2021, VACCINATION SITE PAIN (Vaccination site Pain) had resolved. At the time of the report, PYREXIA (fever) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-065263 (Patient Link).
Rash/swelling/redness/hot to touch/sluggish for 2 days. Taken to urgent care for observation on 11/8 and was given Predisone and bendryl and facility and Rx for Cethalexin (if needed).
48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.  The caller said that need to look in another system to determine if the patient's received the doses in the left or right arm and if this was their first, second or booster doses. This is a case of Expired Product Administered concerning a 67-year-old female patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Expired Product Administered concerning a 67-year-old female patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 15-OCT-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection, one shot (lot number: M005286; expiration date: 08-OCT-2017) for prophylaxis. The primary reporter denied any adverse effect with the patient.
supposed to receive an injection of Bexsero and instead received Menveo; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: supposed to receive an injection of Bexsero and instead received Menveo).  The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date: 24-AUG-2023 The health care professional (HCP) was the reporter.   No further information was known The Bexsero was with lot 25db5 and expiry 31st July 2023. The patient was supposed to received an injection of Bexsero and instead received Menveo, which led to wrong vaccine administered. The reporter consented to follow up.
Patient began to experience sore arm and notice a bruise forming above the injection site with band-aid still on the arm the day after. Bruise was larger than quarter size and bright red when presented at the pharmacy on 09/13/2019 at 1pm. Patient will see primary care provider if bruise or symptoms worsen.
Information has been received from a pharmacist concerning a male pt with arthritis who on approximately 23OCT2003 was vaccinated IM with a 0.5ml second dose of pneumococcal 23v polysaccharide vaccine. On 23OCT2003 the pt developed a swollen and sore are and a fever >102F. No diagnostic lab tests were performed. Unspecified medical attention was sought and no prescription drug was required. It was also reported that in 1998, 5 years ago the pt had received a first dose of pneumococcal 23v polysaccharide vaccine. No product quality complaint was involved. Additional information has been requested.
Chest Pain, Pain in left shoulder, left back, left armpit, headache. Lasted approximately 2 days
Patient was given Flumist at the age of 65. Not recommended to be given over the age of 49.
Patient had swelling in Jaw area. Pharmacist advised taking BENADRYL and Ibuprofen and patient called back the next day saying it was better but not completely gone.
2 cm round red warm raised area. Rx TYLENOL or ibuprofen ATC w/ice to site.
Severe diarrhea and destruction of part of her intestine and subsequent sepsis.  ER doctors "could not rule out the vaccine as a contributing factor."   It was suggested she have a portion of her intestines removed.  She refused and  went on a high dose of antibiotics.  She was hospitalized in the ICU and eventually released to a nursing home when stabilized.  She never regained control of her bowels or had a solid bowel movement.  Her antibiotics were reduced and she again suffered severe abdominal pain and a distended abdomen and return of sepsis.  She went back to ER and was told this would keep happening if she did not have the damaged portion of her intestine removed.  She elected to go home on hospice, where she died.  Her kidney doctor also relayed  to her family that this reaction was a direct result of the vaccine.  When the family questioned reporting this event, every healthcare provider backed off from admitting it was a result of the vaccine or stated they were not the primary physician and thus was not for them to report.
At about 11:00 at night on the day of the vaccine started to get body chills and shaking, teeth chattering, as well as headache.  A few hours later she did throw up. Continue to stay nauseated.  The shaking chills lasted until about 8:00 AM the following morning, and still has them off and on with shaking.  She did throw up again on the 2nd day, but still nauseated and continues with the headache.   The first day was nothing but chills.  The next day had intermittent chills to soaking sweats to chills up until last night 2/25/21.  She took Tylenol for the symptoms.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 31-MAY-2017, the patient was vaccinated with a dose of improperly stored VAQTA lot # N005274 with an expiration date of 03-APR-2018, intramuscularly, in the right arm (exact dose was not provided) and a dose of RECOMBIVAX HB lot # M035487 with an expiration date of 23-FEB-2019, intramuscularly, in the right arm (exact dose was not provided). Administered doses of vaccines underwent a temperature excursion of 35 degrees Fahrenheit (F) for 50 minutes which was detected by a digital data logger. There was a previous excursion reported of 33 F for 4 hours. No adverse event occurred. No product quality (PQC) complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004575:
Case number PHEH2015US026916, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 44-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 23 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The nurse stated that, the reason was unknown for the refrigerator to be out of temperature range. There was not any further problem since the temperature excursion problem. No further information provided. No adverse reaction was experienced by the patient following the medication error. Follow up report received from nurse on 26 Jan 2016: Updated reporters comments.
Fever 102 Severe body aches Tiredness Anorexia Nausea and vomiting  Severe headache Dizziness Left arm numbness
Pt developed itching all over. No SOB, or difficulty swallowing. Had similar reaction with first vaccine, that resolved with Benadryl previously. Pt given option of PO or IV Benadryl, opted for PO Benadryl, and was observed for an additional 30 minutes for symptom resolution
Nausea; Vomiting; Fever; Chills; Muscle aches; Extreme fatigue; Swelling; Red circle rash; Pain at injection site; This is a spontaneous report from a contactable consumer (patient) received via the Regulatory Authority. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 03Mar2021 at 15:00 (Batch/Lot Number: EN6199) (at the age of 28-years-old) as dose 2, single for COVID-19 immunisation. Medical history included bipolar 2; depression; anxiety; obesity. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included alprazolam (XANAX); zolpidem tartrate (AMBIEN); lamotrigine (LAMICTAL ER); venlafaxine hydrochloride (VENLAFAXINE XR); cetirizine hydrochloride (ZYRTEC); all taken for an unspecified indication, start and stop dates were not reported. The patient previously took codeine and experienced drug allergy; first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in left arm on 09Feb2021 at 11:45 (Batch/Lot Number: EN9581)  (at the age of 28-years-old) for COVID-19 immunisation and experienced fever, chills, and  pain at injection site. The patient did not receive any other vaccines 4 weeks prior to COVID-19 vaccine. The patient experienced extreme fatigue on 03Mar2021, night of second dose; nausea, vomiting, fever, chills and muscle aches on 04Mar2021 at 15:00 day after second dose; swelling, red circle rash and pain at injection site on an unspecified date in Mar2021, for 4 days following second dose. The patient underwent laboratory tests which included Saliva rt pcr: negative on 05Mar2021. The patient received Ibuprofen for the events. The adverse events resulted to none. The events were assessed as non-serious. The outcome of events extreme fatigue, nausea, vomiting, fever, chills and muscle aches was recovering; while outcome of events swelling, red circle rash and pain at injection site was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected
C/o redness and swollen at left arm where patient received. No pain, no fever.
Donor reported flu-like symptoms (H/A, N, runny nose, sore throat, aching arm) the evening after receiving Tet. immunization. Symptoms lasted approximately 24 hours (no difficulty swallowing/breathing).